Clinical Guidelines Hub only

Allowed Publications
LayerRx Mapping ID
605
Slot System
Featured Buckets
Featured Buckets Admin

Impact of Multisite Patient Education on Pharmacotherapy for Veterans With Alcohol Use Disorder

Article Type
Changed
Thu, 09/04/2025 - 13:40
Display Headline

Impact of Multisite Patient Education on Pharmacotherapy for Veterans With Alcohol Use Disorder

Excessive alcohol use is one of the leading preventable causes of death in the United States, responsible for about 178,000 deaths annually and an average of 488 daily deaths in 2020 and 2021.1Alcohol-related deaths increased by 49% between 2006 and 2019.2 This trend continued during the COVID-19 pandemic, with death certificates that listed alcohol increasing by > 25% from 2019 to 2020, and another 10% in 2021.3 This increase of alcohol-related deaths includes those as a direct result of chronic alcohol use, such as alcoholic cardiomyopathy, alcoholic hepatitis and cirrhosis, and alcohol-induced pancreatitis, as well as a result of acute use such as alcohol poisoning, suicide by exposure to alcohol, and alcohol-impaired driving fatalities.4

Excessive alcohol consumption poses other serious risks, including cases when intake is abruptly reduced without proper management. Alcohol withdrawal syndrome (AWS) can vary in severity, with potentially life-threatening complications such as hallucinations, seizures, and delirium tremens.5

These risks highlight the importance of professional intervention and support, not only to mitigate risks associated with AWS, but provide a pathway towards recovery from alcohol use disorder (AUD).

According to the 2022 National Survey on Drug Use and Health, 28.8 million US adults had AUD in the prior year, yet only 7.6% of these individuals received treatment and an even smaller group (2.2%) received medication-assisted treatment for alcohol.6,7 This is despite American Psychiatric Association guidelines for the pharmacological treatment of patients with AUD, including the use of naltrexone, acamprosate, disulfiram, topiramate, or gabapentin, depending on therapy goals, past medication trials, medication contraindications, and patient preference.8 Several of these medications are approved by the US Food and Drug Administration (FDA) for the treatment of AUD and have support for effectiveness from randomized controlled trials and meta-analyses.9-11

Clinical practice guidelines for the management of substance use disorders (SUDs) from the US Department of Veterans Affairs (VA) and US Department of Defense have strong recommendations for naltrexone and topiramate as first-line pharmacotherapies for moderate to severe AUD. Acamprosate and disulfiram are weak recommendations as alternative options. Gabapentin is a weak recommendation for cases where first-line treatments are contraindicated or ineffective. The guidelines emphasize the importance of a comprehensive approach to AUD treatment, including psychosocial interventions in addition to pharmacotherapy.12

A 2023 national survey found veterans reported higher alcohol consumption than nonveterans.13 At the end of fiscal year 2023, > 4.4 million veterans—6% of Veterans Health Administration patients—had been diagnosed with AUD.14 However, > 87% of these patients nationally, and 88% of Veterans Integrated Service Network (VISN) 21 patients, were not receiving naltrexone, acamprosate, disulfiram, or topiramate as part of their treatment. The VA Academic Detailing Service (ADS) now includes AUD pharmacotherapy as a campaign focus, highlighting its importance. The ADS is a pharmacy educational outreach program that uses unbiased clinical guidelines to promote aligning prescribing behavior with best practices. Academic detailing methods include speaking with health care practitioners (HCPs), and direct-to-consumer (DTC) patient education.

ADS campaigns include DTC educational handouts. Past ADS projects and research using DTC have demonstrated a significant improvement in outcomes and positively influencing patients’ pharmacotherapy treatment. 15,16 A VA quality improvement project found a positive correlation between the initiation of AUD pharmacotherapy and engagement with mental health care following the distribution of AUD DTC patient education. 17 This project aimed to apply the same principles of prior research to explore the use of DTC across multiple facilities within VISN 21 to increase AUD pharmacotherapy. VISN 21 includes VA facilities and clinics across the Pacific Islands, Nevada, and California and serves about 350,000 veterans.

METHODS

A prospective cohort of VISN 21 veterans with or at high risk for AUD was identified using the VA ADS AUD Dashboard. The cohort included those not on acamprosate, disulfiram, naltrexone, topiramate, or gabapentin for treatment of AUD and had an elevated Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score of ≥ 6 (high risk) with an AUD diagnosis or ≥ 8 (severe risk) without a diagnosis. The AUDIT-C scores used in the dashboard are supported by the VA AUD clinician guide as the minimum scores when AUD pharmacotherapy should be offered to patients.18 Prescriptions filled outside the VA were not included in this dashboard.

Data and patient information were collected using the VA Corporate Data Warehouse. To be eligible, veterans needed a valid mailing address within the VISN 21 region and a primary care, mental health, or SUD clinician prescriber visit scheduled between October 1, 2023, and January 31, 2024. Veterans were excluded if they were in hospice, had a 1-year mortality risk score > 50% based on their Care Assessment Need (CAN) score, or facility leadership opted out of project involvement. Patients with both severe renal and hepatic impairments were excluded because they were ineligible for AUD pharmacotherapy. However, veterans with either renal or hepatic impairment (but not both) were included, as they could be potential candidates for ≥ 1 AUD pharmacotherapy option.

Initial correspondence with facilities was initiated through local academic detailers. A local champion was identified for the 1 facility without an academic detailer. Facilities could opt in or out of the project. Approval was provided by the local pharmacy and therapeutics committee, pharmacy, primary care, or psychiatry leadership. Approval process and clinician involvement varied by site.

Education

The selected AUD patient education was designed and approved by the national VA ADS (eappendix). The DTC patient education provided general knowledge about alcohol, including what constitutes a standard amount of alcohol, what is considered heavy drinking, risks of heavy drinking, creating a plan with a clinician to reduce and manage withdrawal symptoms, and additional resources. The DTC was accompanied by a cover letter that included a local facility contact number.

A centralized mailing facility was used for all materials. VA Northern California Health Care System provided the funding to cover the cost of postage. The list of veterans to be contacted was updated on a rolling basis and DTC education was mailed 2 weeks prior to their scheduled prescriber visit.

The eligible cohort of 1260 veterans received DTC education. A comparator group of 2048 veterans that did not receive DTC education was obtained retrospectively by using the same inclusion and exclusion criteria with a scheduled primary care, mental health, or SUD HCP visit from October 1, 2022, to January 31, 2023. The outcomes assessed were within 30 days of the scheduled visit, with the primary outcome as the initiation of AUD-related pharmacotherapy and the secondary outcome as the placement of a consultation for mental health or SUD services. Any consultations sent to Behavioral Health, Addiction, Mental Health, Psychiatric, and SUD services following the HCP visit, within the specified time frame, were used for the secondary outcome.

Matching and Analysis

A 1-to-1 nearest neighbor propensity score (PS) matching without replacement was used to pair the 1260 veterans from the intervention group with similarly scored comparator group veterans for a PS-matched final dataset of 2520 veterans. The PS model was a multivariate logistic regression with the outcome being exposure and comparator group status. Baseline characteristics used in the PS model were age, birth sex, race, facility of care, baseline AUDIT-C score, and days between project start and scheduled appointment. Covariate imbalance for the PS-matched sample was assessed to ensure the standardized mean difference for all covariates fell under a 0.1 threshold (Figure).19

0525FED-eAUD-F1

A frequency table was provided to compare the discrete distributions of the baseline characteristics in the intervention and comparator groups. Logistic regression analysis was performed to evaluate the association between DTC education exposure and pharmacotherapy initiation, while controlling for potential confounders. Univariate and multivariate P value results for each variable included in the model were reported along with the multivariate odds ratios (ORs) and their associated 95% CIs. Logistic regression analyses were run for both outcomes. Each model included the exposure and comparator group status as well as the baseline characteristics included in the PS model. Statistical significance was set at P < .05. All statistical analyses were performed with R version 4.2.1.

RESULTS

Two of 7 VISN 21 sites did not participate, and 3 had restrictions on participation. DTC education was mailed about 2 weeks prior to scheduled visit for 1260 veterans; 53.6% identified as White, 37.6% were aged 41 to 60 years, and 79.2% had an AUDIT-C ≥ 8 (Table 1). Of those mailed education, there were 173 no-show appointments (13.7%). Thirty-two veterans (2.5%) in the DTC group and 33 veterans (2.6%) in the comparator group received an AUD-related pharmacotherapy prescription (P = .88) (Table 2). One hundred seventy-one veterans (13.6%) in the DTC group and 160 veterans (12.7%) in the comparator group had a consult placed for mental health or SUD services within 30 days of their appointment (P = .59) (Table 3).

0525FED-eAUD-T10525FED-eAUD-T20525FED-eAUD-T3

DISCUSSION

This project did not yield statistically significant differences in either the primary or secondary outcomes within the 30-day follow-up window and found limited impact from the DTC educational outreach to veterans. The percentage of veterans that received AUD-related pharmacotherapy or consultations for mental health or SUD services was similarly low in the DTC and comparator groups. These findings suggest that although DTC education may raise awareness, it may not be sufficient on its own to drive changes in prescribing behavior or referral patterns without system-level support.

Addiction is a complex disease faced with stigma and requiring readiness by both the HCP and patient to move forward in support and treatment. The consequences of stigma can be severe: the more stigma perceived by a person with AUD, the less likely they are to seek treatment.20 Stigma may exist even within HCPs and may lead to compromised care including shortened visits, less engagement, and less empathy.19 Cultural attitude towards alcohol use and intoxication can also be influenced through a wide range of sources including social media, movies, music, and television. Studies have shown targeted alcohol marketing may result in the development of positive beliefs about drinking and expand environments where alcohol use is socially acceptable and encouraged.21 These factors can impact drinking behavior, including the onset of drinking, binge drinking, and increased alcohol consumption.22

Three VISN 21 sites in this study had restrictions on or excluded primary care from participation. Leadership at some of these facilities were concerned that primary care teams did not have the bandwidth to take on additional items and/or there was variable primary care readiness for initiating AUD pharmacotherapy. Further attempts should be made to integrate primary care into the process of initiating AUD treatment as significant research suggests that integrated care models for AUD may be associated with improved process and outcome measures of care.23

There are several differences between this quality improvement project and prior research investigating the impact of DTC education for other conditions, such as the EMPOWER randomized controlled trial and VISN 22 project, which both demonstrated effectiveness of DTC education for reducing benzodiazepine use in geriatric veterans. 15,16 These studies focused on reducing or stopping pharmacotherapy use, whereas this project sought to promote the initiation of AUD pharmacotherapy. These studies evaluated outcomes at least 6 months postindex date, whereas this project evaluated outcomes within 30 days postappointment. Furthermore, the educational content varied significantly. Other projects provided patients with information focused on specific medications and interventions, such as benzodiazepine tapering, while this project mailed general information on heavy drinking, its risks, and strategies for cutting back, without mentioning pharmacotherapy. The DTC material used in this project was chosen because it was a preapproved national VA ADS resource, which expedited the project timeline by avoiding the need for additional approvals at each participating site. These differences may impact the observed effectiveness of DTC education in this project, especially regarding the primary outcome.

Strengths and Limitations

This quality improvement project sent a large sample of veterans DTC education in a clinical setting across multiple sites. Additionally, PS matching methods were used to balance covariates between the comparator and DTC education group, thereby simulating a randomized controlled trial and reducing selection bias. The project brought attention to the VISN 21 AUD treatment rates, stimulated conversation across sites about available treatments and resources for AUD, and sparked collaboration between academic detailing, mental health, and primary care services. The time frame for visits was selected during the winter; the National Institute on Alcohol Abuse and Alcoholism notes this is a time when people may be more likely to engage in excessive alcohol consumption than at other times of the year.24

The 30-day time frame for outcomes may have been too short to observe changes in prescribing or referral patterns. Additionally, the comparator group was comprised of veterans seen from October 1, 2022, to January 31, 2023, where seasonal timing may have influenced alcohol consumption behaviors and skewed the results. There were also no-show appointments in the DTC education group (13.7%), though it is likely some patients rescheduled and still received AUD pharmacotherapy within 30 days of the original appointment. Finally, it was not possible to confirm whether a patient opened and read the education that was mailed to them. This may be another reason to explore electronic distribution of DTC education. This all may have contributed to the lack of statistically significant differences in both the primary and secondary outcomes.

There was a high level of variability between facility participation in the project. Two of 7 sites did not participate, and 3 sites restricted primary care engagement. This represents a significant limitation, particularly for the secondary outcome of placing consultations for MH or SUD services. Facilities that only included mental health or SUD HCPs may have resulted in lower consultation rates due to their inherent specialization, reducing the likelihood of self-referrals.

The project may overestimate prescribed AUD pharmacotherapy in the primary outcome due to potential misclassification of medications. While the project adhered to the national VA ADS AUD dashboard’s definition of AUD pharmacotherapy, including acamprosate, disulfiram, naltrexone, topiramate, and gabapentin, some of these medications have multiple indications. For example, gabapentin is commonly prescribed for peripheral neuropathy, and topiramate is used to treat migraines and seizures. The multipurpose use adds uncertainty about whether they were prescribed specifically for AUD treatment, especially in cases where the HCP is responsible for treating a broad range of disease states, as in primary care.

CONCLUSIONS

Results of this quality improvement project did not show a statistically significant difference between patients sent DTC education and the comparator group for the initiation of AUD pharmacotherapy or placement of a consult to mental health or SUD services within 30 days of their scheduled visit. Future studies may seek to implement stricter criteria to confirm the intended use of topiramate and gabapentin, such as looking for keywords in the prescription instructions for use, performing chart reviews, and/or only including these medications if prescribed by a mental health or SUD HCP. Alternatively, future studies may consider limiting the analysis to only FDA-approved AUD medications: acamprosate, disulfiram, and naltrexone. It is vital to continue to enhance primary care HCP readiness to treat AUD, given the existing relationships and trust they often have with patients. Electronic methods for distributing DTC education could also be advantageous, as these methods may have the ability to track whether a message has been opened and read. Despite a lack of statistical significance, this project sparked crucial conversations and collaboration around AUD, available treatments, and addressing potential barriers to connecting patients to care within VISN 21.

References
  1. Centers for Disease Control and Prevention. Facts about U.S. deaths from excessive alcohol use. August 6, 2024. Accessed February 5, 2025. https://www.cdc.gov/alcohol/facts-stats/
  2. State Health Access Data Assistance Center. Escalating alcohol-involved death rates: trends and variation across the nation and in the states from 2006 to 2019. April 19, 2021. Accessed February 5, 2025. https://www.shadac.org/escalating-alcohol-involved-death-rates-trends-and-variation-across-nation-and-states-2006-2019
  3. National Institute on Alcohol Abuse and Alcoholism. Alcohol- related emergencies and deaths in the United States. Updated November 2024. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-related-emergencies-and-deaths-united-states
  4. Esser MB, Sherk A, Liu Y, Naimi TS. Deaths from excessive alcohol use - United States, 2016- 2021. MMWR Morb Mortal Wkly Rep. 2024;73(8):154-161. doi:10.15585/mmwr.mm7308a1
  5. Canver BR, Newman RK, Gomez AE. Alcohol Withdrawal Syndrome. In: StatPearls. StatPearls Publishing; 2024.
  6. National Institute on Alcohol Abuse and Alcoholism. Alcohol treatment in the United States. Updated January 2025. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-treatment-united-states
  7. National Institute on Alcohol Abuse and Alcoholism. Alcohol use disorder (AUD) in the United States: age groups and demographic characteristics. Updated September 2024. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-use-disorder-aud-united-states-age-groups-and-demographic-characteristics
  8. Reus VI, Fochtmann LJ, Bukstein O, et al. The American Psychiatric Association practice guideline for the pharmacological treatment of patients with alcohol use disorder. Am J Psychiatry. 2018;175(1):86-90. doi:10.1176/appi.ajp.2017.1750101
  9. Blodgett JC, Del Re AC, Maisel NC, Finney JW. A meta-analysis of topiramate’s effects for individuals with alcohol use disorders. Alcohol Clin Exp Res. 2014;38(6):1481-1488. doi:10.1111/acer.12411
  10. Maisel NC, Blodgett JC, Wilbourne PL, Humphreys K, Finney JW. Meta-analysis of naltrexone and acamprosate for treating alcohol use disorders: when are these medications most helpful? Addiction. 2013;108(2):275-293. doi:10.1111/j.1360-0443.2012.04054.x
  11. Jonas DE, Amick HR, Feltner C, et al. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA. 2014;311(18):1889-1900. doi:10.1001/jama.2014.3628
  12. US Department of Veterans Affairs, Department of Defense. VA/DoD clinical practice guideline for the management of substance use disorders. August 2021. Accessed February 5, 2025. https://www.healthquality.va.gov/guidelines/MH/sud/VADODSUDCPG.pdf
  13. Ranney RM, Bernhard PA, Vogt D, et al. Alcohol use and treatment utilization in a national sample of veterans and nonveterans. J Subst Use Addict Treat. 2023;146:208964. doi:10.1016/j.josat.2023.208964
  14. US Department of Veterans Affairs, Pharmacy Benefit Management Service, Academic Detailing Service. AUD Trend Report. https://vaww.pbi.cdw.va.gov/PBIRS/Pages/ReportViewer.aspx?/GPE/PBM_AD/SSRS/AUD/AUD_TrendReport
  15. Mendes MA, Smith JP, Marin JK, et al. Reducing benzodiazepine prescribing in older veterans: a direct-to-consumer educational brochure. Fed Pract. 2018;35(9):36-43.
  16. Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014;174(6):890-898. doi:10.1001/jamainternmed.2014.949
  17. Maloney R, Funmilayo M. Acting on the AUDIT-C: implementation of direct-to-consumer education on unhealth alcohol use. Presented on March 31, 2023; Central Virginia Veterans Affairs Health Care System, Richmond, Virginia.
  18. US Department of Veterans Affairs, Pharmacy Benefit Management Service. Alcohol use disorder (AUD) – leading the charge in the treatment of AUD: a VA clinician’s guide. February 2022. Accessed February 5, 2025. https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/508/10-1530_AUD_ClinicianGuide_508Conformant.pdf
  19. Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011;46(3):399-424. doi:10.1080/00273171.2011.568786
  20. National Institute on Alcohol Abuse and Alcoholism. Stigma: overcoming a pervasive barrier to optimal care. Updated January 6, 2025. Accessed February 5, 2025. https://www.niaaa.nih.gov/health-professionals-communities/core-resource-on-alcohol/stigma-overcoming-pervasive-barrier-optimal-care
  21. Sudhinaraset M, Wigglesworth C, Takeuchi DT. Social and cultural contexts of alcohol use: influences in a socialecological framework. Alcohol Res. 2016;38(1):35-45.
  22. Tanski SE, McClure AC, Li Z, et al. Cued recall of alcohol advertising on television and underage drinking behavior. JAMA Pediatr. 2015;169(3):264-271. doi:10.1001/jamapediatrics.2014.3345
  23. Hyland CJ, McDowell MJ, Bain PA, Huskamp HA, Busch AB. Integration of pharmacotherapy for alcohol use disorder treatment in primary care settings: a scoping review. J Subst Abuse Treat. 2023;144:108919. doi:10.1016/j.jsat.2022.108919
  24. National Institute on Alcohol Abuse and Alcoholism. The truth about holiday spirits. Updated November 2023. Accessed February 5, 2025. ,a href="https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/truth-about-holiday-spirits">https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/truth-about-holiday-spirits
Article PDF
Author and Disclosure Information

Julie R. Beauchamp, PharmDa; Robert Malmstrom, PharmDa; Ramona Shayegani, PharmDa; Steve T. Flynn, PharmD, BCPSa; Amy E. Robinson, PharmDa; Jennifer R. Marin, PharmD, BCPSa; David B. Huberman, PhDa; Janice M. Taylor, PharmD, BCPSa; Scott E. Mambourg, PharmD, BCPSa

Author affiliations 
aVA Sierra Pacific Network (VISN 21)

Author disclosures 
The authors report no actual or potential conflicts of interest in regard to this article.

Correspondence: Julie Beauchamp (julie.beauchamp@ va.gov)

Fed Pract. 2025;42(5). Published online May 17. doi:10.12788/fp.0562

Issue
Federal Practitioner - 42(5)
Publications
Topics
Page Number
1-8
Sections
Author and Disclosure Information

Julie R. Beauchamp, PharmDa; Robert Malmstrom, PharmDa; Ramona Shayegani, PharmDa; Steve T. Flynn, PharmD, BCPSa; Amy E. Robinson, PharmDa; Jennifer R. Marin, PharmD, BCPSa; David B. Huberman, PhDa; Janice M. Taylor, PharmD, BCPSa; Scott E. Mambourg, PharmD, BCPSa

Author affiliations 
aVA Sierra Pacific Network (VISN 21)

Author disclosures 
The authors report no actual or potential conflicts of interest in regard to this article.

Correspondence: Julie Beauchamp (julie.beauchamp@ va.gov)

Fed Pract. 2025;42(5). Published online May 17. doi:10.12788/fp.0562

Author and Disclosure Information

Julie R. Beauchamp, PharmDa; Robert Malmstrom, PharmDa; Ramona Shayegani, PharmDa; Steve T. Flynn, PharmD, BCPSa; Amy E. Robinson, PharmDa; Jennifer R. Marin, PharmD, BCPSa; David B. Huberman, PhDa; Janice M. Taylor, PharmD, BCPSa; Scott E. Mambourg, PharmD, BCPSa

Author affiliations 
aVA Sierra Pacific Network (VISN 21)

Author disclosures 
The authors report no actual or potential conflicts of interest in regard to this article.

Correspondence: Julie Beauchamp (julie.beauchamp@ va.gov)

Fed Pract. 2025;42(5). Published online May 17. doi:10.12788/fp.0562

Article PDF
Article PDF

Excessive alcohol use is one of the leading preventable causes of death in the United States, responsible for about 178,000 deaths annually and an average of 488 daily deaths in 2020 and 2021.1Alcohol-related deaths increased by 49% between 2006 and 2019.2 This trend continued during the COVID-19 pandemic, with death certificates that listed alcohol increasing by > 25% from 2019 to 2020, and another 10% in 2021.3 This increase of alcohol-related deaths includes those as a direct result of chronic alcohol use, such as alcoholic cardiomyopathy, alcoholic hepatitis and cirrhosis, and alcohol-induced pancreatitis, as well as a result of acute use such as alcohol poisoning, suicide by exposure to alcohol, and alcohol-impaired driving fatalities.4

Excessive alcohol consumption poses other serious risks, including cases when intake is abruptly reduced without proper management. Alcohol withdrawal syndrome (AWS) can vary in severity, with potentially life-threatening complications such as hallucinations, seizures, and delirium tremens.5

These risks highlight the importance of professional intervention and support, not only to mitigate risks associated with AWS, but provide a pathway towards recovery from alcohol use disorder (AUD).

According to the 2022 National Survey on Drug Use and Health, 28.8 million US adults had AUD in the prior year, yet only 7.6% of these individuals received treatment and an even smaller group (2.2%) received medication-assisted treatment for alcohol.6,7 This is despite American Psychiatric Association guidelines for the pharmacological treatment of patients with AUD, including the use of naltrexone, acamprosate, disulfiram, topiramate, or gabapentin, depending on therapy goals, past medication trials, medication contraindications, and patient preference.8 Several of these medications are approved by the US Food and Drug Administration (FDA) for the treatment of AUD and have support for effectiveness from randomized controlled trials and meta-analyses.9-11

Clinical practice guidelines for the management of substance use disorders (SUDs) from the US Department of Veterans Affairs (VA) and US Department of Defense have strong recommendations for naltrexone and topiramate as first-line pharmacotherapies for moderate to severe AUD. Acamprosate and disulfiram are weak recommendations as alternative options. Gabapentin is a weak recommendation for cases where first-line treatments are contraindicated or ineffective. The guidelines emphasize the importance of a comprehensive approach to AUD treatment, including psychosocial interventions in addition to pharmacotherapy.12

A 2023 national survey found veterans reported higher alcohol consumption than nonveterans.13 At the end of fiscal year 2023, > 4.4 million veterans—6% of Veterans Health Administration patients—had been diagnosed with AUD.14 However, > 87% of these patients nationally, and 88% of Veterans Integrated Service Network (VISN) 21 patients, were not receiving naltrexone, acamprosate, disulfiram, or topiramate as part of their treatment. The VA Academic Detailing Service (ADS) now includes AUD pharmacotherapy as a campaign focus, highlighting its importance. The ADS is a pharmacy educational outreach program that uses unbiased clinical guidelines to promote aligning prescribing behavior with best practices. Academic detailing methods include speaking with health care practitioners (HCPs), and direct-to-consumer (DTC) patient education.

ADS campaigns include DTC educational handouts. Past ADS projects and research using DTC have demonstrated a significant improvement in outcomes and positively influencing patients’ pharmacotherapy treatment. 15,16 A VA quality improvement project found a positive correlation between the initiation of AUD pharmacotherapy and engagement with mental health care following the distribution of AUD DTC patient education. 17 This project aimed to apply the same principles of prior research to explore the use of DTC across multiple facilities within VISN 21 to increase AUD pharmacotherapy. VISN 21 includes VA facilities and clinics across the Pacific Islands, Nevada, and California and serves about 350,000 veterans.

METHODS

A prospective cohort of VISN 21 veterans with or at high risk for AUD was identified using the VA ADS AUD Dashboard. The cohort included those not on acamprosate, disulfiram, naltrexone, topiramate, or gabapentin for treatment of AUD and had an elevated Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score of ≥ 6 (high risk) with an AUD diagnosis or ≥ 8 (severe risk) without a diagnosis. The AUDIT-C scores used in the dashboard are supported by the VA AUD clinician guide as the minimum scores when AUD pharmacotherapy should be offered to patients.18 Prescriptions filled outside the VA were not included in this dashboard.

Data and patient information were collected using the VA Corporate Data Warehouse. To be eligible, veterans needed a valid mailing address within the VISN 21 region and a primary care, mental health, or SUD clinician prescriber visit scheduled between October 1, 2023, and January 31, 2024. Veterans were excluded if they were in hospice, had a 1-year mortality risk score > 50% based on their Care Assessment Need (CAN) score, or facility leadership opted out of project involvement. Patients with both severe renal and hepatic impairments were excluded because they were ineligible for AUD pharmacotherapy. However, veterans with either renal or hepatic impairment (but not both) were included, as they could be potential candidates for ≥ 1 AUD pharmacotherapy option.

Initial correspondence with facilities was initiated through local academic detailers. A local champion was identified for the 1 facility without an academic detailer. Facilities could opt in or out of the project. Approval was provided by the local pharmacy and therapeutics committee, pharmacy, primary care, or psychiatry leadership. Approval process and clinician involvement varied by site.

Education

The selected AUD patient education was designed and approved by the national VA ADS (eappendix). The DTC patient education provided general knowledge about alcohol, including what constitutes a standard amount of alcohol, what is considered heavy drinking, risks of heavy drinking, creating a plan with a clinician to reduce and manage withdrawal symptoms, and additional resources. The DTC was accompanied by a cover letter that included a local facility contact number.

A centralized mailing facility was used for all materials. VA Northern California Health Care System provided the funding to cover the cost of postage. The list of veterans to be contacted was updated on a rolling basis and DTC education was mailed 2 weeks prior to their scheduled prescriber visit.

The eligible cohort of 1260 veterans received DTC education. A comparator group of 2048 veterans that did not receive DTC education was obtained retrospectively by using the same inclusion and exclusion criteria with a scheduled primary care, mental health, or SUD HCP visit from October 1, 2022, to January 31, 2023. The outcomes assessed were within 30 days of the scheduled visit, with the primary outcome as the initiation of AUD-related pharmacotherapy and the secondary outcome as the placement of a consultation for mental health or SUD services. Any consultations sent to Behavioral Health, Addiction, Mental Health, Psychiatric, and SUD services following the HCP visit, within the specified time frame, were used for the secondary outcome.

Matching and Analysis

A 1-to-1 nearest neighbor propensity score (PS) matching without replacement was used to pair the 1260 veterans from the intervention group with similarly scored comparator group veterans for a PS-matched final dataset of 2520 veterans. The PS model was a multivariate logistic regression with the outcome being exposure and comparator group status. Baseline characteristics used in the PS model were age, birth sex, race, facility of care, baseline AUDIT-C score, and days between project start and scheduled appointment. Covariate imbalance for the PS-matched sample was assessed to ensure the standardized mean difference for all covariates fell under a 0.1 threshold (Figure).19

0525FED-eAUD-F1

A frequency table was provided to compare the discrete distributions of the baseline characteristics in the intervention and comparator groups. Logistic regression analysis was performed to evaluate the association between DTC education exposure and pharmacotherapy initiation, while controlling for potential confounders. Univariate and multivariate P value results for each variable included in the model were reported along with the multivariate odds ratios (ORs) and their associated 95% CIs. Logistic regression analyses were run for both outcomes. Each model included the exposure and comparator group status as well as the baseline characteristics included in the PS model. Statistical significance was set at P < .05. All statistical analyses were performed with R version 4.2.1.

RESULTS

Two of 7 VISN 21 sites did not participate, and 3 had restrictions on participation. DTC education was mailed about 2 weeks prior to scheduled visit for 1260 veterans; 53.6% identified as White, 37.6% were aged 41 to 60 years, and 79.2% had an AUDIT-C ≥ 8 (Table 1). Of those mailed education, there were 173 no-show appointments (13.7%). Thirty-two veterans (2.5%) in the DTC group and 33 veterans (2.6%) in the comparator group received an AUD-related pharmacotherapy prescription (P = .88) (Table 2). One hundred seventy-one veterans (13.6%) in the DTC group and 160 veterans (12.7%) in the comparator group had a consult placed for mental health or SUD services within 30 days of their appointment (P = .59) (Table 3).

0525FED-eAUD-T10525FED-eAUD-T20525FED-eAUD-T3

DISCUSSION

This project did not yield statistically significant differences in either the primary or secondary outcomes within the 30-day follow-up window and found limited impact from the DTC educational outreach to veterans. The percentage of veterans that received AUD-related pharmacotherapy or consultations for mental health or SUD services was similarly low in the DTC and comparator groups. These findings suggest that although DTC education may raise awareness, it may not be sufficient on its own to drive changes in prescribing behavior or referral patterns without system-level support.

Addiction is a complex disease faced with stigma and requiring readiness by both the HCP and patient to move forward in support and treatment. The consequences of stigma can be severe: the more stigma perceived by a person with AUD, the less likely they are to seek treatment.20 Stigma may exist even within HCPs and may lead to compromised care including shortened visits, less engagement, and less empathy.19 Cultural attitude towards alcohol use and intoxication can also be influenced through a wide range of sources including social media, movies, music, and television. Studies have shown targeted alcohol marketing may result in the development of positive beliefs about drinking and expand environments where alcohol use is socially acceptable and encouraged.21 These factors can impact drinking behavior, including the onset of drinking, binge drinking, and increased alcohol consumption.22

Three VISN 21 sites in this study had restrictions on or excluded primary care from participation. Leadership at some of these facilities were concerned that primary care teams did not have the bandwidth to take on additional items and/or there was variable primary care readiness for initiating AUD pharmacotherapy. Further attempts should be made to integrate primary care into the process of initiating AUD treatment as significant research suggests that integrated care models for AUD may be associated with improved process and outcome measures of care.23

There are several differences between this quality improvement project and prior research investigating the impact of DTC education for other conditions, such as the EMPOWER randomized controlled trial and VISN 22 project, which both demonstrated effectiveness of DTC education for reducing benzodiazepine use in geriatric veterans. 15,16 These studies focused on reducing or stopping pharmacotherapy use, whereas this project sought to promote the initiation of AUD pharmacotherapy. These studies evaluated outcomes at least 6 months postindex date, whereas this project evaluated outcomes within 30 days postappointment. Furthermore, the educational content varied significantly. Other projects provided patients with information focused on specific medications and interventions, such as benzodiazepine tapering, while this project mailed general information on heavy drinking, its risks, and strategies for cutting back, without mentioning pharmacotherapy. The DTC material used in this project was chosen because it was a preapproved national VA ADS resource, which expedited the project timeline by avoiding the need for additional approvals at each participating site. These differences may impact the observed effectiveness of DTC education in this project, especially regarding the primary outcome.

Strengths and Limitations

This quality improvement project sent a large sample of veterans DTC education in a clinical setting across multiple sites. Additionally, PS matching methods were used to balance covariates between the comparator and DTC education group, thereby simulating a randomized controlled trial and reducing selection bias. The project brought attention to the VISN 21 AUD treatment rates, stimulated conversation across sites about available treatments and resources for AUD, and sparked collaboration between academic detailing, mental health, and primary care services. The time frame for visits was selected during the winter; the National Institute on Alcohol Abuse and Alcoholism notes this is a time when people may be more likely to engage in excessive alcohol consumption than at other times of the year.24

The 30-day time frame for outcomes may have been too short to observe changes in prescribing or referral patterns. Additionally, the comparator group was comprised of veterans seen from October 1, 2022, to January 31, 2023, where seasonal timing may have influenced alcohol consumption behaviors and skewed the results. There were also no-show appointments in the DTC education group (13.7%), though it is likely some patients rescheduled and still received AUD pharmacotherapy within 30 days of the original appointment. Finally, it was not possible to confirm whether a patient opened and read the education that was mailed to them. This may be another reason to explore electronic distribution of DTC education. This all may have contributed to the lack of statistically significant differences in both the primary and secondary outcomes.

There was a high level of variability between facility participation in the project. Two of 7 sites did not participate, and 3 sites restricted primary care engagement. This represents a significant limitation, particularly for the secondary outcome of placing consultations for MH or SUD services. Facilities that only included mental health or SUD HCPs may have resulted in lower consultation rates due to their inherent specialization, reducing the likelihood of self-referrals.

The project may overestimate prescribed AUD pharmacotherapy in the primary outcome due to potential misclassification of medications. While the project adhered to the national VA ADS AUD dashboard’s definition of AUD pharmacotherapy, including acamprosate, disulfiram, naltrexone, topiramate, and gabapentin, some of these medications have multiple indications. For example, gabapentin is commonly prescribed for peripheral neuropathy, and topiramate is used to treat migraines and seizures. The multipurpose use adds uncertainty about whether they were prescribed specifically for AUD treatment, especially in cases where the HCP is responsible for treating a broad range of disease states, as in primary care.

CONCLUSIONS

Results of this quality improvement project did not show a statistically significant difference between patients sent DTC education and the comparator group for the initiation of AUD pharmacotherapy or placement of a consult to mental health or SUD services within 30 days of their scheduled visit. Future studies may seek to implement stricter criteria to confirm the intended use of topiramate and gabapentin, such as looking for keywords in the prescription instructions for use, performing chart reviews, and/or only including these medications if prescribed by a mental health or SUD HCP. Alternatively, future studies may consider limiting the analysis to only FDA-approved AUD medications: acamprosate, disulfiram, and naltrexone. It is vital to continue to enhance primary care HCP readiness to treat AUD, given the existing relationships and trust they often have with patients. Electronic methods for distributing DTC education could also be advantageous, as these methods may have the ability to track whether a message has been opened and read. Despite a lack of statistical significance, this project sparked crucial conversations and collaboration around AUD, available treatments, and addressing potential barriers to connecting patients to care within VISN 21.

Excessive alcohol use is one of the leading preventable causes of death in the United States, responsible for about 178,000 deaths annually and an average of 488 daily deaths in 2020 and 2021.1Alcohol-related deaths increased by 49% between 2006 and 2019.2 This trend continued during the COVID-19 pandemic, with death certificates that listed alcohol increasing by > 25% from 2019 to 2020, and another 10% in 2021.3 This increase of alcohol-related deaths includes those as a direct result of chronic alcohol use, such as alcoholic cardiomyopathy, alcoholic hepatitis and cirrhosis, and alcohol-induced pancreatitis, as well as a result of acute use such as alcohol poisoning, suicide by exposure to alcohol, and alcohol-impaired driving fatalities.4

Excessive alcohol consumption poses other serious risks, including cases when intake is abruptly reduced without proper management. Alcohol withdrawal syndrome (AWS) can vary in severity, with potentially life-threatening complications such as hallucinations, seizures, and delirium tremens.5

These risks highlight the importance of professional intervention and support, not only to mitigate risks associated with AWS, but provide a pathway towards recovery from alcohol use disorder (AUD).

According to the 2022 National Survey on Drug Use and Health, 28.8 million US adults had AUD in the prior year, yet only 7.6% of these individuals received treatment and an even smaller group (2.2%) received medication-assisted treatment for alcohol.6,7 This is despite American Psychiatric Association guidelines for the pharmacological treatment of patients with AUD, including the use of naltrexone, acamprosate, disulfiram, topiramate, or gabapentin, depending on therapy goals, past medication trials, medication contraindications, and patient preference.8 Several of these medications are approved by the US Food and Drug Administration (FDA) for the treatment of AUD and have support for effectiveness from randomized controlled trials and meta-analyses.9-11

Clinical practice guidelines for the management of substance use disorders (SUDs) from the US Department of Veterans Affairs (VA) and US Department of Defense have strong recommendations for naltrexone and topiramate as first-line pharmacotherapies for moderate to severe AUD. Acamprosate and disulfiram are weak recommendations as alternative options. Gabapentin is a weak recommendation for cases where first-line treatments are contraindicated or ineffective. The guidelines emphasize the importance of a comprehensive approach to AUD treatment, including psychosocial interventions in addition to pharmacotherapy.12

A 2023 national survey found veterans reported higher alcohol consumption than nonveterans.13 At the end of fiscal year 2023, > 4.4 million veterans—6% of Veterans Health Administration patients—had been diagnosed with AUD.14 However, > 87% of these patients nationally, and 88% of Veterans Integrated Service Network (VISN) 21 patients, were not receiving naltrexone, acamprosate, disulfiram, or topiramate as part of their treatment. The VA Academic Detailing Service (ADS) now includes AUD pharmacotherapy as a campaign focus, highlighting its importance. The ADS is a pharmacy educational outreach program that uses unbiased clinical guidelines to promote aligning prescribing behavior with best practices. Academic detailing methods include speaking with health care practitioners (HCPs), and direct-to-consumer (DTC) patient education.

ADS campaigns include DTC educational handouts. Past ADS projects and research using DTC have demonstrated a significant improvement in outcomes and positively influencing patients’ pharmacotherapy treatment. 15,16 A VA quality improvement project found a positive correlation between the initiation of AUD pharmacotherapy and engagement with mental health care following the distribution of AUD DTC patient education. 17 This project aimed to apply the same principles of prior research to explore the use of DTC across multiple facilities within VISN 21 to increase AUD pharmacotherapy. VISN 21 includes VA facilities and clinics across the Pacific Islands, Nevada, and California and serves about 350,000 veterans.

METHODS

A prospective cohort of VISN 21 veterans with or at high risk for AUD was identified using the VA ADS AUD Dashboard. The cohort included those not on acamprosate, disulfiram, naltrexone, topiramate, or gabapentin for treatment of AUD and had an elevated Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score of ≥ 6 (high risk) with an AUD diagnosis or ≥ 8 (severe risk) without a diagnosis. The AUDIT-C scores used in the dashboard are supported by the VA AUD clinician guide as the minimum scores when AUD pharmacotherapy should be offered to patients.18 Prescriptions filled outside the VA were not included in this dashboard.

Data and patient information were collected using the VA Corporate Data Warehouse. To be eligible, veterans needed a valid mailing address within the VISN 21 region and a primary care, mental health, or SUD clinician prescriber visit scheduled between October 1, 2023, and January 31, 2024. Veterans were excluded if they were in hospice, had a 1-year mortality risk score > 50% based on their Care Assessment Need (CAN) score, or facility leadership opted out of project involvement. Patients with both severe renal and hepatic impairments were excluded because they were ineligible for AUD pharmacotherapy. However, veterans with either renal or hepatic impairment (but not both) were included, as they could be potential candidates for ≥ 1 AUD pharmacotherapy option.

Initial correspondence with facilities was initiated through local academic detailers. A local champion was identified for the 1 facility without an academic detailer. Facilities could opt in or out of the project. Approval was provided by the local pharmacy and therapeutics committee, pharmacy, primary care, or psychiatry leadership. Approval process and clinician involvement varied by site.

Education

The selected AUD patient education was designed and approved by the national VA ADS (eappendix). The DTC patient education provided general knowledge about alcohol, including what constitutes a standard amount of alcohol, what is considered heavy drinking, risks of heavy drinking, creating a plan with a clinician to reduce and manage withdrawal symptoms, and additional resources. The DTC was accompanied by a cover letter that included a local facility contact number.

A centralized mailing facility was used for all materials. VA Northern California Health Care System provided the funding to cover the cost of postage. The list of veterans to be contacted was updated on a rolling basis and DTC education was mailed 2 weeks prior to their scheduled prescriber visit.

The eligible cohort of 1260 veterans received DTC education. A comparator group of 2048 veterans that did not receive DTC education was obtained retrospectively by using the same inclusion and exclusion criteria with a scheduled primary care, mental health, or SUD HCP visit from October 1, 2022, to January 31, 2023. The outcomes assessed were within 30 days of the scheduled visit, with the primary outcome as the initiation of AUD-related pharmacotherapy and the secondary outcome as the placement of a consultation for mental health or SUD services. Any consultations sent to Behavioral Health, Addiction, Mental Health, Psychiatric, and SUD services following the HCP visit, within the specified time frame, were used for the secondary outcome.

Matching and Analysis

A 1-to-1 nearest neighbor propensity score (PS) matching without replacement was used to pair the 1260 veterans from the intervention group with similarly scored comparator group veterans for a PS-matched final dataset of 2520 veterans. The PS model was a multivariate logistic regression with the outcome being exposure and comparator group status. Baseline characteristics used in the PS model were age, birth sex, race, facility of care, baseline AUDIT-C score, and days between project start and scheduled appointment. Covariate imbalance for the PS-matched sample was assessed to ensure the standardized mean difference for all covariates fell under a 0.1 threshold (Figure).19

0525FED-eAUD-F1

A frequency table was provided to compare the discrete distributions of the baseline characteristics in the intervention and comparator groups. Logistic regression analysis was performed to evaluate the association between DTC education exposure and pharmacotherapy initiation, while controlling for potential confounders. Univariate and multivariate P value results for each variable included in the model were reported along with the multivariate odds ratios (ORs) and their associated 95% CIs. Logistic regression analyses were run for both outcomes. Each model included the exposure and comparator group status as well as the baseline characteristics included in the PS model. Statistical significance was set at P < .05. All statistical analyses were performed with R version 4.2.1.

RESULTS

Two of 7 VISN 21 sites did not participate, and 3 had restrictions on participation. DTC education was mailed about 2 weeks prior to scheduled visit for 1260 veterans; 53.6% identified as White, 37.6% were aged 41 to 60 years, and 79.2% had an AUDIT-C ≥ 8 (Table 1). Of those mailed education, there were 173 no-show appointments (13.7%). Thirty-two veterans (2.5%) in the DTC group and 33 veterans (2.6%) in the comparator group received an AUD-related pharmacotherapy prescription (P = .88) (Table 2). One hundred seventy-one veterans (13.6%) in the DTC group and 160 veterans (12.7%) in the comparator group had a consult placed for mental health or SUD services within 30 days of their appointment (P = .59) (Table 3).

0525FED-eAUD-T10525FED-eAUD-T20525FED-eAUD-T3

DISCUSSION

This project did not yield statistically significant differences in either the primary or secondary outcomes within the 30-day follow-up window and found limited impact from the DTC educational outreach to veterans. The percentage of veterans that received AUD-related pharmacotherapy or consultations for mental health or SUD services was similarly low in the DTC and comparator groups. These findings suggest that although DTC education may raise awareness, it may not be sufficient on its own to drive changes in prescribing behavior or referral patterns without system-level support.

Addiction is a complex disease faced with stigma and requiring readiness by both the HCP and patient to move forward in support and treatment. The consequences of stigma can be severe: the more stigma perceived by a person with AUD, the less likely they are to seek treatment.20 Stigma may exist even within HCPs and may lead to compromised care including shortened visits, less engagement, and less empathy.19 Cultural attitude towards alcohol use and intoxication can also be influenced through a wide range of sources including social media, movies, music, and television. Studies have shown targeted alcohol marketing may result in the development of positive beliefs about drinking and expand environments where alcohol use is socially acceptable and encouraged.21 These factors can impact drinking behavior, including the onset of drinking, binge drinking, and increased alcohol consumption.22

Three VISN 21 sites in this study had restrictions on or excluded primary care from participation. Leadership at some of these facilities were concerned that primary care teams did not have the bandwidth to take on additional items and/or there was variable primary care readiness for initiating AUD pharmacotherapy. Further attempts should be made to integrate primary care into the process of initiating AUD treatment as significant research suggests that integrated care models for AUD may be associated with improved process and outcome measures of care.23

There are several differences between this quality improvement project and prior research investigating the impact of DTC education for other conditions, such as the EMPOWER randomized controlled trial and VISN 22 project, which both demonstrated effectiveness of DTC education for reducing benzodiazepine use in geriatric veterans. 15,16 These studies focused on reducing or stopping pharmacotherapy use, whereas this project sought to promote the initiation of AUD pharmacotherapy. These studies evaluated outcomes at least 6 months postindex date, whereas this project evaluated outcomes within 30 days postappointment. Furthermore, the educational content varied significantly. Other projects provided patients with information focused on specific medications and interventions, such as benzodiazepine tapering, while this project mailed general information on heavy drinking, its risks, and strategies for cutting back, without mentioning pharmacotherapy. The DTC material used in this project was chosen because it was a preapproved national VA ADS resource, which expedited the project timeline by avoiding the need for additional approvals at each participating site. These differences may impact the observed effectiveness of DTC education in this project, especially regarding the primary outcome.

Strengths and Limitations

This quality improvement project sent a large sample of veterans DTC education in a clinical setting across multiple sites. Additionally, PS matching methods were used to balance covariates between the comparator and DTC education group, thereby simulating a randomized controlled trial and reducing selection bias. The project brought attention to the VISN 21 AUD treatment rates, stimulated conversation across sites about available treatments and resources for AUD, and sparked collaboration between academic detailing, mental health, and primary care services. The time frame for visits was selected during the winter; the National Institute on Alcohol Abuse and Alcoholism notes this is a time when people may be more likely to engage in excessive alcohol consumption than at other times of the year.24

The 30-day time frame for outcomes may have been too short to observe changes in prescribing or referral patterns. Additionally, the comparator group was comprised of veterans seen from October 1, 2022, to January 31, 2023, where seasonal timing may have influenced alcohol consumption behaviors and skewed the results. There were also no-show appointments in the DTC education group (13.7%), though it is likely some patients rescheduled and still received AUD pharmacotherapy within 30 days of the original appointment. Finally, it was not possible to confirm whether a patient opened and read the education that was mailed to them. This may be another reason to explore electronic distribution of DTC education. This all may have contributed to the lack of statistically significant differences in both the primary and secondary outcomes.

There was a high level of variability between facility participation in the project. Two of 7 sites did not participate, and 3 sites restricted primary care engagement. This represents a significant limitation, particularly for the secondary outcome of placing consultations for MH or SUD services. Facilities that only included mental health or SUD HCPs may have resulted in lower consultation rates due to their inherent specialization, reducing the likelihood of self-referrals.

The project may overestimate prescribed AUD pharmacotherapy in the primary outcome due to potential misclassification of medications. While the project adhered to the national VA ADS AUD dashboard’s definition of AUD pharmacotherapy, including acamprosate, disulfiram, naltrexone, topiramate, and gabapentin, some of these medications have multiple indications. For example, gabapentin is commonly prescribed for peripheral neuropathy, and topiramate is used to treat migraines and seizures. The multipurpose use adds uncertainty about whether they were prescribed specifically for AUD treatment, especially in cases where the HCP is responsible for treating a broad range of disease states, as in primary care.

CONCLUSIONS

Results of this quality improvement project did not show a statistically significant difference between patients sent DTC education and the comparator group for the initiation of AUD pharmacotherapy or placement of a consult to mental health or SUD services within 30 days of their scheduled visit. Future studies may seek to implement stricter criteria to confirm the intended use of topiramate and gabapentin, such as looking for keywords in the prescription instructions for use, performing chart reviews, and/or only including these medications if prescribed by a mental health or SUD HCP. Alternatively, future studies may consider limiting the analysis to only FDA-approved AUD medications: acamprosate, disulfiram, and naltrexone. It is vital to continue to enhance primary care HCP readiness to treat AUD, given the existing relationships and trust they often have with patients. Electronic methods for distributing DTC education could also be advantageous, as these methods may have the ability to track whether a message has been opened and read. Despite a lack of statistical significance, this project sparked crucial conversations and collaboration around AUD, available treatments, and addressing potential barriers to connecting patients to care within VISN 21.

References
  1. Centers for Disease Control and Prevention. Facts about U.S. deaths from excessive alcohol use. August 6, 2024. Accessed February 5, 2025. https://www.cdc.gov/alcohol/facts-stats/
  2. State Health Access Data Assistance Center. Escalating alcohol-involved death rates: trends and variation across the nation and in the states from 2006 to 2019. April 19, 2021. Accessed February 5, 2025. https://www.shadac.org/escalating-alcohol-involved-death-rates-trends-and-variation-across-nation-and-states-2006-2019
  3. National Institute on Alcohol Abuse and Alcoholism. Alcohol- related emergencies and deaths in the United States. Updated November 2024. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-related-emergencies-and-deaths-united-states
  4. Esser MB, Sherk A, Liu Y, Naimi TS. Deaths from excessive alcohol use - United States, 2016- 2021. MMWR Morb Mortal Wkly Rep. 2024;73(8):154-161. doi:10.15585/mmwr.mm7308a1
  5. Canver BR, Newman RK, Gomez AE. Alcohol Withdrawal Syndrome. In: StatPearls. StatPearls Publishing; 2024.
  6. National Institute on Alcohol Abuse and Alcoholism. Alcohol treatment in the United States. Updated January 2025. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-treatment-united-states
  7. National Institute on Alcohol Abuse and Alcoholism. Alcohol use disorder (AUD) in the United States: age groups and demographic characteristics. Updated September 2024. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-use-disorder-aud-united-states-age-groups-and-demographic-characteristics
  8. Reus VI, Fochtmann LJ, Bukstein O, et al. The American Psychiatric Association practice guideline for the pharmacological treatment of patients with alcohol use disorder. Am J Psychiatry. 2018;175(1):86-90. doi:10.1176/appi.ajp.2017.1750101
  9. Blodgett JC, Del Re AC, Maisel NC, Finney JW. A meta-analysis of topiramate’s effects for individuals with alcohol use disorders. Alcohol Clin Exp Res. 2014;38(6):1481-1488. doi:10.1111/acer.12411
  10. Maisel NC, Blodgett JC, Wilbourne PL, Humphreys K, Finney JW. Meta-analysis of naltrexone and acamprosate for treating alcohol use disorders: when are these medications most helpful? Addiction. 2013;108(2):275-293. doi:10.1111/j.1360-0443.2012.04054.x
  11. Jonas DE, Amick HR, Feltner C, et al. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA. 2014;311(18):1889-1900. doi:10.1001/jama.2014.3628
  12. US Department of Veterans Affairs, Department of Defense. VA/DoD clinical practice guideline for the management of substance use disorders. August 2021. Accessed February 5, 2025. https://www.healthquality.va.gov/guidelines/MH/sud/VADODSUDCPG.pdf
  13. Ranney RM, Bernhard PA, Vogt D, et al. Alcohol use and treatment utilization in a national sample of veterans and nonveterans. J Subst Use Addict Treat. 2023;146:208964. doi:10.1016/j.josat.2023.208964
  14. US Department of Veterans Affairs, Pharmacy Benefit Management Service, Academic Detailing Service. AUD Trend Report. https://vaww.pbi.cdw.va.gov/PBIRS/Pages/ReportViewer.aspx?/GPE/PBM_AD/SSRS/AUD/AUD_TrendReport
  15. Mendes MA, Smith JP, Marin JK, et al. Reducing benzodiazepine prescribing in older veterans: a direct-to-consumer educational brochure. Fed Pract. 2018;35(9):36-43.
  16. Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014;174(6):890-898. doi:10.1001/jamainternmed.2014.949
  17. Maloney R, Funmilayo M. Acting on the AUDIT-C: implementation of direct-to-consumer education on unhealth alcohol use. Presented on March 31, 2023; Central Virginia Veterans Affairs Health Care System, Richmond, Virginia.
  18. US Department of Veterans Affairs, Pharmacy Benefit Management Service. Alcohol use disorder (AUD) – leading the charge in the treatment of AUD: a VA clinician’s guide. February 2022. Accessed February 5, 2025. https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/508/10-1530_AUD_ClinicianGuide_508Conformant.pdf
  19. Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011;46(3):399-424. doi:10.1080/00273171.2011.568786
  20. National Institute on Alcohol Abuse and Alcoholism. Stigma: overcoming a pervasive barrier to optimal care. Updated January 6, 2025. Accessed February 5, 2025. https://www.niaaa.nih.gov/health-professionals-communities/core-resource-on-alcohol/stigma-overcoming-pervasive-barrier-optimal-care
  21. Sudhinaraset M, Wigglesworth C, Takeuchi DT. Social and cultural contexts of alcohol use: influences in a socialecological framework. Alcohol Res. 2016;38(1):35-45.
  22. Tanski SE, McClure AC, Li Z, et al. Cued recall of alcohol advertising on television and underage drinking behavior. JAMA Pediatr. 2015;169(3):264-271. doi:10.1001/jamapediatrics.2014.3345
  23. Hyland CJ, McDowell MJ, Bain PA, Huskamp HA, Busch AB. Integration of pharmacotherapy for alcohol use disorder treatment in primary care settings: a scoping review. J Subst Abuse Treat. 2023;144:108919. doi:10.1016/j.jsat.2022.108919
  24. National Institute on Alcohol Abuse and Alcoholism. The truth about holiday spirits. Updated November 2023. Accessed February 5, 2025. ,a href="https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/truth-about-holiday-spirits">https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/truth-about-holiday-spirits
References
  1. Centers for Disease Control and Prevention. Facts about U.S. deaths from excessive alcohol use. August 6, 2024. Accessed February 5, 2025. https://www.cdc.gov/alcohol/facts-stats/
  2. State Health Access Data Assistance Center. Escalating alcohol-involved death rates: trends and variation across the nation and in the states from 2006 to 2019. April 19, 2021. Accessed February 5, 2025. https://www.shadac.org/escalating-alcohol-involved-death-rates-trends-and-variation-across-nation-and-states-2006-2019
  3. National Institute on Alcohol Abuse and Alcoholism. Alcohol- related emergencies and deaths in the United States. Updated November 2024. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-related-emergencies-and-deaths-united-states
  4. Esser MB, Sherk A, Liu Y, Naimi TS. Deaths from excessive alcohol use - United States, 2016- 2021. MMWR Morb Mortal Wkly Rep. 2024;73(8):154-161. doi:10.15585/mmwr.mm7308a1
  5. Canver BR, Newman RK, Gomez AE. Alcohol Withdrawal Syndrome. In: StatPearls. StatPearls Publishing; 2024.
  6. National Institute on Alcohol Abuse and Alcoholism. Alcohol treatment in the United States. Updated January 2025. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-treatment-united-states
  7. National Institute on Alcohol Abuse and Alcoholism. Alcohol use disorder (AUD) in the United States: age groups and demographic characteristics. Updated September 2024. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-use-disorder-aud-united-states-age-groups-and-demographic-characteristics
  8. Reus VI, Fochtmann LJ, Bukstein O, et al. The American Psychiatric Association practice guideline for the pharmacological treatment of patients with alcohol use disorder. Am J Psychiatry. 2018;175(1):86-90. doi:10.1176/appi.ajp.2017.1750101
  9. Blodgett JC, Del Re AC, Maisel NC, Finney JW. A meta-analysis of topiramate’s effects for individuals with alcohol use disorders. Alcohol Clin Exp Res. 2014;38(6):1481-1488. doi:10.1111/acer.12411
  10. Maisel NC, Blodgett JC, Wilbourne PL, Humphreys K, Finney JW. Meta-analysis of naltrexone and acamprosate for treating alcohol use disorders: when are these medications most helpful? Addiction. 2013;108(2):275-293. doi:10.1111/j.1360-0443.2012.04054.x
  11. Jonas DE, Amick HR, Feltner C, et al. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA. 2014;311(18):1889-1900. doi:10.1001/jama.2014.3628
  12. US Department of Veterans Affairs, Department of Defense. VA/DoD clinical practice guideline for the management of substance use disorders. August 2021. Accessed February 5, 2025. https://www.healthquality.va.gov/guidelines/MH/sud/VADODSUDCPG.pdf
  13. Ranney RM, Bernhard PA, Vogt D, et al. Alcohol use and treatment utilization in a national sample of veterans and nonveterans. J Subst Use Addict Treat. 2023;146:208964. doi:10.1016/j.josat.2023.208964
  14. US Department of Veterans Affairs, Pharmacy Benefit Management Service, Academic Detailing Service. AUD Trend Report. https://vaww.pbi.cdw.va.gov/PBIRS/Pages/ReportViewer.aspx?/GPE/PBM_AD/SSRS/AUD/AUD_TrendReport
  15. Mendes MA, Smith JP, Marin JK, et al. Reducing benzodiazepine prescribing in older veterans: a direct-to-consumer educational brochure. Fed Pract. 2018;35(9):36-43.
  16. Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014;174(6):890-898. doi:10.1001/jamainternmed.2014.949
  17. Maloney R, Funmilayo M. Acting on the AUDIT-C: implementation of direct-to-consumer education on unhealth alcohol use. Presented on March 31, 2023; Central Virginia Veterans Affairs Health Care System, Richmond, Virginia.
  18. US Department of Veterans Affairs, Pharmacy Benefit Management Service. Alcohol use disorder (AUD) – leading the charge in the treatment of AUD: a VA clinician’s guide. February 2022. Accessed February 5, 2025. https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/508/10-1530_AUD_ClinicianGuide_508Conformant.pdf
  19. Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011;46(3):399-424. doi:10.1080/00273171.2011.568786
  20. National Institute on Alcohol Abuse and Alcoholism. Stigma: overcoming a pervasive barrier to optimal care. Updated January 6, 2025. Accessed February 5, 2025. https://www.niaaa.nih.gov/health-professionals-communities/core-resource-on-alcohol/stigma-overcoming-pervasive-barrier-optimal-care
  21. Sudhinaraset M, Wigglesworth C, Takeuchi DT. Social and cultural contexts of alcohol use: influences in a socialecological framework. Alcohol Res. 2016;38(1):35-45.
  22. Tanski SE, McClure AC, Li Z, et al. Cued recall of alcohol advertising on television and underage drinking behavior. JAMA Pediatr. 2015;169(3):264-271. doi:10.1001/jamapediatrics.2014.3345
  23. Hyland CJ, McDowell MJ, Bain PA, Huskamp HA, Busch AB. Integration of pharmacotherapy for alcohol use disorder treatment in primary care settings: a scoping review. J Subst Abuse Treat. 2023;144:108919. doi:10.1016/j.jsat.2022.108919
  24. National Institute on Alcohol Abuse and Alcoholism. The truth about holiday spirits. Updated November 2023. Accessed February 5, 2025. ,a href="https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/truth-about-holiday-spirits">https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/truth-about-holiday-spirits
Issue
Federal Practitioner - 42(5)
Issue
Federal Practitioner - 42(5)
Page Number
1-8
Page Number
1-8
Publications
Publications
Topics
Article Type
Display Headline

Impact of Multisite Patient Education on Pharmacotherapy for Veterans With Alcohol Use Disorder

Display Headline

Impact of Multisite Patient Education on Pharmacotherapy for Veterans With Alcohol Use Disorder

Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Mon, 05/19/2025 - 12:37
Un-Gate On Date
Mon, 05/19/2025 - 12:37
Use ProPublica
CFC Schedule Remove Status
Mon, 05/19/2025 - 12:37
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
survey writer start date
Mon, 05/19/2025 - 12:37
Media Files

Treatment of low bone density or osteoporosis to prevent fractures in men and women

Article Type
Changed
Fri, 01/18/2019 - 16:52

 

Osteoporosis is defined by a clinically diagnosed fragility fracture or a bone mineral density (BMD) of at least 2.5 SD below the mean for young female adults, usually measured by dual-energy x-ray absorptiometry. Risk factors include age, female sex, post-menopause, hypogonadism or premature ovarian failure, history of cigarette smoking or alcohol consumption (3 or more drinks daily), rheumatoid arthritis, or medications including glucocorticoids, anticoagulants, anticonvulsants, and aromatase inhibitors.

This guideline update focuses on treatment with bisphosphonates (alendronate, risedronate, ibandronate, zoledronic acid) and denosumab. Denosumab, a human monoclonal antibody against RANK-ligand, approved by the Food and Drug Administration for treatment of osteoporosis, has been added to the list of allowed medications since publication of the 2008 guideline. Several therapies have been excluded from the update, including calcitonin, which is no longer widely used for osteoporosis treatment, and etidronate and pamidronate, neither of which are FDA-approved for the prevention of fractures or treatment of osteoporosis. It should be noted that the evidence continues to be insufficient regarding the effectiveness of therapies to prevent fractures or to treat osteoporosis in men.

Dr. Neil Skolnik
Recommendation: Pharmacologic treatment is recommended using alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk of hip and vertebral fractures in women who have known osteoporosis diagnosed as a T score less than –2.5 or those with fragility fracture (strong recommendation with high-quality evidence). Bisphosphonates, denosumab, teriparatide, and/or raloxifene reduce vertebral fractures. Alendronate, risedronate, zoledronic acid, and denosumab reduce both nonvertebral fractures and hip fractures. Moderate-quality evidence from one study that detected fractures radiographically showed that zoledronic acid reduced vertebral fractures in osteoporotic men. Moderate-quality evidence showed that alendronate, risedronate, and teriparatide reduced fracture risk in patients taking glucocorticoids. High-quality evidence showed that bisphosphonates are at least as effective for older patients as they are for younger patients. Evidence is insufficient to determine the comparative effectiveness of pharmacologic therapy or the superiority of one medication over another, within the same class or among classes, for prevention of fractures.

Bisphosphonates are associated with mild upper GI symptoms, atypical subtrochanteric fracture, and rare osteonecrosis of the jaw. There is no significant association between bisphosphonate use and total cardiovascular adverse events. Evidence is insufficient to associate bisphosphonates with increased cancer risk. Zoledronic acid is associated with atrial fibrillation, arthritis/arthralgias, headaches, hypocalcemia, influenza-like symptoms, and an increased incidence of uveitis/episcleritis. Denosumab is associated with mild upper GI symptoms, rash/eczema, and cellulitis.

While in the past additional medications were recommended for osteoporosis, the current guidelines recommend against using raloxifene, ibandronate, teriparatide, menopausal estrogen therapy, or menopausal estrogen plus progesterone therapy for first-line pharmacologic treatment.

The overall effect of calcium, vitamin D, or exercise alone on fracture risk is uncertain. Calcium and vitamin D may be added to treatment regimens, as a majority of trials with bisphosphonate therapy added this supplementation. Dosages should be considered because excessive dosing has been associated with hypercalcemia. Although previous data suggested an association between calcium supplementation and increased risk for myocardial infarction, moderate-quality evidence shows no association, though there is a risk of kidney stones.

Recommendation: Women who have osteoporosis and receive pharmacologic treatment should be treated for 5 years (weak recommendation; low-quality evidence). The evidence to determine the length of treatment is not strong, so recommendation is an extrapolation from existing evidence. High-risk patients may benefit from more than 5 years of treatment. Data suggests that patients treated with alendronate who had preexisting fractures or those with a BMD of –2.5 or less after 5 years of initial therapy may benefit from continued treatment, because these patients experienced a decreased incidence of new clinical vertebral fractures.

Recommendation: Pharmacologic treatment with bisphosphonates to reduce the risk for vertebral fracture can be offered to men who have clinically recognized osteoporosis (weak recommendation, low-quality evidence). No evidence suggests that outcomes associated with pharmacologic treatment would differ between men and women if based on similar BMDs.

Recommendation: Bone density monitoring is not recommended during the 5-year pharmacologic treatment period for osteoporosis in women (weak recommendation, low-quality evidence). Data showed that most women with normal dual-energy x-ray absorptiometry scores did not progress to osteoporosis within 15 years. Data also does not support monitoring BMD during the initial 5 years of treatment in patients taking pharmacologic agents to treat osteoporosis. Several studies showed that women treated with antiresorptive treatment benefited from reduced fractures with treatment even if BMD did not increase.

Only 10% of women with normal or mild osteopenia develop osteoporosis within 15 years; 10% of women with moderate osteopenia develop osteoporosis within 5 years, and 10% of women with advanced osteopenia develop osteoporosis within 1 year.

Recommendation: The decision about whether to treat osteopenic women older then 65 years of age who are at a high risk for fracture should be based on a discussion of with the patient about their risk of fracture and the risk and benefits of treatment. Clinicians can use their judgment regarding the qualitative risk for fracture, or a validated tool such as the FRAX tool that gives 10-year risk of any major osteoporotic fracture and of hip fracture. The FRAX site recommends consideration of treatment for individuals with low bone mass (T-score between –1.0 and –2.5 at the femoral neck or spine) and a 10-year probability of a hip fracture of at least 3% or a 10-year probability of a major osteoporosis-related fracture greater than 20%.
 

 

 

Bottom line:

Clinicians should offer pharmacologic treatment with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk of hip and vertebral fractures in women who have known osteoporosis diagnosed as a T score less than –2.5 or those with a fragility fracture. Pharmacologic therapy should be used for 5 years; however, high risk patients may benefit from longer treatment. There is no benefit to bone density monitoring during the 5-year pharmacologic treatment period. In addition, bisphosphonates should be considered in men who have clinically recognized osteoporosis.

Reference:

Qaseem, A, Forciea, MA, McLean RM, Denberg TD. Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update From the American College of Physicians. Ann Int Med. 2017;166(11):818-39.
 

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Meizinger is a second year resident in the Family Medicine Residency Program at Abington Jefferson Health.

Publications
Topics
Sections

 

Osteoporosis is defined by a clinically diagnosed fragility fracture or a bone mineral density (BMD) of at least 2.5 SD below the mean for young female adults, usually measured by dual-energy x-ray absorptiometry. Risk factors include age, female sex, post-menopause, hypogonadism or premature ovarian failure, history of cigarette smoking or alcohol consumption (3 or more drinks daily), rheumatoid arthritis, or medications including glucocorticoids, anticoagulants, anticonvulsants, and aromatase inhibitors.

This guideline update focuses on treatment with bisphosphonates (alendronate, risedronate, ibandronate, zoledronic acid) and denosumab. Denosumab, a human monoclonal antibody against RANK-ligand, approved by the Food and Drug Administration for treatment of osteoporosis, has been added to the list of allowed medications since publication of the 2008 guideline. Several therapies have been excluded from the update, including calcitonin, which is no longer widely used for osteoporosis treatment, and etidronate and pamidronate, neither of which are FDA-approved for the prevention of fractures or treatment of osteoporosis. It should be noted that the evidence continues to be insufficient regarding the effectiveness of therapies to prevent fractures or to treat osteoporosis in men.

Dr. Neil Skolnik
Recommendation: Pharmacologic treatment is recommended using alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk of hip and vertebral fractures in women who have known osteoporosis diagnosed as a T score less than –2.5 or those with fragility fracture (strong recommendation with high-quality evidence). Bisphosphonates, denosumab, teriparatide, and/or raloxifene reduce vertebral fractures. Alendronate, risedronate, zoledronic acid, and denosumab reduce both nonvertebral fractures and hip fractures. Moderate-quality evidence from one study that detected fractures radiographically showed that zoledronic acid reduced vertebral fractures in osteoporotic men. Moderate-quality evidence showed that alendronate, risedronate, and teriparatide reduced fracture risk in patients taking glucocorticoids. High-quality evidence showed that bisphosphonates are at least as effective for older patients as they are for younger patients. Evidence is insufficient to determine the comparative effectiveness of pharmacologic therapy or the superiority of one medication over another, within the same class or among classes, for prevention of fractures.

Bisphosphonates are associated with mild upper GI symptoms, atypical subtrochanteric fracture, and rare osteonecrosis of the jaw. There is no significant association between bisphosphonate use and total cardiovascular adverse events. Evidence is insufficient to associate bisphosphonates with increased cancer risk. Zoledronic acid is associated with atrial fibrillation, arthritis/arthralgias, headaches, hypocalcemia, influenza-like symptoms, and an increased incidence of uveitis/episcleritis. Denosumab is associated with mild upper GI symptoms, rash/eczema, and cellulitis.

While in the past additional medications were recommended for osteoporosis, the current guidelines recommend against using raloxifene, ibandronate, teriparatide, menopausal estrogen therapy, or menopausal estrogen plus progesterone therapy for first-line pharmacologic treatment.

The overall effect of calcium, vitamin D, or exercise alone on fracture risk is uncertain. Calcium and vitamin D may be added to treatment regimens, as a majority of trials with bisphosphonate therapy added this supplementation. Dosages should be considered because excessive dosing has been associated with hypercalcemia. Although previous data suggested an association between calcium supplementation and increased risk for myocardial infarction, moderate-quality evidence shows no association, though there is a risk of kidney stones.

Recommendation: Women who have osteoporosis and receive pharmacologic treatment should be treated for 5 years (weak recommendation; low-quality evidence). The evidence to determine the length of treatment is not strong, so recommendation is an extrapolation from existing evidence. High-risk patients may benefit from more than 5 years of treatment. Data suggests that patients treated with alendronate who had preexisting fractures or those with a BMD of –2.5 or less after 5 years of initial therapy may benefit from continued treatment, because these patients experienced a decreased incidence of new clinical vertebral fractures.

Recommendation: Pharmacologic treatment with bisphosphonates to reduce the risk for vertebral fracture can be offered to men who have clinically recognized osteoporosis (weak recommendation, low-quality evidence). No evidence suggests that outcomes associated with pharmacologic treatment would differ between men and women if based on similar BMDs.

Recommendation: Bone density monitoring is not recommended during the 5-year pharmacologic treatment period for osteoporosis in women (weak recommendation, low-quality evidence). Data showed that most women with normal dual-energy x-ray absorptiometry scores did not progress to osteoporosis within 15 years. Data also does not support monitoring BMD during the initial 5 years of treatment in patients taking pharmacologic agents to treat osteoporosis. Several studies showed that women treated with antiresorptive treatment benefited from reduced fractures with treatment even if BMD did not increase.

Only 10% of women with normal or mild osteopenia develop osteoporosis within 15 years; 10% of women with moderate osteopenia develop osteoporosis within 5 years, and 10% of women with advanced osteopenia develop osteoporosis within 1 year.

Recommendation: The decision about whether to treat osteopenic women older then 65 years of age who are at a high risk for fracture should be based on a discussion of with the patient about their risk of fracture and the risk and benefits of treatment. Clinicians can use their judgment regarding the qualitative risk for fracture, or a validated tool such as the FRAX tool that gives 10-year risk of any major osteoporotic fracture and of hip fracture. The FRAX site recommends consideration of treatment for individuals with low bone mass (T-score between –1.0 and –2.5 at the femoral neck or spine) and a 10-year probability of a hip fracture of at least 3% or a 10-year probability of a major osteoporosis-related fracture greater than 20%.
 

 

 

Bottom line:

Clinicians should offer pharmacologic treatment with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk of hip and vertebral fractures in women who have known osteoporosis diagnosed as a T score less than –2.5 or those with a fragility fracture. Pharmacologic therapy should be used for 5 years; however, high risk patients may benefit from longer treatment. There is no benefit to bone density monitoring during the 5-year pharmacologic treatment period. In addition, bisphosphonates should be considered in men who have clinically recognized osteoporosis.

Reference:

Qaseem, A, Forciea, MA, McLean RM, Denberg TD. Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update From the American College of Physicians. Ann Int Med. 2017;166(11):818-39.
 

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Meizinger is a second year resident in the Family Medicine Residency Program at Abington Jefferson Health.

 

Osteoporosis is defined by a clinically diagnosed fragility fracture or a bone mineral density (BMD) of at least 2.5 SD below the mean for young female adults, usually measured by dual-energy x-ray absorptiometry. Risk factors include age, female sex, post-menopause, hypogonadism or premature ovarian failure, history of cigarette smoking or alcohol consumption (3 or more drinks daily), rheumatoid arthritis, or medications including glucocorticoids, anticoagulants, anticonvulsants, and aromatase inhibitors.

This guideline update focuses on treatment with bisphosphonates (alendronate, risedronate, ibandronate, zoledronic acid) and denosumab. Denosumab, a human monoclonal antibody against RANK-ligand, approved by the Food and Drug Administration for treatment of osteoporosis, has been added to the list of allowed medications since publication of the 2008 guideline. Several therapies have been excluded from the update, including calcitonin, which is no longer widely used for osteoporosis treatment, and etidronate and pamidronate, neither of which are FDA-approved for the prevention of fractures or treatment of osteoporosis. It should be noted that the evidence continues to be insufficient regarding the effectiveness of therapies to prevent fractures or to treat osteoporosis in men.

Dr. Neil Skolnik
Recommendation: Pharmacologic treatment is recommended using alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk of hip and vertebral fractures in women who have known osteoporosis diagnosed as a T score less than –2.5 or those with fragility fracture (strong recommendation with high-quality evidence). Bisphosphonates, denosumab, teriparatide, and/or raloxifene reduce vertebral fractures. Alendronate, risedronate, zoledronic acid, and denosumab reduce both nonvertebral fractures and hip fractures. Moderate-quality evidence from one study that detected fractures radiographically showed that zoledronic acid reduced vertebral fractures in osteoporotic men. Moderate-quality evidence showed that alendronate, risedronate, and teriparatide reduced fracture risk in patients taking glucocorticoids. High-quality evidence showed that bisphosphonates are at least as effective for older patients as they are for younger patients. Evidence is insufficient to determine the comparative effectiveness of pharmacologic therapy or the superiority of one medication over another, within the same class or among classes, for prevention of fractures.

Bisphosphonates are associated with mild upper GI symptoms, atypical subtrochanteric fracture, and rare osteonecrosis of the jaw. There is no significant association between bisphosphonate use and total cardiovascular adverse events. Evidence is insufficient to associate bisphosphonates with increased cancer risk. Zoledronic acid is associated with atrial fibrillation, arthritis/arthralgias, headaches, hypocalcemia, influenza-like symptoms, and an increased incidence of uveitis/episcleritis. Denosumab is associated with mild upper GI symptoms, rash/eczema, and cellulitis.

While in the past additional medications were recommended for osteoporosis, the current guidelines recommend against using raloxifene, ibandronate, teriparatide, menopausal estrogen therapy, or menopausal estrogen plus progesterone therapy for first-line pharmacologic treatment.

The overall effect of calcium, vitamin D, or exercise alone on fracture risk is uncertain. Calcium and vitamin D may be added to treatment regimens, as a majority of trials with bisphosphonate therapy added this supplementation. Dosages should be considered because excessive dosing has been associated with hypercalcemia. Although previous data suggested an association between calcium supplementation and increased risk for myocardial infarction, moderate-quality evidence shows no association, though there is a risk of kidney stones.

Recommendation: Women who have osteoporosis and receive pharmacologic treatment should be treated for 5 years (weak recommendation; low-quality evidence). The evidence to determine the length of treatment is not strong, so recommendation is an extrapolation from existing evidence. High-risk patients may benefit from more than 5 years of treatment. Data suggests that patients treated with alendronate who had preexisting fractures or those with a BMD of –2.5 or less after 5 years of initial therapy may benefit from continued treatment, because these patients experienced a decreased incidence of new clinical vertebral fractures.

Recommendation: Pharmacologic treatment with bisphosphonates to reduce the risk for vertebral fracture can be offered to men who have clinically recognized osteoporosis (weak recommendation, low-quality evidence). No evidence suggests that outcomes associated with pharmacologic treatment would differ between men and women if based on similar BMDs.

Recommendation: Bone density monitoring is not recommended during the 5-year pharmacologic treatment period for osteoporosis in women (weak recommendation, low-quality evidence). Data showed that most women with normal dual-energy x-ray absorptiometry scores did not progress to osteoporosis within 15 years. Data also does not support monitoring BMD during the initial 5 years of treatment in patients taking pharmacologic agents to treat osteoporosis. Several studies showed that women treated with antiresorptive treatment benefited from reduced fractures with treatment even if BMD did not increase.

Only 10% of women with normal or mild osteopenia develop osteoporosis within 15 years; 10% of women with moderate osteopenia develop osteoporosis within 5 years, and 10% of women with advanced osteopenia develop osteoporosis within 1 year.

Recommendation: The decision about whether to treat osteopenic women older then 65 years of age who are at a high risk for fracture should be based on a discussion of with the patient about their risk of fracture and the risk and benefits of treatment. Clinicians can use their judgment regarding the qualitative risk for fracture, or a validated tool such as the FRAX tool that gives 10-year risk of any major osteoporotic fracture and of hip fracture. The FRAX site recommends consideration of treatment for individuals with low bone mass (T-score between –1.0 and –2.5 at the femoral neck or spine) and a 10-year probability of a hip fracture of at least 3% or a 10-year probability of a major osteoporosis-related fracture greater than 20%.
 

 

 

Bottom line:

Clinicians should offer pharmacologic treatment with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk of hip and vertebral fractures in women who have known osteoporosis diagnosed as a T score less than –2.5 or those with a fragility fracture. Pharmacologic therapy should be used for 5 years; however, high risk patients may benefit from longer treatment. There is no benefit to bone density monitoring during the 5-year pharmacologic treatment period. In addition, bisphosphonates should be considered in men who have clinically recognized osteoporosis.

Reference:

Qaseem, A, Forciea, MA, McLean RM, Denberg TD. Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update From the American College of Physicians. Ann Int Med. 2017;166(11):818-39.
 

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Meizinger is a second year resident in the Family Medicine Residency Program at Abington Jefferson Health.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

GOLD guidelines for the management of COPD – 2017 update

Article Type
Changed
Fri, 01/18/2019 - 16:46


Chronic obstructive lung disease (COPD) is the third leading cause of death in the United States1 and a major cause of mortality and morbidity around the world. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) released a new “2017 Report”2 with modified recommendations for the diagnosis, management, and prevention of COPD. The report contains several changes that are relevant to the primary care provider that will be outlined below.

Redefining COPD

GOLD’s definition of COPD was changed in its 2017 Report: “COPD is a common, preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitations that are due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases.” The report emphasizes that “COPD may be punctuated by periods of acute worsening of respiratory symptoms, called exacerbations.” Note that the terms “emphysema” and “chronic bronchitis” have been removed in favor of a more comprehensive description of the pathophysiology of COPD. Importantly, the report states that cough and sputum production for at least 3 months in each of 2 consecutive years, previously accepted as diagnostic criteria, are present in only a minority of patients. It is noted that chronic respiratory symptoms may exist without spirometric changes and many patients (usually smokers) have structural evidence of COPD without airflow limitation.

Dr. Skolnik and Dr. Lent

Changes to COPD initial assessment

The primary criterion for diagnosis is unchanged: post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) less than 0.70. Spirometry remains important to confirm the diagnosis in those with classic symptoms of dyspnea, chronic cough, and/or sputum production with a history of exposure to noxious particles or gases.

The GOLD assessment system previously incorporated spirometry and included an “ABCD” system such that patients in group A are least severe. Spirometry has been progressively deemphasized in favor of symptom-based classification and the 2017 Report, for the first time, dissociates spirometric findings from severity classification.

The new system uses symptom severity and exacerbation risk to classify COPD. Two specific standardized COPD symptom measurement tools, The Modified British Medical Research Council (mMRC) questionnaire and COPD Assessment Test (CAT), are reported by GOLD as the most widely used. Low symptom severity is considered an mMRC less than or equal to 1 or CAT less than or equal to 9, high symptom severity is considered an mMRC greater than or equal to 2 or CAT greater than or equal to 10. Low risk of exacerbation is defined as no more than one exacerbation not resulting in hospital admission in the last 12 months; high risk of exacerbation is defined as at least two exacerbations or any exacerbations resulting in hospital admission in the last 12 months. Symptom severity and exacerbation risk is divided into four quadrants:
 

• GOLD group A: Low symptom severity, low exacerbation risk.

• GOLD group B: High symptom severity, low exacerbation risk.

• GOLD group C: Low symptom severity, high exacerbation risk.

• GOLD group D: High symptom severity, high exacerbation risk.

Changes to prevention and management of stable COPD

Smoking cessation remains important in the prevention of COPD. The 2017 Report reflects the U.S. Preventive Services Task Force’s guidelines for smoking cessation: Offer nicotine replacement, cessation counseling, and pharmacotherapy (varenicline, bupropion or nortriptyline). There is insufficient evidence to support the use of e-cigarettes. Influenza and pneumococcal vaccinations are recommended. Pulmonary rehabilitation remains important.

The 2017 Report includes an expanded discussion of COPD medications. The role of short-acting bronchodilators (SABD) in COPD remains prominent. Changes include a stronger recommendation to use combination short-acting beta-agonists and short-acting muscarinic antagonists (SABA/SAMA) as these seem to be superior to SABD monotherapy in improving symptoms and FEV1.

There were several changes to the pharmacologic treatment algorithm. For the first time, GOLD proposes escalation strategies. Preference is given to LABA/LAMA (long-acting beta-agonist/long-acting muscarinic antagonists) combinations over LABA/ICS (long-acting beta-agonist/inhaled corticosteroid) combinations as a mainstay of treatment. The rationale for this change is that LABA/LAMAs give greater bronchodilation compared with LABA/ICS, and one study showed a decreased rate of exacerbations compared to LABA/ICS in patients with a history of exacerbations. In addition, patients with COPD who receive ICS appear to have a higher risk of developing pneumonia. GOLD recommendations are:

• Group A: Start with single bronchodilator (short- or long-acting), escalate to alternative class of bronchodilator if necessary.

• Group B: Start with LABA or LAMA, escalate to LABA/LAMA if symptoms persist.

• Group C: Start with LAMA, escalate to LABA/LAMA (preferred) or LABA/ICS if exacerbations continue.

• Group D: Start with LABA/LAMA (preferred) or LAMA monotherapy, escalate to LABA/LAMA/ICS (preferred) or try LABA/ICS before escalating to LAMA/LABA/ICS if symptoms persist or exacerbations continue; roflumilast and/or a macrolide may be considered if further exacerbations occur with LABA/LAMA/ICS.
 

 

 

Bottom line

1. GOLD classification of COPD severity is now based on clinical criteria alone: symptom assessment and risk for exacerbation.

2. SABA/SAMA combination therapy seems to be superior to either SABA or SAMA alone.

3. Patients in group A (milder symptoms, low exacerbation risk) may be initiated on either short- or long-acting bronchodilator therapy.

4. Patients in group B (milder symptoms, increased exacerbation risk) should be initiated on LAMA monotherapy.

5. LABA/LAMA combination therapy seems to be superior to LABA/ICS combination therapy and should be used when long-acting bronchodilator monotherapy fails to control symptoms or reduce exacerbations.

References

1. CDC MMWR 11/23/12

2. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 at http://goldcopd.org (accessed 3/10/2017)
 

Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital. Dr. Lent is chief resident in the program.

Publications
Topics
Sections


Chronic obstructive lung disease (COPD) is the third leading cause of death in the United States1 and a major cause of mortality and morbidity around the world. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) released a new “2017 Report”2 with modified recommendations for the diagnosis, management, and prevention of COPD. The report contains several changes that are relevant to the primary care provider that will be outlined below.

Redefining COPD

GOLD’s definition of COPD was changed in its 2017 Report: “COPD is a common, preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitations that are due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases.” The report emphasizes that “COPD may be punctuated by periods of acute worsening of respiratory symptoms, called exacerbations.” Note that the terms “emphysema” and “chronic bronchitis” have been removed in favor of a more comprehensive description of the pathophysiology of COPD. Importantly, the report states that cough and sputum production for at least 3 months in each of 2 consecutive years, previously accepted as diagnostic criteria, are present in only a minority of patients. It is noted that chronic respiratory symptoms may exist without spirometric changes and many patients (usually smokers) have structural evidence of COPD without airflow limitation.

Dr. Skolnik and Dr. Lent

Changes to COPD initial assessment

The primary criterion for diagnosis is unchanged: post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) less than 0.70. Spirometry remains important to confirm the diagnosis in those with classic symptoms of dyspnea, chronic cough, and/or sputum production with a history of exposure to noxious particles or gases.

The GOLD assessment system previously incorporated spirometry and included an “ABCD” system such that patients in group A are least severe. Spirometry has been progressively deemphasized in favor of symptom-based classification and the 2017 Report, for the first time, dissociates spirometric findings from severity classification.

The new system uses symptom severity and exacerbation risk to classify COPD. Two specific standardized COPD symptom measurement tools, The Modified British Medical Research Council (mMRC) questionnaire and COPD Assessment Test (CAT), are reported by GOLD as the most widely used. Low symptom severity is considered an mMRC less than or equal to 1 or CAT less than or equal to 9, high symptom severity is considered an mMRC greater than or equal to 2 or CAT greater than or equal to 10. Low risk of exacerbation is defined as no more than one exacerbation not resulting in hospital admission in the last 12 months; high risk of exacerbation is defined as at least two exacerbations or any exacerbations resulting in hospital admission in the last 12 months. Symptom severity and exacerbation risk is divided into four quadrants:
 

• GOLD group A: Low symptom severity, low exacerbation risk.

• GOLD group B: High symptom severity, low exacerbation risk.

• GOLD group C: Low symptom severity, high exacerbation risk.

• GOLD group D: High symptom severity, high exacerbation risk.

Changes to prevention and management of stable COPD

Smoking cessation remains important in the prevention of COPD. The 2017 Report reflects the U.S. Preventive Services Task Force’s guidelines for smoking cessation: Offer nicotine replacement, cessation counseling, and pharmacotherapy (varenicline, bupropion or nortriptyline). There is insufficient evidence to support the use of e-cigarettes. Influenza and pneumococcal vaccinations are recommended. Pulmonary rehabilitation remains important.

The 2017 Report includes an expanded discussion of COPD medications. The role of short-acting bronchodilators (SABD) in COPD remains prominent. Changes include a stronger recommendation to use combination short-acting beta-agonists and short-acting muscarinic antagonists (SABA/SAMA) as these seem to be superior to SABD monotherapy in improving symptoms and FEV1.

There were several changes to the pharmacologic treatment algorithm. For the first time, GOLD proposes escalation strategies. Preference is given to LABA/LAMA (long-acting beta-agonist/long-acting muscarinic antagonists) combinations over LABA/ICS (long-acting beta-agonist/inhaled corticosteroid) combinations as a mainstay of treatment. The rationale for this change is that LABA/LAMAs give greater bronchodilation compared with LABA/ICS, and one study showed a decreased rate of exacerbations compared to LABA/ICS in patients with a history of exacerbations. In addition, patients with COPD who receive ICS appear to have a higher risk of developing pneumonia. GOLD recommendations are:

• Group A: Start with single bronchodilator (short- or long-acting), escalate to alternative class of bronchodilator if necessary.

• Group B: Start with LABA or LAMA, escalate to LABA/LAMA if symptoms persist.

• Group C: Start with LAMA, escalate to LABA/LAMA (preferred) or LABA/ICS if exacerbations continue.

• Group D: Start with LABA/LAMA (preferred) or LAMA monotherapy, escalate to LABA/LAMA/ICS (preferred) or try LABA/ICS before escalating to LAMA/LABA/ICS if symptoms persist or exacerbations continue; roflumilast and/or a macrolide may be considered if further exacerbations occur with LABA/LAMA/ICS.
 

 

 

Bottom line

1. GOLD classification of COPD severity is now based on clinical criteria alone: symptom assessment and risk for exacerbation.

2. SABA/SAMA combination therapy seems to be superior to either SABA or SAMA alone.

3. Patients in group A (milder symptoms, low exacerbation risk) may be initiated on either short- or long-acting bronchodilator therapy.

4. Patients in group B (milder symptoms, increased exacerbation risk) should be initiated on LAMA monotherapy.

5. LABA/LAMA combination therapy seems to be superior to LABA/ICS combination therapy and should be used when long-acting bronchodilator monotherapy fails to control symptoms or reduce exacerbations.

References

1. CDC MMWR 11/23/12

2. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 at http://goldcopd.org (accessed 3/10/2017)
 

Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital. Dr. Lent is chief resident in the program.


Chronic obstructive lung disease (COPD) is the third leading cause of death in the United States1 and a major cause of mortality and morbidity around the world. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) released a new “2017 Report”2 with modified recommendations for the diagnosis, management, and prevention of COPD. The report contains several changes that are relevant to the primary care provider that will be outlined below.

Redefining COPD

GOLD’s definition of COPD was changed in its 2017 Report: “COPD is a common, preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitations that are due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases.” The report emphasizes that “COPD may be punctuated by periods of acute worsening of respiratory symptoms, called exacerbations.” Note that the terms “emphysema” and “chronic bronchitis” have been removed in favor of a more comprehensive description of the pathophysiology of COPD. Importantly, the report states that cough and sputum production for at least 3 months in each of 2 consecutive years, previously accepted as diagnostic criteria, are present in only a minority of patients. It is noted that chronic respiratory symptoms may exist without spirometric changes and many patients (usually smokers) have structural evidence of COPD without airflow limitation.

Dr. Skolnik and Dr. Lent

Changes to COPD initial assessment

The primary criterion for diagnosis is unchanged: post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) less than 0.70. Spirometry remains important to confirm the diagnosis in those with classic symptoms of dyspnea, chronic cough, and/or sputum production with a history of exposure to noxious particles or gases.

The GOLD assessment system previously incorporated spirometry and included an “ABCD” system such that patients in group A are least severe. Spirometry has been progressively deemphasized in favor of symptom-based classification and the 2017 Report, for the first time, dissociates spirometric findings from severity classification.

The new system uses symptom severity and exacerbation risk to classify COPD. Two specific standardized COPD symptom measurement tools, The Modified British Medical Research Council (mMRC) questionnaire and COPD Assessment Test (CAT), are reported by GOLD as the most widely used. Low symptom severity is considered an mMRC less than or equal to 1 or CAT less than or equal to 9, high symptom severity is considered an mMRC greater than or equal to 2 or CAT greater than or equal to 10. Low risk of exacerbation is defined as no more than one exacerbation not resulting in hospital admission in the last 12 months; high risk of exacerbation is defined as at least two exacerbations or any exacerbations resulting in hospital admission in the last 12 months. Symptom severity and exacerbation risk is divided into four quadrants:
 

• GOLD group A: Low symptom severity, low exacerbation risk.

• GOLD group B: High symptom severity, low exacerbation risk.

• GOLD group C: Low symptom severity, high exacerbation risk.

• GOLD group D: High symptom severity, high exacerbation risk.

Changes to prevention and management of stable COPD

Smoking cessation remains important in the prevention of COPD. The 2017 Report reflects the U.S. Preventive Services Task Force’s guidelines for smoking cessation: Offer nicotine replacement, cessation counseling, and pharmacotherapy (varenicline, bupropion or nortriptyline). There is insufficient evidence to support the use of e-cigarettes. Influenza and pneumococcal vaccinations are recommended. Pulmonary rehabilitation remains important.

The 2017 Report includes an expanded discussion of COPD medications. The role of short-acting bronchodilators (SABD) in COPD remains prominent. Changes include a stronger recommendation to use combination short-acting beta-agonists and short-acting muscarinic antagonists (SABA/SAMA) as these seem to be superior to SABD monotherapy in improving symptoms and FEV1.

There were several changes to the pharmacologic treatment algorithm. For the first time, GOLD proposes escalation strategies. Preference is given to LABA/LAMA (long-acting beta-agonist/long-acting muscarinic antagonists) combinations over LABA/ICS (long-acting beta-agonist/inhaled corticosteroid) combinations as a mainstay of treatment. The rationale for this change is that LABA/LAMAs give greater bronchodilation compared with LABA/ICS, and one study showed a decreased rate of exacerbations compared to LABA/ICS in patients with a history of exacerbations. In addition, patients with COPD who receive ICS appear to have a higher risk of developing pneumonia. GOLD recommendations are:

• Group A: Start with single bronchodilator (short- or long-acting), escalate to alternative class of bronchodilator if necessary.

• Group B: Start with LABA or LAMA, escalate to LABA/LAMA if symptoms persist.

• Group C: Start with LAMA, escalate to LABA/LAMA (preferred) or LABA/ICS if exacerbations continue.

• Group D: Start with LABA/LAMA (preferred) or LAMA monotherapy, escalate to LABA/LAMA/ICS (preferred) or try LABA/ICS before escalating to LAMA/LABA/ICS if symptoms persist or exacerbations continue; roflumilast and/or a macrolide may be considered if further exacerbations occur with LABA/LAMA/ICS.
 

 

 

Bottom line

1. GOLD classification of COPD severity is now based on clinical criteria alone: symptom assessment and risk for exacerbation.

2. SABA/SAMA combination therapy seems to be superior to either SABA or SAMA alone.

3. Patients in group A (milder symptoms, low exacerbation risk) may be initiated on either short- or long-acting bronchodilator therapy.

4. Patients in group B (milder symptoms, increased exacerbation risk) should be initiated on LAMA monotherapy.

5. LABA/LAMA combination therapy seems to be superior to LABA/ICS combination therapy and should be used when long-acting bronchodilator monotherapy fails to control symptoms or reduce exacerbations.

References

1. CDC MMWR 11/23/12

2. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 at http://goldcopd.org (accessed 3/10/2017)
 

Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital. Dr. Lent is chief resident in the program.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME

AGA Guideline: Transient elastography in liver fibrosis, most used and most accurate

Article Type
Changed
Fri, 01/18/2019 - 16:40

Vibration-controlled transient elastography (VCTE) can accurately diagnose cirrhosis in most patients with chronic liver disease, particularly those with chronic hepatitis B or C, states a new guideline from the AGA Institute, published in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2017.03.017).

 
 

 

Publications
Topics
Sections

Vibration-controlled transient elastography (VCTE) can accurately diagnose cirrhosis in most patients with chronic liver disease, particularly those with chronic hepatitis B or C, states a new guideline from the AGA Institute, published in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2017.03.017).

 
 

 

Vibration-controlled transient elastography (VCTE) can accurately diagnose cirrhosis in most patients with chronic liver disease, particularly those with chronic hepatitis B or C, states a new guideline from the AGA Institute, published in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2017.03.017).

 
 

 

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Article Source

FROM GASTROENTEROLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME

AGA Clinical Practice Update: Expert review recommendations on post-SVR hepatitis C care

Article Type
Changed
Fri, 01/18/2019 - 16:39

 

The AGA Institute issued a clinical practice update for managing hepatitis C virus–infected patients who achieve a sustained virologic response after antiviral therapy, who still require ongoing care for their liver disease. The expert review appears in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2017.03.018).

Even though direct-acting antiviral regimens have produced remarkably high sustained virologic response (SVR) rates and it appears that fewer than 1% of patients relapse, and even though liver fibrosis and cirrhosis may regress with this therapy, continued surveillance and even intervention may be needed “to reduce complications arising from liver damage that has already accrued by the time SVR was attained,” said Ira M. Jacobson, MD, AGAF, chair of the department of medicine, Mount Sinai Beth Israel Medical Center, New York, and his associates.

Dr. Ira M. Jacobson
“Of greatest concern is the ongoing risk of hepatocellular carcinoma,” they noted.

Dr. Jacobson and his associates at the AGA Institute reviewed the current literature and expert opinion to formulate 11 best-practice recommendations for managing this patient population. Among their recommendations:

SVR should be confirmed by hepatitis C virus RNA testing at 12 weeks after completion of an all-oral direct-acting antiviral regimen, and routine confirmation after 48 weeks is also “prudent.” Further testing for later virologic relapse is not supported by the available evidence. However, further periodic testing is advised for patients at risk for reinfection, such as those who continue to use IV drugs.

All patients with stage 3 or higher liver fibrosis or cirrhosis before achieving SVR should continue to be monitored by liver imaging (with or without serum alpha fetoprotein testing) twice a year “for an indefinite duration.” At present, there is no evidence of a finite point beyond which the risk of hepatocellular carcinoma is reduced to the level of people who don’t have a history of liver disease. And there have been documented cases of hepatocellular carcinoma developing more than 5 years after attaining SVR.

Regardless of SVR status, all patients with liver cirrhosis should undergo endoscopic screening for esophagogastric varices. If no varices or only small varices are detected, repeat endoscopy should be done 2-3 years after achieving SVR. If no varices are identified then, “cessation of further endoscopic screening may be considered on an individual patient basis if there are no risk factors for progressive cirrhosis.”

Noninvasive assessment of fibrosis, such as liver elastography, may be considered on an individual basis after SVR is attained, to assess whether fibrosis has progressed or regressed or to guide clinical management.

All patients who achieve SVR must be counseled regarding factors that could further injure the liver and contribute to the progression of fibrosis, hepatic decompensation, or the development of hepatocellular carcinoma. These include alcohol consumption, fatty liver, diabetes, and potential toxins. If serum liver enzyme levels rise, all patients should be evaluated for possible liver injury.

Publications
Topics
Sections

 

The AGA Institute issued a clinical practice update for managing hepatitis C virus–infected patients who achieve a sustained virologic response after antiviral therapy, who still require ongoing care for their liver disease. The expert review appears in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2017.03.018).

Even though direct-acting antiviral regimens have produced remarkably high sustained virologic response (SVR) rates and it appears that fewer than 1% of patients relapse, and even though liver fibrosis and cirrhosis may regress with this therapy, continued surveillance and even intervention may be needed “to reduce complications arising from liver damage that has already accrued by the time SVR was attained,” said Ira M. Jacobson, MD, AGAF, chair of the department of medicine, Mount Sinai Beth Israel Medical Center, New York, and his associates.

Dr. Ira M. Jacobson
“Of greatest concern is the ongoing risk of hepatocellular carcinoma,” they noted.

Dr. Jacobson and his associates at the AGA Institute reviewed the current literature and expert opinion to formulate 11 best-practice recommendations for managing this patient population. Among their recommendations:

SVR should be confirmed by hepatitis C virus RNA testing at 12 weeks after completion of an all-oral direct-acting antiviral regimen, and routine confirmation after 48 weeks is also “prudent.” Further testing for later virologic relapse is not supported by the available evidence. However, further periodic testing is advised for patients at risk for reinfection, such as those who continue to use IV drugs.

All patients with stage 3 or higher liver fibrosis or cirrhosis before achieving SVR should continue to be monitored by liver imaging (with or without serum alpha fetoprotein testing) twice a year “for an indefinite duration.” At present, there is no evidence of a finite point beyond which the risk of hepatocellular carcinoma is reduced to the level of people who don’t have a history of liver disease. And there have been documented cases of hepatocellular carcinoma developing more than 5 years after attaining SVR.

Regardless of SVR status, all patients with liver cirrhosis should undergo endoscopic screening for esophagogastric varices. If no varices or only small varices are detected, repeat endoscopy should be done 2-3 years after achieving SVR. If no varices are identified then, “cessation of further endoscopic screening may be considered on an individual patient basis if there are no risk factors for progressive cirrhosis.”

Noninvasive assessment of fibrosis, such as liver elastography, may be considered on an individual basis after SVR is attained, to assess whether fibrosis has progressed or regressed or to guide clinical management.

All patients who achieve SVR must be counseled regarding factors that could further injure the liver and contribute to the progression of fibrosis, hepatic decompensation, or the development of hepatocellular carcinoma. These include alcohol consumption, fatty liver, diabetes, and potential toxins. If serum liver enzyme levels rise, all patients should be evaluated for possible liver injury.

 

The AGA Institute issued a clinical practice update for managing hepatitis C virus–infected patients who achieve a sustained virologic response after antiviral therapy, who still require ongoing care for their liver disease. The expert review appears in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2017.03.018).

Even though direct-acting antiviral regimens have produced remarkably high sustained virologic response (SVR) rates and it appears that fewer than 1% of patients relapse, and even though liver fibrosis and cirrhosis may regress with this therapy, continued surveillance and even intervention may be needed “to reduce complications arising from liver damage that has already accrued by the time SVR was attained,” said Ira M. Jacobson, MD, AGAF, chair of the department of medicine, Mount Sinai Beth Israel Medical Center, New York, and his associates.

Dr. Ira M. Jacobson
“Of greatest concern is the ongoing risk of hepatocellular carcinoma,” they noted.

Dr. Jacobson and his associates at the AGA Institute reviewed the current literature and expert opinion to formulate 11 best-practice recommendations for managing this patient population. Among their recommendations:

SVR should be confirmed by hepatitis C virus RNA testing at 12 weeks after completion of an all-oral direct-acting antiviral regimen, and routine confirmation after 48 weeks is also “prudent.” Further testing for later virologic relapse is not supported by the available evidence. However, further periodic testing is advised for patients at risk for reinfection, such as those who continue to use IV drugs.

All patients with stage 3 or higher liver fibrosis or cirrhosis before achieving SVR should continue to be monitored by liver imaging (with or without serum alpha fetoprotein testing) twice a year “for an indefinite duration.” At present, there is no evidence of a finite point beyond which the risk of hepatocellular carcinoma is reduced to the level of people who don’t have a history of liver disease. And there have been documented cases of hepatocellular carcinoma developing more than 5 years after attaining SVR.

Regardless of SVR status, all patients with liver cirrhosis should undergo endoscopic screening for esophagogastric varices. If no varices or only small varices are detected, repeat endoscopy should be done 2-3 years after achieving SVR. If no varices are identified then, “cessation of further endoscopic screening may be considered on an individual patient basis if there are no risk factors for progressive cirrhosis.”

Noninvasive assessment of fibrosis, such as liver elastography, may be considered on an individual basis after SVR is attained, to assess whether fibrosis has progressed or regressed or to guide clinical management.

All patients who achieve SVR must be counseled regarding factors that could further injure the liver and contribute to the progression of fibrosis, hepatic decompensation, or the development of hepatocellular carcinoma. These include alcohol consumption, fatty liver, diabetes, and potential toxins. If serum liver enzyme levels rise, all patients should be evaluated for possible liver injury.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: The AGA Institute issued a clinical practice update for managing HCV patients who achieve a sustained virologic response after antiviral therapy, who still require ongoing care for their liver disease.

Major finding: SVR should be confirmed by HCV RNA testing at 12 weeks after completion of an all-oral direct-acting antiviral regimen, and routine confirmation after 48 weeks is also “prudent.”

Data source: A review of the literature and of expert opinion to compile 11 best-practice recommendations for managing post-SVR HCV care.

Disclosures: This work was supported by the AGA Institute. Dr. Jacobson reported ties to AbbVie, Bristol-Myers Squibb, Gilead, Intercept, Janssen, Merck, and Trek; one of his associates reported ties to those groups and to Target PharmaSolutions.

New guideline: Address GTCS frequency to reduce SUDEP risk

Article Type
Changed
Fri, 01/18/2019 - 16:42

 

– Generalized tonic-clonic seizures (GTCS) are a major risk factor for sudden unexpected death in epilepsy (SUDEP), which underscores the importance of advising people with epilepsy about controlling such seizures, according to a new practice guideline from the American Academy of Neurology and the American Epilepsy Society.

Though SUDEP is rare, with an incidence rate of 0.22/1,000 patient-years in children with epilepsy and 1.2/1,000 patient-years in adults with epilepsy, the guideline committee found that people with three or more GTCS per year are 15 times more likely to die suddenly than are those without this seizure type. The risk increases with increasing GTCS frequency. This translates to an absolute risk of up to 18 deaths per 1,000 patient-years for people with epilepsy who have frequent GTCS.

Sharon Worcester/Frontline Medical News
Dr. Cynthia Harden
“It is important that the rate of occurrence of SUDEP and the specific risk factors for SUDEP are communicated to persons and families affected by epilepsy,” lead guideline author, Cynthia L. Harden, MD, said during a press conference at the annual meeting of the American Academy of Neurology. “Our guideline brings clarity to the discussion, giving health care providers practical information they can use to help people with epilepsy reduce their risk.”

Specifically, the guideline recommends that health care providers should tell people with epilepsy that controlling seizures, especially GTCS, may reduce the risk of SUDEP, she said, adding that the guideline shows that “being free of seizures, particularly tonic-clonic seizures, is strongly associated with a decreased risk.”

Sharon Worcester/Frontline Medical News
Dr. Elizabeth Donner
“This guideline makes the conversation much easier with information that may motivate people to take their medications on time, to never skip taking their medications, and to learn and manage their seizure triggers so they can work toward reducing seizures. People who follow their medication schedule or pursue other treatments such as epilepsy surgery may be more likely to become seizure free,” said Dr. Harden, director of Epilepsy Services for the Mount Sinai Health System in New York.

Guideline coauthor, Elizabeth Donner, MD, added that, for this reason, the guideline recommends “that health professionals work with people who continue to have, specifically, these kind of seizures to try and reduce them with medications or with epilepsy surgery, actively weighing the risks and benefits of any new approach to seizure management.”

The recommendations are based on moderate (Level B) evidence.

The team also looked at numerous other risk factors for SUDEP and found that the strength of the evidence was too weak to support additional recommendations, said Dr. Donner, director of the comprehensive epilepsy program at The Hospital for Sick Children in Toronto and chair of the American Epilepsy Society SUDEP Task Force.

“More research is now needed to identify other preventable risk factors for SUDEP so that we can focus future studies on finding ways to reduce how often SUDEP occurs,” she added.

While the message regarding the importance of reducing seizure frequency is not new, it is important that this message be reiterated in the context of SUDEP, Dr. Donner said.

“It’s very important for it to be clear that the risk of frequent generalized tonic-clonic seizures – and we’re not talking about really frequent here; we’re talking about significant increased risk of death with only three per year – is not related only to maintaining a driver’s license, maintaining work, or other outcomes like that. It’s actually related to risk of death,” she said, noting that she hopes this is a motivator for pursuing treatments beyond medication when medication isn’t successful for treating seizures.

The guideline, which is endorsed by the International Child Neurology Association, is available online and in print (Neurology. 2017;88:1674–80).

Dr. Harden receives royalties from Wiley and Up-to-Date. Dr. Donner has received research support from the Canadian Institutes of Health Research, Dravet Canada, and SUDEP Aware. Other guideline authors reported numerous disclosures, including many industry sources.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

– Generalized tonic-clonic seizures (GTCS) are a major risk factor for sudden unexpected death in epilepsy (SUDEP), which underscores the importance of advising people with epilepsy about controlling such seizures, according to a new practice guideline from the American Academy of Neurology and the American Epilepsy Society.

Though SUDEP is rare, with an incidence rate of 0.22/1,000 patient-years in children with epilepsy and 1.2/1,000 patient-years in adults with epilepsy, the guideline committee found that people with three or more GTCS per year are 15 times more likely to die suddenly than are those without this seizure type. The risk increases with increasing GTCS frequency. This translates to an absolute risk of up to 18 deaths per 1,000 patient-years for people with epilepsy who have frequent GTCS.

Sharon Worcester/Frontline Medical News
Dr. Cynthia Harden
“It is important that the rate of occurrence of SUDEP and the specific risk factors for SUDEP are communicated to persons and families affected by epilepsy,” lead guideline author, Cynthia L. Harden, MD, said during a press conference at the annual meeting of the American Academy of Neurology. “Our guideline brings clarity to the discussion, giving health care providers practical information they can use to help people with epilepsy reduce their risk.”

Specifically, the guideline recommends that health care providers should tell people with epilepsy that controlling seizures, especially GTCS, may reduce the risk of SUDEP, she said, adding that the guideline shows that “being free of seizures, particularly tonic-clonic seizures, is strongly associated with a decreased risk.”

Sharon Worcester/Frontline Medical News
Dr. Elizabeth Donner
“This guideline makes the conversation much easier with information that may motivate people to take their medications on time, to never skip taking their medications, and to learn and manage their seizure triggers so they can work toward reducing seizures. People who follow their medication schedule or pursue other treatments such as epilepsy surgery may be more likely to become seizure free,” said Dr. Harden, director of Epilepsy Services for the Mount Sinai Health System in New York.

Guideline coauthor, Elizabeth Donner, MD, added that, for this reason, the guideline recommends “that health professionals work with people who continue to have, specifically, these kind of seizures to try and reduce them with medications or with epilepsy surgery, actively weighing the risks and benefits of any new approach to seizure management.”

The recommendations are based on moderate (Level B) evidence.

The team also looked at numerous other risk factors for SUDEP and found that the strength of the evidence was too weak to support additional recommendations, said Dr. Donner, director of the comprehensive epilepsy program at The Hospital for Sick Children in Toronto and chair of the American Epilepsy Society SUDEP Task Force.

“More research is now needed to identify other preventable risk factors for SUDEP so that we can focus future studies on finding ways to reduce how often SUDEP occurs,” she added.

While the message regarding the importance of reducing seizure frequency is not new, it is important that this message be reiterated in the context of SUDEP, Dr. Donner said.

“It’s very important for it to be clear that the risk of frequent generalized tonic-clonic seizures – and we’re not talking about really frequent here; we’re talking about significant increased risk of death with only three per year – is not related only to maintaining a driver’s license, maintaining work, or other outcomes like that. It’s actually related to risk of death,” she said, noting that she hopes this is a motivator for pursuing treatments beyond medication when medication isn’t successful for treating seizures.

The guideline, which is endorsed by the International Child Neurology Association, is available online and in print (Neurology. 2017;88:1674–80).

Dr. Harden receives royalties from Wiley and Up-to-Date. Dr. Donner has received research support from the Canadian Institutes of Health Research, Dravet Canada, and SUDEP Aware. Other guideline authors reported numerous disclosures, including many industry sources.

 

– Generalized tonic-clonic seizures (GTCS) are a major risk factor for sudden unexpected death in epilepsy (SUDEP), which underscores the importance of advising people with epilepsy about controlling such seizures, according to a new practice guideline from the American Academy of Neurology and the American Epilepsy Society.

Though SUDEP is rare, with an incidence rate of 0.22/1,000 patient-years in children with epilepsy and 1.2/1,000 patient-years in adults with epilepsy, the guideline committee found that people with three or more GTCS per year are 15 times more likely to die suddenly than are those without this seizure type. The risk increases with increasing GTCS frequency. This translates to an absolute risk of up to 18 deaths per 1,000 patient-years for people with epilepsy who have frequent GTCS.

Sharon Worcester/Frontline Medical News
Dr. Cynthia Harden
“It is important that the rate of occurrence of SUDEP and the specific risk factors for SUDEP are communicated to persons and families affected by epilepsy,” lead guideline author, Cynthia L. Harden, MD, said during a press conference at the annual meeting of the American Academy of Neurology. “Our guideline brings clarity to the discussion, giving health care providers practical information they can use to help people with epilepsy reduce their risk.”

Specifically, the guideline recommends that health care providers should tell people with epilepsy that controlling seizures, especially GTCS, may reduce the risk of SUDEP, she said, adding that the guideline shows that “being free of seizures, particularly tonic-clonic seizures, is strongly associated with a decreased risk.”

Sharon Worcester/Frontline Medical News
Dr. Elizabeth Donner
“This guideline makes the conversation much easier with information that may motivate people to take their medications on time, to never skip taking their medications, and to learn and manage their seizure triggers so they can work toward reducing seizures. People who follow their medication schedule or pursue other treatments such as epilepsy surgery may be more likely to become seizure free,” said Dr. Harden, director of Epilepsy Services for the Mount Sinai Health System in New York.

Guideline coauthor, Elizabeth Donner, MD, added that, for this reason, the guideline recommends “that health professionals work with people who continue to have, specifically, these kind of seizures to try and reduce them with medications or with epilepsy surgery, actively weighing the risks and benefits of any new approach to seizure management.”

The recommendations are based on moderate (Level B) evidence.

The team also looked at numerous other risk factors for SUDEP and found that the strength of the evidence was too weak to support additional recommendations, said Dr. Donner, director of the comprehensive epilepsy program at The Hospital for Sick Children in Toronto and chair of the American Epilepsy Society SUDEP Task Force.

“More research is now needed to identify other preventable risk factors for SUDEP so that we can focus future studies on finding ways to reduce how often SUDEP occurs,” she added.

While the message regarding the importance of reducing seizure frequency is not new, it is important that this message be reiterated in the context of SUDEP, Dr. Donner said.

“It’s very important for it to be clear that the risk of frequent generalized tonic-clonic seizures – and we’re not talking about really frequent here; we’re talking about significant increased risk of death with only three per year – is not related only to maintaining a driver’s license, maintaining work, or other outcomes like that. It’s actually related to risk of death,” she said, noting that she hopes this is a motivator for pursuing treatments beyond medication when medication isn’t successful for treating seizures.

The guideline, which is endorsed by the International Child Neurology Association, is available online and in print (Neurology. 2017;88:1674–80).

Dr. Harden receives royalties from Wiley and Up-to-Date. Dr. Donner has received research support from the Canadian Institutes of Health Research, Dravet Canada, and SUDEP Aware. Other guideline authors reported numerous disclosures, including many industry sources.

Publications
Publications
Topics
Article Type
Sections
Article Source

AT AAN 2017

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME

NCCN myelofibrosis guideline: Patient voice is key

Article Type
Changed
Fri, 01/04/2019 - 10:02

 

– Referral to a specialized center with expertise in the management of myeloproliferative neoplasms is strongly recommended for all patients diagnosed with myelofibrosis, according to a new treatment guideline from the National Comprehensive Cancer Network.

The guideline is the first in a series addressing myeloproliferative neoplasms (MPNs), and it focuses on the diagnostic work-up of MPNs, as well as the treatment of myelofibrosis. The guideline panel, led by panel chair Ruben A. Mesa, MD, is working next on guidelines for the other two “core classic” Philadelphia chromosome–negative MPNs: polycythemia vera, and essential thrombocythemia.

Sharon Worcester/Frontline Medical News
Dr. Ruben A. Mesa
Myelofibrosis was addressed first, as it represented the greatest unmet need in terms of guidance, Dr. Mesa said at the annual conference of the National Comprehensive Cancer Network.

Nearly two-thirds of myelofibrosis patients have intermediate-risk 2 or high-risk disease, and treatment decisions in these patients are complex and require patient input – particularly in candidates for allogeneic hematopoietic stem cell transplantation, he said.

“These diseases can be a little different than other malignant diseases,” Dr. Mesa said, explaining that while there is a clear risk of progression to acute myeloid leukemia, and from polycythemia vera and essential thrombocythemia to myelofibrosis, and while the diseases can be fatal, the burden patients face is not solely related to mortality.

There are implications in terms of health that are independent of that, such as the risk of thrombosis and bleeding, the potential for cytopenia, and severe splenomegaly that results in significant symptoms, he said.

Further, while molecular mutations and their implications for prognosis are a “rapidly moving part of the discussion,” the care of patients with MPNs involves far more than a molecular understanding of the disease.

In fact, the role of molecular changes in these patients is speculative, he said.

While such changes can be assessed and used for patient stratification, their role in myelofibrosis – unlike in other diseases such as chronic myeloid leukemia where the level of change in a target gene is highly relevant and prognostic, is not yet clear.

Thus, a core aspect of the guideline is inclusion of the voice of the patient in individualizing care, he said, noting that many factors should be considered, including how well the patient metabolizes drugs, and the symptom profile, psychosocial circumstances, support structure, and personal beliefs.

“It’s not solely about the tumor,” he stressed.

In fact, the answer to the question of whether a patient can be symptomatic enough to require a specific treatment is “no,” because of the potential for side effects, risk, expense, and other considerations.

“So the voice of the patient is always a key part [of the decision],” he said, noting also that as with all NCCN guidelines, this guideline is a partnership with the treating physician; deciding who is a transplant candidate is a nuanced issue for which the panel provides “discussion and guidance.”

“But clearly, these guidelines are the most useful and helpful in the setting of experienced providers bringing all of their experiences to bear,” he said.

In general, however, the guidelines call for allogeneic hematopoietic stem cell transplantation (HCT) in those with intermediate-risk 2 or high-risk disease who are transplant candidates, and treatment based on assessment of symptom burden (using the MPN–Symptom Assessment Form Total Symptom Score–10 Items) in those who are not HCT candidates. Those with platelets at 50,000 or below should be considered for clinical trial enrollment, and those with platelets above 50,000 should be considered for a clinical trial or treatment with the oral JAK1 and JAK2 inhibitor ruxolitinib, which has been shown to have beneficial effects on both symptoms and survival and which is approved for patients with platelets above 50,000. .

Treated patients should be monitored for response and for signs and symptoms of disease progression every 3-6 months. Treatment should continue in those who respond, as well as in those who do not – as long as there is no disease progression.

Those with progressive disease include patients who are moving toward acute leukemia, and those with overt acute leukemia.

“Here is where the key decision occurs. Are they or are they not a transplant candidate? If they are a candidate, we have a potentially curative track which would include cytoreduction followed by transplant,” Dr. Mesa said.

Cytoreduction can involve hypomethylating agents if the patient doesn’t have excess blast cells or too high a burden of disease.

Acute myeloid leukemia–like induction chemotherapy followed by allogeneic HCT is also an option in these patients.

As for treatment of low-risk myelofibrosis, the guideline states that asymptomatic patients can be observed or enrolled in a clinical trial and monitored for progression every 3-6 months, and that symptomatic patients should receive ruxolitinib or interferons (which are used off label), or be enrolled in a clinical trial. Treatment is important for patients with particularly difficult symptoms, he said, noting that some patients have had pruritus so severe that they have committed suicide. Treatment should continue unless monitoring shows signs of progression to intermediate risk 1, intermediate risk 2/high-risk, or advanced stage disease.

For those with intermediate risk 1 disease, the guideline calls for observation or ruxolitinib in those who are symptomatic, or clinical trial enrollment or allogeneic HCT. Treatment should continue unless monitoring shows disease progression, in which case the appropriate algorithm should be considered.

The guideline also addresses several special circumstances, including the management of anemia in myelofibrosis patients, which can be a difficult issue, he said.

Since the guideline was first published in December, two updates have been incorporated, and Dr. Mesa said that he anticipates regular updates given the rapidly evolving understanding of MPNs and new findings with respect to potential treatment strategies.

He noted that a number of drugs are currently in clinical trials involving patients with myelofibrosis, including the JAK2/FLT3 inhibitor pacritinib, the JAK1/JAK2 inhibitor momelotinib, the active antifibrosing agent PRM-151, and the telomerase inhibitor imetelstat, as well as numerous drug combinations.

Going forward, the guideline panel will be focusing on four different areas of assessment, including new therapies and new genetic therapies, improving transplant outcomes, MPN symptom and quality of life assessment, and nonpharmacologic interventions such as yoga.

“We certainly hope to complement things over time, to look not only at pharmacologic interventions, but others that patients may be able to utilize from a toolkit of resources,” he said.

 

 

COMFORT-1 update: ruxolitinib responses durable in myelofibrosis

To date, ruxolitinib is the only Food and Drug Administration–approved drug for the treatment of myelofibrosis.

The randomized controlled phase III COMFORT I and II trials conducted in the United States and Europe, respectively, demonstrated that the oral JAK1/JAK2 inhibitor has a rapid, beneficial impact on both survival and disease-associated enlargement of the spleen and improvement in related symptoms, Dr. Mesa said.

A 5-year update on data from 309 patients in the COMFORT-1 trial, as reported at the annual meeting of the American Society of Clinical Oncology in 2016, confirmed the durability of treatment responses to ruxolitinib in patients initially randomized to receive the drug, he said.

“We were able to demonstrate a continued survival advantage for those individuals receiving ruxolitinib,” he added.

At weeks 24 and 264, the mean spleen volume reduction was 31.6% and 37.6%, respectively, in those originally randomized to ruxolitinib. The median duration of at least 35% spleen volume reduction was 168.3 weeks.

Overall survival favored ruxolitinib (hazard ratio, 0.69). Median overall survival in the ruxolitinib group had not yet been reached.

“But we realize our work is not done. The survival curve does not plateau; we are not curing these patients. We’re having meaningful impact, but we have room to continue to improve,” he said.

Also, there is an initial drop in platelet counts that tends to stabilize, but not improve, and there is worsening of anemia (new onset grade 3 or 4 anemia was 25.2% with ruxolitinib, and 26.1% in 111 of 154 patients who crossed over from the placebo group), and although this tends to improve, these are among areas of unmet need, he added.

Further, long-term risks of treatment include cutaneous malignancies (basal cell carcinoma occurred in 7.7% and 9.0% of treatment and crossover patients, respectively), which are difficult to separate from baseline hydroxyurea use, and increased risk of herpes zoster (which occurred in 10.3% and 13.5% of treated and crossover patients).

However, there appears to be no increased risk – and there may be a slight decreased risk – of progression to acute leukemia, Dr. Mesa said.

Dr. Mesa disclosed that he has received consulting fees, honoraria, and/or grant/research support from ARIAD Pharmaceuticals, Celgene, CTI BioPharma, Galena Biopharma, Gilead Sciences, Incyte, Novartis Pharmaceuticals, and Promedior.

Body

A step toward harmonizing treatment

Myelofibrosis is a rare chronic leukemia with a complex biology. Disease heterogeneity poses several challenges in the appropriate selection and timing of treatments in this disorder. The NCCN Practice Guidelines in Myelofibrosis is an important step towards harmonizing clinical practice for treating this disease and improving the care of patients. 

Vikas Gupta, MD, FRCP, FRCPath, is Director of The Elizabeth and Tony Comper MPN Program at Princess Margaret Cancer Centre in Toronto and a member of the editorial advisory board of Hematology News.


 

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event
Body

A step toward harmonizing treatment

Myelofibrosis is a rare chronic leukemia with a complex biology. Disease heterogeneity poses several challenges in the appropriate selection and timing of treatments in this disorder. The NCCN Practice Guidelines in Myelofibrosis is an important step towards harmonizing clinical practice for treating this disease and improving the care of patients. 

Vikas Gupta, MD, FRCP, FRCPath, is Director of The Elizabeth and Tony Comper MPN Program at Princess Margaret Cancer Centre in Toronto and a member of the editorial advisory board of Hematology News.


 

Body

A step toward harmonizing treatment

Myelofibrosis is a rare chronic leukemia with a complex biology. Disease heterogeneity poses several challenges in the appropriate selection and timing of treatments in this disorder. The NCCN Practice Guidelines in Myelofibrosis is an important step towards harmonizing clinical practice for treating this disease and improving the care of patients. 

Vikas Gupta, MD, FRCP, FRCPath, is Director of The Elizabeth and Tony Comper MPN Program at Princess Margaret Cancer Centre in Toronto and a member of the editorial advisory board of Hematology News.


 

 

– Referral to a specialized center with expertise in the management of myeloproliferative neoplasms is strongly recommended for all patients diagnosed with myelofibrosis, according to a new treatment guideline from the National Comprehensive Cancer Network.

The guideline is the first in a series addressing myeloproliferative neoplasms (MPNs), and it focuses on the diagnostic work-up of MPNs, as well as the treatment of myelofibrosis. The guideline panel, led by panel chair Ruben A. Mesa, MD, is working next on guidelines for the other two “core classic” Philadelphia chromosome–negative MPNs: polycythemia vera, and essential thrombocythemia.

Sharon Worcester/Frontline Medical News
Dr. Ruben A. Mesa
Myelofibrosis was addressed first, as it represented the greatest unmet need in terms of guidance, Dr. Mesa said at the annual conference of the National Comprehensive Cancer Network.

Nearly two-thirds of myelofibrosis patients have intermediate-risk 2 or high-risk disease, and treatment decisions in these patients are complex and require patient input – particularly in candidates for allogeneic hematopoietic stem cell transplantation, he said.

“These diseases can be a little different than other malignant diseases,” Dr. Mesa said, explaining that while there is a clear risk of progression to acute myeloid leukemia, and from polycythemia vera and essential thrombocythemia to myelofibrosis, and while the diseases can be fatal, the burden patients face is not solely related to mortality.

There are implications in terms of health that are independent of that, such as the risk of thrombosis and bleeding, the potential for cytopenia, and severe splenomegaly that results in significant symptoms, he said.

Further, while molecular mutations and their implications for prognosis are a “rapidly moving part of the discussion,” the care of patients with MPNs involves far more than a molecular understanding of the disease.

In fact, the role of molecular changes in these patients is speculative, he said.

While such changes can be assessed and used for patient stratification, their role in myelofibrosis – unlike in other diseases such as chronic myeloid leukemia where the level of change in a target gene is highly relevant and prognostic, is not yet clear.

Thus, a core aspect of the guideline is inclusion of the voice of the patient in individualizing care, he said, noting that many factors should be considered, including how well the patient metabolizes drugs, and the symptom profile, psychosocial circumstances, support structure, and personal beliefs.

“It’s not solely about the tumor,” he stressed.

In fact, the answer to the question of whether a patient can be symptomatic enough to require a specific treatment is “no,” because of the potential for side effects, risk, expense, and other considerations.

“So the voice of the patient is always a key part [of the decision],” he said, noting also that as with all NCCN guidelines, this guideline is a partnership with the treating physician; deciding who is a transplant candidate is a nuanced issue for which the panel provides “discussion and guidance.”

“But clearly, these guidelines are the most useful and helpful in the setting of experienced providers bringing all of their experiences to bear,” he said.

In general, however, the guidelines call for allogeneic hematopoietic stem cell transplantation (HCT) in those with intermediate-risk 2 or high-risk disease who are transplant candidates, and treatment based on assessment of symptom burden (using the MPN–Symptom Assessment Form Total Symptom Score–10 Items) in those who are not HCT candidates. Those with platelets at 50,000 or below should be considered for clinical trial enrollment, and those with platelets above 50,000 should be considered for a clinical trial or treatment with the oral JAK1 and JAK2 inhibitor ruxolitinib, which has been shown to have beneficial effects on both symptoms and survival and which is approved for patients with platelets above 50,000. .

Treated patients should be monitored for response and for signs and symptoms of disease progression every 3-6 months. Treatment should continue in those who respond, as well as in those who do not – as long as there is no disease progression.

Those with progressive disease include patients who are moving toward acute leukemia, and those with overt acute leukemia.

“Here is where the key decision occurs. Are they or are they not a transplant candidate? If they are a candidate, we have a potentially curative track which would include cytoreduction followed by transplant,” Dr. Mesa said.

Cytoreduction can involve hypomethylating agents if the patient doesn’t have excess blast cells or too high a burden of disease.

Acute myeloid leukemia–like induction chemotherapy followed by allogeneic HCT is also an option in these patients.

As for treatment of low-risk myelofibrosis, the guideline states that asymptomatic patients can be observed or enrolled in a clinical trial and monitored for progression every 3-6 months, and that symptomatic patients should receive ruxolitinib or interferons (which are used off label), or be enrolled in a clinical trial. Treatment is important for patients with particularly difficult symptoms, he said, noting that some patients have had pruritus so severe that they have committed suicide. Treatment should continue unless monitoring shows signs of progression to intermediate risk 1, intermediate risk 2/high-risk, or advanced stage disease.

For those with intermediate risk 1 disease, the guideline calls for observation or ruxolitinib in those who are symptomatic, or clinical trial enrollment or allogeneic HCT. Treatment should continue unless monitoring shows disease progression, in which case the appropriate algorithm should be considered.

The guideline also addresses several special circumstances, including the management of anemia in myelofibrosis patients, which can be a difficult issue, he said.

Since the guideline was first published in December, two updates have been incorporated, and Dr. Mesa said that he anticipates regular updates given the rapidly evolving understanding of MPNs and new findings with respect to potential treatment strategies.

He noted that a number of drugs are currently in clinical trials involving patients with myelofibrosis, including the JAK2/FLT3 inhibitor pacritinib, the JAK1/JAK2 inhibitor momelotinib, the active antifibrosing agent PRM-151, and the telomerase inhibitor imetelstat, as well as numerous drug combinations.

Going forward, the guideline panel will be focusing on four different areas of assessment, including new therapies and new genetic therapies, improving transplant outcomes, MPN symptom and quality of life assessment, and nonpharmacologic interventions such as yoga.

“We certainly hope to complement things over time, to look not only at pharmacologic interventions, but others that patients may be able to utilize from a toolkit of resources,” he said.

 

 

COMFORT-1 update: ruxolitinib responses durable in myelofibrosis

To date, ruxolitinib is the only Food and Drug Administration–approved drug for the treatment of myelofibrosis.

The randomized controlled phase III COMFORT I and II trials conducted in the United States and Europe, respectively, demonstrated that the oral JAK1/JAK2 inhibitor has a rapid, beneficial impact on both survival and disease-associated enlargement of the spleen and improvement in related symptoms, Dr. Mesa said.

A 5-year update on data from 309 patients in the COMFORT-1 trial, as reported at the annual meeting of the American Society of Clinical Oncology in 2016, confirmed the durability of treatment responses to ruxolitinib in patients initially randomized to receive the drug, he said.

“We were able to demonstrate a continued survival advantage for those individuals receiving ruxolitinib,” he added.

At weeks 24 and 264, the mean spleen volume reduction was 31.6% and 37.6%, respectively, in those originally randomized to ruxolitinib. The median duration of at least 35% spleen volume reduction was 168.3 weeks.

Overall survival favored ruxolitinib (hazard ratio, 0.69). Median overall survival in the ruxolitinib group had not yet been reached.

“But we realize our work is not done. The survival curve does not plateau; we are not curing these patients. We’re having meaningful impact, but we have room to continue to improve,” he said.

Also, there is an initial drop in platelet counts that tends to stabilize, but not improve, and there is worsening of anemia (new onset grade 3 or 4 anemia was 25.2% with ruxolitinib, and 26.1% in 111 of 154 patients who crossed over from the placebo group), and although this tends to improve, these are among areas of unmet need, he added.

Further, long-term risks of treatment include cutaneous malignancies (basal cell carcinoma occurred in 7.7% and 9.0% of treatment and crossover patients, respectively), which are difficult to separate from baseline hydroxyurea use, and increased risk of herpes zoster (which occurred in 10.3% and 13.5% of treated and crossover patients).

However, there appears to be no increased risk – and there may be a slight decreased risk – of progression to acute leukemia, Dr. Mesa said.

Dr. Mesa disclosed that he has received consulting fees, honoraria, and/or grant/research support from ARIAD Pharmaceuticals, Celgene, CTI BioPharma, Galena Biopharma, Gilead Sciences, Incyte, Novartis Pharmaceuticals, and Promedior.

 

– Referral to a specialized center with expertise in the management of myeloproliferative neoplasms is strongly recommended for all patients diagnosed with myelofibrosis, according to a new treatment guideline from the National Comprehensive Cancer Network.

The guideline is the first in a series addressing myeloproliferative neoplasms (MPNs), and it focuses on the diagnostic work-up of MPNs, as well as the treatment of myelofibrosis. The guideline panel, led by panel chair Ruben A. Mesa, MD, is working next on guidelines for the other two “core classic” Philadelphia chromosome–negative MPNs: polycythemia vera, and essential thrombocythemia.

Sharon Worcester/Frontline Medical News
Dr. Ruben A. Mesa
Myelofibrosis was addressed first, as it represented the greatest unmet need in terms of guidance, Dr. Mesa said at the annual conference of the National Comprehensive Cancer Network.

Nearly two-thirds of myelofibrosis patients have intermediate-risk 2 or high-risk disease, and treatment decisions in these patients are complex and require patient input – particularly in candidates for allogeneic hematopoietic stem cell transplantation, he said.

“These diseases can be a little different than other malignant diseases,” Dr. Mesa said, explaining that while there is a clear risk of progression to acute myeloid leukemia, and from polycythemia vera and essential thrombocythemia to myelofibrosis, and while the diseases can be fatal, the burden patients face is not solely related to mortality.

There are implications in terms of health that are independent of that, such as the risk of thrombosis and bleeding, the potential for cytopenia, and severe splenomegaly that results in significant symptoms, he said.

Further, while molecular mutations and their implications for prognosis are a “rapidly moving part of the discussion,” the care of patients with MPNs involves far more than a molecular understanding of the disease.

In fact, the role of molecular changes in these patients is speculative, he said.

While such changes can be assessed and used for patient stratification, their role in myelofibrosis – unlike in other diseases such as chronic myeloid leukemia where the level of change in a target gene is highly relevant and prognostic, is not yet clear.

Thus, a core aspect of the guideline is inclusion of the voice of the patient in individualizing care, he said, noting that many factors should be considered, including how well the patient metabolizes drugs, and the symptom profile, psychosocial circumstances, support structure, and personal beliefs.

“It’s not solely about the tumor,” he stressed.

In fact, the answer to the question of whether a patient can be symptomatic enough to require a specific treatment is “no,” because of the potential for side effects, risk, expense, and other considerations.

“So the voice of the patient is always a key part [of the decision],” he said, noting also that as with all NCCN guidelines, this guideline is a partnership with the treating physician; deciding who is a transplant candidate is a nuanced issue for which the panel provides “discussion and guidance.”

“But clearly, these guidelines are the most useful and helpful in the setting of experienced providers bringing all of their experiences to bear,” he said.

In general, however, the guidelines call for allogeneic hematopoietic stem cell transplantation (HCT) in those with intermediate-risk 2 or high-risk disease who are transplant candidates, and treatment based on assessment of symptom burden (using the MPN–Symptom Assessment Form Total Symptom Score–10 Items) in those who are not HCT candidates. Those with platelets at 50,000 or below should be considered for clinical trial enrollment, and those with platelets above 50,000 should be considered for a clinical trial or treatment with the oral JAK1 and JAK2 inhibitor ruxolitinib, which has been shown to have beneficial effects on both symptoms and survival and which is approved for patients with platelets above 50,000. .

Treated patients should be monitored for response and for signs and symptoms of disease progression every 3-6 months. Treatment should continue in those who respond, as well as in those who do not – as long as there is no disease progression.

Those with progressive disease include patients who are moving toward acute leukemia, and those with overt acute leukemia.

“Here is where the key decision occurs. Are they or are they not a transplant candidate? If they are a candidate, we have a potentially curative track which would include cytoreduction followed by transplant,” Dr. Mesa said.

Cytoreduction can involve hypomethylating agents if the patient doesn’t have excess blast cells or too high a burden of disease.

Acute myeloid leukemia–like induction chemotherapy followed by allogeneic HCT is also an option in these patients.

As for treatment of low-risk myelofibrosis, the guideline states that asymptomatic patients can be observed or enrolled in a clinical trial and monitored for progression every 3-6 months, and that symptomatic patients should receive ruxolitinib or interferons (which are used off label), or be enrolled in a clinical trial. Treatment is important for patients with particularly difficult symptoms, he said, noting that some patients have had pruritus so severe that they have committed suicide. Treatment should continue unless monitoring shows signs of progression to intermediate risk 1, intermediate risk 2/high-risk, or advanced stage disease.

For those with intermediate risk 1 disease, the guideline calls for observation or ruxolitinib in those who are symptomatic, or clinical trial enrollment or allogeneic HCT. Treatment should continue unless monitoring shows disease progression, in which case the appropriate algorithm should be considered.

The guideline also addresses several special circumstances, including the management of anemia in myelofibrosis patients, which can be a difficult issue, he said.

Since the guideline was first published in December, two updates have been incorporated, and Dr. Mesa said that he anticipates regular updates given the rapidly evolving understanding of MPNs and new findings with respect to potential treatment strategies.

He noted that a number of drugs are currently in clinical trials involving patients with myelofibrosis, including the JAK2/FLT3 inhibitor pacritinib, the JAK1/JAK2 inhibitor momelotinib, the active antifibrosing agent PRM-151, and the telomerase inhibitor imetelstat, as well as numerous drug combinations.

Going forward, the guideline panel will be focusing on four different areas of assessment, including new therapies and new genetic therapies, improving transplant outcomes, MPN symptom and quality of life assessment, and nonpharmacologic interventions such as yoga.

“We certainly hope to complement things over time, to look not only at pharmacologic interventions, but others that patients may be able to utilize from a toolkit of resources,” he said.

 

 

COMFORT-1 update: ruxolitinib responses durable in myelofibrosis

To date, ruxolitinib is the only Food and Drug Administration–approved drug for the treatment of myelofibrosis.

The randomized controlled phase III COMFORT I and II trials conducted in the United States and Europe, respectively, demonstrated that the oral JAK1/JAK2 inhibitor has a rapid, beneficial impact on both survival and disease-associated enlargement of the spleen and improvement in related symptoms, Dr. Mesa said.

A 5-year update on data from 309 patients in the COMFORT-1 trial, as reported at the annual meeting of the American Society of Clinical Oncology in 2016, confirmed the durability of treatment responses to ruxolitinib in patients initially randomized to receive the drug, he said.

“We were able to demonstrate a continued survival advantage for those individuals receiving ruxolitinib,” he added.

At weeks 24 and 264, the mean spleen volume reduction was 31.6% and 37.6%, respectively, in those originally randomized to ruxolitinib. The median duration of at least 35% spleen volume reduction was 168.3 weeks.

Overall survival favored ruxolitinib (hazard ratio, 0.69). Median overall survival in the ruxolitinib group had not yet been reached.

“But we realize our work is not done. The survival curve does not plateau; we are not curing these patients. We’re having meaningful impact, but we have room to continue to improve,” he said.

Also, there is an initial drop in platelet counts that tends to stabilize, but not improve, and there is worsening of anemia (new onset grade 3 or 4 anemia was 25.2% with ruxolitinib, and 26.1% in 111 of 154 patients who crossed over from the placebo group), and although this tends to improve, these are among areas of unmet need, he added.

Further, long-term risks of treatment include cutaneous malignancies (basal cell carcinoma occurred in 7.7% and 9.0% of treatment and crossover patients, respectively), which are difficult to separate from baseline hydroxyurea use, and increased risk of herpes zoster (which occurred in 10.3% and 13.5% of treated and crossover patients).

However, there appears to be no increased risk – and there may be a slight decreased risk – of progression to acute leukemia, Dr. Mesa said.

Dr. Mesa disclosed that he has received consulting fees, honoraria, and/or grant/research support from ARIAD Pharmaceuticals, Celgene, CTI BioPharma, Galena Biopharma, Gilead Sciences, Incyte, Novartis Pharmaceuticals, and Promedior.

Publications
Publications
Topics
Article Type
Click for Credit Status
Active
Sections
Article Source

EXPERT ANALYSIS AT THE NCCN ANNUAL CONFERENCE

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
CME ID
135158

Eliminating hepatitis in the United States: A road map

Article Type
Changed
Fri, 01/18/2019 - 16:39

 

An ambitious new report by the National Academies of Sciences, Engineering, and Medicine lays out a detailed path by which some 90,000 deaths from hepatitis B and C infection could be prevented by 2030.

 

 

Publications
Topics
Sections

 

An ambitious new report by the National Academies of Sciences, Engineering, and Medicine lays out a detailed path by which some 90,000 deaths from hepatitis B and C infection could be prevented by 2030.

 

 

 

An ambitious new report by the National Academies of Sciences, Engineering, and Medicine lays out a detailed path by which some 90,000 deaths from hepatitis B and C infection could be prevented by 2030.

 

 

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM THE NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME

USPSTF: No recommendation on screening for celiac disease

Low threshold for screening considered “reasonable”
Article Type
Changed
Fri, 01/18/2019 - 16:39

 

The current evidence is insufficient for the U.S. Preventive Services Task Force to recommend either for or against routine screening of asymptomatic people for celiac disease, according to a Recommendation Statement published online March 28 in JAMA.

Body

 

Even though the current evidence on the effectiveness of screening for celiac disease is scarce or absent, it remains reasonable for clinicians to have a low threshold for testing patients, especially in high-risk populations such as those with an affected family member or a related autoimmune disorder.

This is because most celiac disease is unrecognized, and patients can present with diverse symptoms rather than the classic triad of abdominal pain, diarrhea, and weight loss.

Dr. Joseph A. Murray
As less-invasive testing becomes available and gluten-free diets become more accessible to patients, reducing the burden of diagnosis and treatment, the medical research community must come forward with the data to determine who should be screened and treated and when and how they should be screened.

Rok Seon Choung, MD, and Joseph A. Murray, MD , are in the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn. Dr. Murray reported ties to Alvine Pharmaceuticals, Alba Therapeutics, Celimmune, BioLineRx, and numerous others. Dr. Choung and Dr. Murray made these remarks in an editorial accompanying the USPSTF reports (JAMA. 2017 Mar 28;317:1221-3).

Publications
Topics
Sections
Body

 

Even though the current evidence on the effectiveness of screening for celiac disease is scarce or absent, it remains reasonable for clinicians to have a low threshold for testing patients, especially in high-risk populations such as those with an affected family member or a related autoimmune disorder.

This is because most celiac disease is unrecognized, and patients can present with diverse symptoms rather than the classic triad of abdominal pain, diarrhea, and weight loss.

Dr. Joseph A. Murray
As less-invasive testing becomes available and gluten-free diets become more accessible to patients, reducing the burden of diagnosis and treatment, the medical research community must come forward with the data to determine who should be screened and treated and when and how they should be screened.

Rok Seon Choung, MD, and Joseph A. Murray, MD , are in the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn. Dr. Murray reported ties to Alvine Pharmaceuticals, Alba Therapeutics, Celimmune, BioLineRx, and numerous others. Dr. Choung and Dr. Murray made these remarks in an editorial accompanying the USPSTF reports (JAMA. 2017 Mar 28;317:1221-3).

Body

 

Even though the current evidence on the effectiveness of screening for celiac disease is scarce or absent, it remains reasonable for clinicians to have a low threshold for testing patients, especially in high-risk populations such as those with an affected family member or a related autoimmune disorder.

This is because most celiac disease is unrecognized, and patients can present with diverse symptoms rather than the classic triad of abdominal pain, diarrhea, and weight loss.

Dr. Joseph A. Murray
As less-invasive testing becomes available and gluten-free diets become more accessible to patients, reducing the burden of diagnosis and treatment, the medical research community must come forward with the data to determine who should be screened and treated and when and how they should be screened.

Rok Seon Choung, MD, and Joseph A. Murray, MD , are in the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn. Dr. Murray reported ties to Alvine Pharmaceuticals, Alba Therapeutics, Celimmune, BioLineRx, and numerous others. Dr. Choung and Dr. Murray made these remarks in an editorial accompanying the USPSTF reports (JAMA. 2017 Mar 28;317:1221-3).

Title
Low threshold for screening considered “reasonable”
Low threshold for screening considered “reasonable”

 

The current evidence is insufficient for the U.S. Preventive Services Task Force to recommend either for or against routine screening of asymptomatic people for celiac disease, according to a Recommendation Statement published online March 28 in JAMA.

 

The current evidence is insufficient for the U.S. Preventive Services Task Force to recommend either for or against routine screening of asymptomatic people for celiac disease, according to a Recommendation Statement published online March 28 in JAMA.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: The current evidence is insufficient for the USPSTF to recommend either for or against routine screening of asymptomatic people for celiac disease.

Major finding: Only 4 studies out of the 3,036 that were examined addressed the question of screening adequately.

Data source: An assessment of the benefits and harms of screening based on a review of four studies.

Disclosures: The USPSTF’s work is supported by the U.S. Agency for Healthcare Research and Quality. The authors’ financial disclosures are available at www.uspreventiveservicestaskforce.org.

USPSTF affirms optional pelvic screening

Lack of evidence, agreed; next steps unsure
Article Type
Changed
Fri, 01/18/2019 - 16:35

Current evidence fails to support or reject routine screening pelvic exams for asymptomatic, low-risk, nonpregnant adult women, the U.S. Preventive Services Task Force concluded after reviewing the evidence on the accuracy, benefits, and potential harms.

The USPSTF issued an inconclusive “I” statement that was published online March 7 (JAMA. 2017;317[9]:947-53).

Researchers found no data comparing the impact of no screening versus screening pelvic examinations on patient health outcomes including reducing all-cause mortality, reducing cancer-specific and disease-specific morbidity and mortality, and improving quality of life.

“No direct evidence was identified for overall benefits and harms of the pelvic examination as a one-time or periodic screening test,” Janelle M. Guirguis-Blake, MD, of the University of Washington, Tacoma, and colleagues wrote in the accompanying evidence report (JAMA. 2017;317[9]:954-66). The review comprised nine studies: one addressing the harms of screening and eight addressing both harms and accuracy.

Although screening pelvic exams may identify serious conditions as well as benign ones, the potential remains for false-positive and false-negative results that might lead to invasive surgery and unnecessary testing and procedures, the researchers noted. However, the recommendations do not apply to certain conditions for which screening is already recommended, including cervical cancer (via Pap smear), gonorrhea, and chlamydia.

The recommendations are primarily a call for more research rather than a clear guide for clinicians, according to the USPSTF. The research gaps include studies on the physical and psychological harms of pelvic screening for asymptomatic women in primary care; the ability of screening to detect conditions beyond ovarian cancer, genital herpes, bacterial vaginosis, and trichomoniasis; and the impact of screening on a variety of health outcomes, including quality of life.

Given the inadequate evidence to recommend for or against screening, the USPSTF cited the recommendations of other organizations. Both the American College of Physicians and the American Academy of Family Physicians recommend against performing screening pelvic exams in asymptomatic, nonpregnant adult women. The American College of Obstetricians and Gynecologists recommends annual pelvic exams for women 21 years and older but acknowledges a lack of evidence and has said it should be a shared decision between the patient and clinician.

The USPSTF members reported having no relevant financial conflicts.

Body

The USPSTF task force finding of insufficient evidence to support or refute screening pelvic exams conflicts with the views of other organizations, George F. Sawaya, MD, wrote in an editorial (JAMA 2017 Mar 7. doi: 10.1001/jamainternmed.2017.0271).

The American College of Physicians currently recommends against routine screening in asymptomatic, nonpregnant women, while the American College of Obstetricians and Gynecologists recommends in favor of an annual pelvic exam “based on expert opinion” despite the lack of evidence, he said.

“The USPSTF believes that in the setting of an ‘I’ statement, clinicians should be forthright with patients about the uncertainty concerning the balance of benefits and harms,” Dr. Sawaya wrote.

“But perhaps the conversation should focus on the uncertainty among the three professional groups,” he added. “Women should know the facts: that all three groups agree there is no scientific evidence that these examinations are beneficial; that there is evidence of harms including ‘false alarms,’ further testing, and even unnecessary surgery; and that one group strongly recommends against screening examinations, believing them to be more harmful than beneficial,” he said.

The USPSTF recommendation is not a surprise, Colleen McNicholas, DO, MSCI, and Jeffrey F. Peipert, MD, PhD, noted in a second editorial (JAMA 2017;317[9]:910-11). “Despite lack of rigorous research, many would argue that the periodic examination provides opportunity for counseling and trust building between the patient and physician and thus should be universally implemented,” they wrote. However, many women express fear and anxiety before the exam and discomfort, pain, or embarrassment during the exam. “To ignore this aspect when comparing individual parts of the examination seems insensitive and inappropriate,” they added.

“Women, as patients, should be involved in the decision regarding whether to perform a pelvic examination, and clinicians should not require that the patient undergo this procedure to obtain screening, counseling, and age-appropriate health services,” they concluded.
 

Dr. Sawaya is affiliated with the University of California, San Francisco. He reported having no financial conflicts. Dr. Peipert is affiliated with Indiana University School of Medicine, Indianapolis, and disclosed receiving grants from Teva Pharmaceuticals, Bayer Healthcare Pharmaceuticals, and Merck, as well as serving on the advisory boards of Perrigo and Teva. Dr. McNicholas is affiliated with Washington University, St. Louis, and reported having no financial conflicts.

Publications
Topics
Sections
Related Articles
Body

The USPSTF task force finding of insufficient evidence to support or refute screening pelvic exams conflicts with the views of other organizations, George F. Sawaya, MD, wrote in an editorial (JAMA 2017 Mar 7. doi: 10.1001/jamainternmed.2017.0271).

The American College of Physicians currently recommends against routine screening in asymptomatic, nonpregnant women, while the American College of Obstetricians and Gynecologists recommends in favor of an annual pelvic exam “based on expert opinion” despite the lack of evidence, he said.

“The USPSTF believes that in the setting of an ‘I’ statement, clinicians should be forthright with patients about the uncertainty concerning the balance of benefits and harms,” Dr. Sawaya wrote.

“But perhaps the conversation should focus on the uncertainty among the three professional groups,” he added. “Women should know the facts: that all three groups agree there is no scientific evidence that these examinations are beneficial; that there is evidence of harms including ‘false alarms,’ further testing, and even unnecessary surgery; and that one group strongly recommends against screening examinations, believing them to be more harmful than beneficial,” he said.

The USPSTF recommendation is not a surprise, Colleen McNicholas, DO, MSCI, and Jeffrey F. Peipert, MD, PhD, noted in a second editorial (JAMA 2017;317[9]:910-11). “Despite lack of rigorous research, many would argue that the periodic examination provides opportunity for counseling and trust building between the patient and physician and thus should be universally implemented,” they wrote. However, many women express fear and anxiety before the exam and discomfort, pain, or embarrassment during the exam. “To ignore this aspect when comparing individual parts of the examination seems insensitive and inappropriate,” they added.

“Women, as patients, should be involved in the decision regarding whether to perform a pelvic examination, and clinicians should not require that the patient undergo this procedure to obtain screening, counseling, and age-appropriate health services,” they concluded.
 

Dr. Sawaya is affiliated with the University of California, San Francisco. He reported having no financial conflicts. Dr. Peipert is affiliated with Indiana University School of Medicine, Indianapolis, and disclosed receiving grants from Teva Pharmaceuticals, Bayer Healthcare Pharmaceuticals, and Merck, as well as serving on the advisory boards of Perrigo and Teva. Dr. McNicholas is affiliated with Washington University, St. Louis, and reported having no financial conflicts.

Body

The USPSTF task force finding of insufficient evidence to support or refute screening pelvic exams conflicts with the views of other organizations, George F. Sawaya, MD, wrote in an editorial (JAMA 2017 Mar 7. doi: 10.1001/jamainternmed.2017.0271).

The American College of Physicians currently recommends against routine screening in asymptomatic, nonpregnant women, while the American College of Obstetricians and Gynecologists recommends in favor of an annual pelvic exam “based on expert opinion” despite the lack of evidence, he said.

“The USPSTF believes that in the setting of an ‘I’ statement, clinicians should be forthright with patients about the uncertainty concerning the balance of benefits and harms,” Dr. Sawaya wrote.

“But perhaps the conversation should focus on the uncertainty among the three professional groups,” he added. “Women should know the facts: that all three groups agree there is no scientific evidence that these examinations are beneficial; that there is evidence of harms including ‘false alarms,’ further testing, and even unnecessary surgery; and that one group strongly recommends against screening examinations, believing them to be more harmful than beneficial,” he said.

The USPSTF recommendation is not a surprise, Colleen McNicholas, DO, MSCI, and Jeffrey F. Peipert, MD, PhD, noted in a second editorial (JAMA 2017;317[9]:910-11). “Despite lack of rigorous research, many would argue that the periodic examination provides opportunity for counseling and trust building between the patient and physician and thus should be universally implemented,” they wrote. However, many women express fear and anxiety before the exam and discomfort, pain, or embarrassment during the exam. “To ignore this aspect when comparing individual parts of the examination seems insensitive and inappropriate,” they added.

“Women, as patients, should be involved in the decision regarding whether to perform a pelvic examination, and clinicians should not require that the patient undergo this procedure to obtain screening, counseling, and age-appropriate health services,” they concluded.
 

Dr. Sawaya is affiliated with the University of California, San Francisco. He reported having no financial conflicts. Dr. Peipert is affiliated with Indiana University School of Medicine, Indianapolis, and disclosed receiving grants from Teva Pharmaceuticals, Bayer Healthcare Pharmaceuticals, and Merck, as well as serving on the advisory boards of Perrigo and Teva. Dr. McNicholas is affiliated with Washington University, St. Louis, and reported having no financial conflicts.

Title
Lack of evidence, agreed; next steps unsure
Lack of evidence, agreed; next steps unsure

Current evidence fails to support or reject routine screening pelvic exams for asymptomatic, low-risk, nonpregnant adult women, the U.S. Preventive Services Task Force concluded after reviewing the evidence on the accuracy, benefits, and potential harms.

The USPSTF issued an inconclusive “I” statement that was published online March 7 (JAMA. 2017;317[9]:947-53).

Researchers found no data comparing the impact of no screening versus screening pelvic examinations on patient health outcomes including reducing all-cause mortality, reducing cancer-specific and disease-specific morbidity and mortality, and improving quality of life.

“No direct evidence was identified for overall benefits and harms of the pelvic examination as a one-time or periodic screening test,” Janelle M. Guirguis-Blake, MD, of the University of Washington, Tacoma, and colleagues wrote in the accompanying evidence report (JAMA. 2017;317[9]:954-66). The review comprised nine studies: one addressing the harms of screening and eight addressing both harms and accuracy.

Although screening pelvic exams may identify serious conditions as well as benign ones, the potential remains for false-positive and false-negative results that might lead to invasive surgery and unnecessary testing and procedures, the researchers noted. However, the recommendations do not apply to certain conditions for which screening is already recommended, including cervical cancer (via Pap smear), gonorrhea, and chlamydia.

The recommendations are primarily a call for more research rather than a clear guide for clinicians, according to the USPSTF. The research gaps include studies on the physical and psychological harms of pelvic screening for asymptomatic women in primary care; the ability of screening to detect conditions beyond ovarian cancer, genital herpes, bacterial vaginosis, and trichomoniasis; and the impact of screening on a variety of health outcomes, including quality of life.

Given the inadequate evidence to recommend for or against screening, the USPSTF cited the recommendations of other organizations. Both the American College of Physicians and the American Academy of Family Physicians recommend against performing screening pelvic exams in asymptomatic, nonpregnant adult women. The American College of Obstetricians and Gynecologists recommends annual pelvic exams for women 21 years and older but acknowledges a lack of evidence and has said it should be a shared decision between the patient and clinician.

The USPSTF members reported having no relevant financial conflicts.

Current evidence fails to support or reject routine screening pelvic exams for asymptomatic, low-risk, nonpregnant adult women, the U.S. Preventive Services Task Force concluded after reviewing the evidence on the accuracy, benefits, and potential harms.

The USPSTF issued an inconclusive “I” statement that was published online March 7 (JAMA. 2017;317[9]:947-53).

Researchers found no data comparing the impact of no screening versus screening pelvic examinations on patient health outcomes including reducing all-cause mortality, reducing cancer-specific and disease-specific morbidity and mortality, and improving quality of life.

“No direct evidence was identified for overall benefits and harms of the pelvic examination as a one-time or periodic screening test,” Janelle M. Guirguis-Blake, MD, of the University of Washington, Tacoma, and colleagues wrote in the accompanying evidence report (JAMA. 2017;317[9]:954-66). The review comprised nine studies: one addressing the harms of screening and eight addressing both harms and accuracy.

Although screening pelvic exams may identify serious conditions as well as benign ones, the potential remains for false-positive and false-negative results that might lead to invasive surgery and unnecessary testing and procedures, the researchers noted. However, the recommendations do not apply to certain conditions for which screening is already recommended, including cervical cancer (via Pap smear), gonorrhea, and chlamydia.

The recommendations are primarily a call for more research rather than a clear guide for clinicians, according to the USPSTF. The research gaps include studies on the physical and psychological harms of pelvic screening for asymptomatic women in primary care; the ability of screening to detect conditions beyond ovarian cancer, genital herpes, bacterial vaginosis, and trichomoniasis; and the impact of screening on a variety of health outcomes, including quality of life.

Given the inadequate evidence to recommend for or against screening, the USPSTF cited the recommendations of other organizations. Both the American College of Physicians and the American Academy of Family Physicians recommend against performing screening pelvic exams in asymptomatic, nonpregnant adult women. The American College of Obstetricians and Gynecologists recommends annual pelvic exams for women 21 years and older but acknowledges a lack of evidence and has said it should be a shared decision between the patient and clinician.

The USPSTF members reported having no relevant financial conflicts.

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Article Source

FROM JAMA

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME