Cannabis Often Used as a Substitute for Traditional Medications

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Nearly two thirds of patients with rheumatic conditions switched to medical cannabis from medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids, with the substitution being associated with greater self-reported improvement in symptoms than nonsubstitution.

METHODOLOGY:

  • Researchers conducted a secondary analysis of a cross-sectional survey to investigate the prevalence of switching to medical cannabis from traditional medications in patients with rheumatic conditions from the United States and Canada.
  • The survey included questions on current and past medical cannabis use, sociodemographic characteristics, medication taken and substituted, substance use, and patient-reported outcomes.
  • Of the 1727 patients who completed the survey, 763 patients (mean age, 59 years; 84.1% women) reported current use of cannabis and were included in this analysis.
  • Participants were asked if they had substituted any medications with medical cannabis and were sub-grouped accordingly.
  • They also reported any changes in symptoms after initiating cannabis, the current and anticipated duration of medical cannabis use, methods of ingestion, cannabinoid content, and frequency of use.

TAKEAWAY:

  • Overall, 62.5% reported substituting medical cannabis for certain medications, including NSAIDs (54.7%), opioids (48.6%), sleep aids (29.6%), muscle relaxants (25.2%), benzodiazepines (15.5%), and gabapentinoids (10.5%).
  • The most common reasons given for substituting medical cannabis were fewer side effects (39%), better symptom control (27%), and fewer adverse effects (12%).
  • Participants who substituted medical cannabis reported significant improvements in symptoms such as pain, sleep, joint stiffness, muscle spasms, and inflammation, and in overall health, compared with those who did not substitute it for medications.
  • The substitution group was more likely to use inhalation methods (smoking and vaporizing) than the nonsubstitution group; they also used medical cannabis more frequently and preferred products containing delta-9-tetrahydrocannabinol.

IN PRACTICE:

“The changing legal status of cannabis has allowed a greater openness with more people willing to try cannabis for symptom relief. These encouraging results of medication reduction and favorable effect of [medical cannabis] require confirmation with more rigorous methods. At this time, survey information may be seen as a signal for effect, rather than sound evidence that could be applicable to those with musculoskeletal complaints in general,” the authors wrote. 

SOURCE:

The study was led by Kevin F. Boehnke, PhD, University of Michigan Medical School, Ann Arbor, and was published online in ACR Open Rheumatology.

LIMITATIONS: 

The cross-sectional nature of the study limited the determination of causality between medical cannabis use and symptom improvement. Moreover, the anonymous and self-reported nature of the survey at a single timepoint may have introduced recall bias. The sample predominantly consisted of older, White females, which may have limited the generalizability of the findings to other demographic groups.

DISCLOSURES:

Some authors received grant support from the National Institute on Drug Abuse and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some others received payments, honoraria, grant funding, consulting fees, and travel support, and reported other ties with pharmaceutical companies and other institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Nearly two thirds of patients with rheumatic conditions switched to medical cannabis from medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids, with the substitution being associated with greater self-reported improvement in symptoms than nonsubstitution.

METHODOLOGY:

  • Researchers conducted a secondary analysis of a cross-sectional survey to investigate the prevalence of switching to medical cannabis from traditional medications in patients with rheumatic conditions from the United States and Canada.
  • The survey included questions on current and past medical cannabis use, sociodemographic characteristics, medication taken and substituted, substance use, and patient-reported outcomes.
  • Of the 1727 patients who completed the survey, 763 patients (mean age, 59 years; 84.1% women) reported current use of cannabis and were included in this analysis.
  • Participants were asked if they had substituted any medications with medical cannabis and were sub-grouped accordingly.
  • They also reported any changes in symptoms after initiating cannabis, the current and anticipated duration of medical cannabis use, methods of ingestion, cannabinoid content, and frequency of use.

TAKEAWAY:

  • Overall, 62.5% reported substituting medical cannabis for certain medications, including NSAIDs (54.7%), opioids (48.6%), sleep aids (29.6%), muscle relaxants (25.2%), benzodiazepines (15.5%), and gabapentinoids (10.5%).
  • The most common reasons given for substituting medical cannabis were fewer side effects (39%), better symptom control (27%), and fewer adverse effects (12%).
  • Participants who substituted medical cannabis reported significant improvements in symptoms such as pain, sleep, joint stiffness, muscle spasms, and inflammation, and in overall health, compared with those who did not substitute it for medications.
  • The substitution group was more likely to use inhalation methods (smoking and vaporizing) than the nonsubstitution group; they also used medical cannabis more frequently and preferred products containing delta-9-tetrahydrocannabinol.

IN PRACTICE:

“The changing legal status of cannabis has allowed a greater openness with more people willing to try cannabis for symptom relief. These encouraging results of medication reduction and favorable effect of [medical cannabis] require confirmation with more rigorous methods. At this time, survey information may be seen as a signal for effect, rather than sound evidence that could be applicable to those with musculoskeletal complaints in general,” the authors wrote. 

SOURCE:

The study was led by Kevin F. Boehnke, PhD, University of Michigan Medical School, Ann Arbor, and was published online in ACR Open Rheumatology.

LIMITATIONS: 

The cross-sectional nature of the study limited the determination of causality between medical cannabis use and symptom improvement. Moreover, the anonymous and self-reported nature of the survey at a single timepoint may have introduced recall bias. The sample predominantly consisted of older, White females, which may have limited the generalizability of the findings to other demographic groups.

DISCLOSURES:

Some authors received grant support from the National Institute on Drug Abuse and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some others received payments, honoraria, grant funding, consulting fees, and travel support, and reported other ties with pharmaceutical companies and other institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Nearly two thirds of patients with rheumatic conditions switched to medical cannabis from medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids, with the substitution being associated with greater self-reported improvement in symptoms than nonsubstitution.

METHODOLOGY:

  • Researchers conducted a secondary analysis of a cross-sectional survey to investigate the prevalence of switching to medical cannabis from traditional medications in patients with rheumatic conditions from the United States and Canada.
  • The survey included questions on current and past medical cannabis use, sociodemographic characteristics, medication taken and substituted, substance use, and patient-reported outcomes.
  • Of the 1727 patients who completed the survey, 763 patients (mean age, 59 years; 84.1% women) reported current use of cannabis and were included in this analysis.
  • Participants were asked if they had substituted any medications with medical cannabis and were sub-grouped accordingly.
  • They also reported any changes in symptoms after initiating cannabis, the current and anticipated duration of medical cannabis use, methods of ingestion, cannabinoid content, and frequency of use.

TAKEAWAY:

  • Overall, 62.5% reported substituting medical cannabis for certain medications, including NSAIDs (54.7%), opioids (48.6%), sleep aids (29.6%), muscle relaxants (25.2%), benzodiazepines (15.5%), and gabapentinoids (10.5%).
  • The most common reasons given for substituting medical cannabis were fewer side effects (39%), better symptom control (27%), and fewer adverse effects (12%).
  • Participants who substituted medical cannabis reported significant improvements in symptoms such as pain, sleep, joint stiffness, muscle spasms, and inflammation, and in overall health, compared with those who did not substitute it for medications.
  • The substitution group was more likely to use inhalation methods (smoking and vaporizing) than the nonsubstitution group; they also used medical cannabis more frequently and preferred products containing delta-9-tetrahydrocannabinol.

IN PRACTICE:

“The changing legal status of cannabis has allowed a greater openness with more people willing to try cannabis for symptom relief. These encouraging results of medication reduction and favorable effect of [medical cannabis] require confirmation with more rigorous methods. At this time, survey information may be seen as a signal for effect, rather than sound evidence that could be applicable to those with musculoskeletal complaints in general,” the authors wrote. 

SOURCE:

The study was led by Kevin F. Boehnke, PhD, University of Michigan Medical School, Ann Arbor, and was published online in ACR Open Rheumatology.

LIMITATIONS: 

The cross-sectional nature of the study limited the determination of causality between medical cannabis use and symptom improvement. Moreover, the anonymous and self-reported nature of the survey at a single timepoint may have introduced recall bias. The sample predominantly consisted of older, White females, which may have limited the generalizability of the findings to other demographic groups.

DISCLOSURES:

Some authors received grant support from the National Institute on Drug Abuse and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some others received payments, honoraria, grant funding, consulting fees, and travel support, and reported other ties with pharmaceutical companies and other institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Weight Loss Drugs Don’t Reduce Oocyte Retrieval

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The use of glucagon-like peptide 1 (GLP-1) agonists within a year had no apparent effect on the number of oocytes retrieved in controlled ovarian hyperstimulation (COH), based on data from 73 patients in a multicenter study.

Obesity rates continue to rise in women of reproductive age and many women are using GLP-1 agonists for weight loss, but data on the effect of these drugs on fertility treatments are lacking, said Victoria K. Lazarov, MD, of Icahn School of Medicine at Mount Sinai, New York City, in an abstract presented at the American Society for Reproductive Medicine (ASRM) 2024 scientific congress.

Clinical opinions regarding the use, duration, and discontinuation of GLP-1 agonists during fertility treatments are variable given the limited research, Lazarov noted in her abstract. More data are needed to standardize patient counseling.

Lazarov and colleagues reviewed data from patients who sought treatment at clinics affiliated with a national fertility network from 2005 to 2023 who also utilized a GLP-1 agonist within 1 year of COH.

The study population included 73 adult women; participants were divided into six groups based on the number of days without GLP-1 agonist use prior to retrieval (0-14, 15-30, 31-60, 61-90, 91-180, and 181-365 days). The primary outcome was oocyte yield following COH.

Overall, the mean oocyte yields were not significantly different across the six timing groups (14.4, 16.2, 16.8, 7.7, 13.8, and 15, respectively; = .40).

In a secondary subgroup analysis, the researchers found an inverse relationship between oocyte yield and timing of GLP-1 agonist discontinuation in patients with body mass index (BMI) > 35. However, no changes in oocyte yield were observed in patients with BMIs in the normal or overweight range. Neither duration of GLP-1 agonist use or indication for use had a significant effect on oocyte yield across exposure group.

The findings were limited by several factors, including the relatively small study population, especially the small number of patients with obesity. “Additional investigation is needed to clarify potential effects of GLP-1 agonist use on aspiration risk during oocyte retrieval and embryo creation outcomes,” the researchers wrote in their abstract.

However, the results suggest that most women who use GLP-1 agonists experience no significant effects on oocyte retrieval and embryo creation, and that GLP-1 agonists may have a role in improving oocyte yield for obese patients, the researchers concluded.
 

Larger Studies Needed for Real Reassurance

“Infertility patients who are overweight have lower chances for conception and higher risks of pregnancy complications,” Mark Trolice, MD, professor at the University of Central Florida College of Medicine, Orlando, and founder/director of The IVF Center, Winter Park, Florida, said in an interview.

The use of GLP-1 agonists has dramatically increased given the medication’s effectiveness for weight loss, as well as its use to manage diabetes, but the use of GLP-1 agonists in pregnancy is not well known and current recommendations advise discontinuation of the medication for 6-8 weeks prior to conception, said Trolice, who was not involved in the study.

GLP-1 agonist use is associated with lowered blood glucose levels, Trolice said. “Additionally, the medication can delay gastric emptying and suppress appetite, both of which assist in weight management.”

The current study examined whether there was a difference in oocyte retrieval number in women based on days of discontinuation of GLP-1 agonists prior to the procedure, Trolice told this news organization. “Given the drug’s mechanism of action, there is no apparent biological influence that would impact oocyte yield. Consequently, the study outcome is not unexpected.”

The study purports potential reassurance that GLP-1 exposure, regardless of the duration of discontinuation, has no impact on egg retrieval number, said Trolice. However, “Based on the size of the study, to accept the findings as definitive would risk a type II statistical error.”

Two key areas for additional research are urgently needed, Trolice said, namely, the duration of time to discontinue GLP-1 agonists, if at all, prior to conception, and the discontinuation interval, if at all, prior to anesthesia to avoid airway complications.

The American Society of Anesthesiologists advises patients on daily dosing to consider holding GLP-1 agonists on the day of a procedure or surgery, and those on weekly dosing should consider discontinuing the medication 1 week before the procedure or surgery, Trolice noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Trolice had no financial conflicts to disclose and serves on the editorial advisory board of OB/GYN News.

A version of this article first appeared on Medscape.com.

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The use of glucagon-like peptide 1 (GLP-1) agonists within a year had no apparent effect on the number of oocytes retrieved in controlled ovarian hyperstimulation (COH), based on data from 73 patients in a multicenter study.

Obesity rates continue to rise in women of reproductive age and many women are using GLP-1 agonists for weight loss, but data on the effect of these drugs on fertility treatments are lacking, said Victoria K. Lazarov, MD, of Icahn School of Medicine at Mount Sinai, New York City, in an abstract presented at the American Society for Reproductive Medicine (ASRM) 2024 scientific congress.

Clinical opinions regarding the use, duration, and discontinuation of GLP-1 agonists during fertility treatments are variable given the limited research, Lazarov noted in her abstract. More data are needed to standardize patient counseling.

Lazarov and colleagues reviewed data from patients who sought treatment at clinics affiliated with a national fertility network from 2005 to 2023 who also utilized a GLP-1 agonist within 1 year of COH.

The study population included 73 adult women; participants were divided into six groups based on the number of days without GLP-1 agonist use prior to retrieval (0-14, 15-30, 31-60, 61-90, 91-180, and 181-365 days). The primary outcome was oocyte yield following COH.

Overall, the mean oocyte yields were not significantly different across the six timing groups (14.4, 16.2, 16.8, 7.7, 13.8, and 15, respectively; = .40).

In a secondary subgroup analysis, the researchers found an inverse relationship between oocyte yield and timing of GLP-1 agonist discontinuation in patients with body mass index (BMI) > 35. However, no changes in oocyte yield were observed in patients with BMIs in the normal or overweight range. Neither duration of GLP-1 agonist use or indication for use had a significant effect on oocyte yield across exposure group.

The findings were limited by several factors, including the relatively small study population, especially the small number of patients with obesity. “Additional investigation is needed to clarify potential effects of GLP-1 agonist use on aspiration risk during oocyte retrieval and embryo creation outcomes,” the researchers wrote in their abstract.

However, the results suggest that most women who use GLP-1 agonists experience no significant effects on oocyte retrieval and embryo creation, and that GLP-1 agonists may have a role in improving oocyte yield for obese patients, the researchers concluded.
 

Larger Studies Needed for Real Reassurance

“Infertility patients who are overweight have lower chances for conception and higher risks of pregnancy complications,” Mark Trolice, MD, professor at the University of Central Florida College of Medicine, Orlando, and founder/director of The IVF Center, Winter Park, Florida, said in an interview.

The use of GLP-1 agonists has dramatically increased given the medication’s effectiveness for weight loss, as well as its use to manage diabetes, but the use of GLP-1 agonists in pregnancy is not well known and current recommendations advise discontinuation of the medication for 6-8 weeks prior to conception, said Trolice, who was not involved in the study.

GLP-1 agonist use is associated with lowered blood glucose levels, Trolice said. “Additionally, the medication can delay gastric emptying and suppress appetite, both of which assist in weight management.”

The current study examined whether there was a difference in oocyte retrieval number in women based on days of discontinuation of GLP-1 agonists prior to the procedure, Trolice told this news organization. “Given the drug’s mechanism of action, there is no apparent biological influence that would impact oocyte yield. Consequently, the study outcome is not unexpected.”

The study purports potential reassurance that GLP-1 exposure, regardless of the duration of discontinuation, has no impact on egg retrieval number, said Trolice. However, “Based on the size of the study, to accept the findings as definitive would risk a type II statistical error.”

Two key areas for additional research are urgently needed, Trolice said, namely, the duration of time to discontinue GLP-1 agonists, if at all, prior to conception, and the discontinuation interval, if at all, prior to anesthesia to avoid airway complications.

The American Society of Anesthesiologists advises patients on daily dosing to consider holding GLP-1 agonists on the day of a procedure or surgery, and those on weekly dosing should consider discontinuing the medication 1 week before the procedure or surgery, Trolice noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Trolice had no financial conflicts to disclose and serves on the editorial advisory board of OB/GYN News.

A version of this article first appeared on Medscape.com.

The use of glucagon-like peptide 1 (GLP-1) agonists within a year had no apparent effect on the number of oocytes retrieved in controlled ovarian hyperstimulation (COH), based on data from 73 patients in a multicenter study.

Obesity rates continue to rise in women of reproductive age and many women are using GLP-1 agonists for weight loss, but data on the effect of these drugs on fertility treatments are lacking, said Victoria K. Lazarov, MD, of Icahn School of Medicine at Mount Sinai, New York City, in an abstract presented at the American Society for Reproductive Medicine (ASRM) 2024 scientific congress.

Clinical opinions regarding the use, duration, and discontinuation of GLP-1 agonists during fertility treatments are variable given the limited research, Lazarov noted in her abstract. More data are needed to standardize patient counseling.

Lazarov and colleagues reviewed data from patients who sought treatment at clinics affiliated with a national fertility network from 2005 to 2023 who also utilized a GLP-1 agonist within 1 year of COH.

The study population included 73 adult women; participants were divided into six groups based on the number of days without GLP-1 agonist use prior to retrieval (0-14, 15-30, 31-60, 61-90, 91-180, and 181-365 days). The primary outcome was oocyte yield following COH.

Overall, the mean oocyte yields were not significantly different across the six timing groups (14.4, 16.2, 16.8, 7.7, 13.8, and 15, respectively; = .40).

In a secondary subgroup analysis, the researchers found an inverse relationship between oocyte yield and timing of GLP-1 agonist discontinuation in patients with body mass index (BMI) > 35. However, no changes in oocyte yield were observed in patients with BMIs in the normal or overweight range. Neither duration of GLP-1 agonist use or indication for use had a significant effect on oocyte yield across exposure group.

The findings were limited by several factors, including the relatively small study population, especially the small number of patients with obesity. “Additional investigation is needed to clarify potential effects of GLP-1 agonist use on aspiration risk during oocyte retrieval and embryo creation outcomes,” the researchers wrote in their abstract.

However, the results suggest that most women who use GLP-1 agonists experience no significant effects on oocyte retrieval and embryo creation, and that GLP-1 agonists may have a role in improving oocyte yield for obese patients, the researchers concluded.
 

Larger Studies Needed for Real Reassurance

“Infertility patients who are overweight have lower chances for conception and higher risks of pregnancy complications,” Mark Trolice, MD, professor at the University of Central Florida College of Medicine, Orlando, and founder/director of The IVF Center, Winter Park, Florida, said in an interview.

The use of GLP-1 agonists has dramatically increased given the medication’s effectiveness for weight loss, as well as its use to manage diabetes, but the use of GLP-1 agonists in pregnancy is not well known and current recommendations advise discontinuation of the medication for 6-8 weeks prior to conception, said Trolice, who was not involved in the study.

GLP-1 agonist use is associated with lowered blood glucose levels, Trolice said. “Additionally, the medication can delay gastric emptying and suppress appetite, both of which assist in weight management.”

The current study examined whether there was a difference in oocyte retrieval number in women based on days of discontinuation of GLP-1 agonists prior to the procedure, Trolice told this news organization. “Given the drug’s mechanism of action, there is no apparent biological influence that would impact oocyte yield. Consequently, the study outcome is not unexpected.”

The study purports potential reassurance that GLP-1 exposure, regardless of the duration of discontinuation, has no impact on egg retrieval number, said Trolice. However, “Based on the size of the study, to accept the findings as definitive would risk a type II statistical error.”

Two key areas for additional research are urgently needed, Trolice said, namely, the duration of time to discontinue GLP-1 agonists, if at all, prior to conception, and the discontinuation interval, if at all, prior to anesthesia to avoid airway complications.

The American Society of Anesthesiologists advises patients on daily dosing to consider holding GLP-1 agonists on the day of a procedure or surgery, and those on weekly dosing should consider discontinuing the medication 1 week before the procedure or surgery, Trolice noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Trolice had no financial conflicts to disclose and serves on the editorial advisory board of OB/GYN News.

A version of this article first appeared on Medscape.com.

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Primary Care Physicians Underutilize Nonantibiotic Prophylaxis for Recurrent UTIs

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While primary care physicians are generally comfortable prescribing vaginal estrogen therapy for recurrent urinary tract infections (UTIs), other nonantibiotic prophylactic options remain significantly underutilized, according to new research that highlights a crucial gap in antibiotic stewardship practices among primary care physicians.

UTIs are the most common bacterial infection in women of all ages, and an estimated 30%-40% of women will experience reinfection within 6 months. Recurrent UTI is typically defined as two or more infections within 6 months or a greater number of infections within a year, according to the American Academy of Family Physicians.

Antibiotics are the first line of defense in preventing and treating recurrent UTIs, but repeated and prolonged use could lead to antibiotic resistance.

Researchers at the University of North Carolina surveyed 40 primary care physicians at one academic medical center and found that 96% of primary care physicians prescribe vaginal estrogen therapy for recurrent UTI prevention, with 58% doing so “often.” Estrogen deficiency and urinary retention are strong contributors to infection.

However, 78% of physicians surveyed said they had never prescribed methenamine hippurate, and 85% said they had never prescribed D-mannose.

Physicians with specialized training in menopausal care felt more at ease prescribing vaginal estrogen therapy to patients with complex medical histories, such as those with a family history of breast cancer or endometrial cancer. This suggests that enhanced education could play a vital role in increasing comfort levels among general practitioners, said Lauren Tholemeier, MD, a urogynecology fellow at the University of North Carolina at Chapel Hill.

“Primary care physicians are the front line of managing patients with recurrent UTI,” said Tholemeier.

“There’s an opportunity for further education on, and even awareness of, methenamine hippurate and D-mannose as an option that has data behind it and can be included as a tool” for patient care, she said.

Indeed, physicians who saw six or more recurrent patients with UTI each month were more likely to prescribe methenamine hippurate, the study found, suggesting that familiarity with recurrent UTI cases can lead to greater confidence in employing alternative prophylactic strategies.

Tholemeier presented her research at the American Urogynecologic Society’s PFD Week in Washington, DC.

Expanding physician knowledge and utilization of all available nonantibiotic therapies can help them better care for patients who don’t necessarily have access to a subspecialist, Tholemeier said.

According to the American Urogynecologic Society’s best practice guidelines, there is limited evidence supporting routine use of D-mannose to prevent recurrent UTI. Methenamine hippurate, however, may be effective for short-term UTI prevention, according to the group.

By broadening the use of vaginal estrogen therapy, methenamine hippurate, and D-mannose, primary care physicians can help reduce reliance on antibiotics for recurrent UTI prevention — a practice that may contribute to growing antibiotic resistance, said Tholemeier.

“The end goal isn’t going to be to say that we should never prescribe antibiotics for UTI infection,” said Tholemeier, adding that, in some cases, physicians can consider using these other medications in conjunction with antibiotics.

“But it’s knowing they [clinicians] have some other options in their toolbox,” she said.

A version of this article first appeared on Medscape.com.

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While primary care physicians are generally comfortable prescribing vaginal estrogen therapy for recurrent urinary tract infections (UTIs), other nonantibiotic prophylactic options remain significantly underutilized, according to new research that highlights a crucial gap in antibiotic stewardship practices among primary care physicians.

UTIs are the most common bacterial infection in women of all ages, and an estimated 30%-40% of women will experience reinfection within 6 months. Recurrent UTI is typically defined as two or more infections within 6 months or a greater number of infections within a year, according to the American Academy of Family Physicians.

Antibiotics are the first line of defense in preventing and treating recurrent UTIs, but repeated and prolonged use could lead to antibiotic resistance.

Researchers at the University of North Carolina surveyed 40 primary care physicians at one academic medical center and found that 96% of primary care physicians prescribe vaginal estrogen therapy for recurrent UTI prevention, with 58% doing so “often.” Estrogen deficiency and urinary retention are strong contributors to infection.

However, 78% of physicians surveyed said they had never prescribed methenamine hippurate, and 85% said they had never prescribed D-mannose.

Physicians with specialized training in menopausal care felt more at ease prescribing vaginal estrogen therapy to patients with complex medical histories, such as those with a family history of breast cancer or endometrial cancer. This suggests that enhanced education could play a vital role in increasing comfort levels among general practitioners, said Lauren Tholemeier, MD, a urogynecology fellow at the University of North Carolina at Chapel Hill.

“Primary care physicians are the front line of managing patients with recurrent UTI,” said Tholemeier.

“There’s an opportunity for further education on, and even awareness of, methenamine hippurate and D-mannose as an option that has data behind it and can be included as a tool” for patient care, she said.

Indeed, physicians who saw six or more recurrent patients with UTI each month were more likely to prescribe methenamine hippurate, the study found, suggesting that familiarity with recurrent UTI cases can lead to greater confidence in employing alternative prophylactic strategies.

Tholemeier presented her research at the American Urogynecologic Society’s PFD Week in Washington, DC.

Expanding physician knowledge and utilization of all available nonantibiotic therapies can help them better care for patients who don’t necessarily have access to a subspecialist, Tholemeier said.

According to the American Urogynecologic Society’s best practice guidelines, there is limited evidence supporting routine use of D-mannose to prevent recurrent UTI. Methenamine hippurate, however, may be effective for short-term UTI prevention, according to the group.

By broadening the use of vaginal estrogen therapy, methenamine hippurate, and D-mannose, primary care physicians can help reduce reliance on antibiotics for recurrent UTI prevention — a practice that may contribute to growing antibiotic resistance, said Tholemeier.

“The end goal isn’t going to be to say that we should never prescribe antibiotics for UTI infection,” said Tholemeier, adding that, in some cases, physicians can consider using these other medications in conjunction with antibiotics.

“But it’s knowing they [clinicians] have some other options in their toolbox,” she said.

A version of this article first appeared on Medscape.com.

While primary care physicians are generally comfortable prescribing vaginal estrogen therapy for recurrent urinary tract infections (UTIs), other nonantibiotic prophylactic options remain significantly underutilized, according to new research that highlights a crucial gap in antibiotic stewardship practices among primary care physicians.

UTIs are the most common bacterial infection in women of all ages, and an estimated 30%-40% of women will experience reinfection within 6 months. Recurrent UTI is typically defined as two or more infections within 6 months or a greater number of infections within a year, according to the American Academy of Family Physicians.

Antibiotics are the first line of defense in preventing and treating recurrent UTIs, but repeated and prolonged use could lead to antibiotic resistance.

Researchers at the University of North Carolina surveyed 40 primary care physicians at one academic medical center and found that 96% of primary care physicians prescribe vaginal estrogen therapy for recurrent UTI prevention, with 58% doing so “often.” Estrogen deficiency and urinary retention are strong contributors to infection.

However, 78% of physicians surveyed said they had never prescribed methenamine hippurate, and 85% said they had never prescribed D-mannose.

Physicians with specialized training in menopausal care felt more at ease prescribing vaginal estrogen therapy to patients with complex medical histories, such as those with a family history of breast cancer or endometrial cancer. This suggests that enhanced education could play a vital role in increasing comfort levels among general practitioners, said Lauren Tholemeier, MD, a urogynecology fellow at the University of North Carolina at Chapel Hill.

“Primary care physicians are the front line of managing patients with recurrent UTI,” said Tholemeier.

“There’s an opportunity for further education on, and even awareness of, methenamine hippurate and D-mannose as an option that has data behind it and can be included as a tool” for patient care, she said.

Indeed, physicians who saw six or more recurrent patients with UTI each month were more likely to prescribe methenamine hippurate, the study found, suggesting that familiarity with recurrent UTI cases can lead to greater confidence in employing alternative prophylactic strategies.

Tholemeier presented her research at the American Urogynecologic Society’s PFD Week in Washington, DC.

Expanding physician knowledge and utilization of all available nonantibiotic therapies can help them better care for patients who don’t necessarily have access to a subspecialist, Tholemeier said.

According to the American Urogynecologic Society’s best practice guidelines, there is limited evidence supporting routine use of D-mannose to prevent recurrent UTI. Methenamine hippurate, however, may be effective for short-term UTI prevention, according to the group.

By broadening the use of vaginal estrogen therapy, methenamine hippurate, and D-mannose, primary care physicians can help reduce reliance on antibiotics for recurrent UTI prevention — a practice that may contribute to growing antibiotic resistance, said Tholemeier.

“The end goal isn’t going to be to say that we should never prescribe antibiotics for UTI infection,” said Tholemeier, adding that, in some cases, physicians can consider using these other medications in conjunction with antibiotics.

“But it’s knowing they [clinicians] have some other options in their toolbox,” she said.

A version of this article first appeared on Medscape.com.

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Maternal BMI and Eating Disorders Tied to Mental Health in Kids

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TOPLINE:

Children of mothers who had obesity or eating disorders before or during pregnancy may face higher risks for neurodevelopmental and psychiatric disorders.

METHODOLOGY:

  • Researchers conducted a population-based cohort study to investigate the association of maternal eating disorders and high prepregnancy body mass index (BMI) with psychiatric disorder and neurodevelopmental diagnoses in offspring.
  • They used Finnish national registers to assess all live births from 2004 through 2014, with follow-up until 2021.
  • Data of 392,098 mothers (mean age, 30.15 years) and 649,956 offspring (48.86% girls) were included.
  • Maternal eating disorders and prepregnancy BMI were the main exposures, with 1.60% of mothers having a history of eating disorders; 5.89% were underweight and 53.13% had obesity.
  • Diagnoses of children were identified and grouped by ICD-10 codes of mental, behavioral, and neurodevelopmental disorders, mood disorders, anxiety disorders, sleep disorders, attention-deficit/hyperactivity disorder, and conduct disorders, among several others.

TAKEAWAY:

  • From birth until 7-17 years of age, 16.43% of offspring were diagnosed with a neurodevelopmental or psychiatric disorder.
  • Maternal eating disorders were associated with psychiatric disorders in the offspring, with the largest effect sizes observed for sleep disorders (hazard ratio [HR], 2.36) and social functioning and tic disorders (HR, 2.18; P < .001 for both).
  • The offspring of mothers with severe prepregnancy obesity had a more than twofold increased risk for intellectual disabilities (HR, 2.04; 95% CI, 1.83-2.28); being underweight before pregnancy was also linked to many psychiatric disorders in offspring.
  • The occurrence of adverse birth outcomes along with maternal eating disorders or high BMI further increased the risk for neurodevelopmental and psychiatric disorders in the offspring.

IN PRACTICE:

“The findings underline the risk of offspring mental illness associated with maternal eating disorders and prepregnancy BMI and suggest the need to consider these exposures clinically to help prevent offspring mental illness,” the authors wrote.

SOURCE:

This study was led by Ida A.K. Nilsson, PhD, of the Department of Molecular Medicine and Surgery at the Karolinska Institutet in Stockholm, Sweden, and was published online in JAMA Network Open.

LIMITATIONS:

A limitation of the study was the relatively short follow-up time, which restricted the inclusion of late-onset psychiatric disorder diagnoses, such as schizophrenia spectrum disorders. Paternal data and genetic information, which may have influenced the interpretation of the data, were not available. Another potential bias was that mothers with eating disorders may have been more perceptive to their child’s eating behavior, leading to greater access to care and diagnosis for these children.

DISCLOSURES:

This work was supported by the Swedish Research Council, the regional agreement on medical training and clinical research between Region Stockholm and the Karolinska Institutet, the Swedish Brain Foundation, and other sources. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Children of mothers who had obesity or eating disorders before or during pregnancy may face higher risks for neurodevelopmental and psychiatric disorders.

METHODOLOGY:

  • Researchers conducted a population-based cohort study to investigate the association of maternal eating disorders and high prepregnancy body mass index (BMI) with psychiatric disorder and neurodevelopmental diagnoses in offspring.
  • They used Finnish national registers to assess all live births from 2004 through 2014, with follow-up until 2021.
  • Data of 392,098 mothers (mean age, 30.15 years) and 649,956 offspring (48.86% girls) were included.
  • Maternal eating disorders and prepregnancy BMI were the main exposures, with 1.60% of mothers having a history of eating disorders; 5.89% were underweight and 53.13% had obesity.
  • Diagnoses of children were identified and grouped by ICD-10 codes of mental, behavioral, and neurodevelopmental disorders, mood disorders, anxiety disorders, sleep disorders, attention-deficit/hyperactivity disorder, and conduct disorders, among several others.

TAKEAWAY:

  • From birth until 7-17 years of age, 16.43% of offspring were diagnosed with a neurodevelopmental or psychiatric disorder.
  • Maternal eating disorders were associated with psychiatric disorders in the offspring, with the largest effect sizes observed for sleep disorders (hazard ratio [HR], 2.36) and social functioning and tic disorders (HR, 2.18; P < .001 for both).
  • The offspring of mothers with severe prepregnancy obesity had a more than twofold increased risk for intellectual disabilities (HR, 2.04; 95% CI, 1.83-2.28); being underweight before pregnancy was also linked to many psychiatric disorders in offspring.
  • The occurrence of adverse birth outcomes along with maternal eating disorders or high BMI further increased the risk for neurodevelopmental and psychiatric disorders in the offspring.

IN PRACTICE:

“The findings underline the risk of offspring mental illness associated with maternal eating disorders and prepregnancy BMI and suggest the need to consider these exposures clinically to help prevent offspring mental illness,” the authors wrote.

SOURCE:

This study was led by Ida A.K. Nilsson, PhD, of the Department of Molecular Medicine and Surgery at the Karolinska Institutet in Stockholm, Sweden, and was published online in JAMA Network Open.

LIMITATIONS:

A limitation of the study was the relatively short follow-up time, which restricted the inclusion of late-onset psychiatric disorder diagnoses, such as schizophrenia spectrum disorders. Paternal data and genetic information, which may have influenced the interpretation of the data, were not available. Another potential bias was that mothers with eating disorders may have been more perceptive to their child’s eating behavior, leading to greater access to care and diagnosis for these children.

DISCLOSURES:

This work was supported by the Swedish Research Council, the regional agreement on medical training and clinical research between Region Stockholm and the Karolinska Institutet, the Swedish Brain Foundation, and other sources. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Children of mothers who had obesity or eating disorders before or during pregnancy may face higher risks for neurodevelopmental and psychiatric disorders.

METHODOLOGY:

  • Researchers conducted a population-based cohort study to investigate the association of maternal eating disorders and high prepregnancy body mass index (BMI) with psychiatric disorder and neurodevelopmental diagnoses in offspring.
  • They used Finnish national registers to assess all live births from 2004 through 2014, with follow-up until 2021.
  • Data of 392,098 mothers (mean age, 30.15 years) and 649,956 offspring (48.86% girls) were included.
  • Maternal eating disorders and prepregnancy BMI were the main exposures, with 1.60% of mothers having a history of eating disorders; 5.89% were underweight and 53.13% had obesity.
  • Diagnoses of children were identified and grouped by ICD-10 codes of mental, behavioral, and neurodevelopmental disorders, mood disorders, anxiety disorders, sleep disorders, attention-deficit/hyperactivity disorder, and conduct disorders, among several others.

TAKEAWAY:

  • From birth until 7-17 years of age, 16.43% of offspring were diagnosed with a neurodevelopmental or psychiatric disorder.
  • Maternal eating disorders were associated with psychiatric disorders in the offspring, with the largest effect sizes observed for sleep disorders (hazard ratio [HR], 2.36) and social functioning and tic disorders (HR, 2.18; P < .001 for both).
  • The offspring of mothers with severe prepregnancy obesity had a more than twofold increased risk for intellectual disabilities (HR, 2.04; 95% CI, 1.83-2.28); being underweight before pregnancy was also linked to many psychiatric disorders in offspring.
  • The occurrence of adverse birth outcomes along with maternal eating disorders or high BMI further increased the risk for neurodevelopmental and psychiatric disorders in the offspring.

IN PRACTICE:

“The findings underline the risk of offspring mental illness associated with maternal eating disorders and prepregnancy BMI and suggest the need to consider these exposures clinically to help prevent offspring mental illness,” the authors wrote.

SOURCE:

This study was led by Ida A.K. Nilsson, PhD, of the Department of Molecular Medicine and Surgery at the Karolinska Institutet in Stockholm, Sweden, and was published online in JAMA Network Open.

LIMITATIONS:

A limitation of the study was the relatively short follow-up time, which restricted the inclusion of late-onset psychiatric disorder diagnoses, such as schizophrenia spectrum disorders. Paternal data and genetic information, which may have influenced the interpretation of the data, were not available. Another potential bias was that mothers with eating disorders may have been more perceptive to their child’s eating behavior, leading to greater access to care and diagnosis for these children.

DISCLOSURES:

This work was supported by the Swedish Research Council, the regional agreement on medical training and clinical research between Region Stockholm and the Karolinska Institutet, the Swedish Brain Foundation, and other sources. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Semiannual Time Changes Linked to Accidents, Heart Attacks

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As people turn their clocks back an hour on November 3 to mark the end of daylight saving time and return to standard time, they should remain aware of their sleep health and of potential risks associated with shifts in sleep patterns, according to a University of Calgary psychology professor who researches circadian cycles.

Notably, previous studies have shown that the twice-yearly time change is associated with increases in car accidents and workplace injuries, as well as heart attacks and strokes, owing to disrupted sleep, said Michael Antle, PhD, head of the psychology department and member of the Hotchkiss Brain Institute at the Cumming School of Medicine, University of Calgary, Alberta, Canada.

In an interview, Antle explained the science behind the health risks associated with time changes, offered tips to prepare for the shift, and discussed scientists’ suggestion to move to year-round standard time. This interview has been condensed and edited for clarity.

Why is it important to pay attention to circadian rhythms?

Circadian rhythms are patterns of physiologic and behavioral changes that affect everything inside the body and everything we do, including when hormones are secreted, digestive juices are ready to digest, and growth hormones are released at night. The body is a carefully coordinated orchestra, and everything has to happen at the right time.

When we start messing with those rhythms, that’s when states of disease start coming on and we don’t feel well. You’ve probably experienced it — when you try to stay up late, eat at the wrong times, or have jet lag. Flying across one or two time zones is usually tolerable, but if you fly across the world, it can be profound and make you feel bad, even up to a week. Similar shifts happen with the time changes.

How do the time changes affect health risks?

The wintertime change is generally more tolerable, and you’ll hear people talk about “gaining an hour” of sleep. It’s better than that, because we’re realigning our social clocks — such as our work schedules and school schedules — with daylight. We tend to go to bed relative to the sun but wake up based on when our boss says to be at our desk, so an earlier sunset helps us to fall asleep earlier and is healthier for our body.

In the spring, the opposite happens, and the time change affects us much more than just one bad night of sleep. For some people, it can feel like losing an hour of sleep every day for weeks, and that abrupt change can lead to car accidents, workplace injuries, heart attacks, and strokes. Our body experiences extra strain when we’re not awake and ready for the day.

What does your research show?

Most of my work focuses on preclinical models to understand what’s going on in the brain and body. Because we can’t study this ethically in humans, we learn a lot from animal models, especially mice. In a recent study looking at mild circadian disruption — where we raised mice on days that were about 75 minutes shorter — we saw they started developing diabetes, heart disease, and insulin resistance within in a few months, or about the time they were a young adult.

 

 

Oftentimes, people think about their sleep rhythm as an arbitrary choice, but in fact, it does affect your health. We know that if your human circadian clock runs slow, morning light can help fix that and reset it, whereas evening light moves us in the other direction and makes it harder to get up in the morning. 

Some people want to switch to one year-round time. What do you advocate? 

In most cases, the standard time (or winter time) is the more natural time that fits better with our body cycle. If we follow a time where we get up before sunrise or have a later sunset, then it’s linked to more social jet lag, where people are less attentive at work, don’t learn as well at school, and have more accidents.

Instead of picking what sounds good or chasing the name — such as “daylight saving time” — we need to think about the right time for us and our circadian clock. Some places, such as Maine in the United States, would actually fit better with the Atlantic time zone or the Maritime provinces in Canada, whereas some parts of Alberta are geographically west of Los Angeles based on longitude and would fit better with the Pacific time zone. Sticking with a year-round daylight saving time in some cities in Alberta would mean people wouldn’t see the sun until 10:30 AM in the winter, which is really late and could affect activities such as skiing and hockey.

The Canadian Society for Chronobiology advocates for year-round standard time to align our social clocks with our biological clocks. Sleep and circadian rhythm experts in the US and globally have issued similar position statements.

What tips do you suggest to help people adjust their circadian clocks in November?

For people who know their bodies and that it will affect them more, give yourself extra time. If your schedule permits, plan ahead and change your clocks sooner, especially if you’re able to do so over the weekend. Don’t rush around while tired — rushing when you’re not ready leads to those increased accidents on the road or on the job. Know that the sun will still be mismatched for a bit and your body clock will take time to adjust, so you might feel out of sorts for a few days.

Antle reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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As people turn their clocks back an hour on November 3 to mark the end of daylight saving time and return to standard time, they should remain aware of their sleep health and of potential risks associated with shifts in sleep patterns, according to a University of Calgary psychology professor who researches circadian cycles.

Notably, previous studies have shown that the twice-yearly time change is associated with increases in car accidents and workplace injuries, as well as heart attacks and strokes, owing to disrupted sleep, said Michael Antle, PhD, head of the psychology department and member of the Hotchkiss Brain Institute at the Cumming School of Medicine, University of Calgary, Alberta, Canada.

In an interview, Antle explained the science behind the health risks associated with time changes, offered tips to prepare for the shift, and discussed scientists’ suggestion to move to year-round standard time. This interview has been condensed and edited for clarity.

Why is it important to pay attention to circadian rhythms?

Circadian rhythms are patterns of physiologic and behavioral changes that affect everything inside the body and everything we do, including when hormones are secreted, digestive juices are ready to digest, and growth hormones are released at night. The body is a carefully coordinated orchestra, and everything has to happen at the right time.

When we start messing with those rhythms, that’s when states of disease start coming on and we don’t feel well. You’ve probably experienced it — when you try to stay up late, eat at the wrong times, or have jet lag. Flying across one or two time zones is usually tolerable, but if you fly across the world, it can be profound and make you feel bad, even up to a week. Similar shifts happen with the time changes.

How do the time changes affect health risks?

The wintertime change is generally more tolerable, and you’ll hear people talk about “gaining an hour” of sleep. It’s better than that, because we’re realigning our social clocks — such as our work schedules and school schedules — with daylight. We tend to go to bed relative to the sun but wake up based on when our boss says to be at our desk, so an earlier sunset helps us to fall asleep earlier and is healthier for our body.

In the spring, the opposite happens, and the time change affects us much more than just one bad night of sleep. For some people, it can feel like losing an hour of sleep every day for weeks, and that abrupt change can lead to car accidents, workplace injuries, heart attacks, and strokes. Our body experiences extra strain when we’re not awake and ready for the day.

What does your research show?

Most of my work focuses on preclinical models to understand what’s going on in the brain and body. Because we can’t study this ethically in humans, we learn a lot from animal models, especially mice. In a recent study looking at mild circadian disruption — where we raised mice on days that were about 75 minutes shorter — we saw they started developing diabetes, heart disease, and insulin resistance within in a few months, or about the time they were a young adult.

 

 

Oftentimes, people think about their sleep rhythm as an arbitrary choice, but in fact, it does affect your health. We know that if your human circadian clock runs slow, morning light can help fix that and reset it, whereas evening light moves us in the other direction and makes it harder to get up in the morning. 

Some people want to switch to one year-round time. What do you advocate? 

In most cases, the standard time (or winter time) is the more natural time that fits better with our body cycle. If we follow a time where we get up before sunrise or have a later sunset, then it’s linked to more social jet lag, where people are less attentive at work, don’t learn as well at school, and have more accidents.

Instead of picking what sounds good or chasing the name — such as “daylight saving time” — we need to think about the right time for us and our circadian clock. Some places, such as Maine in the United States, would actually fit better with the Atlantic time zone or the Maritime provinces in Canada, whereas some parts of Alberta are geographically west of Los Angeles based on longitude and would fit better with the Pacific time zone. Sticking with a year-round daylight saving time in some cities in Alberta would mean people wouldn’t see the sun until 10:30 AM in the winter, which is really late and could affect activities such as skiing and hockey.

The Canadian Society for Chronobiology advocates for year-round standard time to align our social clocks with our biological clocks. Sleep and circadian rhythm experts in the US and globally have issued similar position statements.

What tips do you suggest to help people adjust their circadian clocks in November?

For people who know their bodies and that it will affect them more, give yourself extra time. If your schedule permits, plan ahead and change your clocks sooner, especially if you’re able to do so over the weekend. Don’t rush around while tired — rushing when you’re not ready leads to those increased accidents on the road or on the job. Know that the sun will still be mismatched for a bit and your body clock will take time to adjust, so you might feel out of sorts for a few days.

Antle reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

As people turn their clocks back an hour on November 3 to mark the end of daylight saving time and return to standard time, they should remain aware of their sleep health and of potential risks associated with shifts in sleep patterns, according to a University of Calgary psychology professor who researches circadian cycles.

Notably, previous studies have shown that the twice-yearly time change is associated with increases in car accidents and workplace injuries, as well as heart attacks and strokes, owing to disrupted sleep, said Michael Antle, PhD, head of the psychology department and member of the Hotchkiss Brain Institute at the Cumming School of Medicine, University of Calgary, Alberta, Canada.

In an interview, Antle explained the science behind the health risks associated with time changes, offered tips to prepare for the shift, and discussed scientists’ suggestion to move to year-round standard time. This interview has been condensed and edited for clarity.

Why is it important to pay attention to circadian rhythms?

Circadian rhythms are patterns of physiologic and behavioral changes that affect everything inside the body and everything we do, including when hormones are secreted, digestive juices are ready to digest, and growth hormones are released at night. The body is a carefully coordinated orchestra, and everything has to happen at the right time.

When we start messing with those rhythms, that’s when states of disease start coming on and we don’t feel well. You’ve probably experienced it — when you try to stay up late, eat at the wrong times, or have jet lag. Flying across one or two time zones is usually tolerable, but if you fly across the world, it can be profound and make you feel bad, even up to a week. Similar shifts happen with the time changes.

How do the time changes affect health risks?

The wintertime change is generally more tolerable, and you’ll hear people talk about “gaining an hour” of sleep. It’s better than that, because we’re realigning our social clocks — such as our work schedules and school schedules — with daylight. We tend to go to bed relative to the sun but wake up based on when our boss says to be at our desk, so an earlier sunset helps us to fall asleep earlier and is healthier for our body.

In the spring, the opposite happens, and the time change affects us much more than just one bad night of sleep. For some people, it can feel like losing an hour of sleep every day for weeks, and that abrupt change can lead to car accidents, workplace injuries, heart attacks, and strokes. Our body experiences extra strain when we’re not awake and ready for the day.

What does your research show?

Most of my work focuses on preclinical models to understand what’s going on in the brain and body. Because we can’t study this ethically in humans, we learn a lot from animal models, especially mice. In a recent study looking at mild circadian disruption — where we raised mice on days that were about 75 minutes shorter — we saw they started developing diabetes, heart disease, and insulin resistance within in a few months, or about the time they were a young adult.

 

 

Oftentimes, people think about their sleep rhythm as an arbitrary choice, but in fact, it does affect your health. We know that if your human circadian clock runs slow, morning light can help fix that and reset it, whereas evening light moves us in the other direction and makes it harder to get up in the morning. 

Some people want to switch to one year-round time. What do you advocate? 

In most cases, the standard time (or winter time) is the more natural time that fits better with our body cycle. If we follow a time where we get up before sunrise or have a later sunset, then it’s linked to more social jet lag, where people are less attentive at work, don’t learn as well at school, and have more accidents.

Instead of picking what sounds good or chasing the name — such as “daylight saving time” — we need to think about the right time for us and our circadian clock. Some places, such as Maine in the United States, would actually fit better with the Atlantic time zone or the Maritime provinces in Canada, whereas some parts of Alberta are geographically west of Los Angeles based on longitude and would fit better with the Pacific time zone. Sticking with a year-round daylight saving time in some cities in Alberta would mean people wouldn’t see the sun until 10:30 AM in the winter, which is really late and could affect activities such as skiing and hockey.

The Canadian Society for Chronobiology advocates for year-round standard time to align our social clocks with our biological clocks. Sleep and circadian rhythm experts in the US and globally have issued similar position statements.

What tips do you suggest to help people adjust their circadian clocks in November?

For people who know their bodies and that it will affect them more, give yourself extra time. If your schedule permits, plan ahead and change your clocks sooner, especially if you’re able to do so over the weekend. Don’t rush around while tired — rushing when you’re not ready leads to those increased accidents on the road or on the job. Know that the sun will still be mismatched for a bit and your body clock will take time to adjust, so you might feel out of sorts for a few days.

Antle reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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COVID on the Floor Linked to Outbreaks on Two Hospital Wards

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The viral burden of SARS-CoV-2 on floors, even in healthcare worker–only areas, was strongly associated with COVID-19 outbreaks in two acute-care hospitals, according to a new study from Ontario, Canada.

With every 10-fold increase in viral copies, the chance of an impending outbreak of COVID-19 rose 22-fold. The results suggest that frequent floor sampling could play an important role in a more localized surveillance of the virus, the authors wrote.

“These data add to the mounting evidence that built environment detection for SARS-CoV-2 may provide an additional layer of monitoring and could help inform local infection prevention and control measures,” they wrote.

The study was published online in Infection Control & Hospital Epidemiology
 

Preventing Future Suffering 

The current study builds on the researchers’ previous work, which found the same correlation between viral load on floors and COVID outbreaks in long-term care homes. 

Currently, the best-known method of environmental surveillance for COVID is wastewater detection. “Swabbing the floors would be another approach to surveillance,” senior author Caroline Nott, MD, infectious disease physician at the Ottawa Hospital, said in an interview. 

“We do have environmental surveillance with wastewater, but while this may tell you what’s going on in the city, it doesn’t tell you what is going on in a particular ward of a hospital, for instance,” she added. 

Nott and her colleagues believe that swabbing, which is easy and relatively inexpensive, will become another tool to examine the built environment. “Instead of having to close a whole hospital, for example, we could just close one room instead of an entire ward if swabbing showed a high concentration of COVID,” Nott said. 

The current study was conducted at two hospitals in Ontario between July 2022 and March 2023. The floors of healthcare worker–only areas on four inpatient adult wards were swabbed. These areas included changing rooms, meeting rooms, staff washrooms, nursing stations, and interdisciplinary team rooms.

SARS-CoV-2 RNA was detected on 537 of 760 floor swabs (71%). The overall positivity rate in the first hospital was 90% (n = 280). In the second hospital, the rate was 60% (n = 480).

Four COVID-19 outbreaks occurred in the first acute care hospital, and seven outbreaks occurred at the second hospital. Outbreaks occurred mostly among hospitalized patients (140 cases), but also in four hospital workers.

COVID-19 still requires vigilance, said Nott. “We weren’t prepared for COVID, and so as a result, many people died or have suffered long-term effects, especially vulnerable people like those being treated in hospital or in long-term care facilities. We want to develop methods to prevent similar suffering in the future, whether it’s a new COVID variant or a different pathogen altogether.” 
 

Changing Surveillance Practice?

“This is a good study,” Steven Rogak, PhD, professor of mechanical engineering at the University of British Columbia (UBC) in Vancouver, Canada, said in an interivew. “The fundamental idea is that respiratory droplets and aerosols will deposit on the floor, and polymerase chain reaction [PCR] tests of swabs will provide a surrogate measurement of what might have been inhaled. There are solid statistics that it worked for the hospitals studied,” said Rogak, who studies aerosols at UBC’s Energy and Aerosols Laboratory. Rogak did not participate in the study. 

“The authors note several limitations, including that increased healthcare worker testing may have been triggered by the higher values of PCR counts from the floor swabs. But this doesn’t seem to be a problem to me, because if the floor swabs motivate the hospital to test workers more, and that results in identifying outbreaks sooner, then great,” he said.

“Another limitation is that if the hospital has better HVAC or uses air purifiers, it could remove the most infectious aerosols, but the large droplets that fall quickly to the ground would remain, and this would still result in high PCR counts from floor swabs. In this case, perhaps the floor swabs would be a poorer indication of impending outbreaks,” said Rogak.

Determining the best timing and location for floor swabbing might be challenging and specific to the particular hospital, he added. ”For example, you would not want to take swabs from floors right after they are cleaned. Overall, I think this method deserves further development, and it could become a standard technique, but the details might require refinement for widespread application.”

Adrian Popp, MD, chair of the Infectious Disease Service at Huntington Hospital–Northwell Health in New York, said that, although interesting, the study would not change his current practice.

“I’m going to start testing the environment in different rooms in the hospital, and yes, I might find different amounts of COVID, but what does that mean? If pieces of RNA from COVID are on the floor, the likelihood is that they’re not infectious,” Popp said in an interview.

“Hospital workers do get sick with COVID, and sometimes they are asymptomatic and come to work. Patients may come into the hospital for another reason and be sick with COVID. There are many ways people who work in the hospital, as well as the patients, can get COVID. To me, it means that in that hospital and community there is a lot of COVID, but I can’t tell if there is causation here. Who is giving COVID to whom? What am I supposed to do with the information?” 

The study was supported by the Northern Ontario Academic Medicine Association Clinical Innovation Opportunities Fund, the Ottawa Hospital Academic Medical Organization Innovation Fund, and a Canadian Institutes of Health Research Operating Grant. One author was a consultant for ProofDx, a startup company creating a point-of-care diagnostic test for COVID-19, and is an advisor for SIGNAL1, a startup company deploying machine-learning models to improve inpatient care. Nott, Rogak, and Popp reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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The viral burden of SARS-CoV-2 on floors, even in healthcare worker–only areas, was strongly associated with COVID-19 outbreaks in two acute-care hospitals, according to a new study from Ontario, Canada.

With every 10-fold increase in viral copies, the chance of an impending outbreak of COVID-19 rose 22-fold. The results suggest that frequent floor sampling could play an important role in a more localized surveillance of the virus, the authors wrote.

“These data add to the mounting evidence that built environment detection for SARS-CoV-2 may provide an additional layer of monitoring and could help inform local infection prevention and control measures,” they wrote.

The study was published online in Infection Control & Hospital Epidemiology
 

Preventing Future Suffering 

The current study builds on the researchers’ previous work, which found the same correlation between viral load on floors and COVID outbreaks in long-term care homes. 

Currently, the best-known method of environmental surveillance for COVID is wastewater detection. “Swabbing the floors would be another approach to surveillance,” senior author Caroline Nott, MD, infectious disease physician at the Ottawa Hospital, said in an interview. 

“We do have environmental surveillance with wastewater, but while this may tell you what’s going on in the city, it doesn’t tell you what is going on in a particular ward of a hospital, for instance,” she added. 

Nott and her colleagues believe that swabbing, which is easy and relatively inexpensive, will become another tool to examine the built environment. “Instead of having to close a whole hospital, for example, we could just close one room instead of an entire ward if swabbing showed a high concentration of COVID,” Nott said. 

The current study was conducted at two hospitals in Ontario between July 2022 and March 2023. The floors of healthcare worker–only areas on four inpatient adult wards were swabbed. These areas included changing rooms, meeting rooms, staff washrooms, nursing stations, and interdisciplinary team rooms.

SARS-CoV-2 RNA was detected on 537 of 760 floor swabs (71%). The overall positivity rate in the first hospital was 90% (n = 280). In the second hospital, the rate was 60% (n = 480).

Four COVID-19 outbreaks occurred in the first acute care hospital, and seven outbreaks occurred at the second hospital. Outbreaks occurred mostly among hospitalized patients (140 cases), but also in four hospital workers.

COVID-19 still requires vigilance, said Nott. “We weren’t prepared for COVID, and so as a result, many people died or have suffered long-term effects, especially vulnerable people like those being treated in hospital or in long-term care facilities. We want to develop methods to prevent similar suffering in the future, whether it’s a new COVID variant or a different pathogen altogether.” 
 

Changing Surveillance Practice?

“This is a good study,” Steven Rogak, PhD, professor of mechanical engineering at the University of British Columbia (UBC) in Vancouver, Canada, said in an interivew. “The fundamental idea is that respiratory droplets and aerosols will deposit on the floor, and polymerase chain reaction [PCR] tests of swabs will provide a surrogate measurement of what might have been inhaled. There are solid statistics that it worked for the hospitals studied,” said Rogak, who studies aerosols at UBC’s Energy and Aerosols Laboratory. Rogak did not participate in the study. 

“The authors note several limitations, including that increased healthcare worker testing may have been triggered by the higher values of PCR counts from the floor swabs. But this doesn’t seem to be a problem to me, because if the floor swabs motivate the hospital to test workers more, and that results in identifying outbreaks sooner, then great,” he said.

“Another limitation is that if the hospital has better HVAC or uses air purifiers, it could remove the most infectious aerosols, but the large droplets that fall quickly to the ground would remain, and this would still result in high PCR counts from floor swabs. In this case, perhaps the floor swabs would be a poorer indication of impending outbreaks,” said Rogak.

Determining the best timing and location for floor swabbing might be challenging and specific to the particular hospital, he added. ”For example, you would not want to take swabs from floors right after they are cleaned. Overall, I think this method deserves further development, and it could become a standard technique, but the details might require refinement for widespread application.”

Adrian Popp, MD, chair of the Infectious Disease Service at Huntington Hospital–Northwell Health in New York, said that, although interesting, the study would not change his current practice.

“I’m going to start testing the environment in different rooms in the hospital, and yes, I might find different amounts of COVID, but what does that mean? If pieces of RNA from COVID are on the floor, the likelihood is that they’re not infectious,” Popp said in an interview.

“Hospital workers do get sick with COVID, and sometimes they are asymptomatic and come to work. Patients may come into the hospital for another reason and be sick with COVID. There are many ways people who work in the hospital, as well as the patients, can get COVID. To me, it means that in that hospital and community there is a lot of COVID, but I can’t tell if there is causation here. Who is giving COVID to whom? What am I supposed to do with the information?” 

The study was supported by the Northern Ontario Academic Medicine Association Clinical Innovation Opportunities Fund, the Ottawa Hospital Academic Medical Organization Innovation Fund, and a Canadian Institutes of Health Research Operating Grant. One author was a consultant for ProofDx, a startup company creating a point-of-care diagnostic test for COVID-19, and is an advisor for SIGNAL1, a startup company deploying machine-learning models to improve inpatient care. Nott, Rogak, and Popp reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The viral burden of SARS-CoV-2 on floors, even in healthcare worker–only areas, was strongly associated with COVID-19 outbreaks in two acute-care hospitals, according to a new study from Ontario, Canada.

With every 10-fold increase in viral copies, the chance of an impending outbreak of COVID-19 rose 22-fold. The results suggest that frequent floor sampling could play an important role in a more localized surveillance of the virus, the authors wrote.

“These data add to the mounting evidence that built environment detection for SARS-CoV-2 may provide an additional layer of monitoring and could help inform local infection prevention and control measures,” they wrote.

The study was published online in Infection Control & Hospital Epidemiology
 

Preventing Future Suffering 

The current study builds on the researchers’ previous work, which found the same correlation between viral load on floors and COVID outbreaks in long-term care homes. 

Currently, the best-known method of environmental surveillance for COVID is wastewater detection. “Swabbing the floors would be another approach to surveillance,” senior author Caroline Nott, MD, infectious disease physician at the Ottawa Hospital, said in an interview. 

“We do have environmental surveillance with wastewater, but while this may tell you what’s going on in the city, it doesn’t tell you what is going on in a particular ward of a hospital, for instance,” she added. 

Nott and her colleagues believe that swabbing, which is easy and relatively inexpensive, will become another tool to examine the built environment. “Instead of having to close a whole hospital, for example, we could just close one room instead of an entire ward if swabbing showed a high concentration of COVID,” Nott said. 

The current study was conducted at two hospitals in Ontario between July 2022 and March 2023. The floors of healthcare worker–only areas on four inpatient adult wards were swabbed. These areas included changing rooms, meeting rooms, staff washrooms, nursing stations, and interdisciplinary team rooms.

SARS-CoV-2 RNA was detected on 537 of 760 floor swabs (71%). The overall positivity rate in the first hospital was 90% (n = 280). In the second hospital, the rate was 60% (n = 480).

Four COVID-19 outbreaks occurred in the first acute care hospital, and seven outbreaks occurred at the second hospital. Outbreaks occurred mostly among hospitalized patients (140 cases), but also in four hospital workers.

COVID-19 still requires vigilance, said Nott. “We weren’t prepared for COVID, and so as a result, many people died or have suffered long-term effects, especially vulnerable people like those being treated in hospital or in long-term care facilities. We want to develop methods to prevent similar suffering in the future, whether it’s a new COVID variant or a different pathogen altogether.” 
 

Changing Surveillance Practice?

“This is a good study,” Steven Rogak, PhD, professor of mechanical engineering at the University of British Columbia (UBC) in Vancouver, Canada, said in an interivew. “The fundamental idea is that respiratory droplets and aerosols will deposit on the floor, and polymerase chain reaction [PCR] tests of swabs will provide a surrogate measurement of what might have been inhaled. There are solid statistics that it worked for the hospitals studied,” said Rogak, who studies aerosols at UBC’s Energy and Aerosols Laboratory. Rogak did not participate in the study. 

“The authors note several limitations, including that increased healthcare worker testing may have been triggered by the higher values of PCR counts from the floor swabs. But this doesn’t seem to be a problem to me, because if the floor swabs motivate the hospital to test workers more, and that results in identifying outbreaks sooner, then great,” he said.

“Another limitation is that if the hospital has better HVAC or uses air purifiers, it could remove the most infectious aerosols, but the large droplets that fall quickly to the ground would remain, and this would still result in high PCR counts from floor swabs. In this case, perhaps the floor swabs would be a poorer indication of impending outbreaks,” said Rogak.

Determining the best timing and location for floor swabbing might be challenging and specific to the particular hospital, he added. ”For example, you would not want to take swabs from floors right after they are cleaned. Overall, I think this method deserves further development, and it could become a standard technique, but the details might require refinement for widespread application.”

Adrian Popp, MD, chair of the Infectious Disease Service at Huntington Hospital–Northwell Health in New York, said that, although interesting, the study would not change his current practice.

“I’m going to start testing the environment in different rooms in the hospital, and yes, I might find different amounts of COVID, but what does that mean? If pieces of RNA from COVID are on the floor, the likelihood is that they’re not infectious,” Popp said in an interview.

“Hospital workers do get sick with COVID, and sometimes they are asymptomatic and come to work. Patients may come into the hospital for another reason and be sick with COVID. There are many ways people who work in the hospital, as well as the patients, can get COVID. To me, it means that in that hospital and community there is a lot of COVID, but I can’t tell if there is causation here. Who is giving COVID to whom? What am I supposed to do with the information?” 

The study was supported by the Northern Ontario Academic Medicine Association Clinical Innovation Opportunities Fund, the Ottawa Hospital Academic Medical Organization Innovation Fund, and a Canadian Institutes of Health Research Operating Grant. One author was a consultant for ProofDx, a startup company creating a point-of-care diagnostic test for COVID-19, and is an advisor for SIGNAL1, a startup company deploying machine-learning models to improve inpatient care. Nott, Rogak, and Popp reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Which Specialists Should Lead BP Control Efforts?

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Current efforts to control high blood pressure (BP) are failing in the United States and globally.

The first World Health Organization (WHO) global report on hypertension found that only 54% of adults with hypertension are diagnosed, 42% get treatment, and just 21% have their hypertension controlled.

In the United States, almost half (48%) of adults have high BP, defined as a systolic BP > 130 mm Hg, or a diastolic BP > 80 mm Hg, or are taking medication for high BP, according to the Centers for Disease Control and Prevention. Only about one in four adults (22.5%) with high BP have their BP under control.

High BP is a major risk factor for coronary heart disease, heart failure, and stroke, and the problem of controlling it is only getting worse. In 2024, the American Heart Association estimates that, “among adults, prevalence of hypertension will increase from 51.2% in 2020 to 61.0% in 2050.”
 

Pharmacists Most Effective

Though many factors contribute to hypertension, researchers have found that the kind of specialist leading the hypertension team may play a role in success. Currently, most BP control teams are led by physicians in primary care.

In a recent meta-analysis involving 100 randomized controlled trials and more than 90,000 patients in Circulation, Katherine T. Mills, PhD, School of Public Health, Tulane University, New Orleans, Louisiana, and colleagues found that, while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Those groups’ efforts resulted in the greatest systolic BP drops: −7.3 mm Hg (pharmacists) and −7.1 mm Hg (community health workers). Groups led by nurses and physicians saw systolic changes of −3 and −2.4 mm Hg, respectively.

Similarly, pharmacist- and community health worker–led efforts saw the greatest diastolic BP reductions (−3.8 and −3.1 mm Hg), compared with nurse-led (−1.6) and physician-led (−1.2) efforts.
 

Reductions Enough to Cut Cardiovascular Disease Risk

The reduction numbers for pharmacists are clinically meaningful, Mills said in an interview. “It’s greater than a lot of what we see from individual lifestyle changes,” such as reducing sodium intake or increasing physical activity.

“It’s a big enough blood pressure change to have meaningful reduction in risk of cardiovascular disease,” she said.

This evidence that the leader of the team matters is particularly important because the treatment of hypertension is not in doubt. Something else is not working the way it should.

“We have basically all the scientific evidence we need in terms of what interventions work. But there’s a big gap between that and what’s actually being done in the real world,” she said.

Mills said she was not surprised that pharmacists got the best results “because so much of it has to do with titrating medications and finding the right kind of medications for each patient.”

Additionally, BP management and control falls right into pharmacists’ wheelhouse, Mills noted, including evaluating medication side effects and talking to patients about medication adherence.
 

Why Pharmacists May Be More Successful

In an accompanying editorial, Ross T. Tsuyuki, PharmD, with the EPICORE Centre, Division of Cardiology, University of Alberta in Edmonton, Canada, and coauthors said the Mills study provides further data to support pharmacists leading BP control efforts, but it’s not the data that have been keeping the model from changing. The barriers include turf wars and lack of legislative change.

The editorialists also said having pharmacist-led BP teams is only the first step. “We need pharmacists to independently prescribe,” they wrote.

“Since individual states govern the scope of practice of pharmacists,” the editorialists wrote, “we have the enormous task of changing regulations to allow pharmacists to independently prescribe for hypertension. But it can be done. The Canadian province of Alberta allows pharmacists to prescribe. And more recently, Idaho. While most states allow some sort of collaborative (dependent) prescribing, that is only a first step.”

Allowing pharmacists to independently prescribe will help populations who do not have a physician or can’t get access to a physician, the editorialists wrote. But changing state legislation would be a lengthy and complex effort.
 

Physician-Led BP Control Model ‘Seems to Fail Miserably’

Coauthor of the editorial, Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview that, currently, physician-led teams are the norm, “and that model seems to fail miserably.”

He offered several key reasons for that. In primary care, patients with hypertension often have other problems — they may have high cholesterol or diabetes. “They may have acute illnesses that bother them as well as hypertension that doesn’t bother them,” he said.

Physicians tend to find excuses not to increase or add BP medications, Rader said. “We tend then to blame ‘white coat effect’ or say ‘you’re just nervous today.’ ”

Pharmacists, comparatively, are more protocol driven, he said. “They essentially look at blood pressure and they have an algorithm in their mind. If the blood pressure hits the guideline-stated bar, start this medication. If it hits another bar, increase or add another medication.”

Rader said turf wars are also keeping physician-led teams from changing, fueled by fears that patients will seek care from pharmacists instead of physicians.

“I don’t think the pharmacists will steal a single patient,” Rader said. “If a physician had a healthcare partner like a pharmacist to optimize blood pressure, then [patients] come back to the physician with normalized BP on the right medications. I think it’s a total win-win. I think we just have to get over that.”

Pharmacist-led warfarin clinics are very well established, Rader said, “but for whatever reason, when it comes to blood pressure, physicians are a little bit more hesitant.”
 

Collaboration Yes, Independent No

Hypertension expert Donald J. DiPette, MD, Health Sciences Distinguished Professor in the Department of Internal Medicine at University of South Carolina, Columbia, said he completely agrees with Mills and colleagues’ conclusion. “Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.”

The conclusion “is in line with the thinking of major organizations,” said DiPette, who helped develop the WHO’s most recent pharmacological treatment of hypertension guidelines. “WHO suggests that pharmacological treatment of hypertension can be provided by nonphysician professionals such as pharmacists and nurses as long as the following conditions are met: Proper training, prescribing authority, specific management protocols, and physician oversight.”

DiPette strongly believes BP control efforts should be supervised by a physician, but that could come in different ways. He suggested a collaborative but physician-supervised development of a protocol. Everyone contributes, but the physician signs off on it.

As for the Idaho example of independent practice for pharmacists, DiPette said he doesn’t think that will make a big difference in control rates. “That’s still not team-based care.”
 

Community Health Workers Key

He said he was also glad to see community healthcare workers emerge as the next-most-effective group after pharmacists to lead BP control teams. This is particularly important as BP control efforts globally need to consider the cultural experience of individual communities. “The community worker is on the ground, and can help overcome some of the cultural barriers,” he said.

“The key is to focus on team-based care and moving away from silo practice,” DiPette said.

Physicians, he said, often fall into “clinical or therapeutic inertia,” where BP is concerned. “We fail to titrate or add additional hypertensive medications even when they’re clearly indicated by the blood pressure. This is a problem not with the individual patient or the healthcare system, this is on us as physicians.”

Nonphysicians are more aligned with following protocols and guidelines, irrespective of the dynamics of what’s going on, he said.

And following protocols rigidly is a good thing for hypertension. “We’re not overtreating hypertension,” he emphasized. “We’re undertreating it.”

Reversing the trend on hypertension will take a sea change in medicine — changing institutions, systems, and individuals who have been doing things the same way for decades, he said.

“Our hypertension control rates are dismal,” DiPette said. “What’s more alarming is they’re going down. That’s the urgency. That’s the burning platform. We must strongly consider doing something different.”

Tsuyuki has received investigator-initiated arm’s length research grants from Merck, Pfizer, AstraZeneca, and Sanofi. He has been a speaker/consultant for Merck, Emergent BioSolutions, and Shoppers Drug Mart/Loblaw Companies Limited. Rader has been a consultant for Bristol Meyers Squibb, Cytokinetics, Idorsia, Medtronic, and ReCor Medical. Mills and coauthors reported no relevant financial relationships. DiPette declared no relevant financial relationships. He was part of a leadership team that developed WHO guidelines on hypertension.

A version of this article first appeared on Medscape.com.

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Current efforts to control high blood pressure (BP) are failing in the United States and globally.

The first World Health Organization (WHO) global report on hypertension found that only 54% of adults with hypertension are diagnosed, 42% get treatment, and just 21% have their hypertension controlled.

In the United States, almost half (48%) of adults have high BP, defined as a systolic BP > 130 mm Hg, or a diastolic BP > 80 mm Hg, or are taking medication for high BP, according to the Centers for Disease Control and Prevention. Only about one in four adults (22.5%) with high BP have their BP under control.

High BP is a major risk factor for coronary heart disease, heart failure, and stroke, and the problem of controlling it is only getting worse. In 2024, the American Heart Association estimates that, “among adults, prevalence of hypertension will increase from 51.2% in 2020 to 61.0% in 2050.”
 

Pharmacists Most Effective

Though many factors contribute to hypertension, researchers have found that the kind of specialist leading the hypertension team may play a role in success. Currently, most BP control teams are led by physicians in primary care.

In a recent meta-analysis involving 100 randomized controlled trials and more than 90,000 patients in Circulation, Katherine T. Mills, PhD, School of Public Health, Tulane University, New Orleans, Louisiana, and colleagues found that, while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Those groups’ efforts resulted in the greatest systolic BP drops: −7.3 mm Hg (pharmacists) and −7.1 mm Hg (community health workers). Groups led by nurses and physicians saw systolic changes of −3 and −2.4 mm Hg, respectively.

Similarly, pharmacist- and community health worker–led efforts saw the greatest diastolic BP reductions (−3.8 and −3.1 mm Hg), compared with nurse-led (−1.6) and physician-led (−1.2) efforts.
 

Reductions Enough to Cut Cardiovascular Disease Risk

The reduction numbers for pharmacists are clinically meaningful, Mills said in an interview. “It’s greater than a lot of what we see from individual lifestyle changes,” such as reducing sodium intake or increasing physical activity.

“It’s a big enough blood pressure change to have meaningful reduction in risk of cardiovascular disease,” she said.

This evidence that the leader of the team matters is particularly important because the treatment of hypertension is not in doubt. Something else is not working the way it should.

“We have basically all the scientific evidence we need in terms of what interventions work. But there’s a big gap between that and what’s actually being done in the real world,” she said.

Mills said she was not surprised that pharmacists got the best results “because so much of it has to do with titrating medications and finding the right kind of medications for each patient.”

Additionally, BP management and control falls right into pharmacists’ wheelhouse, Mills noted, including evaluating medication side effects and talking to patients about medication adherence.
 

Why Pharmacists May Be More Successful

In an accompanying editorial, Ross T. Tsuyuki, PharmD, with the EPICORE Centre, Division of Cardiology, University of Alberta in Edmonton, Canada, and coauthors said the Mills study provides further data to support pharmacists leading BP control efforts, but it’s not the data that have been keeping the model from changing. The barriers include turf wars and lack of legislative change.

The editorialists also said having pharmacist-led BP teams is only the first step. “We need pharmacists to independently prescribe,” they wrote.

“Since individual states govern the scope of practice of pharmacists,” the editorialists wrote, “we have the enormous task of changing regulations to allow pharmacists to independently prescribe for hypertension. But it can be done. The Canadian province of Alberta allows pharmacists to prescribe. And more recently, Idaho. While most states allow some sort of collaborative (dependent) prescribing, that is only a first step.”

Allowing pharmacists to independently prescribe will help populations who do not have a physician or can’t get access to a physician, the editorialists wrote. But changing state legislation would be a lengthy and complex effort.
 

Physician-Led BP Control Model ‘Seems to Fail Miserably’

Coauthor of the editorial, Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview that, currently, physician-led teams are the norm, “and that model seems to fail miserably.”

He offered several key reasons for that. In primary care, patients with hypertension often have other problems — they may have high cholesterol or diabetes. “They may have acute illnesses that bother them as well as hypertension that doesn’t bother them,” he said.

Physicians tend to find excuses not to increase or add BP medications, Rader said. “We tend then to blame ‘white coat effect’ or say ‘you’re just nervous today.’ ”

Pharmacists, comparatively, are more protocol driven, he said. “They essentially look at blood pressure and they have an algorithm in their mind. If the blood pressure hits the guideline-stated bar, start this medication. If it hits another bar, increase or add another medication.”

Rader said turf wars are also keeping physician-led teams from changing, fueled by fears that patients will seek care from pharmacists instead of physicians.

“I don’t think the pharmacists will steal a single patient,” Rader said. “If a physician had a healthcare partner like a pharmacist to optimize blood pressure, then [patients] come back to the physician with normalized BP on the right medications. I think it’s a total win-win. I think we just have to get over that.”

Pharmacist-led warfarin clinics are very well established, Rader said, “but for whatever reason, when it comes to blood pressure, physicians are a little bit more hesitant.”
 

Collaboration Yes, Independent No

Hypertension expert Donald J. DiPette, MD, Health Sciences Distinguished Professor in the Department of Internal Medicine at University of South Carolina, Columbia, said he completely agrees with Mills and colleagues’ conclusion. “Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.”

The conclusion “is in line with the thinking of major organizations,” said DiPette, who helped develop the WHO’s most recent pharmacological treatment of hypertension guidelines. “WHO suggests that pharmacological treatment of hypertension can be provided by nonphysician professionals such as pharmacists and nurses as long as the following conditions are met: Proper training, prescribing authority, specific management protocols, and physician oversight.”

DiPette strongly believes BP control efforts should be supervised by a physician, but that could come in different ways. He suggested a collaborative but physician-supervised development of a protocol. Everyone contributes, but the physician signs off on it.

As for the Idaho example of independent practice for pharmacists, DiPette said he doesn’t think that will make a big difference in control rates. “That’s still not team-based care.”
 

Community Health Workers Key

He said he was also glad to see community healthcare workers emerge as the next-most-effective group after pharmacists to lead BP control teams. This is particularly important as BP control efforts globally need to consider the cultural experience of individual communities. “The community worker is on the ground, and can help overcome some of the cultural barriers,” he said.

“The key is to focus on team-based care and moving away from silo practice,” DiPette said.

Physicians, he said, often fall into “clinical or therapeutic inertia,” where BP is concerned. “We fail to titrate or add additional hypertensive medications even when they’re clearly indicated by the blood pressure. This is a problem not with the individual patient or the healthcare system, this is on us as physicians.”

Nonphysicians are more aligned with following protocols and guidelines, irrespective of the dynamics of what’s going on, he said.

And following protocols rigidly is a good thing for hypertension. “We’re not overtreating hypertension,” he emphasized. “We’re undertreating it.”

Reversing the trend on hypertension will take a sea change in medicine — changing institutions, systems, and individuals who have been doing things the same way for decades, he said.

“Our hypertension control rates are dismal,” DiPette said. “What’s more alarming is they’re going down. That’s the urgency. That’s the burning platform. We must strongly consider doing something different.”

Tsuyuki has received investigator-initiated arm’s length research grants from Merck, Pfizer, AstraZeneca, and Sanofi. He has been a speaker/consultant for Merck, Emergent BioSolutions, and Shoppers Drug Mart/Loblaw Companies Limited. Rader has been a consultant for Bristol Meyers Squibb, Cytokinetics, Idorsia, Medtronic, and ReCor Medical. Mills and coauthors reported no relevant financial relationships. DiPette declared no relevant financial relationships. He was part of a leadership team that developed WHO guidelines on hypertension.

A version of this article first appeared on Medscape.com.

Current efforts to control high blood pressure (BP) are failing in the United States and globally.

The first World Health Organization (WHO) global report on hypertension found that only 54% of adults with hypertension are diagnosed, 42% get treatment, and just 21% have their hypertension controlled.

In the United States, almost half (48%) of adults have high BP, defined as a systolic BP > 130 mm Hg, or a diastolic BP > 80 mm Hg, or are taking medication for high BP, according to the Centers for Disease Control and Prevention. Only about one in four adults (22.5%) with high BP have their BP under control.

High BP is a major risk factor for coronary heart disease, heart failure, and stroke, and the problem of controlling it is only getting worse. In 2024, the American Heart Association estimates that, “among adults, prevalence of hypertension will increase from 51.2% in 2020 to 61.0% in 2050.”
 

Pharmacists Most Effective

Though many factors contribute to hypertension, researchers have found that the kind of specialist leading the hypertension team may play a role in success. Currently, most BP control teams are led by physicians in primary care.

In a recent meta-analysis involving 100 randomized controlled trials and more than 90,000 patients in Circulation, Katherine T. Mills, PhD, School of Public Health, Tulane University, New Orleans, Louisiana, and colleagues found that, while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Those groups’ efforts resulted in the greatest systolic BP drops: −7.3 mm Hg (pharmacists) and −7.1 mm Hg (community health workers). Groups led by nurses and physicians saw systolic changes of −3 and −2.4 mm Hg, respectively.

Similarly, pharmacist- and community health worker–led efforts saw the greatest diastolic BP reductions (−3.8 and −3.1 mm Hg), compared with nurse-led (−1.6) and physician-led (−1.2) efforts.
 

Reductions Enough to Cut Cardiovascular Disease Risk

The reduction numbers for pharmacists are clinically meaningful, Mills said in an interview. “It’s greater than a lot of what we see from individual lifestyle changes,” such as reducing sodium intake or increasing physical activity.

“It’s a big enough blood pressure change to have meaningful reduction in risk of cardiovascular disease,” she said.

This evidence that the leader of the team matters is particularly important because the treatment of hypertension is not in doubt. Something else is not working the way it should.

“We have basically all the scientific evidence we need in terms of what interventions work. But there’s a big gap between that and what’s actually being done in the real world,” she said.

Mills said she was not surprised that pharmacists got the best results “because so much of it has to do with titrating medications and finding the right kind of medications for each patient.”

Additionally, BP management and control falls right into pharmacists’ wheelhouse, Mills noted, including evaluating medication side effects and talking to patients about medication adherence.
 

Why Pharmacists May Be More Successful

In an accompanying editorial, Ross T. Tsuyuki, PharmD, with the EPICORE Centre, Division of Cardiology, University of Alberta in Edmonton, Canada, and coauthors said the Mills study provides further data to support pharmacists leading BP control efforts, but it’s not the data that have been keeping the model from changing. The barriers include turf wars and lack of legislative change.

The editorialists also said having pharmacist-led BP teams is only the first step. “We need pharmacists to independently prescribe,” they wrote.

“Since individual states govern the scope of practice of pharmacists,” the editorialists wrote, “we have the enormous task of changing regulations to allow pharmacists to independently prescribe for hypertension. But it can be done. The Canadian province of Alberta allows pharmacists to prescribe. And more recently, Idaho. While most states allow some sort of collaborative (dependent) prescribing, that is only a first step.”

Allowing pharmacists to independently prescribe will help populations who do not have a physician or can’t get access to a physician, the editorialists wrote. But changing state legislation would be a lengthy and complex effort.
 

Physician-Led BP Control Model ‘Seems to Fail Miserably’

Coauthor of the editorial, Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview that, currently, physician-led teams are the norm, “and that model seems to fail miserably.”

He offered several key reasons for that. In primary care, patients with hypertension often have other problems — they may have high cholesterol or diabetes. “They may have acute illnesses that bother them as well as hypertension that doesn’t bother them,” he said.

Physicians tend to find excuses not to increase or add BP medications, Rader said. “We tend then to blame ‘white coat effect’ or say ‘you’re just nervous today.’ ”

Pharmacists, comparatively, are more protocol driven, he said. “They essentially look at blood pressure and they have an algorithm in their mind. If the blood pressure hits the guideline-stated bar, start this medication. If it hits another bar, increase or add another medication.”

Rader said turf wars are also keeping physician-led teams from changing, fueled by fears that patients will seek care from pharmacists instead of physicians.

“I don’t think the pharmacists will steal a single patient,” Rader said. “If a physician had a healthcare partner like a pharmacist to optimize blood pressure, then [patients] come back to the physician with normalized BP on the right medications. I think it’s a total win-win. I think we just have to get over that.”

Pharmacist-led warfarin clinics are very well established, Rader said, “but for whatever reason, when it comes to blood pressure, physicians are a little bit more hesitant.”
 

Collaboration Yes, Independent No

Hypertension expert Donald J. DiPette, MD, Health Sciences Distinguished Professor in the Department of Internal Medicine at University of South Carolina, Columbia, said he completely agrees with Mills and colleagues’ conclusion. “Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.”

The conclusion “is in line with the thinking of major organizations,” said DiPette, who helped develop the WHO’s most recent pharmacological treatment of hypertension guidelines. “WHO suggests that pharmacological treatment of hypertension can be provided by nonphysician professionals such as pharmacists and nurses as long as the following conditions are met: Proper training, prescribing authority, specific management protocols, and physician oversight.”

DiPette strongly believes BP control efforts should be supervised by a physician, but that could come in different ways. He suggested a collaborative but physician-supervised development of a protocol. Everyone contributes, but the physician signs off on it.

As for the Idaho example of independent practice for pharmacists, DiPette said he doesn’t think that will make a big difference in control rates. “That’s still not team-based care.”
 

Community Health Workers Key

He said he was also glad to see community healthcare workers emerge as the next-most-effective group after pharmacists to lead BP control teams. This is particularly important as BP control efforts globally need to consider the cultural experience of individual communities. “The community worker is on the ground, and can help overcome some of the cultural barriers,” he said.

“The key is to focus on team-based care and moving away from silo practice,” DiPette said.

Physicians, he said, often fall into “clinical or therapeutic inertia,” where BP is concerned. “We fail to titrate or add additional hypertensive medications even when they’re clearly indicated by the blood pressure. This is a problem not with the individual patient or the healthcare system, this is on us as physicians.”

Nonphysicians are more aligned with following protocols and guidelines, irrespective of the dynamics of what’s going on, he said.

And following protocols rigidly is a good thing for hypertension. “We’re not overtreating hypertension,” he emphasized. “We’re undertreating it.”

Reversing the trend on hypertension will take a sea change in medicine — changing institutions, systems, and individuals who have been doing things the same way for decades, he said.

“Our hypertension control rates are dismal,” DiPette said. “What’s more alarming is they’re going down. That’s the urgency. That’s the burning platform. We must strongly consider doing something different.”

Tsuyuki has received investigator-initiated arm’s length research grants from Merck, Pfizer, AstraZeneca, and Sanofi. He has been a speaker/consultant for Merck, Emergent BioSolutions, and Shoppers Drug Mart/Loblaw Companies Limited. Rader has been a consultant for Bristol Meyers Squibb, Cytokinetics, Idorsia, Medtronic, and ReCor Medical. Mills and coauthors reported no relevant financial relationships. DiPette declared no relevant financial relationships. He was part of a leadership team that developed WHO guidelines on hypertension.

A version of this article first appeared on Medscape.com.

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Over-the-Counter UTI Products: What Primary Care Clinicians Need to Know

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When it comes to managing urinary tract infections (UTIs), patients often turn to over-the-counter (OTC) products in search of quick relief. However, recent research suggests some products promise more than they can deliver and can vary widely in price and ingredients. For primary care clinicians, understanding these differences could make all the difference in offering effective, cost-conscious advice to patients.

Researchers from the University of Wisconsin analyzed OTC products marketed for urinary tract health in three major US drugstores and found significant price variations and a wide array of active ingredients.

Their study, presented at the American Urogynecologic Society’s PFD Week conference, found that the price of OTC products fluctuates dramatically. Phenazopyridine hydrochloride, commonly used for UTI symptom relief, ranged from $0.17 to $0.83 per tablet, the study found. Methenamine/sodium salicylate combinations, which are marketed for UTI prevention, varied from $0.13 to $0.33 per tablet. Cranberry supplements — often touted for their preventive benefits — showed the most extreme price range, from as low as $0.07 to as high as $1.00 per serving.

The study also looked into the ingredients, which were categorized into five main groups: Phenazopyridine hydrochloride, methenamine/sodium salicylate, cranberry supplements, D-mannose, and cranberry/D-mannose combinations.

These ingredients vary not only in price but also in the strength of scientific evidence supporting their use.

The researchers concluded:

  • Phenazopyridine hydrochloride offers effective symptom relief but is not a UTI treatment.
  • Methenamine/sodium salicylate shows potential for preventing recurrent UTIs in certain patients.
  • Cranberry supplements have limited evidence for preventing UTIs, with no proof they treat infections.
  • D-mannose has shown promise for short-term use in preventing recurrent UTIs, though more research is needed to weigh its effectiveness in the long run.

“No OTC product within its respective category is superior to another,” said Ushma J. Patel, MD, a fellow in Urogynecology and Reconstructive Pelvic Surgery at the University of Wisconsin School of Medicine and Public Health, Madison, and lead author of the study.

Patel and her coresearcher also found that many products are falsely marketed as treatments for UTI.

“The products in each type of category are for symptom relief or UTI prevention — not treatment,” said Patel. “These products within the categories described are interchangeable, and consumers should make cost-effective choices as no product is superior to another within its respective category.”

This presents the opportunity for clinicians to guide individuals to pick the right products while explaining that symptom relief doesn’t necessarily mean an infection is being treated, Patel said.

Indeed, Patel proposed that clinicians utilize a summary table created from their findings to offer patients vetted information about OTC UTI products.

And, while OTC products can provide benefits, they should not replace proper medical evaluation and treatment of UTIs.

“If patients are experiencing ongoing symptoms or develop new-onset symptoms despite trialing an over-the-counter product, they should contact a healthcare provider,” said Patel. “OTC products can provide symptom relief until patients are able to see a healthcare provider.”

The researchers reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

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When it comes to managing urinary tract infections (UTIs), patients often turn to over-the-counter (OTC) products in search of quick relief. However, recent research suggests some products promise more than they can deliver and can vary widely in price and ingredients. For primary care clinicians, understanding these differences could make all the difference in offering effective, cost-conscious advice to patients.

Researchers from the University of Wisconsin analyzed OTC products marketed for urinary tract health in three major US drugstores and found significant price variations and a wide array of active ingredients.

Their study, presented at the American Urogynecologic Society’s PFD Week conference, found that the price of OTC products fluctuates dramatically. Phenazopyridine hydrochloride, commonly used for UTI symptom relief, ranged from $0.17 to $0.83 per tablet, the study found. Methenamine/sodium salicylate combinations, which are marketed for UTI prevention, varied from $0.13 to $0.33 per tablet. Cranberry supplements — often touted for their preventive benefits — showed the most extreme price range, from as low as $0.07 to as high as $1.00 per serving.

The study also looked into the ingredients, which were categorized into five main groups: Phenazopyridine hydrochloride, methenamine/sodium salicylate, cranberry supplements, D-mannose, and cranberry/D-mannose combinations.

These ingredients vary not only in price but also in the strength of scientific evidence supporting their use.

The researchers concluded:

  • Phenazopyridine hydrochloride offers effective symptom relief but is not a UTI treatment.
  • Methenamine/sodium salicylate shows potential for preventing recurrent UTIs in certain patients.
  • Cranberry supplements have limited evidence for preventing UTIs, with no proof they treat infections.
  • D-mannose has shown promise for short-term use in preventing recurrent UTIs, though more research is needed to weigh its effectiveness in the long run.

“No OTC product within its respective category is superior to another,” said Ushma J. Patel, MD, a fellow in Urogynecology and Reconstructive Pelvic Surgery at the University of Wisconsin School of Medicine and Public Health, Madison, and lead author of the study.

Patel and her coresearcher also found that many products are falsely marketed as treatments for UTI.

“The products in each type of category are for symptom relief or UTI prevention — not treatment,” said Patel. “These products within the categories described are interchangeable, and consumers should make cost-effective choices as no product is superior to another within its respective category.”

This presents the opportunity for clinicians to guide individuals to pick the right products while explaining that symptom relief doesn’t necessarily mean an infection is being treated, Patel said.

Indeed, Patel proposed that clinicians utilize a summary table created from their findings to offer patients vetted information about OTC UTI products.

And, while OTC products can provide benefits, they should not replace proper medical evaluation and treatment of UTIs.

“If patients are experiencing ongoing symptoms or develop new-onset symptoms despite trialing an over-the-counter product, they should contact a healthcare provider,” said Patel. “OTC products can provide symptom relief until patients are able to see a healthcare provider.”

The researchers reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

When it comes to managing urinary tract infections (UTIs), patients often turn to over-the-counter (OTC) products in search of quick relief. However, recent research suggests some products promise more than they can deliver and can vary widely in price and ingredients. For primary care clinicians, understanding these differences could make all the difference in offering effective, cost-conscious advice to patients.

Researchers from the University of Wisconsin analyzed OTC products marketed for urinary tract health in three major US drugstores and found significant price variations and a wide array of active ingredients.

Their study, presented at the American Urogynecologic Society’s PFD Week conference, found that the price of OTC products fluctuates dramatically. Phenazopyridine hydrochloride, commonly used for UTI symptom relief, ranged from $0.17 to $0.83 per tablet, the study found. Methenamine/sodium salicylate combinations, which are marketed for UTI prevention, varied from $0.13 to $0.33 per tablet. Cranberry supplements — often touted for their preventive benefits — showed the most extreme price range, from as low as $0.07 to as high as $1.00 per serving.

The study also looked into the ingredients, which were categorized into five main groups: Phenazopyridine hydrochloride, methenamine/sodium salicylate, cranberry supplements, D-mannose, and cranberry/D-mannose combinations.

These ingredients vary not only in price but also in the strength of scientific evidence supporting their use.

The researchers concluded:

  • Phenazopyridine hydrochloride offers effective symptom relief but is not a UTI treatment.
  • Methenamine/sodium salicylate shows potential for preventing recurrent UTIs in certain patients.
  • Cranberry supplements have limited evidence for preventing UTIs, with no proof they treat infections.
  • D-mannose has shown promise for short-term use in preventing recurrent UTIs, though more research is needed to weigh its effectiveness in the long run.

“No OTC product within its respective category is superior to another,” said Ushma J. Patel, MD, a fellow in Urogynecology and Reconstructive Pelvic Surgery at the University of Wisconsin School of Medicine and Public Health, Madison, and lead author of the study.

Patel and her coresearcher also found that many products are falsely marketed as treatments for UTI.

“The products in each type of category are for symptom relief or UTI prevention — not treatment,” said Patel. “These products within the categories described are interchangeable, and consumers should make cost-effective choices as no product is superior to another within its respective category.”

This presents the opportunity for clinicians to guide individuals to pick the right products while explaining that symptom relief doesn’t necessarily mean an infection is being treated, Patel said.

Indeed, Patel proposed that clinicians utilize a summary table created from their findings to offer patients vetted information about OTC UTI products.

And, while OTC products can provide benefits, they should not replace proper medical evaluation and treatment of UTIs.

“If patients are experiencing ongoing symptoms or develop new-onset symptoms despite trialing an over-the-counter product, they should contact a healthcare provider,” said Patel. “OTC products can provide symptom relief until patients are able to see a healthcare provider.”

The researchers reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

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FDA OKs New Drug for Urinary Tract Infections

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The Food and Drug Administration (FDA) has approved Orlynvah, a new oral treatment for uncomplicated urinary tract infections (UTIs) in women who have limited options for effective antibiotic therapy.

Uncomplicated UTIs are bladder infections that typically affect women who don’t have other issues like kidney disease or urinary tract abnormalities. These infections are common, affecting around half of all women at least once in their lives.

Treating UTIs can be difficult when standard antibiotics don’t work well, often because of antibiotic resistance or certain health conditions. Orlynvah offers a promising new option by combining two drugs, sulopenem etzadroxil and probenecid, in one oral tablet. This combination helps keep the antibiotic in the body longer, making it work better, especially against bacteria that resist traditional treatments. Orlynvah is specifically approved to target infections from bacteria like Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, which can be harder to treat.

Marjorie Golden, MD, an infectious disease specialist at Yale New Haven Hospital in Connecticut, described Orlynvah as a much-needed alternative for women struggling with difficult-to-treat UTIs. 

“Orlynvah has the potential to be an important treatment option for those who need it,” she said in a news release from Iterum Therapeutics, the drug’s maker.

The FDA approved Orlynvah based on two large clinical trials involving over 3,800 women. In these studies, Orlynvah worked as well as or better than antibiotics like ciprofloxacin and Augmentin. It was generally well-tolerated, though common side effects included diarrhea, nausea, yeast infections, and headaches.

The FDA advises people to discuss their medical history with their doctor before taking Orlynvah, especially if they have conditions like gout, kidney stones, or allergies to other antibiotics.

A version of this article first appeared on Medscape.com.

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The Food and Drug Administration (FDA) has approved Orlynvah, a new oral treatment for uncomplicated urinary tract infections (UTIs) in women who have limited options for effective antibiotic therapy.

Uncomplicated UTIs are bladder infections that typically affect women who don’t have other issues like kidney disease or urinary tract abnormalities. These infections are common, affecting around half of all women at least once in their lives.

Treating UTIs can be difficult when standard antibiotics don’t work well, often because of antibiotic resistance or certain health conditions. Orlynvah offers a promising new option by combining two drugs, sulopenem etzadroxil and probenecid, in one oral tablet. This combination helps keep the antibiotic in the body longer, making it work better, especially against bacteria that resist traditional treatments. Orlynvah is specifically approved to target infections from bacteria like Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, which can be harder to treat.

Marjorie Golden, MD, an infectious disease specialist at Yale New Haven Hospital in Connecticut, described Orlynvah as a much-needed alternative for women struggling with difficult-to-treat UTIs. 

“Orlynvah has the potential to be an important treatment option for those who need it,” she said in a news release from Iterum Therapeutics, the drug’s maker.

The FDA approved Orlynvah based on two large clinical trials involving over 3,800 women. In these studies, Orlynvah worked as well as or better than antibiotics like ciprofloxacin and Augmentin. It was generally well-tolerated, though common side effects included diarrhea, nausea, yeast infections, and headaches.

The FDA advises people to discuss their medical history with their doctor before taking Orlynvah, especially if they have conditions like gout, kidney stones, or allergies to other antibiotics.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved Orlynvah, a new oral treatment for uncomplicated urinary tract infections (UTIs) in women who have limited options for effective antibiotic therapy.

Uncomplicated UTIs are bladder infections that typically affect women who don’t have other issues like kidney disease or urinary tract abnormalities. These infections are common, affecting around half of all women at least once in their lives.

Treating UTIs can be difficult when standard antibiotics don’t work well, often because of antibiotic resistance or certain health conditions. Orlynvah offers a promising new option by combining two drugs, sulopenem etzadroxil and probenecid, in one oral tablet. This combination helps keep the antibiotic in the body longer, making it work better, especially against bacteria that resist traditional treatments. Orlynvah is specifically approved to target infections from bacteria like Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, which can be harder to treat.

Marjorie Golden, MD, an infectious disease specialist at Yale New Haven Hospital in Connecticut, described Orlynvah as a much-needed alternative for women struggling with difficult-to-treat UTIs. 

“Orlynvah has the potential to be an important treatment option for those who need it,” she said in a news release from Iterum Therapeutics, the drug’s maker.

The FDA approved Orlynvah based on two large clinical trials involving over 3,800 women. In these studies, Orlynvah worked as well as or better than antibiotics like ciprofloxacin and Augmentin. It was generally well-tolerated, though common side effects included diarrhea, nausea, yeast infections, and headaches.

The FDA advises people to discuss their medical history with their doctor before taking Orlynvah, especially if they have conditions like gout, kidney stones, or allergies to other antibiotics.

A version of this article first appeared on Medscape.com.

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Screening Options for Rare Malignancies

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Dear colleagues,

As gastroenterologists and endoscopists, we spend significant time preventing and diagnosing GI malignancies. While colorectal and esophageal cancer and their precursor lesions are well known to us, our approach to rarer malignancies is less well defined.

For instance, is it worthwhile screening for pancreatic cancer, and, if so, how should this be done? Likewise, diagnosing cholangiocarcinoma is challenging; how best should one evaluate for this in higher risk populations, such as primary sclerosing cholangitis? And what about the costs, financial and otherwise, associated with screening?

Dr. Gyanprakash A. Ketwaroo


In this issue of Perspectives, Dr. Darshan Kothari and Dr. Daniel Bernstein discuss their approach to pancreatic cancer screening, including who is eligible, the preferred screening modalities, and the barriers to screening. In the accompanying perspective, Dr. Aparna Goel and Dr. Judah Kupferman focus on cholangiocarcinoma screening, identifying high-risk populations and discussing some of the concerns with screening, necessitating shared decision-making.

We welcome your thoughts on this issue. Share with us on X at @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.

An Approach to Pancreatic Cancer Screening

BY DANIEL A. BERNSTEIN, MD, AND DARSHAN KOTHARI, MD

Pancreatic cancer carries a dismal prognosis, now accounting for the third-most cancer-related mortality in the United States. A small proportion of patients are diagnosed at a local stage of disease, with over half found to have metastatic disease at presentation. Given the low overall incidence and lifetime risk in the general population, population-based screening is not justified.

About 10% of cases of pancreas cancer are associated with germ-line mutations and/or with a strong family history of pancreatic cancer. Several academic societies and expert committees now recommend regular screening for pancreatic cancer in patients who are considered high-risk individuals, as they carry a fivefold relative risk for pancreatic cancer. Moreover, studies suggest that screening has the potential to identify early-stage resectable disease and decrease mortality in this patient population.

Duke University
Dr. Daniel Bernstein

Patients who benefit from pancreatic cancer screening are those who carry an increased lifetime risk (in excess of 5%) of pancreatic cancer. High-risk individuals include those with germ-line mutations and/or those with a family history of pancreatic cancer in first-degree relatives. Consensus guidelines by the International Cancer of the Pancreas Screening Consortium and the American Society for Gastrointestinal Endoscopy provide medical centers with detailed recommendations on who and when to start screening.

High-risk individuals fall into three categories:

  • Patients with high-risk germline mutations including: familial atypical multiple mole melanoma syndrome (CDKN2A), hereditary breast and ovarian cancer syndromes (BRCA1, BRCA2, and PALB2), Peutz-Jeghers syndrome (STK11), and hereditary pancreatitis (PRSS1 and SPINK1)
  • Patients with low- to moderate-risk germ-line mutations with at least one first-degree relative with pancreatic cancer: Lynch Syndrome (particularly MLH1 mutation), ataxia-telangiectasia (ATM), or Li-Fraumeni syndrome (p53)
  • Patients with one first-degree relative with pancreatic cancer who in turn has one first-degree relative with pancreatic cancer (eg, a patient’s mother and maternal aunt or a patient’s father and patient’s sister)
 

 

Consistent with established guidelines, we recommend screening for high-risk patients beginning at age 50, or 10 years before the youngest age at which pancreas cancer was diagnosed in an affected relative. Screening is recommended earlier in patients with particularly high risk: at age 40 for patients with CDKN2A and STKI11 mutations and age 40 for patients with PRSS1 mutation or 20 years after the first attack of acute pancreatitis. For patients with a strong family history of pancreas cancer, we recommend comprehensive evaluation by a certified genetic counselor at a high-volume cancer center.

Duke University
Dr. Darshan Kothari

In practice, patients at our institution who are identified as high risk based on the above criteria are referred for an initial consultation at our pancreas center. In most cases, this should occur no sooner than 5 years prior to the recommended starting age for screening. All patients who are identified as high risk should be screened annually for diabetes given the growing evidence base supporting an association between new-onset diabetes and pancreatic cancer.

After an initial visit and discussion of the risks and benefits of screening, most screening protocols start with a baseline endoscopic ultrasound (EUS) and contrast-enhanced magnetic resonance abdomen with magnetic resonance cholangiopancreatography (MRI/MRCP), which will be repeated annually or sooner as the clinical condition warrants. A sooner-interval EUS should be considered for patients already undergoing screening who are newly found to have diabetes.

At our institution, we start with an in-person clinic evaluation followed by EUS. Thereafter, patients undergo MRI/MRCP (synchronized with a same-day clinic visit) alternating with EUS every 6 months to ensure patients are seen twice a year, though there is no specific data to support this approach. Non-diabetics also undergo yearly diabetes screening which will trigger an EUS if patients become diabetic.

We engage in shared decision-making with our high-risk individuals undergoing pancreatic cancer screening and at each visit we review their concurrent medical conditions and suitability to continue screening. We consider discontinuing screening after age 75, at the onset of any life-limiting illness, or after a discussion of risks and benefits if comorbidities lead to a substantial deterioration in a patient’s overall health status.

While a growing body of evidence exists to support the application of pancreatic cancer screening in high-risk individuals, this preventive service remains underutilized. Recent analysis of the screening cohort at our institution showed a demographically homogeneous group of mostly highly educated, high-income White females. These findings are consistent with the patient cohorts described in other pancreatic cancer screening programs and represent only a fraction of people who would qualify for pancreatic cancer screening.

A survey of patients undergoing screening at our institution identified cost, travel, and time associated with pancreatic cancer screening to be frequent challenges to participation. Further studies are needed to fully explore the barriers and psychological burden of pancreas cancer screening in high-risk individuals, and to identify ways to enrich the cohort of patients undergoing screening. This may involve novel methods to identify family members of patients with a new diagnosis of pancreas cancer and increasing health literacy around pancreatic cancer screening among patients and providers.

Pancreatic cancer screening has the potential to identify early-stage disease in patients who are at high risk because of germ-line mutations and/or family history. We recommend that patients engage in pancreatic cancer screening at high-volume centers with well-supported oncology, genetics, and research infrastructure.

Dr. Bernstein is a gastroenterology fellow at Duke University School of Medicine, Durham, North Carolina. Dr. Kothari is an associate professor of medicine in gastroenterology and hepatology at Duke University School of Medicine.

Screening for Cholangiocarcinoma

BY JUDAH KUPFERMAN, MD, AND APARNA GOEL, MD

Cholangiocarcinoma is a rare but aggressive cancer of the bile ducts that poses many diagnostic challenges. Approximately 3% of gastrointestinal cancers are attributed to cholangiocarcinoma, and while the annual incidence of disease in the United States is about 1.26 per 100,000 people, the incidence of intrahepatic disease has been rising considerably.1,2 Screening for cholangiocarcinoma is reserved for high-risk individuals — such as those with primary sclerosing cholangitis (PSC), secondary sclerosing cholangitis (SSC), and biliary tract disorders such as choledochal cysts or Caroli’s disease. The goal is to balance the benefits of early diagnosis with the costs and risks associated with screening, particularly given the limitations of available tools like MRI with cholangiopancreatography (MRCP), which has a sensitivity of 70%-85%. In general, we recommend annual cholangiocarcinoma screening for high-risk individuals with MRI and MRCP as well as with cancer antigen (CA) 19-9. .

Stanford School of Medicine
Dr. Judah Kupferman

Screening in Patients with Primary Sclerosing Cholangitis

The lifetime risk of cholangiocarcinoma in patients with PSC is 10%-15% with an annual risk of 0.5%-1.5%. In our experience, this is often the most feared complication for PSC patients, even more so than the risk of liver transplantation. We recommend annual MRI with MRCP in addition to CA 19-9 for patients with PSC in the first decade of their diagnosis, as most cancers are diagnosed during this period. If a patient’s imaging has remained stable for over a decade and there is minimal hepatic fibrosis, we discuss the option of reducing screening frequency to every 2 years to minimize costs and exposure to MRI contrast risks.

If MRI reveals a concerning new large duct stricture, we will evaluate this with an endoscopic retrograde cholangiopancreatography (ERCP), as differentiating benign and malignant strictures is quite challenging with MRI. We generally recommend ERCP with brush cytology and fluorescence in situ hybridization to improve diagnostic yield. Depending on imaging findings and location of the new large duct stricture, we may consider cholangioscopy during ERCP for direct visualization of the bile duct and directed tissue biopsies. Unfortunately, even in young, asymptomatic patients who undergo regular screening, cholangiocarcinoma is frequently diagnosed at an advanced stage.
 

Screening in Patients with Secondary Sclerosing Cholangitis

Patients with SSC may develop cholangiocarcinoma because of chronic inflammatory and fibrotic processes, such as IgG4-associated cholangiopathy, sarcoidosis, ischemic cholangiopathy, cystic fibrosis, recurrent pyogenic cholangitis, severe sepsis (as recently seen from SARS-CoV-2), surgical complications, or other etiologies. When the condition is reversible, such as with IgG4-associated cholangiopathy, cancer screening may not be necessary. However, when irreversible damage occurs, the cancer risk increases, though it varies by disease type and severity. In most cases, we recommend routine screening for cholangiocarcinoma with MRI and CA 19-9 in this population.

Stanford School of Medicine
Dr. Aparna Goel

Screening in Patients with Biliary Tract Disorders

Biliary tract disorders such as choledochal cysts and Caroli’s disease also harbor an increased risk of cholangiocarcinoma. Choledochal cysts are congenital cystic dilations of the bile duct that have a 10%-30% lifetime risk of malignant transformation to cholangiocarcinoma. Surgical intervention to remove the cyst is often recommended because of this high risk. However, some patients may be unable or unwilling to undergo this surgery or they may have residual cysts. We recommend ongoing screening with MRI and CA 19-9 for these patients. Similarly, Caroli’s disease is a congenital disease associated with intrahepatic and extrahepatic bile duct cysts and associated with a 5%-15% lifetime risk of cholangiocarcinoma. MRI with MRCP and CA 19-9 should be performed routinely for patients with Caroli’s disease and syndrome.

Risks and Challenges in Cholangiocarcinoma Screening

While MRI with MRCP is the gold standard for cholangiocarcinoma screening, its limitations must be carefully considered. One growing concern is the potential for gadolinium retention in the brain, bones, or skin following repeated MRI scans. Though the long-term effects of gadolinium retention are not fully understood, we factor this into screening decisions, particularly for younger patients who may undergo decades of regular imaging.

MRI is not always feasible for certain patients, including those with metal implants, on hemodialysis, or with severe allergic reactions. In such cases, CT or ultrasound may serve as alternatives, though with lower sensitivity for detecting cholangiocarcinoma. Additionally, claustrophobia during MRI can be addressed with sedation, but this underscores the importance of shared decision-making.

From our perspective, cholangiocarcinoma screening in high-risk patients is crucial but not without challenges. Our current screening methods, while essential, are far from perfect, often missing early cancers or leading to unnecessary interventions. Because of these limitations, the window for treatment of localized disease can easily be missed. In our practice, we tailor screening strategies to each patient’s specific needs, weighing the potential benefits against the risks, costs, and the inherent uncertainty of early detection tools. We believe it is essential to involve patients in this decision-making process to provide a balanced, individualized approach that considers both clinical evidence and the personal preferences of each person.

Dr. Kupferman is a gastroenterology fellow at Stanford University School of Medicine in California. Dr. Goel is a transplant hepatologist and a clinical associate professor in gastroenterology & hepatology at Stanford.

References

1. Vithayathil M and Khan SA. J Hepatol. 2022 Dec. doi: 10.1016/j.jhep.2022.07.022.

2. Patel N and Benipal B. Cureus. 2019 Jan. doi: 10.7759/cureus.3962.

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Dear colleagues,

As gastroenterologists and endoscopists, we spend significant time preventing and diagnosing GI malignancies. While colorectal and esophageal cancer and their precursor lesions are well known to us, our approach to rarer malignancies is less well defined.

For instance, is it worthwhile screening for pancreatic cancer, and, if so, how should this be done? Likewise, diagnosing cholangiocarcinoma is challenging; how best should one evaluate for this in higher risk populations, such as primary sclerosing cholangitis? And what about the costs, financial and otherwise, associated with screening?

Dr. Gyanprakash A. Ketwaroo


In this issue of Perspectives, Dr. Darshan Kothari and Dr. Daniel Bernstein discuss their approach to pancreatic cancer screening, including who is eligible, the preferred screening modalities, and the barriers to screening. In the accompanying perspective, Dr. Aparna Goel and Dr. Judah Kupferman focus on cholangiocarcinoma screening, identifying high-risk populations and discussing some of the concerns with screening, necessitating shared decision-making.

We welcome your thoughts on this issue. Share with us on X at @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.

An Approach to Pancreatic Cancer Screening

BY DANIEL A. BERNSTEIN, MD, AND DARSHAN KOTHARI, MD

Pancreatic cancer carries a dismal prognosis, now accounting for the third-most cancer-related mortality in the United States. A small proportion of patients are diagnosed at a local stage of disease, with over half found to have metastatic disease at presentation. Given the low overall incidence and lifetime risk in the general population, population-based screening is not justified.

About 10% of cases of pancreas cancer are associated with germ-line mutations and/or with a strong family history of pancreatic cancer. Several academic societies and expert committees now recommend regular screening for pancreatic cancer in patients who are considered high-risk individuals, as they carry a fivefold relative risk for pancreatic cancer. Moreover, studies suggest that screening has the potential to identify early-stage resectable disease and decrease mortality in this patient population.

Duke University
Dr. Daniel Bernstein

Patients who benefit from pancreatic cancer screening are those who carry an increased lifetime risk (in excess of 5%) of pancreatic cancer. High-risk individuals include those with germ-line mutations and/or those with a family history of pancreatic cancer in first-degree relatives. Consensus guidelines by the International Cancer of the Pancreas Screening Consortium and the American Society for Gastrointestinal Endoscopy provide medical centers with detailed recommendations on who and when to start screening.

High-risk individuals fall into three categories:

  • Patients with high-risk germline mutations including: familial atypical multiple mole melanoma syndrome (CDKN2A), hereditary breast and ovarian cancer syndromes (BRCA1, BRCA2, and PALB2), Peutz-Jeghers syndrome (STK11), and hereditary pancreatitis (PRSS1 and SPINK1)
  • Patients with low- to moderate-risk germ-line mutations with at least one first-degree relative with pancreatic cancer: Lynch Syndrome (particularly MLH1 mutation), ataxia-telangiectasia (ATM), or Li-Fraumeni syndrome (p53)
  • Patients with one first-degree relative with pancreatic cancer who in turn has one first-degree relative with pancreatic cancer (eg, a patient’s mother and maternal aunt or a patient’s father and patient’s sister)
 

 

Consistent with established guidelines, we recommend screening for high-risk patients beginning at age 50, or 10 years before the youngest age at which pancreas cancer was diagnosed in an affected relative. Screening is recommended earlier in patients with particularly high risk: at age 40 for patients with CDKN2A and STKI11 mutations and age 40 for patients with PRSS1 mutation or 20 years after the first attack of acute pancreatitis. For patients with a strong family history of pancreas cancer, we recommend comprehensive evaluation by a certified genetic counselor at a high-volume cancer center.

Duke University
Dr. Darshan Kothari

In practice, patients at our institution who are identified as high risk based on the above criteria are referred for an initial consultation at our pancreas center. In most cases, this should occur no sooner than 5 years prior to the recommended starting age for screening. All patients who are identified as high risk should be screened annually for diabetes given the growing evidence base supporting an association between new-onset diabetes and pancreatic cancer.

After an initial visit and discussion of the risks and benefits of screening, most screening protocols start with a baseline endoscopic ultrasound (EUS) and contrast-enhanced magnetic resonance abdomen with magnetic resonance cholangiopancreatography (MRI/MRCP), which will be repeated annually or sooner as the clinical condition warrants. A sooner-interval EUS should be considered for patients already undergoing screening who are newly found to have diabetes.

At our institution, we start with an in-person clinic evaluation followed by EUS. Thereafter, patients undergo MRI/MRCP (synchronized with a same-day clinic visit) alternating with EUS every 6 months to ensure patients are seen twice a year, though there is no specific data to support this approach. Non-diabetics also undergo yearly diabetes screening which will trigger an EUS if patients become diabetic.

We engage in shared decision-making with our high-risk individuals undergoing pancreatic cancer screening and at each visit we review their concurrent medical conditions and suitability to continue screening. We consider discontinuing screening after age 75, at the onset of any life-limiting illness, or after a discussion of risks and benefits if comorbidities lead to a substantial deterioration in a patient’s overall health status.

While a growing body of evidence exists to support the application of pancreatic cancer screening in high-risk individuals, this preventive service remains underutilized. Recent analysis of the screening cohort at our institution showed a demographically homogeneous group of mostly highly educated, high-income White females. These findings are consistent with the patient cohorts described in other pancreatic cancer screening programs and represent only a fraction of people who would qualify for pancreatic cancer screening.

A survey of patients undergoing screening at our institution identified cost, travel, and time associated with pancreatic cancer screening to be frequent challenges to participation. Further studies are needed to fully explore the barriers and psychological burden of pancreas cancer screening in high-risk individuals, and to identify ways to enrich the cohort of patients undergoing screening. This may involve novel methods to identify family members of patients with a new diagnosis of pancreas cancer and increasing health literacy around pancreatic cancer screening among patients and providers.

Pancreatic cancer screening has the potential to identify early-stage disease in patients who are at high risk because of germ-line mutations and/or family history. We recommend that patients engage in pancreatic cancer screening at high-volume centers with well-supported oncology, genetics, and research infrastructure.

Dr. Bernstein is a gastroenterology fellow at Duke University School of Medicine, Durham, North Carolina. Dr. Kothari is an associate professor of medicine in gastroenterology and hepatology at Duke University School of Medicine.

Screening for Cholangiocarcinoma

BY JUDAH KUPFERMAN, MD, AND APARNA GOEL, MD

Cholangiocarcinoma is a rare but aggressive cancer of the bile ducts that poses many diagnostic challenges. Approximately 3% of gastrointestinal cancers are attributed to cholangiocarcinoma, and while the annual incidence of disease in the United States is about 1.26 per 100,000 people, the incidence of intrahepatic disease has been rising considerably.1,2 Screening for cholangiocarcinoma is reserved for high-risk individuals — such as those with primary sclerosing cholangitis (PSC), secondary sclerosing cholangitis (SSC), and biliary tract disorders such as choledochal cysts or Caroli’s disease. The goal is to balance the benefits of early diagnosis with the costs and risks associated with screening, particularly given the limitations of available tools like MRI with cholangiopancreatography (MRCP), which has a sensitivity of 70%-85%. In general, we recommend annual cholangiocarcinoma screening for high-risk individuals with MRI and MRCP as well as with cancer antigen (CA) 19-9. .

Stanford School of Medicine
Dr. Judah Kupferman

Screening in Patients with Primary Sclerosing Cholangitis

The lifetime risk of cholangiocarcinoma in patients with PSC is 10%-15% with an annual risk of 0.5%-1.5%. In our experience, this is often the most feared complication for PSC patients, even more so than the risk of liver transplantation. We recommend annual MRI with MRCP in addition to CA 19-9 for patients with PSC in the first decade of their diagnosis, as most cancers are diagnosed during this period. If a patient’s imaging has remained stable for over a decade and there is minimal hepatic fibrosis, we discuss the option of reducing screening frequency to every 2 years to minimize costs and exposure to MRI contrast risks.

If MRI reveals a concerning new large duct stricture, we will evaluate this with an endoscopic retrograde cholangiopancreatography (ERCP), as differentiating benign and malignant strictures is quite challenging with MRI. We generally recommend ERCP with brush cytology and fluorescence in situ hybridization to improve diagnostic yield. Depending on imaging findings and location of the new large duct stricture, we may consider cholangioscopy during ERCP for direct visualization of the bile duct and directed tissue biopsies. Unfortunately, even in young, asymptomatic patients who undergo regular screening, cholangiocarcinoma is frequently diagnosed at an advanced stage.
 

Screening in Patients with Secondary Sclerosing Cholangitis

Patients with SSC may develop cholangiocarcinoma because of chronic inflammatory and fibrotic processes, such as IgG4-associated cholangiopathy, sarcoidosis, ischemic cholangiopathy, cystic fibrosis, recurrent pyogenic cholangitis, severe sepsis (as recently seen from SARS-CoV-2), surgical complications, or other etiologies. When the condition is reversible, such as with IgG4-associated cholangiopathy, cancer screening may not be necessary. However, when irreversible damage occurs, the cancer risk increases, though it varies by disease type and severity. In most cases, we recommend routine screening for cholangiocarcinoma with MRI and CA 19-9 in this population.

Stanford School of Medicine
Dr. Aparna Goel

Screening in Patients with Biliary Tract Disorders

Biliary tract disorders such as choledochal cysts and Caroli’s disease also harbor an increased risk of cholangiocarcinoma. Choledochal cysts are congenital cystic dilations of the bile duct that have a 10%-30% lifetime risk of malignant transformation to cholangiocarcinoma. Surgical intervention to remove the cyst is often recommended because of this high risk. However, some patients may be unable or unwilling to undergo this surgery or they may have residual cysts. We recommend ongoing screening with MRI and CA 19-9 for these patients. Similarly, Caroli’s disease is a congenital disease associated with intrahepatic and extrahepatic bile duct cysts and associated with a 5%-15% lifetime risk of cholangiocarcinoma. MRI with MRCP and CA 19-9 should be performed routinely for patients with Caroli’s disease and syndrome.

Risks and Challenges in Cholangiocarcinoma Screening

While MRI with MRCP is the gold standard for cholangiocarcinoma screening, its limitations must be carefully considered. One growing concern is the potential for gadolinium retention in the brain, bones, or skin following repeated MRI scans. Though the long-term effects of gadolinium retention are not fully understood, we factor this into screening decisions, particularly for younger patients who may undergo decades of regular imaging.

MRI is not always feasible for certain patients, including those with metal implants, on hemodialysis, or with severe allergic reactions. In such cases, CT or ultrasound may serve as alternatives, though with lower sensitivity for detecting cholangiocarcinoma. Additionally, claustrophobia during MRI can be addressed with sedation, but this underscores the importance of shared decision-making.

From our perspective, cholangiocarcinoma screening in high-risk patients is crucial but not without challenges. Our current screening methods, while essential, are far from perfect, often missing early cancers or leading to unnecessary interventions. Because of these limitations, the window for treatment of localized disease can easily be missed. In our practice, we tailor screening strategies to each patient’s specific needs, weighing the potential benefits against the risks, costs, and the inherent uncertainty of early detection tools. We believe it is essential to involve patients in this decision-making process to provide a balanced, individualized approach that considers both clinical evidence and the personal preferences of each person.

Dr. Kupferman is a gastroenterology fellow at Stanford University School of Medicine in California. Dr. Goel is a transplant hepatologist and a clinical associate professor in gastroenterology & hepatology at Stanford.

References

1. Vithayathil M and Khan SA. J Hepatol. 2022 Dec. doi: 10.1016/j.jhep.2022.07.022.

2. Patel N and Benipal B. Cureus. 2019 Jan. doi: 10.7759/cureus.3962.

Dear colleagues,

As gastroenterologists and endoscopists, we spend significant time preventing and diagnosing GI malignancies. While colorectal and esophageal cancer and their precursor lesions are well known to us, our approach to rarer malignancies is less well defined.

For instance, is it worthwhile screening for pancreatic cancer, and, if so, how should this be done? Likewise, diagnosing cholangiocarcinoma is challenging; how best should one evaluate for this in higher risk populations, such as primary sclerosing cholangitis? And what about the costs, financial and otherwise, associated with screening?

Dr. Gyanprakash A. Ketwaroo


In this issue of Perspectives, Dr. Darshan Kothari and Dr. Daniel Bernstein discuss their approach to pancreatic cancer screening, including who is eligible, the preferred screening modalities, and the barriers to screening. In the accompanying perspective, Dr. Aparna Goel and Dr. Judah Kupferman focus on cholangiocarcinoma screening, identifying high-risk populations and discussing some of the concerns with screening, necessitating shared decision-making.

We welcome your thoughts on this issue. Share with us on X at @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.

An Approach to Pancreatic Cancer Screening

BY DANIEL A. BERNSTEIN, MD, AND DARSHAN KOTHARI, MD

Pancreatic cancer carries a dismal prognosis, now accounting for the third-most cancer-related mortality in the United States. A small proportion of patients are diagnosed at a local stage of disease, with over half found to have metastatic disease at presentation. Given the low overall incidence and lifetime risk in the general population, population-based screening is not justified.

About 10% of cases of pancreas cancer are associated with germ-line mutations and/or with a strong family history of pancreatic cancer. Several academic societies and expert committees now recommend regular screening for pancreatic cancer in patients who are considered high-risk individuals, as they carry a fivefold relative risk for pancreatic cancer. Moreover, studies suggest that screening has the potential to identify early-stage resectable disease and decrease mortality in this patient population.

Duke University
Dr. Daniel Bernstein

Patients who benefit from pancreatic cancer screening are those who carry an increased lifetime risk (in excess of 5%) of pancreatic cancer. High-risk individuals include those with germ-line mutations and/or those with a family history of pancreatic cancer in first-degree relatives. Consensus guidelines by the International Cancer of the Pancreas Screening Consortium and the American Society for Gastrointestinal Endoscopy provide medical centers with detailed recommendations on who and when to start screening.

High-risk individuals fall into three categories:

  • Patients with high-risk germline mutations including: familial atypical multiple mole melanoma syndrome (CDKN2A), hereditary breast and ovarian cancer syndromes (BRCA1, BRCA2, and PALB2), Peutz-Jeghers syndrome (STK11), and hereditary pancreatitis (PRSS1 and SPINK1)
  • Patients with low- to moderate-risk germ-line mutations with at least one first-degree relative with pancreatic cancer: Lynch Syndrome (particularly MLH1 mutation), ataxia-telangiectasia (ATM), or Li-Fraumeni syndrome (p53)
  • Patients with one first-degree relative with pancreatic cancer who in turn has one first-degree relative with pancreatic cancer (eg, a patient’s mother and maternal aunt or a patient’s father and patient’s sister)
 

 

Consistent with established guidelines, we recommend screening for high-risk patients beginning at age 50, or 10 years before the youngest age at which pancreas cancer was diagnosed in an affected relative. Screening is recommended earlier in patients with particularly high risk: at age 40 for patients with CDKN2A and STKI11 mutations and age 40 for patients with PRSS1 mutation or 20 years after the first attack of acute pancreatitis. For patients with a strong family history of pancreas cancer, we recommend comprehensive evaluation by a certified genetic counselor at a high-volume cancer center.

Duke University
Dr. Darshan Kothari

In practice, patients at our institution who are identified as high risk based on the above criteria are referred for an initial consultation at our pancreas center. In most cases, this should occur no sooner than 5 years prior to the recommended starting age for screening. All patients who are identified as high risk should be screened annually for diabetes given the growing evidence base supporting an association between new-onset diabetes and pancreatic cancer.

After an initial visit and discussion of the risks and benefits of screening, most screening protocols start with a baseline endoscopic ultrasound (EUS) and contrast-enhanced magnetic resonance abdomen with magnetic resonance cholangiopancreatography (MRI/MRCP), which will be repeated annually or sooner as the clinical condition warrants. A sooner-interval EUS should be considered for patients already undergoing screening who are newly found to have diabetes.

At our institution, we start with an in-person clinic evaluation followed by EUS. Thereafter, patients undergo MRI/MRCP (synchronized with a same-day clinic visit) alternating with EUS every 6 months to ensure patients are seen twice a year, though there is no specific data to support this approach. Non-diabetics also undergo yearly diabetes screening which will trigger an EUS if patients become diabetic.

We engage in shared decision-making with our high-risk individuals undergoing pancreatic cancer screening and at each visit we review their concurrent medical conditions and suitability to continue screening. We consider discontinuing screening after age 75, at the onset of any life-limiting illness, or after a discussion of risks and benefits if comorbidities lead to a substantial deterioration in a patient’s overall health status.

While a growing body of evidence exists to support the application of pancreatic cancer screening in high-risk individuals, this preventive service remains underutilized. Recent analysis of the screening cohort at our institution showed a demographically homogeneous group of mostly highly educated, high-income White females. These findings are consistent with the patient cohorts described in other pancreatic cancer screening programs and represent only a fraction of people who would qualify for pancreatic cancer screening.

A survey of patients undergoing screening at our institution identified cost, travel, and time associated with pancreatic cancer screening to be frequent challenges to participation. Further studies are needed to fully explore the barriers and psychological burden of pancreas cancer screening in high-risk individuals, and to identify ways to enrich the cohort of patients undergoing screening. This may involve novel methods to identify family members of patients with a new diagnosis of pancreas cancer and increasing health literacy around pancreatic cancer screening among patients and providers.

Pancreatic cancer screening has the potential to identify early-stage disease in patients who are at high risk because of germ-line mutations and/or family history. We recommend that patients engage in pancreatic cancer screening at high-volume centers with well-supported oncology, genetics, and research infrastructure.

Dr. Bernstein is a gastroenterology fellow at Duke University School of Medicine, Durham, North Carolina. Dr. Kothari is an associate professor of medicine in gastroenterology and hepatology at Duke University School of Medicine.

Screening for Cholangiocarcinoma

BY JUDAH KUPFERMAN, MD, AND APARNA GOEL, MD

Cholangiocarcinoma is a rare but aggressive cancer of the bile ducts that poses many diagnostic challenges. Approximately 3% of gastrointestinal cancers are attributed to cholangiocarcinoma, and while the annual incidence of disease in the United States is about 1.26 per 100,000 people, the incidence of intrahepatic disease has been rising considerably.1,2 Screening for cholangiocarcinoma is reserved for high-risk individuals — such as those with primary sclerosing cholangitis (PSC), secondary sclerosing cholangitis (SSC), and biliary tract disorders such as choledochal cysts or Caroli’s disease. The goal is to balance the benefits of early diagnosis with the costs and risks associated with screening, particularly given the limitations of available tools like MRI with cholangiopancreatography (MRCP), which has a sensitivity of 70%-85%. In general, we recommend annual cholangiocarcinoma screening for high-risk individuals with MRI and MRCP as well as with cancer antigen (CA) 19-9. .

Stanford School of Medicine
Dr. Judah Kupferman

Screening in Patients with Primary Sclerosing Cholangitis

The lifetime risk of cholangiocarcinoma in patients with PSC is 10%-15% with an annual risk of 0.5%-1.5%. In our experience, this is often the most feared complication for PSC patients, even more so than the risk of liver transplantation. We recommend annual MRI with MRCP in addition to CA 19-9 for patients with PSC in the first decade of their diagnosis, as most cancers are diagnosed during this period. If a patient’s imaging has remained stable for over a decade and there is minimal hepatic fibrosis, we discuss the option of reducing screening frequency to every 2 years to minimize costs and exposure to MRI contrast risks.

If MRI reveals a concerning new large duct stricture, we will evaluate this with an endoscopic retrograde cholangiopancreatography (ERCP), as differentiating benign and malignant strictures is quite challenging with MRI. We generally recommend ERCP with brush cytology and fluorescence in situ hybridization to improve diagnostic yield. Depending on imaging findings and location of the new large duct stricture, we may consider cholangioscopy during ERCP for direct visualization of the bile duct and directed tissue biopsies. Unfortunately, even in young, asymptomatic patients who undergo regular screening, cholangiocarcinoma is frequently diagnosed at an advanced stage.
 

Screening in Patients with Secondary Sclerosing Cholangitis

Patients with SSC may develop cholangiocarcinoma because of chronic inflammatory and fibrotic processes, such as IgG4-associated cholangiopathy, sarcoidosis, ischemic cholangiopathy, cystic fibrosis, recurrent pyogenic cholangitis, severe sepsis (as recently seen from SARS-CoV-2), surgical complications, or other etiologies. When the condition is reversible, such as with IgG4-associated cholangiopathy, cancer screening may not be necessary. However, when irreversible damage occurs, the cancer risk increases, though it varies by disease type and severity. In most cases, we recommend routine screening for cholangiocarcinoma with MRI and CA 19-9 in this population.

Stanford School of Medicine
Dr. Aparna Goel

Screening in Patients with Biliary Tract Disorders

Biliary tract disorders such as choledochal cysts and Caroli’s disease also harbor an increased risk of cholangiocarcinoma. Choledochal cysts are congenital cystic dilations of the bile duct that have a 10%-30% lifetime risk of malignant transformation to cholangiocarcinoma. Surgical intervention to remove the cyst is often recommended because of this high risk. However, some patients may be unable or unwilling to undergo this surgery or they may have residual cysts. We recommend ongoing screening with MRI and CA 19-9 for these patients. Similarly, Caroli’s disease is a congenital disease associated with intrahepatic and extrahepatic bile duct cysts and associated with a 5%-15% lifetime risk of cholangiocarcinoma. MRI with MRCP and CA 19-9 should be performed routinely for patients with Caroli’s disease and syndrome.

Risks and Challenges in Cholangiocarcinoma Screening

While MRI with MRCP is the gold standard for cholangiocarcinoma screening, its limitations must be carefully considered. One growing concern is the potential for gadolinium retention in the brain, bones, or skin following repeated MRI scans. Though the long-term effects of gadolinium retention are not fully understood, we factor this into screening decisions, particularly for younger patients who may undergo decades of regular imaging.

MRI is not always feasible for certain patients, including those with metal implants, on hemodialysis, or with severe allergic reactions. In such cases, CT or ultrasound may serve as alternatives, though with lower sensitivity for detecting cholangiocarcinoma. Additionally, claustrophobia during MRI can be addressed with sedation, but this underscores the importance of shared decision-making.

From our perspective, cholangiocarcinoma screening in high-risk patients is crucial but not without challenges. Our current screening methods, while essential, are far from perfect, often missing early cancers or leading to unnecessary interventions. Because of these limitations, the window for treatment of localized disease can easily be missed. In our practice, we tailor screening strategies to each patient’s specific needs, weighing the potential benefits against the risks, costs, and the inherent uncertainty of early detection tools. We believe it is essential to involve patients in this decision-making process to provide a balanced, individualized approach that considers both clinical evidence and the personal preferences of each person.

Dr. Kupferman is a gastroenterology fellow at Stanford University School of Medicine in California. Dr. Goel is a transplant hepatologist and a clinical associate professor in gastroenterology & hepatology at Stanford.

References

1. Vithayathil M and Khan SA. J Hepatol. 2022 Dec. doi: 10.1016/j.jhep.2022.07.022.

2. Patel N and Benipal B. Cureus. 2019 Jan. doi: 10.7759/cureus.3962.

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