CHICAGO – The Global Registry for Endovascular Aortic Treatment is a unique resource that, although still early in its planned 10-year follow-up period, has already yielded important insights into one of the hottest topics in endovascular repair of abdominal aortic aneurysms: that is, the impact of the proximal aortic neck, Clayton J. Brinster, MD, said at a symposium on vascular surgery sponsored by Northwestern University.

The Global Registry for Endovascular Aortic Treatment (GREAT) is a prospective, observational, real-world registry that enrolled more than 5,000 consecutive patients undergoing endovascular aortic repair (EVAR) in the United States, Europe, Australia, New Zealand, and Brazil before enrollment closed in October 2016.

GREAT is the largest stent graft registry in the world. One of its special features is that it has essentially no exclusion criteria. This enables researchers to compare outcomes in patients undergoing on-label EVAR using devices deployed within the official instructions for use (IFU) to results in real-world practice, which not infrequently entails treatment for nonstandard indications using devices outside the narrowly defined IFU generated via pivotal clinical trials, explained Dr. Brinster, a vascular surgeon at the Ochsner Clinic Foundation in New Orleans.

The biggest limitation of GREAT is that it’s sponsored by Gore and restricted to recipients of GORE thoracic and abdominal stent grafts. However, the registry has an oversight and safety monitoring board that is independent of the company, Dr. Brinster continued.

He highlighted three recently published studies that have utilized early GREAT data to examine the impact on EVAR outcomes of various features of the proximal aortic neck.

 

 

Noncylindrical neck anatomy

An international team of investigators analyzed the incidence and impact of noncylindrical neck anatomy, defined as a 2-mm or greater change in diameter over the first 15 mm of proximal aortic neck length. Of 3,077 GREAT participants treated with the Gore Excluder endograft, 1,312, or 43%, had an hourglass, tapered, or conical neck shape that qualified as noncylindrical. Noncylindrical necks were more common in women. Fifteen percent of patients with a noncylindrical neck received the device outside the Excluder IFU, as did 11% with a cylindrical neck.

After an average follow-up of about 20 months, the noncylindrical neck group had a 3.1% rate of device-related intervention, significantly better than the 4.9% rate in patients with a cylindrical neck. In a multivariate regression analysis, female gender and maximum abdominal aortic aneurysm diameter were significant risk factors for device-related or endoleak-specific reintervention; noncylindrical neck morphology was not. Indeed, women were 2.2-fold more likely to require device-related reintervention than men (J Vasc Surg. 2018; 68[6]:1714-24).
 

Large proximal aortic neck

Of 3,166 consecutive patients in GREAT, 37.6% had a large aortic neck diameter, defined as 25 mm or wider. The rate of 5-year freedom from type Ia endoleak was 96.8% in the large-neck group, significantly less than the 98.6% rate in patients with a normal aortic neck diameter. Of note, rates didn’t diverge until after 2 years of follow-up, emphasizing the need for careful long-term surveillance despite initial technical success.

The 5-year rate of freedom from the primary composite endpoint of type Ia endoleak, reintervention, aortic rupture, or isolated aortic-related mortality was also significantly worse in the large-neck group: 81.3% versus 87%. Moreover, the 5-year survival rate was only 64.6% in the large–aortic neck group, compared with 76.5% in the comparator arm, even though aortic-related mortality didn’t differ between the two groups. “The findings raise the question of whether young patients, with predicted life expectancies exceeding 10 years, should receive standard endovascular intervention if they have large aortic neck diameters at baseline (Eur J Vasc Endovasc Surg. 2018;56[2]:189-99).

Severe neck angulation

Australian investigators wondered if the IFU for the Gore C3 Excluder was overly restrictive in defining abdominal aortic aneurysms with necks greater than 60 degrees as off-label for the device. In the first 1,394 patients enrolled in GREAT, the researchers identified 127 (9.2%) who exhibited more than 60 and less than 140 degrees of neck angulation and didn’t require endoanchors for proximal fixation. Their mean neck angle was 78 degrees, with a mean neck length of 29 mm. Mean graft oversizing was 23.5%, which was also outside the Excluder IFU.

During a median follow-up of 236 days there were 7 type Ia endoleaks, for an incidence of 5.6%. The degree of neck angulation, neck length, and the amount of oversizing were not associated with endoleak (Ann Vasc Surg. 2018;49:152-57). However, Dr. Brinster wants to see longer follow-up data before he is prepared to accept that a mean 23.5% graft oversizing is a benign intervention.

“One must remember that, with that percentage of oversizing in an already abnormal neck, aortic neck dilation could be a significant problem longer term,” the vascular surgeon said.

Dr. Brinster reported having no conflicts regarding his presentation.

bjancin@mdedge.com

CHICAGO – The Global Registry for Endovascular Aortic Treatment is a unique resource that, although still early in its planned 10-year follow-up period, has already yielded important insights into one of the hottest topics in endovascular repair of abdominal aortic aneurysms: that is, the impact of the proximal aortic neck, Clayton J. Brinster, MD, said at a symposium on vascular surgery sponsored by Northwestern University.

The Global Registry for Endovascular Aortic Treatment (GREAT) is a prospective, observational, real-world registry that enrolled more than 5,000 consecutive patients undergoing endovascular aortic repair (EVAR) in the United States, Europe, Australia, New Zealand, and Brazil before enrollment closed in October 2016.

GREAT is the largest stent graft registry in the world. One of its special features is that it has essentially no exclusion criteria. This enables researchers to compare outcomes in patients undergoing on-label EVAR using devices deployed within the official instructions for use (IFU) to results in real-world practice, which not infrequently entails treatment for nonstandard indications using devices outside the narrowly defined IFU generated via pivotal clinical trials, explained Dr. Brinster, a vascular surgeon at the Ochsner Clinic Foundation in New Orleans.

The biggest limitation of GREAT is that it’s sponsored by Gore and restricted to recipients of GORE thoracic and abdominal stent grafts. However, the registry has an oversight and safety monitoring board that is independent of the company, Dr. Brinster continued.

He highlighted three recently published studies that have utilized early GREAT data to examine the impact on EVAR outcomes of various features of the proximal aortic neck.

 

 

Noncylindrical neck anatomy

An international team of investigators analyzed the incidence and impact of noncylindrical neck anatomy, defined as a 2-mm or greater change in diameter over the first 15 mm of proximal aortic neck length. Of 3,077 GREAT participants treated with the Gore Excluder endograft, 1,312, or 43%, had an hourglass, tapered, or conical neck shape that qualified as noncylindrical. Noncylindrical necks were more common in women. Fifteen percent of patients with a noncylindrical neck received the device outside the Excluder IFU, as did 11% with a cylindrical neck.

After an average follow-up of about 20 months, the noncylindrical neck group had a 3.1% rate of device-related intervention, significantly better than the 4.9% rate in patients with a cylindrical neck. In a multivariate regression analysis, female gender and maximum abdominal aortic aneurysm diameter were significant risk factors for device-related or endoleak-specific reintervention; noncylindrical neck morphology was not. Indeed, women were 2.2-fold more likely to require device-related reintervention than men (J Vasc Surg. 2018; 68[6]:1714-24).
 

Large proximal aortic neck

Of 3,166 consecutive patients in GREAT, 37.6% had a large aortic neck diameter, defined as 25 mm or wider. The rate of 5-year freedom from type Ia endoleak was 96.8% in the large-neck group, significantly less than the 98.6% rate in patients with a normal aortic neck diameter. Of note, rates didn’t diverge until after 2 years of follow-up, emphasizing the need for careful long-term surveillance despite initial technical success.

The 5-year rate of freedom from the primary composite endpoint of type Ia endoleak, reintervention, aortic rupture, or isolated aortic-related mortality was also significantly worse in the large-neck group: 81.3% versus 87%. Moreover, the 5-year survival rate was only 64.6% in the large–aortic neck group, compared with 76.5% in the comparator arm, even though aortic-related mortality didn’t differ between the two groups. “The findings raise the question of whether young patients, with predicted life expectancies exceeding 10 years, should receive standard endovascular intervention if they have large aortic neck diameters at baseline (Eur J Vasc Endovasc Surg. 2018;56[2]:189-99).

Severe neck angulation

Australian investigators wondered if the IFU for the Gore C3 Excluder was overly restrictive in defining abdominal aortic aneurysms with necks greater than 60 degrees as off-label for the device. In the first 1,394 patients enrolled in GREAT, the researchers identified 127 (9.2%) who exhibited more than 60 and less than 140 degrees of neck angulation and didn’t require endoanchors for proximal fixation. Their mean neck angle was 78 degrees, with a mean neck length of 29 mm. Mean graft oversizing was 23.5%, which was also outside the Excluder IFU.

During a median follow-up of 236 days there were 7 type Ia endoleaks, for an incidence of 5.6%. The degree of neck angulation, neck length, and the amount of oversizing were not associated with endoleak (Ann Vasc Surg. 2018;49:152-57). However, Dr. Brinster wants to see longer follow-up data before he is prepared to accept that a mean 23.5% graft oversizing is a benign intervention.

“One must remember that, with that percentage of oversizing in an already abnormal neck, aortic neck dilation could be a significant problem longer term,” the vascular surgeon said.

Dr. Brinster reported having no conflicts regarding his presentation.

bjancin@mdedge.com

CHICAGO – The Global Registry for Endovascular Aortic Treatment is a unique resource that, although still early in its planned 10-year follow-up period, has already yielded important insights into one of the hottest topics in endovascular repair of abdominal aortic aneurysms: that is, the impact of the proximal aortic neck, Clayton J. Brinster, MD, said at a symposium on vascular surgery sponsored by Northwestern University.

The Global Registry for Endovascular Aortic Treatment (GREAT) is a prospective, observational, real-world registry that enrolled more than 5,000 consecutive patients undergoing endovascular aortic repair (EVAR) in the United States, Europe, Australia, New Zealand, and Brazil before enrollment closed in October 2016.

GREAT is the largest stent graft registry in the world. One of its special features is that it has essentially no exclusion criteria. This enables researchers to compare outcomes in patients undergoing on-label EVAR using devices deployed within the official instructions for use (IFU) to results in real-world practice, which not infrequently entails treatment for nonstandard indications using devices outside the narrowly defined IFU generated via pivotal clinical trials, explained Dr. Brinster, a vascular surgeon at the Ochsner Clinic Foundation in New Orleans.

The biggest limitation of GREAT is that it’s sponsored by Gore and restricted to recipients of GORE thoracic and abdominal stent grafts. However, the registry has an oversight and safety monitoring board that is independent of the company, Dr. Brinster continued.

He highlighted three recently published studies that have utilized early GREAT data to examine the impact on EVAR outcomes of various features of the proximal aortic neck.

 

 

Noncylindrical neck anatomy

An international team of investigators analyzed the incidence and impact of noncylindrical neck anatomy, defined as a 2-mm or greater change in diameter over the first 15 mm of proximal aortic neck length. Of 3,077 GREAT participants treated with the Gore Excluder endograft, 1,312, or 43%, had an hourglass, tapered, or conical neck shape that qualified as noncylindrical. Noncylindrical necks were more common in women. Fifteen percent of patients with a noncylindrical neck received the device outside the Excluder IFU, as did 11% with a cylindrical neck.

After an average follow-up of about 20 months, the noncylindrical neck group had a 3.1% rate of device-related intervention, significantly better than the 4.9% rate in patients with a cylindrical neck. In a multivariate regression analysis, female gender and maximum abdominal aortic aneurysm diameter were significant risk factors for device-related or endoleak-specific reintervention; noncylindrical neck morphology was not. Indeed, women were 2.2-fold more likely to require device-related reintervention than men (J Vasc Surg. 2018; 68[6]:1714-24).
 

Large proximal aortic neck

Of 3,166 consecutive patients in GREAT, 37.6% had a large aortic neck diameter, defined as 25 mm or wider. The rate of 5-year freedom from type Ia endoleak was 96.8% in the large-neck group, significantly less than the 98.6% rate in patients with a normal aortic neck diameter. Of note, rates didn’t diverge until after 2 years of follow-up, emphasizing the need for careful long-term surveillance despite initial technical success.

The 5-year rate of freedom from the primary composite endpoint of type Ia endoleak, reintervention, aortic rupture, or isolated aortic-related mortality was also significantly worse in the large-neck group: 81.3% versus 87%. Moreover, the 5-year survival rate was only 64.6% in the large–aortic neck group, compared with 76.5% in the comparator arm, even though aortic-related mortality didn’t differ between the two groups. “The findings raise the question of whether young patients, with predicted life expectancies exceeding 10 years, should receive standard endovascular intervention if they have large aortic neck diameters at baseline (Eur J Vasc Endovasc Surg. 2018;56[2]:189-99).

Severe neck angulation

Australian investigators wondered if the IFU for the Gore C3 Excluder was overly restrictive in defining abdominal aortic aneurysms with necks greater than 60 degrees as off-label for the device. In the first 1,394 patients enrolled in GREAT, the researchers identified 127 (9.2%) who exhibited more than 60 and less than 140 degrees of neck angulation and didn’t require endoanchors for proximal fixation. Their mean neck angle was 78 degrees, with a mean neck length of 29 mm. Mean graft oversizing was 23.5%, which was also outside the Excluder IFU.

During a median follow-up of 236 days there were 7 type Ia endoleaks, for an incidence of 5.6%. The degree of neck angulation, neck length, and the amount of oversizing were not associated with endoleak (Ann Vasc Surg. 2018;49:152-57). However, Dr. Brinster wants to see longer follow-up data before he is prepared to accept that a mean 23.5% graft oversizing is a benign intervention.

“One must remember that, with that percentage of oversizing in an already abnormal neck, aortic neck dilation could be a significant problem longer term,” the vascular surgeon said.

Dr. Brinster reported having no conflicts regarding his presentation.

bjancin@mdedge.com

Treatment with budesonide oral suspension (BOS) was generally well tolerated and maintained a histologic response in some patients with eosinophilic esophagitis (EoE), according to the results of the 24-week, open-label extension phase of a multicenter, randomized, placebo-controlled, industry-sponsored trial.

Rates of histologic response (up to 6 eosinophils per high-power field) were “modest” – 23% among patients who stayed on BOS throughout the study and 48.5% among patients who initiated BOS after 12 weeks on placebo, reported Evan S. Dellon, MD, MPH, of the University of North Carolina in Chapel Hill and his associates. However, these rates “need to be viewed in the context of a highly symptomatic and histologically severe population with eosinophilic esophagitis,” they contended. A total of 11% of budesonide initiators developed esophageal candidiasis, they reported in Clinical Gastroenterology and Hepatology.

Budesonide oral suspension is a mucoadherent formulation of topical corticosteroid that has recently been developed to treat EoE. Previously, during the randomized, double-blind component of this phase 2 trial, 93 patients aged 11-40 years with active EoE and dysphagia received either BOS (2 mg) or placebo twice daily (Gastroenterology. 2017 Mar;157[4]:776-86). After 12 weeks, rates of histologic response were 39% for BOS versus 3% for placebo, and BOS significantly improved patients’ mean peak eosinophil count and scores on the Dysphagia Symptom Questionnaire, compared with baseline and compared with the response in the placebo group. During the open-label extension phase, 45 BOS continuers and 37 BOS initiators received 2 mg once daily for 12 weeks and then had the option to increase the BOS dose to 1.5-2.0 mg twice daily.

The rate of drug-related adverse events was 19% among BOS initiators and 4% among BOS continuers. One patient in each group developed oral candidiasis, while four BOS initiators (11%) developed esophageal candidiasis. Three BOS continuers had subnormal morning cortisol levels; while these were subclinical cases, they merit attention since long-term corticosteroids for EoE have been linked with possible hypothalamic–pituitary–adrenal axis suppression, the researchers noted.

In addition, while BOS initiators tended to maintain their endoscopic response, only 42% of those with an initial histologic response maintained a histologic response after 36 weeks of treatment or when leaving the study. Post hoc analyses confirmed that prolonged BOS treatment does not increase the chances of histologic or endoscopic response. Prior studies have suggested that EoE can become steroid-refractory over time and that certain molecular and histologic markers might predict resistance, the investigators noted.

Meritage Pharma (now part of Shire) was involved in the study design and conduct, data collection and management, and manuscript review. Dr. Dellon disclosed research funding from Meritage and Shire and a consulting relationship with Shire, along with ties to several other pharmaceutical companies. All six coinvestigators also disclosed ties to Meritage, Shire, or both, and two are Shire employees and stockholders.

*This story was updated on Feb. 7, 2019.

SOURCE: Dellon ES et al. Clin Gastroenterol Hepatol. 2018 Jun 11. doi: 10.1016/j.cgh.2018.05.051.

Treatment with budesonide oral suspension (BOS) was generally well tolerated and maintained a histologic response in some patients with eosinophilic esophagitis (EoE), according to the results of the 24-week, open-label extension phase of a multicenter, randomized, placebo-controlled, industry-sponsored trial.

Rates of histologic response (up to 6 eosinophils per high-power field) were “modest” – 23% among patients who stayed on BOS throughout the study and 48.5% among patients who initiated BOS after 12 weeks on placebo, reported Evan S. Dellon, MD, MPH, of the University of North Carolina in Chapel Hill and his associates. However, these rates “need to be viewed in the context of a highly symptomatic and histologically severe population with eosinophilic esophagitis,” they contended. A total of 11% of budesonide initiators developed esophageal candidiasis, they reported in Clinical Gastroenterology and Hepatology.

Budesonide oral suspension is a mucoadherent formulation of topical corticosteroid that has recently been developed to treat EoE. Previously, during the randomized, double-blind component of this phase 2 trial, 93 patients aged 11-40 years with active EoE and dysphagia received either BOS (2 mg) or placebo twice daily (Gastroenterology. 2017 Mar;157[4]:776-86). After 12 weeks, rates of histologic response were 39% for BOS versus 3% for placebo, and BOS significantly improved patients’ mean peak eosinophil count and scores on the Dysphagia Symptom Questionnaire, compared with baseline and compared with the response in the placebo group. During the open-label extension phase, 45 BOS continuers and 37 BOS initiators received 2 mg once daily for 12 weeks and then had the option to increase the BOS dose to 1.5-2.0 mg twice daily.

The rate of drug-related adverse events was 19% among BOS initiators and 4% among BOS continuers. One patient in each group developed oral candidiasis, while four BOS initiators (11%) developed esophageal candidiasis. Three BOS continuers had subnormal morning cortisol levels; while these were subclinical cases, they merit attention since long-term corticosteroids for EoE have been linked with possible hypothalamic–pituitary–adrenal axis suppression, the researchers noted.

In addition, while BOS initiators tended to maintain their endoscopic response, only 42% of those with an initial histologic response maintained a histologic response after 36 weeks of treatment or when leaving the study. Post hoc analyses confirmed that prolonged BOS treatment does not increase the chances of histologic or endoscopic response. Prior studies have suggested that EoE can become steroid-refractory over time and that certain molecular and histologic markers might predict resistance, the investigators noted.

Meritage Pharma (now part of Shire) was involved in the study design and conduct, data collection and management, and manuscript review. Dr. Dellon disclosed research funding from Meritage and Shire and a consulting relationship with Shire, along with ties to several other pharmaceutical companies. All six coinvestigators also disclosed ties to Meritage, Shire, or both, and two are Shire employees and stockholders.

*This story was updated on Feb. 7, 2019.

SOURCE: Dellon ES et al. Clin Gastroenterol Hepatol. 2018 Jun 11. doi: 10.1016/j.cgh.2018.05.051.

Treatment with budesonide oral suspension (BOS) was generally well tolerated and maintained a histologic response in some patients with eosinophilic esophagitis (EoE), according to the results of the 24-week, open-label extension phase of a multicenter, randomized, placebo-controlled, industry-sponsored trial.

Rates of histologic response (up to 6 eosinophils per high-power field) were “modest” – 23% among patients who stayed on BOS throughout the study and 48.5% among patients who initiated BOS after 12 weeks on placebo, reported Evan S. Dellon, MD, MPH, of the University of North Carolina in Chapel Hill and his associates. However, these rates “need to be viewed in the context of a highly symptomatic and histologically severe population with eosinophilic esophagitis,” they contended. A total of 11% of budesonide initiators developed esophageal candidiasis, they reported in Clinical Gastroenterology and Hepatology.

Budesonide oral suspension is a mucoadherent formulation of topical corticosteroid that has recently been developed to treat EoE. Previously, during the randomized, double-blind component of this phase 2 trial, 93 patients aged 11-40 years with active EoE and dysphagia received either BOS (2 mg) or placebo twice daily (Gastroenterology. 2017 Mar;157[4]:776-86). After 12 weeks, rates of histologic response were 39% for BOS versus 3% for placebo, and BOS significantly improved patients’ mean peak eosinophil count and scores on the Dysphagia Symptom Questionnaire, compared with baseline and compared with the response in the placebo group. During the open-label extension phase, 45 BOS continuers and 37 BOS initiators received 2 mg once daily for 12 weeks and then had the option to increase the BOS dose to 1.5-2.0 mg twice daily.

The rate of drug-related adverse events was 19% among BOS initiators and 4% among BOS continuers. One patient in each group developed oral candidiasis, while four BOS initiators (11%) developed esophageal candidiasis. Three BOS continuers had subnormal morning cortisol levels; while these were subclinical cases, they merit attention since long-term corticosteroids for EoE have been linked with possible hypothalamic–pituitary–adrenal axis suppression, the researchers noted.

In addition, while BOS initiators tended to maintain their endoscopic response, only 42% of those with an initial histologic response maintained a histologic response after 36 weeks of treatment or when leaving the study. Post hoc analyses confirmed that prolonged BOS treatment does not increase the chances of histologic or endoscopic response. Prior studies have suggested that EoE can become steroid-refractory over time and that certain molecular and histologic markers might predict resistance, the investigators noted.

Meritage Pharma (now part of Shire) was involved in the study design and conduct, data collection and management, and manuscript review. Dr. Dellon disclosed research funding from Meritage and Shire and a consulting relationship with Shire, along with ties to several other pharmaceutical companies. All six coinvestigators also disclosed ties to Meritage, Shire, or both, and two are Shire employees and stockholders.

*This story was updated on Feb. 7, 2019.

SOURCE: Dellon ES et al. Clin Gastroenterol Hepatol. 2018 Jun 11. doi: 10.1016/j.cgh.2018.05.051.

Specially formulated topical pain creams are no better than placebo creams for relieving localized chronic pain, according to results from a double-blind, randomized, placebo-controlled trial.

nebari/ThinkStock

Study authors led by Robert E. Brutcher, PharmD, PhD, of Walter Reed National Military Medical Center in Bethesda, Md., said their findings published Feb. 4 in Annals of Internal Medicine suggest compounded pain creams should not be routinely used for chronic pain conditions.

The researchers noted that the use of compounded topical pain creams has increased dramatically despite “weak evidence” supporting their efficacy to treat localized pain, and this is particularly the case in military personnel, where the authors said treatments without central effect may be particularly beneficial because “opioid therapy may render a service member nondeployable and medications that affect the central nervous system may have a negative effect on judgment and motor skills.”

They noted a report from the U.S. Government Accountability Office that showed Tricare’s pharmacy benefits program paid $259 million for compounded medications in the 2013 fiscal year, a figure that increased to $746 million in 2014.

“The soaring costs, coupled with sparse efficacy data prompted the Defense Health Agency to evaluate this issue,” they wrote.

The objectives of the current study were to assess the efficacy of compounded pain creams for chronic pain conditions and determine whether efficacy differed for the various pain classifications.

“We hypothesized that, compared with placebo, compounded topical pain creams would provide greater pain relief and functional improvement,” they said.

The randomized trial involved 133 patients diagnosed with neuropathic pain, 133 with nociceptive pain, and 133 with mixed pain who had attended pain clinics at Walter Reed. Patients were aged between 18 and 90 years and had localized pain in the face, back or buttocks, neck, abdomen, chest, groin, or in up to two extremities. To be included in the study, they were also required to have an average pain score of 4 or greater on a 0- to 10-point numerical rating scale during the preceding week and have symptoms lasting longer than 6 weeks.

Patients in all three pain subgroups were randomized in a 1:1 ratio to receive either a compounded pain cream or a placebo cream. The authors noted that their “pain cream formulations were selected on the basis of accepted systemic indications for neuropathic and nociceptive pain.”

The formulation given to participants with neuropathic pain (n = 68) contained 10% ketamine, 6% gabapentin, 0.2% clonidine, and 2% lidocaine. The patients with nociceptive pain (n = 66) received a cream with 10% ketoprofen, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine. Those with mixed pain (n = 68) were given a cream containing 10% ketamine, 6% gabapentin, 3% diclofenac, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine. The authors said the concentrations of individual medications were based on previous trials that evaluated topical use.

The patients, who had a mean age across the groups that ranged from 48 to 57 years, applied cream to affected areas three times per day, with the amount dispensed determined by the size of the area experiencing pain. About half of the patients were women.

The primary outcome measures were an average pain score 1 month after treatment. A positive categorical response was a reduction in pain score of 2 or more points coupled with a score above 3 on a 5-point satisfaction scale. Secondary outcomes included Short Form-36 Health Survey scores, satisfaction, and categorical response. Participants with a positive outcome were followed to 3 months.

Change in the primary outcome of average pain score at 1 month did not differ between the active cream and placebo groups for any type of pain classification. The change was only –0.1 points (95% confidence interval, –0.8 to 0.5 points) for neuropathic pain, –0.3 points (95% CI, –0.9 to 0.2 points) for nociceptive pain, and –0.3 points (95% CI, –0.9 to 0.2 points) for mixed pain.

Among all patients combined, an overall change in average pain scores of –0.3 points (95% CI, –0.6 to 0.1 points) that favored the active-ingredient cream also did not differ between the treatment and placebo groups.

“The lower 95% confidence bounds for the 1-month between-group differences were all 0.9 points or less and excluded clinically meaningful benefits with the compounded topical pain cream,” the authors wrote.

Secondary outcomes also did not differ between the two study groups for any type of pain classification or for the entire cohort.

“Although participants in both treatment and control groups had improvement in their pain throughout the study, no significant differences were observed in pain scores, functional improvement, or satisfaction in the cohort or in any subgroup,” the authors concluded.

They noted that their findings were consistent with previous studies that also showed a lack of efficacy for most topical pain creams.

While some randomized trials have suggested positive findings for capsaicin, lidocaine, and NSAIDs, the authors noted that they did not find a similar benefit in their study population.

“Administered as stand-alone agents, lidocaine and NSAIDs may alleviate pain, although the effect size is small and the number needed to treat is large,” they wrote.

“Considering the increased costs of using a non–FDA-approved and regulated compounded cream rather than a single agent, we caution against routine use of compounded creams for chronic pain,” they wrote.

They noted that their study had several limitations, including that conventional treatments had failed in some of the participants before they enrolled in the study, increasing the likelihood that subsequent therapy would not be effective.

The authors suggested that future studies should aim to establish whether targeting specific types of pain or adding other agents like dimethyl sulfoxide would result in better outcomes.

The Centers for Rehabilitation Sciences Research in the U.S. Department of Defense’s Defense Health Agency funded the study. Two authors reported receiving grants and personal fees from several pharmaceutical companies.

SOURCE: Brutcher RE et al. Ann Intern Med. 2019 Feb 4. doi: 10.7326/M18-2736.

Specially formulated topical pain creams are no better than placebo creams for relieving localized chronic pain, according to results from a double-blind, randomized, placebo-controlled trial.

nebari/ThinkStock

Study authors led by Robert E. Brutcher, PharmD, PhD, of Walter Reed National Military Medical Center in Bethesda, Md., said their findings published Feb. 4 in Annals of Internal Medicine suggest compounded pain creams should not be routinely used for chronic pain conditions.

The researchers noted that the use of compounded topical pain creams has increased dramatically despite “weak evidence” supporting their efficacy to treat localized pain, and this is particularly the case in military personnel, where the authors said treatments without central effect may be particularly beneficial because “opioid therapy may render a service member nondeployable and medications that affect the central nervous system may have a negative effect on judgment and motor skills.”

They noted a report from the U.S. Government Accountability Office that showed Tricare’s pharmacy benefits program paid $259 million for compounded medications in the 2013 fiscal year, a figure that increased to $746 million in 2014.

“The soaring costs, coupled with sparse efficacy data prompted the Defense Health Agency to evaluate this issue,” they wrote.

The objectives of the current study were to assess the efficacy of compounded pain creams for chronic pain conditions and determine whether efficacy differed for the various pain classifications.

“We hypothesized that, compared with placebo, compounded topical pain creams would provide greater pain relief and functional improvement,” they said.

The randomized trial involved 133 patients diagnosed with neuropathic pain, 133 with nociceptive pain, and 133 with mixed pain who had attended pain clinics at Walter Reed. Patients were aged between 18 and 90 years and had localized pain in the face, back or buttocks, neck, abdomen, chest, groin, or in up to two extremities. To be included in the study, they were also required to have an average pain score of 4 or greater on a 0- to 10-point numerical rating scale during the preceding week and have symptoms lasting longer than 6 weeks.

Patients in all three pain subgroups were randomized in a 1:1 ratio to receive either a compounded pain cream or a placebo cream. The authors noted that their “pain cream formulations were selected on the basis of accepted systemic indications for neuropathic and nociceptive pain.”

The formulation given to participants with neuropathic pain (n = 68) contained 10% ketamine, 6% gabapentin, 0.2% clonidine, and 2% lidocaine. The patients with nociceptive pain (n = 66) received a cream with 10% ketoprofen, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine. Those with mixed pain (n = 68) were given a cream containing 10% ketamine, 6% gabapentin, 3% diclofenac, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine. The authors said the concentrations of individual medications were based on previous trials that evaluated topical use.

The patients, who had a mean age across the groups that ranged from 48 to 57 years, applied cream to affected areas three times per day, with the amount dispensed determined by the size of the area experiencing pain. About half of the patients were women.

The primary outcome measures were an average pain score 1 month after treatment. A positive categorical response was a reduction in pain score of 2 or more points coupled with a score above 3 on a 5-point satisfaction scale. Secondary outcomes included Short Form-36 Health Survey scores, satisfaction, and categorical response. Participants with a positive outcome were followed to 3 months.

Change in the primary outcome of average pain score at 1 month did not differ between the active cream and placebo groups for any type of pain classification. The change was only –0.1 points (95% confidence interval, –0.8 to 0.5 points) for neuropathic pain, –0.3 points (95% CI, –0.9 to 0.2 points) for nociceptive pain, and –0.3 points (95% CI, –0.9 to 0.2 points) for mixed pain.

Among all patients combined, an overall change in average pain scores of –0.3 points (95% CI, –0.6 to 0.1 points) that favored the active-ingredient cream also did not differ between the treatment and placebo groups.

“The lower 95% confidence bounds for the 1-month between-group differences were all 0.9 points or less and excluded clinically meaningful benefits with the compounded topical pain cream,” the authors wrote.

Secondary outcomes also did not differ between the two study groups for any type of pain classification or for the entire cohort.

“Although participants in both treatment and control groups had improvement in their pain throughout the study, no significant differences were observed in pain scores, functional improvement, or satisfaction in the cohort or in any subgroup,” the authors concluded.

They noted that their findings were consistent with previous studies that also showed a lack of efficacy for most topical pain creams.

While some randomized trials have suggested positive findings for capsaicin, lidocaine, and NSAIDs, the authors noted that they did not find a similar benefit in their study population.

“Administered as stand-alone agents, lidocaine and NSAIDs may alleviate pain, although the effect size is small and the number needed to treat is large,” they wrote.

“Considering the increased costs of using a non–FDA-approved and regulated compounded cream rather than a single agent, we caution against routine use of compounded creams for chronic pain,” they wrote.

They noted that their study had several limitations, including that conventional treatments had failed in some of the participants before they enrolled in the study, increasing the likelihood that subsequent therapy would not be effective.

The authors suggested that future studies should aim to establish whether targeting specific types of pain or adding other agents like dimethyl sulfoxide would result in better outcomes.

The Centers for Rehabilitation Sciences Research in the U.S. Department of Defense’s Defense Health Agency funded the study. Two authors reported receiving grants and personal fees from several pharmaceutical companies.

SOURCE: Brutcher RE et al. Ann Intern Med. 2019 Feb 4. doi: 10.7326/M18-2736.

Specially formulated topical pain creams are no better than placebo creams for relieving localized chronic pain, according to results from a double-blind, randomized, placebo-controlled trial.

nebari/ThinkStock

Study authors led by Robert E. Brutcher, PharmD, PhD, of Walter Reed National Military Medical Center in Bethesda, Md., said their findings published Feb. 4 in Annals of Internal Medicine suggest compounded pain creams should not be routinely used for chronic pain conditions.

The researchers noted that the use of compounded topical pain creams has increased dramatically despite “weak evidence” supporting their efficacy to treat localized pain, and this is particularly the case in military personnel, where the authors said treatments without central effect may be particularly beneficial because “opioid therapy may render a service member nondeployable and medications that affect the central nervous system may have a negative effect on judgment and motor skills.”

They noted a report from the U.S. Government Accountability Office that showed Tricare’s pharmacy benefits program paid $259 million for compounded medications in the 2013 fiscal year, a figure that increased to $746 million in 2014.

“The soaring costs, coupled with sparse efficacy data prompted the Defense Health Agency to evaluate this issue,” they wrote.

The objectives of the current study were to assess the efficacy of compounded pain creams for chronic pain conditions and determine whether efficacy differed for the various pain classifications.

“We hypothesized that, compared with placebo, compounded topical pain creams would provide greater pain relief and functional improvement,” they said.

The randomized trial involved 133 patients diagnosed with neuropathic pain, 133 with nociceptive pain, and 133 with mixed pain who had attended pain clinics at Walter Reed. Patients were aged between 18 and 90 years and had localized pain in the face, back or buttocks, neck, abdomen, chest, groin, or in up to two extremities. To be included in the study, they were also required to have an average pain score of 4 or greater on a 0- to 10-point numerical rating scale during the preceding week and have symptoms lasting longer than 6 weeks.

Patients in all three pain subgroups were randomized in a 1:1 ratio to receive either a compounded pain cream or a placebo cream. The authors noted that their “pain cream formulations were selected on the basis of accepted systemic indications for neuropathic and nociceptive pain.”

The formulation given to participants with neuropathic pain (n = 68) contained 10% ketamine, 6% gabapentin, 0.2% clonidine, and 2% lidocaine. The patients with nociceptive pain (n = 66) received a cream with 10% ketoprofen, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine. Those with mixed pain (n = 68) were given a cream containing 10% ketamine, 6% gabapentin, 3% diclofenac, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine. The authors said the concentrations of individual medications were based on previous trials that evaluated topical use.

The patients, who had a mean age across the groups that ranged from 48 to 57 years, applied cream to affected areas three times per day, with the amount dispensed determined by the size of the area experiencing pain. About half of the patients were women.

The primary outcome measures were an average pain score 1 month after treatment. A positive categorical response was a reduction in pain score of 2 or more points coupled with a score above 3 on a 5-point satisfaction scale. Secondary outcomes included Short Form-36 Health Survey scores, satisfaction, and categorical response. Participants with a positive outcome were followed to 3 months.

Change in the primary outcome of average pain score at 1 month did not differ between the active cream and placebo groups for any type of pain classification. The change was only –0.1 points (95% confidence interval, –0.8 to 0.5 points) for neuropathic pain, –0.3 points (95% CI, –0.9 to 0.2 points) for nociceptive pain, and –0.3 points (95% CI, –0.9 to 0.2 points) for mixed pain.

Among all patients combined, an overall change in average pain scores of –0.3 points (95% CI, –0.6 to 0.1 points) that favored the active-ingredient cream also did not differ between the treatment and placebo groups.

“The lower 95% confidence bounds for the 1-month between-group differences were all 0.9 points or less and excluded clinically meaningful benefits with the compounded topical pain cream,” the authors wrote.

Secondary outcomes also did not differ between the two study groups for any type of pain classification or for the entire cohort.

“Although participants in both treatment and control groups had improvement in their pain throughout the study, no significant differences were observed in pain scores, functional improvement, or satisfaction in the cohort or in any subgroup,” the authors concluded.

They noted that their findings were consistent with previous studies that also showed a lack of efficacy for most topical pain creams.

While some randomized trials have suggested positive findings for capsaicin, lidocaine, and NSAIDs, the authors noted that they did not find a similar benefit in their study population.

“Administered as stand-alone agents, lidocaine and NSAIDs may alleviate pain, although the effect size is small and the number needed to treat is large,” they wrote.

“Considering the increased costs of using a non–FDA-approved and regulated compounded cream rather than a single agent, we caution against routine use of compounded creams for chronic pain,” they wrote.

They noted that their study had several limitations, including that conventional treatments had failed in some of the participants before they enrolled in the study, increasing the likelihood that subsequent therapy would not be effective.

The authors suggested that future studies should aim to establish whether targeting specific types of pain or adding other agents like dimethyl sulfoxide would result in better outcomes.

The Centers for Rehabilitation Sciences Research in the U.S. Department of Defense’s Defense Health Agency funded the study. Two authors reported receiving grants and personal fees from several pharmaceutical companies.

SOURCE: Brutcher RE et al. Ann Intern Med. 2019 Feb 4. doi: 10.7326/M18-2736.

Public health experts have attributed the alarming rise in hepatitis C virus (HCV) infection rates in recent years to the opioid epidemic, and a new Rand study suggests that an effort to deter opioid abuse – namely the 2010 abuse-deterrent reformulation of OxyContin – is partly to blame.

Between 2004 and 2015, HCV infection rates in the United States nearly tripled, but a closer look showed that states with above-median rates of OxyContin misuse prior to the reformulation had a 222% increase in HCV rates, compared with a 75% increase in states with below-median OxyContin misuse, said David Powell, PhD, a senior economist at Rand in Arlington, Va., and his colleagues, Abby Alpert, PhD, and Rosalie L. Pacula, PhD. The report was published in Health Affairs.

The coauthors found that hepatitis C infection rates were not significantly different between the two groups of states before the reformulation (0.350 vs. 0.260). But after 2010, there were large and statistically significant differences in the rates (1.128 vs. 0.455; P less than 0.01), they wrote, noting that the above-median states experienced an additional 0.58 HCV infections per 100,000 population through 2015 relative to the below-median states).

HCV infection rates declined during the 1990s followed by a plateau beginning around 2003, then rose sharply beginning in 2010, coinciding with the introduction of the release of the abuse-deterrent formulation of OxyContin, which is one of the most commonly misused opioid analgesics, the investigators said, explaining that the reformulated version was harder to crush or dissolve, making it more difficult to inhale or inject.

“Prior studies have shown that, after OxyContin became more difficult to abuse, some nonmedical users of OxyContin switched to heroin (a pharmacologically similar opiate),” they noted.

This led to a decline of more than 40% in OxyContin misuse but also to a sharp increase in heroin overdoses after 2010.

The investigators assessed whether the related increase in heroin use might explain the increase in HCV infections, which can be transmitted through shared needle use.

Using a quasi-experimental difference-in-differences approach, they examined whether states with higher exposure to the reformulated OxyContin had faster growth of HCV infection rates after the reformulations, and as a falsification exercise, they also looked at whether the nonmedical use of pain relievers other than OxyContin predicted post-reformulation HCV infection rate increases.

HCV infection rates for each calendar year from 2004 to 2015 were assessed using confirmed case reports collected by the Centers for Disease Control and Prevention, and nonmedical OxyContin use was measured using self-reported data from the National Survey on Drug Use and Health, which is the largest U.S. survey on substance use disorder.

The two groups of states had similar demographic and economic conditions, except that the above-median misuse states had smaller populations and a larger proportion of white residents.

Of note, the patterns of HCV infection mirrored those of heroin overdoses. There was small relative increase in HCV infection rates in 2010 in the above-median OxyContin misuse states, and the gap between above- and below-median misuse states widened more rapidly from 2011 to 2013. “This striking inflection point in the trend of hepatitis C infections for high-misuse states after 2010 mimics the inflection in heroin overdoses that occurred as a result of the reformulation,” they said, noting that heroin morality per 100,000 population was nearly identical in the two groups of states in the pre-reformulation period (0.859 and 0.847).

The falsification exercise looking at nonmedical use of pain relievers other than OxyContin in the two groups of states showed that after 2010 groups’ rates of hepatitis C infections grew at virtually identical rates.

“Thus, the differential risk in hepatitis C infections was uniquely associated with OxyContin misuse, rather than prescription pain reliever misuse more generally,” they said. “This suggests that it was the OxyContin reformulation, not other policies broadly affecting opioids, that drove much of the differential growth.”

The investigators controlled for numerous other factors, including opioid policies that might have an impact on OxyContin and heroin use, prescription drug monitoring programs and pain clinic regulations, as well as the role of major pill-mill crackdowns in 2010 and 2011.

The findings represent a “substantial public health concern,” they said, explaining that, while “considerable policy attention is being given to managing the opioid epidemic ... a ‘silent epidemic’ of hepatitis C has emerged as a result of a transition in the mode of administration toward injection drug use.”

In 2017, the CDC reported on this link between the opioid epidemic and rising HCV infection rates, as well.

“It is possible that this transition will also lead to rising rates of other infectious diseases tied to injection drug use, including HIV,” Dr. Powell and his colleagues wrote.

Their findings regarding the unintended consequences of the OxyContin reformulation suggest that caution is warranted with respect to future interventions that limit the supply of abusable prescription opioids, they said, adding that “such interventions must be paired with polices that alleviate the harms associated with switching to illicit drugs, such as improved access to substance use disorder treatment and increased efforts aimed at identifying and treating diseases associated with injection drug use.”

However, policy makers and medical professionals also must recognize that reducing opioid-related mortality and increasing access to drug treatment might not be sufficient to fully address all of the public health consequences associated with the opioid crisis. As additional reformulations of opioids are promoted and more policies seek to limit access to prescription opioids, “both the medical and the law enforcement communities must recognize the critical transition from prescription opioids to other drugs, particularly those that are injected, and be prepared to consider complementary strategies that can effectively reduce the additional harms from the particular mode of drug use,” they concluded.

The coauthors cited several limitations, including the possibility that true hepatitis C infection rates might have been underestimated in the study.

He and Dr. Pacula received funding from the National Institute on Drug Abuse. Dr. Powell also cited funding from the Rand Alumni Impact Award.

sworcester@mdedge.com

SOURCE: Powell D et al. Health Aff. 2019;38(2):287-94.

Public health experts have attributed the alarming rise in hepatitis C virus (HCV) infection rates in recent years to the opioid epidemic, and a new Rand study suggests that an effort to deter opioid abuse – namely the 2010 abuse-deterrent reformulation of OxyContin – is partly to blame.

Between 2004 and 2015, HCV infection rates in the United States nearly tripled, but a closer look showed that states with above-median rates of OxyContin misuse prior to the reformulation had a 222% increase in HCV rates, compared with a 75% increase in states with below-median OxyContin misuse, said David Powell, PhD, a senior economist at Rand in Arlington, Va., and his colleagues, Abby Alpert, PhD, and Rosalie L. Pacula, PhD. The report was published in Health Affairs.

The coauthors found that hepatitis C infection rates were not significantly different between the two groups of states before the reformulation (0.350 vs. 0.260). But after 2010, there were large and statistically significant differences in the rates (1.128 vs. 0.455; P less than 0.01), they wrote, noting that the above-median states experienced an additional 0.58 HCV infections per 100,000 population through 2015 relative to the below-median states).

HCV infection rates declined during the 1990s followed by a plateau beginning around 2003, then rose sharply beginning in 2010, coinciding with the introduction of the release of the abuse-deterrent formulation of OxyContin, which is one of the most commonly misused opioid analgesics, the investigators said, explaining that the reformulated version was harder to crush or dissolve, making it more difficult to inhale or inject.

“Prior studies have shown that, after OxyContin became more difficult to abuse, some nonmedical users of OxyContin switched to heroin (a pharmacologically similar opiate),” they noted.

This led to a decline of more than 40% in OxyContin misuse but also to a sharp increase in heroin overdoses after 2010.

The investigators assessed whether the related increase in heroin use might explain the increase in HCV infections, which can be transmitted through shared needle use.

Using a quasi-experimental difference-in-differences approach, they examined whether states with higher exposure to the reformulated OxyContin had faster growth of HCV infection rates after the reformulations, and as a falsification exercise, they also looked at whether the nonmedical use of pain relievers other than OxyContin predicted post-reformulation HCV infection rate increases.

HCV infection rates for each calendar year from 2004 to 2015 were assessed using confirmed case reports collected by the Centers for Disease Control and Prevention, and nonmedical OxyContin use was measured using self-reported data from the National Survey on Drug Use and Health, which is the largest U.S. survey on substance use disorder.

The two groups of states had similar demographic and economic conditions, except that the above-median misuse states had smaller populations and a larger proportion of white residents.

Of note, the patterns of HCV infection mirrored those of heroin overdoses. There was small relative increase in HCV infection rates in 2010 in the above-median OxyContin misuse states, and the gap between above- and below-median misuse states widened more rapidly from 2011 to 2013. “This striking inflection point in the trend of hepatitis C infections for high-misuse states after 2010 mimics the inflection in heroin overdoses that occurred as a result of the reformulation,” they said, noting that heroin morality per 100,000 population was nearly identical in the two groups of states in the pre-reformulation period (0.859 and 0.847).

The falsification exercise looking at nonmedical use of pain relievers other than OxyContin in the two groups of states showed that after 2010 groups’ rates of hepatitis C infections grew at virtually identical rates.

“Thus, the differential risk in hepatitis C infections was uniquely associated with OxyContin misuse, rather than prescription pain reliever misuse more generally,” they said. “This suggests that it was the OxyContin reformulation, not other policies broadly affecting opioids, that drove much of the differential growth.”

The investigators controlled for numerous other factors, including opioid policies that might have an impact on OxyContin and heroin use, prescription drug monitoring programs and pain clinic regulations, as well as the role of major pill-mill crackdowns in 2010 and 2011.

The findings represent a “substantial public health concern,” they said, explaining that, while “considerable policy attention is being given to managing the opioid epidemic ... a ‘silent epidemic’ of hepatitis C has emerged as a result of a transition in the mode of administration toward injection drug use.”

In 2017, the CDC reported on this link between the opioid epidemic and rising HCV infection rates, as well.

“It is possible that this transition will also lead to rising rates of other infectious diseases tied to injection drug use, including HIV,” Dr. Powell and his colleagues wrote.

Their findings regarding the unintended consequences of the OxyContin reformulation suggest that caution is warranted with respect to future interventions that limit the supply of abusable prescription opioids, they said, adding that “such interventions must be paired with polices that alleviate the harms associated with switching to illicit drugs, such as improved access to substance use disorder treatment and increased efforts aimed at identifying and treating diseases associated with injection drug use.”

However, policy makers and medical professionals also must recognize that reducing opioid-related mortality and increasing access to drug treatment might not be sufficient to fully address all of the public health consequences associated with the opioid crisis. As additional reformulations of opioids are promoted and more policies seek to limit access to prescription opioids, “both the medical and the law enforcement communities must recognize the critical transition from prescription opioids to other drugs, particularly those that are injected, and be prepared to consider complementary strategies that can effectively reduce the additional harms from the particular mode of drug use,” they concluded.

The coauthors cited several limitations, including the possibility that true hepatitis C infection rates might have been underestimated in the study.

He and Dr. Pacula received funding from the National Institute on Drug Abuse. Dr. Powell also cited funding from the Rand Alumni Impact Award.

sworcester@mdedge.com

SOURCE: Powell D et al. Health Aff. 2019;38(2):287-94.

Public health experts have attributed the alarming rise in hepatitis C virus (HCV) infection rates in recent years to the opioid epidemic, and a new Rand study suggests that an effort to deter opioid abuse – namely the 2010 abuse-deterrent reformulation of OxyContin – is partly to blame.

Between 2004 and 2015, HCV infection rates in the United States nearly tripled, but a closer look showed that states with above-median rates of OxyContin misuse prior to the reformulation had a 222% increase in HCV rates, compared with a 75% increase in states with below-median OxyContin misuse, said David Powell, PhD, a senior economist at Rand in Arlington, Va., and his colleagues, Abby Alpert, PhD, and Rosalie L. Pacula, PhD. The report was published in Health Affairs.

The coauthors found that hepatitis C infection rates were not significantly different between the two groups of states before the reformulation (0.350 vs. 0.260). But after 2010, there were large and statistically significant differences in the rates (1.128 vs. 0.455; P less than 0.01), they wrote, noting that the above-median states experienced an additional 0.58 HCV infections per 100,000 population through 2015 relative to the below-median states).

HCV infection rates declined during the 1990s followed by a plateau beginning around 2003, then rose sharply beginning in 2010, coinciding with the introduction of the release of the abuse-deterrent formulation of OxyContin, which is one of the most commonly misused opioid analgesics, the investigators said, explaining that the reformulated version was harder to crush or dissolve, making it more difficult to inhale or inject.

“Prior studies have shown that, after OxyContin became more difficult to abuse, some nonmedical users of OxyContin switched to heroin (a pharmacologically similar opiate),” they noted.

This led to a decline of more than 40% in OxyContin misuse but also to a sharp increase in heroin overdoses after 2010.

The investigators assessed whether the related increase in heroin use might explain the increase in HCV infections, which can be transmitted through shared needle use.

Using a quasi-experimental difference-in-differences approach, they examined whether states with higher exposure to the reformulated OxyContin had faster growth of HCV infection rates after the reformulations, and as a falsification exercise, they also looked at whether the nonmedical use of pain relievers other than OxyContin predicted post-reformulation HCV infection rate increases.

HCV infection rates for each calendar year from 2004 to 2015 were assessed using confirmed case reports collected by the Centers for Disease Control and Prevention, and nonmedical OxyContin use was measured using self-reported data from the National Survey on Drug Use and Health, which is the largest U.S. survey on substance use disorder.

The two groups of states had similar demographic and economic conditions, except that the above-median misuse states had smaller populations and a larger proportion of white residents.

Of note, the patterns of HCV infection mirrored those of heroin overdoses. There was small relative increase in HCV infection rates in 2010 in the above-median OxyContin misuse states, and the gap between above- and below-median misuse states widened more rapidly from 2011 to 2013. “This striking inflection point in the trend of hepatitis C infections for high-misuse states after 2010 mimics the inflection in heroin overdoses that occurred as a result of the reformulation,” they said, noting that heroin morality per 100,000 population was nearly identical in the two groups of states in the pre-reformulation period (0.859 and 0.847).

The falsification exercise looking at nonmedical use of pain relievers other than OxyContin in the two groups of states showed that after 2010 groups’ rates of hepatitis C infections grew at virtually identical rates.

“Thus, the differential risk in hepatitis C infections was uniquely associated with OxyContin misuse, rather than prescription pain reliever misuse more generally,” they said. “This suggests that it was the OxyContin reformulation, not other policies broadly affecting opioids, that drove much of the differential growth.”

The investigators controlled for numerous other factors, including opioid policies that might have an impact on OxyContin and heroin use, prescription drug monitoring programs and pain clinic regulations, as well as the role of major pill-mill crackdowns in 2010 and 2011.

The findings represent a “substantial public health concern,” they said, explaining that, while “considerable policy attention is being given to managing the opioid epidemic ... a ‘silent epidemic’ of hepatitis C has emerged as a result of a transition in the mode of administration toward injection drug use.”

In 2017, the CDC reported on this link between the opioid epidemic and rising HCV infection rates, as well.

“It is possible that this transition will also lead to rising rates of other infectious diseases tied to injection drug use, including HIV,” Dr. Powell and his colleagues wrote.

Their findings regarding the unintended consequences of the OxyContin reformulation suggest that caution is warranted with respect to future interventions that limit the supply of abusable prescription opioids, they said, adding that “such interventions must be paired with polices that alleviate the harms associated with switching to illicit drugs, such as improved access to substance use disorder treatment and increased efforts aimed at identifying and treating diseases associated with injection drug use.”

However, policy makers and medical professionals also must recognize that reducing opioid-related mortality and increasing access to drug treatment might not be sufficient to fully address all of the public health consequences associated with the opioid crisis. As additional reformulations of opioids are promoted and more policies seek to limit access to prescription opioids, “both the medical and the law enforcement communities must recognize the critical transition from prescription opioids to other drugs, particularly those that are injected, and be prepared to consider complementary strategies that can effectively reduce the additional harms from the particular mode of drug use,” they concluded.

The coauthors cited several limitations, including the possibility that true hepatitis C infection rates might have been underestimated in the study.

He and Dr. Pacula received funding from the National Institute on Drug Abuse. Dr. Powell also cited funding from the Rand Alumni Impact Award.

sworcester@mdedge.com

SOURCE: Powell D et al. Health Aff. 2019;38(2):287-94.

BOSTON – An atrial mapping catheter that combines ultrasound anatomic mapping with nontouch, high-resolution, charge-density mapping resulted in a high, 73% freedom from recurrent atrial fibrillation rate 12 months after ablation procedures guided by this catheter in a single-arm, multicenter study with 121 patients with persistent atrial fibrillation followed for 1 year.

Mitchel L. Zoler/MDedge News

The AcQMap device tested in the study “allows you to quickly remap” the left atrium after an initial pulmonary vein isolation or after other types of ablations to find remaining areas of abnormal electrical activity on the atrial walls and then “go after those,” Atul Verma, MD, said at the annual International AF Symposium.

An analysis he reported showed that the single patient variable that linked with the highest rate of 1-year freedom from recurrent atrial fibrillation (AF) was having at least three atrial targets ablated in addition to pulmonary vein isolation. Patients who received this number of added ablations were more than nine times more likely to be free from AF after 12 months, compared with patients who received fewer additional ablations, said Dr. Verma, a cardiac electrophysiologist at Southlake Regional Health Centre in Newmarket, Ont.

The AcQMap catheter “identifies more places to ablate.” What makes it unique among currently available mapping devices is its high resolution, its use of charge-density mapping rather than voltage-based mapping, and its speed, Dr. Verma said in an interview.

The AcQMap device has Food and Drug Administration marketing approval for mapping and so is available for routine U.S. use. However, Dr. Verma cautioned that the increased freedom from persistent AF after using the catheter during ablation that he reported should be confirmed by a randomized trial. Another electrophysiologist who performs ablations but was not involved with the study, Vivek Reddy, MD, agreed with this caveat.

Mitchel L. Zoler/MDedge News

“Nonrandomized trials of ablation in patients with persistent AF are at best hypothesis generating. We’ve learned that the hard way; we have been burned too many times. To assess mapping of AF activity you need a randomized, controlled trial,” said Dr. Reddy, professor of medicine and director of cardiac arrhythmia services at Mount Sinai Hospital in New York.

The UNCOVER-AF (Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation) study ran at 13 centers in Canada and Europe and enrolled 129 patients who had persistent AF for an average of almost 2 years, of whom 127 actually underwent an ablation procedure and 121 were followed for 12 months post ablation. Operators were free to use the AcQMap device to map the left atrium as many times as they thought necessary, generally once at the start of the procedure, a second time after they completed pulmonary vein isolation, and then a variable number of subsequent times. On average they performed about four mappings in each patient. At entry, patients had received an average of one antiarrhythmic drug. After their ablation treatment, about 10% of patients received an antiarrhythmic drug.

The investigators found no major adverse events linked to use of the mapping device. Three patients had major adverse events related to the overall ablation procedure: Two developed cardiac tamponade, and one had a stroke. No patients had an esophageal fistula or symptomatic pulmonary vein stenosis.

After the single ablation procedure and at 12-month follow-up, the prevalence of freedom from recurrent AF was 73%, and freedom from any atrial arrhythmia was 69%. As a historical comparison, Dr. Verma cited the 12-month outcome following pulmonary vein isolation and other ablative measures in the STAR AF II (Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II) trial, which reported a 59% freedom from AF rate and a 49% freedom from any atrial arrhythmia rate with or without antiarrhythmic drug treatment after pulmonary vein isolation (N Engl J Med. 2015 May 7;372[19]:1812-22).

Multivariate analysis of the new data showed that, in addition to ablation of three or more targets, two other variables also linked significantly with long-term freedom from AF: Ablation of at least two types of electrical abnormalities in the left atrial wall, which boosted the 12-month AF-free rate by 2.8 fold, and being in sinus rhythm at the start of the ablation procedure, which linked with a 5-fold higher rate of long-term freedom from AF.

Dr. Verma also reported the AF burden measured after ablation in 96 patients who each underwent an average of 85 hours of postablation heart rhythm monitoring. Ninety percent of these patients showed no AF episodes of more than 30 seconds throughout the duration of their monitoring.

UNCOVER-AF was funded by Acutus, the company that markets the AcQMap catheter. Dr. Verma has been an advisor to or speaker on behalf of Bayer, Biosense Webster, Boehringer Ingelheim, and Medtronic, and St. Jude (Abbott), and he has received research funding from Bayer, Biosense Webster, Boehringer Ingelheim, and Medtronic. He had no personal disclosures relative to Acutus. Dr. Reddy has been a consultant to, received research funding from, and has an equity stake in Acutus, and has similar relationships with more than three dozen other companies.

mzoler@mdedge.com

BOSTON – An atrial mapping catheter that combines ultrasound anatomic mapping with nontouch, high-resolution, charge-density mapping resulted in a high, 73% freedom from recurrent atrial fibrillation rate 12 months after ablation procedures guided by this catheter in a single-arm, multicenter study with 121 patients with persistent atrial fibrillation followed for 1 year.

Mitchel L. Zoler/MDedge News

The AcQMap device tested in the study “allows you to quickly remap” the left atrium after an initial pulmonary vein isolation or after other types of ablations to find remaining areas of abnormal electrical activity on the atrial walls and then “go after those,” Atul Verma, MD, said at the annual International AF Symposium.

An analysis he reported showed that the single patient variable that linked with the highest rate of 1-year freedom from recurrent atrial fibrillation (AF) was having at least three atrial targets ablated in addition to pulmonary vein isolation. Patients who received this number of added ablations were more than nine times more likely to be free from AF after 12 months, compared with patients who received fewer additional ablations, said Dr. Verma, a cardiac electrophysiologist at Southlake Regional Health Centre in Newmarket, Ont.

The AcQMap catheter “identifies more places to ablate.” What makes it unique among currently available mapping devices is its high resolution, its use of charge-density mapping rather than voltage-based mapping, and its speed, Dr. Verma said in an interview.

The AcQMap device has Food and Drug Administration marketing approval for mapping and so is available for routine U.S. use. However, Dr. Verma cautioned that the increased freedom from persistent AF after using the catheter during ablation that he reported should be confirmed by a randomized trial. Another electrophysiologist who performs ablations but was not involved with the study, Vivek Reddy, MD, agreed with this caveat.

Mitchel L. Zoler/MDedge News

“Nonrandomized trials of ablation in patients with persistent AF are at best hypothesis generating. We’ve learned that the hard way; we have been burned too many times. To assess mapping of AF activity you need a randomized, controlled trial,” said Dr. Reddy, professor of medicine and director of cardiac arrhythmia services at Mount Sinai Hospital in New York.

The UNCOVER-AF (Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation) study ran at 13 centers in Canada and Europe and enrolled 129 patients who had persistent AF for an average of almost 2 years, of whom 127 actually underwent an ablation procedure and 121 were followed for 12 months post ablation. Operators were free to use the AcQMap device to map the left atrium as many times as they thought necessary, generally once at the start of the procedure, a second time after they completed pulmonary vein isolation, and then a variable number of subsequent times. On average they performed about four mappings in each patient. At entry, patients had received an average of one antiarrhythmic drug. After their ablation treatment, about 10% of patients received an antiarrhythmic drug.

The investigators found no major adverse events linked to use of the mapping device. Three patients had major adverse events related to the overall ablation procedure: Two developed cardiac tamponade, and one had a stroke. No patients had an esophageal fistula or symptomatic pulmonary vein stenosis.

After the single ablation procedure and at 12-month follow-up, the prevalence of freedom from recurrent AF was 73%, and freedom from any atrial arrhythmia was 69%. As a historical comparison, Dr. Verma cited the 12-month outcome following pulmonary vein isolation and other ablative measures in the STAR AF II (Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II) trial, which reported a 59% freedom from AF rate and a 49% freedom from any atrial arrhythmia rate with or without antiarrhythmic drug treatment after pulmonary vein isolation (N Engl J Med. 2015 May 7;372[19]:1812-22).

Multivariate analysis of the new data showed that, in addition to ablation of three or more targets, two other variables also linked significantly with long-term freedom from AF: Ablation of at least two types of electrical abnormalities in the left atrial wall, which boosted the 12-month AF-free rate by 2.8 fold, and being in sinus rhythm at the start of the ablation procedure, which linked with a 5-fold higher rate of long-term freedom from AF.

Dr. Verma also reported the AF burden measured after ablation in 96 patients who each underwent an average of 85 hours of postablation heart rhythm monitoring. Ninety percent of these patients showed no AF episodes of more than 30 seconds throughout the duration of their monitoring.

UNCOVER-AF was funded by Acutus, the company that markets the AcQMap catheter. Dr. Verma has been an advisor to or speaker on behalf of Bayer, Biosense Webster, Boehringer Ingelheim, and Medtronic, and St. Jude (Abbott), and he has received research funding from Bayer, Biosense Webster, Boehringer Ingelheim, and Medtronic. He had no personal disclosures relative to Acutus. Dr. Reddy has been a consultant to, received research funding from, and has an equity stake in Acutus, and has similar relationships with more than three dozen other companies.

mzoler@mdedge.com

BOSTON – An atrial mapping catheter that combines ultrasound anatomic mapping with nontouch, high-resolution, charge-density mapping resulted in a high, 73% freedom from recurrent atrial fibrillation rate 12 months after ablation procedures guided by this catheter in a single-arm, multicenter study with 121 patients with persistent atrial fibrillation followed for 1 year.

Mitchel L. Zoler/MDedge News

The AcQMap device tested in the study “allows you to quickly remap” the left atrium after an initial pulmonary vein isolation or after other types of ablations to find remaining areas of abnormal electrical activity on the atrial walls and then “go after those,” Atul Verma, MD, said at the annual International AF Symposium.

An analysis he reported showed that the single patient variable that linked with the highest rate of 1-year freedom from recurrent atrial fibrillation (AF) was having at least three atrial targets ablated in addition to pulmonary vein isolation. Patients who received this number of added ablations were more than nine times more likely to be free from AF after 12 months, compared with patients who received fewer additional ablations, said Dr. Verma, a cardiac electrophysiologist at Southlake Regional Health Centre in Newmarket, Ont.

The AcQMap catheter “identifies more places to ablate.” What makes it unique among currently available mapping devices is its high resolution, its use of charge-density mapping rather than voltage-based mapping, and its speed, Dr. Verma said in an interview.

The AcQMap device has Food and Drug Administration marketing approval for mapping and so is available for routine U.S. use. However, Dr. Verma cautioned that the increased freedom from persistent AF after using the catheter during ablation that he reported should be confirmed by a randomized trial. Another electrophysiologist who performs ablations but was not involved with the study, Vivek Reddy, MD, agreed with this caveat.

Mitchel L. Zoler/MDedge News

“Nonrandomized trials of ablation in patients with persistent AF are at best hypothesis generating. We’ve learned that the hard way; we have been burned too many times. To assess mapping of AF activity you need a randomized, controlled trial,” said Dr. Reddy, professor of medicine and director of cardiac arrhythmia services at Mount Sinai Hospital in New York.

The UNCOVER-AF (Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation) study ran at 13 centers in Canada and Europe and enrolled 129 patients who had persistent AF for an average of almost 2 years, of whom 127 actually underwent an ablation procedure and 121 were followed for 12 months post ablation. Operators were free to use the AcQMap device to map the left atrium as many times as they thought necessary, generally once at the start of the procedure, a second time after they completed pulmonary vein isolation, and then a variable number of subsequent times. On average they performed about four mappings in each patient. At entry, patients had received an average of one antiarrhythmic drug. After their ablation treatment, about 10% of patients received an antiarrhythmic drug.

The investigators found no major adverse events linked to use of the mapping device. Three patients had major adverse events related to the overall ablation procedure: Two developed cardiac tamponade, and one had a stroke. No patients had an esophageal fistula or symptomatic pulmonary vein stenosis.

After the single ablation procedure and at 12-month follow-up, the prevalence of freedom from recurrent AF was 73%, and freedom from any atrial arrhythmia was 69%. As a historical comparison, Dr. Verma cited the 12-month outcome following pulmonary vein isolation and other ablative measures in the STAR AF II (Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II) trial, which reported a 59% freedom from AF rate and a 49% freedom from any atrial arrhythmia rate with or without antiarrhythmic drug treatment after pulmonary vein isolation (N Engl J Med. 2015 May 7;372[19]:1812-22).

Multivariate analysis of the new data showed that, in addition to ablation of three or more targets, two other variables also linked significantly with long-term freedom from AF: Ablation of at least two types of electrical abnormalities in the left atrial wall, which boosted the 12-month AF-free rate by 2.8 fold, and being in sinus rhythm at the start of the ablation procedure, which linked with a 5-fold higher rate of long-term freedom from AF.

Dr. Verma also reported the AF burden measured after ablation in 96 patients who each underwent an average of 85 hours of postablation heart rhythm monitoring. Ninety percent of these patients showed no AF episodes of more than 30 seconds throughout the duration of their monitoring.

UNCOVER-AF was funded by Acutus, the company that markets the AcQMap catheter. Dr. Verma has been an advisor to or speaker on behalf of Bayer, Biosense Webster, Boehringer Ingelheim, and Medtronic, and St. Jude (Abbott), and he has received research funding from Bayer, Biosense Webster, Boehringer Ingelheim, and Medtronic. He had no personal disclosures relative to Acutus. Dr. Reddy has been a consultant to, received research funding from, and has an equity stake in Acutus, and has similar relationships with more than three dozen other companies.

mzoler@mdedge.com

“I’d be a millionaire if I could get rid of my conscience.”

A friend of mine in obstetrics said that yesterday. We were talking about the various quackery products pushed over the Internet and in some stores. These things claim to heal anything from Parkinson’s disease to a broken heart, and are generally sold by someone without real medical training. Generally, they also include some comment about this being a cure that doctors are hiding from you.

Of course, all of this is untrue. If there were actually cure for some horrible neurologic disease, I’d be thrilled to prescribe it. I’m here to reduce suffering, not prolong it.

I get it. People want to believe there’s hope when there is none. Even if it’s just something like forgetting a broken relationship, they want to believe there’s a way to make it happen quickly and painlessly.

It would be nice if it worked that way, but it doesn’t. Worse, people in these unfortunate medical or emotional situations are often vulnerable to these sales pitches, and there’s no shortage of unscrupulous individuals willing to prey on them.

What bothers me most in these cases is when doctors, with training similar to mine, push these “remedies.” Often they’re sold in a case in the waiting room and recommended during the visit. I assume these physicians either have lost their conscience and don’t care, or over time have somehow convinced themselves that what they’re doing is right.

Having a doctor selling or endorsing such a product gives it a credibility that it usually won’t get from an average Internet huckster, even if it’s for the same thing.

I’m sure some doctors have convinced themselves that the product is harmless, and therefore falls under primum non nocere. But being harmless isn’t the same as being effective, which is what the patient wants.

Like my friend said, with the financial pressures modern physicians are under, it’s easy to look at things like this as a way to improve cash flow and the bottom line. But you can’t lose sight of the patients. They’re why we are here, and selling them a product that will do them no good isn’t right.

Hippocrates’ “Do no harm” is a key part of being a doctor, but Jiminy Cricket’s “always let your conscience be your guide” is part of being a good doctor. We should never forget that.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

“I’d be a millionaire if I could get rid of my conscience.”

A friend of mine in obstetrics said that yesterday. We were talking about the various quackery products pushed over the Internet and in some stores. These things claim to heal anything from Parkinson’s disease to a broken heart, and are generally sold by someone without real medical training. Generally, they also include some comment about this being a cure that doctors are hiding from you.

Of course, all of this is untrue. If there were actually cure for some horrible neurologic disease, I’d be thrilled to prescribe it. I’m here to reduce suffering, not prolong it.

I get it. People want to believe there’s hope when there is none. Even if it’s just something like forgetting a broken relationship, they want to believe there’s a way to make it happen quickly and painlessly.

It would be nice if it worked that way, but it doesn’t. Worse, people in these unfortunate medical or emotional situations are often vulnerable to these sales pitches, and there’s no shortage of unscrupulous individuals willing to prey on them.

What bothers me most in these cases is when doctors, with training similar to mine, push these “remedies.” Often they’re sold in a case in the waiting room and recommended during the visit. I assume these physicians either have lost their conscience and don’t care, or over time have somehow convinced themselves that what they’re doing is right.

Having a doctor selling or endorsing such a product gives it a credibility that it usually won’t get from an average Internet huckster, even if it’s for the same thing.

I’m sure some doctors have convinced themselves that the product is harmless, and therefore falls under primum non nocere. But being harmless isn’t the same as being effective, which is what the patient wants.

Like my friend said, with the financial pressures modern physicians are under, it’s easy to look at things like this as a way to improve cash flow and the bottom line. But you can’t lose sight of the patients. They’re why we are here, and selling them a product that will do them no good isn’t right.

Hippocrates’ “Do no harm” is a key part of being a doctor, but Jiminy Cricket’s “always let your conscience be your guide” is part of being a good doctor. We should never forget that.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

“I’d be a millionaire if I could get rid of my conscience.”

A friend of mine in obstetrics said that yesterday. We were talking about the various quackery products pushed over the Internet and in some stores. These things claim to heal anything from Parkinson’s disease to a broken heart, and are generally sold by someone without real medical training. Generally, they also include some comment about this being a cure that doctors are hiding from you.

Of course, all of this is untrue. If there were actually cure for some horrible neurologic disease, I’d be thrilled to prescribe it. I’m here to reduce suffering, not prolong it.

I get it. People want to believe there’s hope when there is none. Even if it’s just something like forgetting a broken relationship, they want to believe there’s a way to make it happen quickly and painlessly.

It would be nice if it worked that way, but it doesn’t. Worse, people in these unfortunate medical or emotional situations are often vulnerable to these sales pitches, and there’s no shortage of unscrupulous individuals willing to prey on them.

What bothers me most in these cases is when doctors, with training similar to mine, push these “remedies.” Often they’re sold in a case in the waiting room and recommended during the visit. I assume these physicians either have lost their conscience and don’t care, or over time have somehow convinced themselves that what they’re doing is right.

Having a doctor selling or endorsing such a product gives it a credibility that it usually won’t get from an average Internet huckster, even if it’s for the same thing.

I’m sure some doctors have convinced themselves that the product is harmless, and therefore falls under primum non nocere. But being harmless isn’t the same as being effective, which is what the patient wants.

Like my friend said, with the financial pressures modern physicians are under, it’s easy to look at things like this as a way to improve cash flow and the bottom line. But you can’t lose sight of the patients. They’re why we are here, and selling them a product that will do them no good isn’t right.

Hippocrates’ “Do no harm” is a key part of being a doctor, but Jiminy Cricket’s “always let your conscience be your guide” is part of being a good doctor. We should never forget that.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Stryker has announced a voluntary field action for its Lifepak 15 monitor/defibrillators, according to a safety alert from the Food and Drug Administration.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The company is notifying certain Lifepak 15 customers of an issue causing the device to lock up after a defibrillation shock is delivered. The lockup displays as a blank monitor with the LED lights on, indicating that the power is on, but the keypad and device become nonfunctional, the FDA said. This lockup can delay delivery of therapy, which can cause injury or death.

Since the introduction of the device in 2009, 58 complaints regarding the issue have been reported, including 6 that resulted in death. In all, 13,003 devices are included in the field action.

Customers should continue to use their devices if they have been affected until a correction can be completed. If the lockup occurs, the user should press and hold the “on” button until the LED turns off, then hit the “on” button again. If this does not reset the device, the batteries should be removed and reinserted, or the device should be removed and reconnected to its power adapter, the FDA said.

Find the full press release on the FDA website.

lfranki@mdedge.com

Stryker has announced a voluntary field action for its Lifepak 15 monitor/defibrillators, according to a safety alert from the Food and Drug Administration.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The company is notifying certain Lifepak 15 customers of an issue causing the device to lock up after a defibrillation shock is delivered. The lockup displays as a blank monitor with the LED lights on, indicating that the power is on, but the keypad and device become nonfunctional, the FDA said. This lockup can delay delivery of therapy, which can cause injury or death.

Since the introduction of the device in 2009, 58 complaints regarding the issue have been reported, including 6 that resulted in death. In all, 13,003 devices are included in the field action.

Customers should continue to use their devices if they have been affected until a correction can be completed. If the lockup occurs, the user should press and hold the “on” button until the LED turns off, then hit the “on” button again. If this does not reset the device, the batteries should be removed and reinserted, or the device should be removed and reconnected to its power adapter, the FDA said.

Find the full press release on the FDA website.

lfranki@mdedge.com

Stryker has announced a voluntary field action for its Lifepak 15 monitor/defibrillators, according to a safety alert from the Food and Drug Administration.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The company is notifying certain Lifepak 15 customers of an issue causing the device to lock up after a defibrillation shock is delivered. The lockup displays as a blank monitor with the LED lights on, indicating that the power is on, but the keypad and device become nonfunctional, the FDA said. This lockup can delay delivery of therapy, which can cause injury or death.

Since the introduction of the device in 2009, 58 complaints regarding the issue have been reported, including 6 that resulted in death. In all, 13,003 devices are included in the field action.

Customers should continue to use their devices if they have been affected until a correction can be completed. If the lockup occurs, the user should press and hold the “on” button until the LED turns off, then hit the “on” button again. If this does not reset the device, the batteries should be removed and reinserted, or the device should be removed and reconnected to its power adapter, the FDA said.

Find the full press release on the FDA website.

lfranki@mdedge.com

Automated office blood pressure readings appear to be more accurate than routine office readings and BP readings in research settings, according to a recent systematic review and meta-analysis.

Based on the evidence, automated office BP (AOBP) readings should now be the preferred method of reading a patient’s BP in clinical practice despite initial reluctance to incorporate this technique over other methods, the researchers wrote in JAMA Internal Medicine.

“The existing evidence supports the use of AOBP to screen patients for possible hypertension in clinical practice, especially if one takes into account the white coat effect associated with current manual or oscillometric techniques for office BP measurement,” wrote Michael Roerecke, PhD, of the University of Toronto, and his colleagues.

Dr. Roerecke and his colleagues identified 31 articles with 9,279 participants (4,736 men, 4,543 women) where AOBP was compared with another method of BP reading, such as awake ambulatory, routine office, and research BP readings. The AOBP reading was performed with a fully automated oscillometric sphygmomanometer with the patient resting in a quiet area.

The researchers found systolic AOBP of 130 mm Hg was associated with significantly higher readings from routine office (mean difference, 14.5 mm Hg) or research BP readings (7.0 mm Hg), while participants had similar AOBP and awake ambulatory BP readings (0.3 mm Hg). All differences were statistically significant (P less than .001).

“If AOBP is to be used in clinical practice, readings must closely adhere to the procedures used in the AOBP studies in this meta-analysis, including multiple BP readings recorded with a fully automated oscillometric sphygmomanometer while the patient rests alone in a quiet place,” the researchers wrote.

Potential limitations of the study were the large statistical heterogeneity of the sample, though the researchers noted little clinical heterogeneity, and that most studies measured AOBP and awake ambulatory BP on the same day to limit differences in timing.

The authors reported no relevant conflicts of interest.

SOURCE: Roerecke M et al. JAMA Intern Med. 2019 Feb 4. doi: 10.1001/jamainternmed.2018.6551.

Automated office blood pressure readings appear to be more accurate than routine office readings and BP readings in research settings, according to a recent systematic review and meta-analysis.

Based on the evidence, automated office BP (AOBP) readings should now be the preferred method of reading a patient’s BP in clinical practice despite initial reluctance to incorporate this technique over other methods, the researchers wrote in JAMA Internal Medicine.

“The existing evidence supports the use of AOBP to screen patients for possible hypertension in clinical practice, especially if one takes into account the white coat effect associated with current manual or oscillometric techniques for office BP measurement,” wrote Michael Roerecke, PhD, of the University of Toronto, and his colleagues.

Dr. Roerecke and his colleagues identified 31 articles with 9,279 participants (4,736 men, 4,543 women) where AOBP was compared with another method of BP reading, such as awake ambulatory, routine office, and research BP readings. The AOBP reading was performed with a fully automated oscillometric sphygmomanometer with the patient resting in a quiet area.

The researchers found systolic AOBP of 130 mm Hg was associated with significantly higher readings from routine office (mean difference, 14.5 mm Hg) or research BP readings (7.0 mm Hg), while participants had similar AOBP and awake ambulatory BP readings (0.3 mm Hg). All differences were statistically significant (P less than .001).

“If AOBP is to be used in clinical practice, readings must closely adhere to the procedures used in the AOBP studies in this meta-analysis, including multiple BP readings recorded with a fully automated oscillometric sphygmomanometer while the patient rests alone in a quiet place,” the researchers wrote.

Potential limitations of the study were the large statistical heterogeneity of the sample, though the researchers noted little clinical heterogeneity, and that most studies measured AOBP and awake ambulatory BP on the same day to limit differences in timing.

The authors reported no relevant conflicts of interest.

SOURCE: Roerecke M et al. JAMA Intern Med. 2019 Feb 4. doi: 10.1001/jamainternmed.2018.6551.

Automated office blood pressure readings appear to be more accurate than routine office readings and BP readings in research settings, according to a recent systematic review and meta-analysis.

Based on the evidence, automated office BP (AOBP) readings should now be the preferred method of reading a patient’s BP in clinical practice despite initial reluctance to incorporate this technique over other methods, the researchers wrote in JAMA Internal Medicine.

“The existing evidence supports the use of AOBP to screen patients for possible hypertension in clinical practice, especially if one takes into account the white coat effect associated with current manual or oscillometric techniques for office BP measurement,” wrote Michael Roerecke, PhD, of the University of Toronto, and his colleagues.

Dr. Roerecke and his colleagues identified 31 articles with 9,279 participants (4,736 men, 4,543 women) where AOBP was compared with another method of BP reading, such as awake ambulatory, routine office, and research BP readings. The AOBP reading was performed with a fully automated oscillometric sphygmomanometer with the patient resting in a quiet area.

The researchers found systolic AOBP of 130 mm Hg was associated with significantly higher readings from routine office (mean difference, 14.5 mm Hg) or research BP readings (7.0 mm Hg), while participants had similar AOBP and awake ambulatory BP readings (0.3 mm Hg). All differences were statistically significant (P less than .001).

“If AOBP is to be used in clinical practice, readings must closely adhere to the procedures used in the AOBP studies in this meta-analysis, including multiple BP readings recorded with a fully automated oscillometric sphygmomanometer while the patient rests alone in a quiet place,” the researchers wrote.

Potential limitations of the study were the large statistical heterogeneity of the sample, though the researchers noted little clinical heterogeneity, and that most studies measured AOBP and awake ambulatory BP on the same day to limit differences in timing.

The authors reported no relevant conflicts of interest.

SOURCE: Roerecke M et al. JAMA Intern Med. 2019 Feb 4. doi: 10.1001/jamainternmed.2018.6551.

Despite concern about the rise of nonvaccine serotypes following widespread PCV13 immunization, cases of community-acquired pneumonia (CAP) remain nearly as low as after initial implementation of the vaccine and severe cases have not risen at all.

luiscar/Thinkstock

This was the finding of a prospective time-series analysis study from eight French pediatric emergency departments between June 2009 and May 2017.

The 12,587 children with CAP enrolled in the study between June 2009 and May 2017 were all aged 15 years or younger and came from one of eight French pediatric EDs.

Pediatric pneumonia cases per 1,000 ED visits dropped 44% after PCV13 was implemented, a decrease from 6.3 to 3.5 cases of CAP per 1,000 pediatric visits from June 2011 to May 2014, with a slight but statistically significant increase to 3.8 cases of CAP per 1,000 pediatric visits from June 2014 to May 2017. However, there was no statistically significant increase in cases with pleural effusion, hospitalization, or high inflammatory biomarkers.

“These results contrast with the recent increase in frequency of invasive pneumococcal disease observed in several countries during the same period linked to serotype replacement beyond 5 years after PCV13 implementation,” reported Naïm Ouldali, MD, of the Association Clinique et Thérapeutique Infantile du Val-de-Marne in France, and associates. The report is in JAMA Pediatrics.

“This difference in the trends suggests different consequences of serotype replacement on pneumococcal CAP vs invasive pneumococcal disease,” they wrote. “The recent slight increase in the number of all CAP cases and virus involvement may reflect changes in the epidemiology of other pathogens and/or serotype replacement with less pathogenic serotypes.”

This latter point arose from discovering no dominant serotype during the study period. Of the 11 serotypes not covered by PCV13, none appeared in more than four cases.

“The implementation of PCV13 has led to the quasi-disappearance of the more invasive serotypes and increase in others in nasopharyngeal flora, which greatly reduces the frequency of the more severe forms of CAP, but could also play a role in the slight increase in frequency of the more benign forms,” the authors reported.

Among the study’s limitations was lack of a control group, precluding the ability to attribute findings to any changes in case reporting. And “participating physicians were encouraged to not change their practice, including test use, and no other potential interfering intervention.”

Funding sources for this study included the Pediatric Infectious Diseases Group of the French Pediatrics Society, Association Clinique et Thérapeutique Infantile du Val-de-Marne, the Foundation for Medical Research and a Pfizer Investigator Initiated Research grant.

Dr Ouldali has received grants from GlaxoSmithKline, and many of the authors have financial ties and/or have received non-financial support from AstraZeneca, Biocodex, GlaxoSmithKline, Merck, Novartis, Pfizer and/or Sanofi Pasteur.

SOURCE: Ouldali N et al. JAMA Pediatrics. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.5273.

Despite concern about the rise of nonvaccine serotypes following widespread PCV13 immunization, cases of community-acquired pneumonia (CAP) remain nearly as low as after initial implementation of the vaccine and severe cases have not risen at all.

luiscar/Thinkstock

This was the finding of a prospective time-series analysis study from eight French pediatric emergency departments between June 2009 and May 2017.

The 12,587 children with CAP enrolled in the study between June 2009 and May 2017 were all aged 15 years or younger and came from one of eight French pediatric EDs.

Pediatric pneumonia cases per 1,000 ED visits dropped 44% after PCV13 was implemented, a decrease from 6.3 to 3.5 cases of CAP per 1,000 pediatric visits from June 2011 to May 2014, with a slight but statistically significant increase to 3.8 cases of CAP per 1,000 pediatric visits from June 2014 to May 2017. However, there was no statistically significant increase in cases with pleural effusion, hospitalization, or high inflammatory biomarkers.

“These results contrast with the recent increase in frequency of invasive pneumococcal disease observed in several countries during the same period linked to serotype replacement beyond 5 years after PCV13 implementation,” reported Naïm Ouldali, MD, of the Association Clinique et Thérapeutique Infantile du Val-de-Marne in France, and associates. The report is in JAMA Pediatrics.

“This difference in the trends suggests different consequences of serotype replacement on pneumococcal CAP vs invasive pneumococcal disease,” they wrote. “The recent slight increase in the number of all CAP cases and virus involvement may reflect changes in the epidemiology of other pathogens and/or serotype replacement with less pathogenic serotypes.”

This latter point arose from discovering no dominant serotype during the study period. Of the 11 serotypes not covered by PCV13, none appeared in more than four cases.

“The implementation of PCV13 has led to the quasi-disappearance of the more invasive serotypes and increase in others in nasopharyngeal flora, which greatly reduces the frequency of the more severe forms of CAP, but could also play a role in the slight increase in frequency of the more benign forms,” the authors reported.

Among the study’s limitations was lack of a control group, precluding the ability to attribute findings to any changes in case reporting. And “participating physicians were encouraged to not change their practice, including test use, and no other potential interfering intervention.”

Funding sources for this study included the Pediatric Infectious Diseases Group of the French Pediatrics Society, Association Clinique et Thérapeutique Infantile du Val-de-Marne, the Foundation for Medical Research and a Pfizer Investigator Initiated Research grant.

Dr Ouldali has received grants from GlaxoSmithKline, and many of the authors have financial ties and/or have received non-financial support from AstraZeneca, Biocodex, GlaxoSmithKline, Merck, Novartis, Pfizer and/or Sanofi Pasteur.

SOURCE: Ouldali N et al. JAMA Pediatrics. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.5273.

Despite concern about the rise of nonvaccine serotypes following widespread PCV13 immunization, cases of community-acquired pneumonia (CAP) remain nearly as low as after initial implementation of the vaccine and severe cases have not risen at all.

luiscar/Thinkstock

This was the finding of a prospective time-series analysis study from eight French pediatric emergency departments between June 2009 and May 2017.

The 12,587 children with CAP enrolled in the study between June 2009 and May 2017 were all aged 15 years or younger and came from one of eight French pediatric EDs.

Pediatric pneumonia cases per 1,000 ED visits dropped 44% after PCV13 was implemented, a decrease from 6.3 to 3.5 cases of CAP per 1,000 pediatric visits from June 2011 to May 2014, with a slight but statistically significant increase to 3.8 cases of CAP per 1,000 pediatric visits from June 2014 to May 2017. However, there was no statistically significant increase in cases with pleural effusion, hospitalization, or high inflammatory biomarkers.

“These results contrast with the recent increase in frequency of invasive pneumococcal disease observed in several countries during the same period linked to serotype replacement beyond 5 years after PCV13 implementation,” reported Naïm Ouldali, MD, of the Association Clinique et Thérapeutique Infantile du Val-de-Marne in France, and associates. The report is in JAMA Pediatrics.

“This difference in the trends suggests different consequences of serotype replacement on pneumococcal CAP vs invasive pneumococcal disease,” they wrote. “The recent slight increase in the number of all CAP cases and virus involvement may reflect changes in the epidemiology of other pathogens and/or serotype replacement with less pathogenic serotypes.”

This latter point arose from discovering no dominant serotype during the study period. Of the 11 serotypes not covered by PCV13, none appeared in more than four cases.

“The implementation of PCV13 has led to the quasi-disappearance of the more invasive serotypes and increase in others in nasopharyngeal flora, which greatly reduces the frequency of the more severe forms of CAP, but could also play a role in the slight increase in frequency of the more benign forms,” the authors reported.

Among the study’s limitations was lack of a control group, precluding the ability to attribute findings to any changes in case reporting. And “participating physicians were encouraged to not change their practice, including test use, and no other potential interfering intervention.”

Funding sources for this study included the Pediatric Infectious Diseases Group of the French Pediatrics Society, Association Clinique et Thérapeutique Infantile du Val-de-Marne, the Foundation for Medical Research and a Pfizer Investigator Initiated Research grant.

Dr Ouldali has received grants from GlaxoSmithKline, and many of the authors have financial ties and/or have received non-financial support from AstraZeneca, Biocodex, GlaxoSmithKline, Merck, Novartis, Pfizer and/or Sanofi Pasteur.

SOURCE: Ouldali N et al. JAMA Pediatrics. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.5273.

I’m very excited about the first issue of The New Gastroenterologist in 2019, which has some fantastic articles that I hope you will find interesting and useful. The In Focus feature this month covers acute pancreatitis, which is an incredibly important topic for all in our field. Amar Mandalia and Matthew DiMagno (University of Michigan) provide a comprehensive overview of the management of acute pancreatitis, including a review of the recent AGA guideline on this topic. This article can be found online, as well as in print in the February issue of GI & Hepatology News.

Rhonda Cole (Michael E. DeBakey VAMC/Baylor) addresses the important topic of how to deal with difficult people, and she provides some useful tips for situations that many of us struggle with. Also in this issue, Rishi Naik (Vanderbilt) and current Associate Editor of Gastroenterology John Inadomi (University of Washington) provide some tips on how to write an effective cover letter for a journal submission. Anna Duloy and Sachin Wani (University of Colorado) provide an overview of the current state of training in advanced endoscopy, which will be very helpful for all those considering a fellowship or incorporation of these procedures into their practices.

For those looking to pick the right private practice position, David Ramsay (Digestive Health Specialists, Winston-Salem, N.C.) provides some useful tips to help you find the job that will be the best fit. In prior issues of The New Gastroenterologist, there have been several articles discussing saving for retirement, but how about how to effectively save for your children’s education? To address that topic, Michael Clancy (Drexel) provides an informative overview of 529 college savings accounts.

Finally, Gyanprakash Ketwaroo (Baylor), Peter Liang (NYU Langone), Carol Brown, and Celena NuQuay (AGA) provide an overview of one of the most important and impactful initiatives from the AGA for the early career community – the AGA Regional Practice Skills Workshops. These workshops are a tremendous resource for early career GIs, and I would recommend that you check one out if you have not already had the opportunity.

If you’re interested in browsing older articles from The New Gastroenterologist, articles from previous issues can be found on our webpage. Also, we are always looking for new ideas and new contributors. If you have suggestions or are interested, please contact me at bryson.katona@uphs.upenn.edu or the managing editor, Ryan Farrell, at rfarrell@gastro.org

Sincerely,

Bryson W. Katona, MD, PhD
Editor in Chief

Dr. Katona is an assistant professor of medicine in the division of gastroenterology at the University of Pennsylvania, Philadelphia.

I’m very excited about the first issue of The New Gastroenterologist in 2019, which has some fantastic articles that I hope you will find interesting and useful. The In Focus feature this month covers acute pancreatitis, which is an incredibly important topic for all in our field. Amar Mandalia and Matthew DiMagno (University of Michigan) provide a comprehensive overview of the management of acute pancreatitis, including a review of the recent AGA guideline on this topic. This article can be found online, as well as in print in the February issue of GI & Hepatology News.

Rhonda Cole (Michael E. DeBakey VAMC/Baylor) addresses the important topic of how to deal with difficult people, and she provides some useful tips for situations that many of us struggle with. Also in this issue, Rishi Naik (Vanderbilt) and current Associate Editor of Gastroenterology John Inadomi (University of Washington) provide some tips on how to write an effective cover letter for a journal submission. Anna Duloy and Sachin Wani (University of Colorado) provide an overview of the current state of training in advanced endoscopy, which will be very helpful for all those considering a fellowship or incorporation of these procedures into their practices.

For those looking to pick the right private practice position, David Ramsay (Digestive Health Specialists, Winston-Salem, N.C.) provides some useful tips to help you find the job that will be the best fit. In prior issues of The New Gastroenterologist, there have been several articles discussing saving for retirement, but how about how to effectively save for your children’s education? To address that topic, Michael Clancy (Drexel) provides an informative overview of 529 college savings accounts.

Finally, Gyanprakash Ketwaroo (Baylor), Peter Liang (NYU Langone), Carol Brown, and Celena NuQuay (AGA) provide an overview of one of the most important and impactful initiatives from the AGA for the early career community – the AGA Regional Practice Skills Workshops. These workshops are a tremendous resource for early career GIs, and I would recommend that you check one out if you have not already had the opportunity.

If you’re interested in browsing older articles from The New Gastroenterologist, articles from previous issues can be found on our webpage. Also, we are always looking for new ideas and new contributors. If you have suggestions or are interested, please contact me at bryson.katona@uphs.upenn.edu or the managing editor, Ryan Farrell, at rfarrell@gastro.org

Sincerely,

Bryson W. Katona, MD, PhD
Editor in Chief

Dr. Katona is an assistant professor of medicine in the division of gastroenterology at the University of Pennsylvania, Philadelphia.

I’m very excited about the first issue of The New Gastroenterologist in 2019, which has some fantastic articles that I hope you will find interesting and useful. The In Focus feature this month covers acute pancreatitis, which is an incredibly important topic for all in our field. Amar Mandalia and Matthew DiMagno (University of Michigan) provide a comprehensive overview of the management of acute pancreatitis, including a review of the recent AGA guideline on this topic. This article can be found online, as well as in print in the February issue of GI & Hepatology News.

Rhonda Cole (Michael E. DeBakey VAMC/Baylor) addresses the important topic of how to deal with difficult people, and she provides some useful tips for situations that many of us struggle with. Also in this issue, Rishi Naik (Vanderbilt) and current Associate Editor of Gastroenterology John Inadomi (University of Washington) provide some tips on how to write an effective cover letter for a journal submission. Anna Duloy and Sachin Wani (University of Colorado) provide an overview of the current state of training in advanced endoscopy, which will be very helpful for all those considering a fellowship or incorporation of these procedures into their practices.

For those looking to pick the right private practice position, David Ramsay (Digestive Health Specialists, Winston-Salem, N.C.) provides some useful tips to help you find the job that will be the best fit. In prior issues of The New Gastroenterologist, there have been several articles discussing saving for retirement, but how about how to effectively save for your children’s education? To address that topic, Michael Clancy (Drexel) provides an informative overview of 529 college savings accounts.

Finally, Gyanprakash Ketwaroo (Baylor), Peter Liang (NYU Langone), Carol Brown, and Celena NuQuay (AGA) provide an overview of one of the most important and impactful initiatives from the AGA for the early career community – the AGA Regional Practice Skills Workshops. These workshops are a tremendous resource for early career GIs, and I would recommend that you check one out if you have not already had the opportunity.

If you’re interested in browsing older articles from The New Gastroenterologist, articles from previous issues can be found on our webpage. Also, we are always looking for new ideas and new contributors. If you have suggestions or are interested, please contact me at bryson.katona@uphs.upenn.edu or the managing editor, Ryan Farrell, at rfarrell@gastro.org

Sincerely,

Bryson W. Katona, MD, PhD
Editor in Chief

Dr. Katona is an assistant professor of medicine in the division of gastroenterology at the University of Pennsylvania, Philadelphia.