Conference Coverage

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; P = .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; P = .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; P = .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.

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.

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.

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.

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.

If standard therapies don’t give relief to patients with refractory cough associated with interstitial lung disease, maybe a little poison could do the trick.

Among 41 patients with idiopathic interstitial pneumonia with autoimmune features (IPAFs) who had intractable cough, treatment with the traditional Chinese medicine semen strychni was associated with a significant improvement in patient-reported outcomes, reported Mingwan Su, MD, from Guang’anmen Hospital and the China Academy of Chinese Medical Sciences in Beijing, China.

“Semen strychni is associated with reduction in cough and can be an effective drug therapy for refractory cough in association with IPAFs,” she said in an oral abstract session at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

Semen strychni is derived from the dried seeds of the plant Strychnos nux-vomica L. Its main toxic component is strychnine, the poison said to be favored by legendary mystery writer Agatha Christie.

Semen strychni is a central nervous system agonist that has reported efficacy in the treatment of musculoskeletal and autoimmune conditions, including rheumatoid arthritis, myasthenia gravis, and amyotrophic lateral sclerosis.

The medication also has immunomodulatory properties, Su said, and is thought to have beneficial effects against cough associated with IPAFs by reducing hypersensitivity.
 

Case-Control Study

To test this, Su and colleagues conducted a single-center retrospective study of the effects of semen strychni on 41 patients with IPAF-associated cough who were treated with low-dose oral semen strychni 300 mg/d for 2 weeks. These patients were paired with 41 control individuals matched for age, sex, and disease course. Control individuals received standard of care therapies.

The investigators found that for the primary endpoint of a change in the visual analog scale (VAS) at 2 weeks, there was a significantly greater reduction from baseline among patients treated with semen strychni compared with control individuals, with a baseline mean VAS score of 4.9 reduced to 2.1 at the end of treatment, vs 4.6 pre- to 3.3 post-treatment for control individuals. This difference translated to an odds ratio (OR) favoring semen strychni of 0.75 (P < .001).

In addition, the toxic compound was also associated with greater patient-reported improvement in the quality of life, as measured using the Leicester Cough Questionnaire, a 19-item scale that measures quality of life for people with chronic cough. Patients in the experimental arm had mean scores of 11.9 before treatment and 19 at the end of therapy compared with 12 and 15.1 points, respectively, among individuals in the control arm. This translated to an OR of 3.8 (P < .001) for patients on semen strychni.

The toxin appeared to be generally safe. There were no reported cases of pain, fainting, or bleeding in either study group, although there was one case of muscle twitching in the semen strychni group, Su reported.

There is evidence to suggest that semen strychni may have a calming effect on cough through action in the STAT3 pathway, considered to be a promising therapeutic target for musculoskeletal conditions, Su noted.
 

Not Ready for Prime Time

“My feeling is that these kinds of abstracts are welcome, but this is far from reality at this point,” said Vijay Balasubramanian, MD, clinical professor of medicine and director of the Pulmonary Hypertension Program at the University of California San Francisco.

“We need some kind of a regulated way of understanding dose characteristics and pharmacokinetics, and so it should be followed by more systematic studies,” he said in an interview.

Both Balasubramanian and his co-moderator Andrew R. Berman, MD, director of the Division of Pulmonary and Critical Care Medicine and Allergy and Rheumatology at Rutgers Health New Jersey Medical School in Newark, New Jersey, said that they sympathize with clinicians and their patients who seek out unusual therapies such as semen strychni.

“It’s very frustrating to treat chronic cough, especially associated with fibrotic lung disease, and the extent to which researchers will go to find that one product that perhaps can make a difference is understandable,” Berman told this news organization.

Su did not report a study funding source. Su, Balasubramanian, and Berman reported no relevant financial relationships.

 

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

If standard therapies don’t give relief to patients with refractory cough associated with interstitial lung disease, maybe a little poison could do the trick.

Among 41 patients with idiopathic interstitial pneumonia with autoimmune features (IPAFs) who had intractable cough, treatment with the traditional Chinese medicine semen strychni was associated with a significant improvement in patient-reported outcomes, reported Mingwan Su, MD, from Guang’anmen Hospital and the China Academy of Chinese Medical Sciences in Beijing, China.

“Semen strychni is associated with reduction in cough and can be an effective drug therapy for refractory cough in association with IPAFs,” she said in an oral abstract session at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

Semen strychni is derived from the dried seeds of the plant Strychnos nux-vomica L. Its main toxic component is strychnine, the poison said to be favored by legendary mystery writer Agatha Christie.

Semen strychni is a central nervous system agonist that has reported efficacy in the treatment of musculoskeletal and autoimmune conditions, including rheumatoid arthritis, myasthenia gravis, and amyotrophic lateral sclerosis.

The medication also has immunomodulatory properties, Su said, and is thought to have beneficial effects against cough associated with IPAFs by reducing hypersensitivity.
 

Case-Control Study

To test this, Su and colleagues conducted a single-center retrospective study of the effects of semen strychni on 41 patients with IPAF-associated cough who were treated with low-dose oral semen strychni 300 mg/d for 2 weeks. These patients were paired with 41 control individuals matched for age, sex, and disease course. Control individuals received standard of care therapies.

The investigators found that for the primary endpoint of a change in the visual analog scale (VAS) at 2 weeks, there was a significantly greater reduction from baseline among patients treated with semen strychni compared with control individuals, with a baseline mean VAS score of 4.9 reduced to 2.1 at the end of treatment, vs 4.6 pre- to 3.3 post-treatment for control individuals. This difference translated to an odds ratio (OR) favoring semen strychni of 0.75 (P < .001).

In addition, the toxic compound was also associated with greater patient-reported improvement in the quality of life, as measured using the Leicester Cough Questionnaire, a 19-item scale that measures quality of life for people with chronic cough. Patients in the experimental arm had mean scores of 11.9 before treatment and 19 at the end of therapy compared with 12 and 15.1 points, respectively, among individuals in the control arm. This translated to an OR of 3.8 (P < .001) for patients on semen strychni.

The toxin appeared to be generally safe. There were no reported cases of pain, fainting, or bleeding in either study group, although there was one case of muscle twitching in the semen strychni group, Su reported.

There is evidence to suggest that semen strychni may have a calming effect on cough through action in the STAT3 pathway, considered to be a promising therapeutic target for musculoskeletal conditions, Su noted.
 

Not Ready for Prime Time

“My feeling is that these kinds of abstracts are welcome, but this is far from reality at this point,” said Vijay Balasubramanian, MD, clinical professor of medicine and director of the Pulmonary Hypertension Program at the University of California San Francisco.

“We need some kind of a regulated way of understanding dose characteristics and pharmacokinetics, and so it should be followed by more systematic studies,” he said in an interview.

Both Balasubramanian and his co-moderator Andrew R. Berman, MD, director of the Division of Pulmonary and Critical Care Medicine and Allergy and Rheumatology at Rutgers Health New Jersey Medical School in Newark, New Jersey, said that they sympathize with clinicians and their patients who seek out unusual therapies such as semen strychni.

“It’s very frustrating to treat chronic cough, especially associated with fibrotic lung disease, and the extent to which researchers will go to find that one product that perhaps can make a difference is understandable,” Berman told this news organization.

Su did not report a study funding source. Su, Balasubramanian, and Berman reported no relevant financial relationships.

 

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

If standard therapies don’t give relief to patients with refractory cough associated with interstitial lung disease, maybe a little poison could do the trick.

Among 41 patients with idiopathic interstitial pneumonia with autoimmune features (IPAFs) who had intractable cough, treatment with the traditional Chinese medicine semen strychni was associated with a significant improvement in patient-reported outcomes, reported Mingwan Su, MD, from Guang’anmen Hospital and the China Academy of Chinese Medical Sciences in Beijing, China.

“Semen strychni is associated with reduction in cough and can be an effective drug therapy for refractory cough in association with IPAFs,” she said in an oral abstract session at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

Semen strychni is derived from the dried seeds of the plant Strychnos nux-vomica L. Its main toxic component is strychnine, the poison said to be favored by legendary mystery writer Agatha Christie.

Semen strychni is a central nervous system agonist that has reported efficacy in the treatment of musculoskeletal and autoimmune conditions, including rheumatoid arthritis, myasthenia gravis, and amyotrophic lateral sclerosis.

The medication also has immunomodulatory properties, Su said, and is thought to have beneficial effects against cough associated with IPAFs by reducing hypersensitivity.
 

Case-Control Study

To test this, Su and colleagues conducted a single-center retrospective study of the effects of semen strychni on 41 patients with IPAF-associated cough who were treated with low-dose oral semen strychni 300 mg/d for 2 weeks. These patients were paired with 41 control individuals matched for age, sex, and disease course. Control individuals received standard of care therapies.

The investigators found that for the primary endpoint of a change in the visual analog scale (VAS) at 2 weeks, there was a significantly greater reduction from baseline among patients treated with semen strychni compared with control individuals, with a baseline mean VAS score of 4.9 reduced to 2.1 at the end of treatment, vs 4.6 pre- to 3.3 post-treatment for control individuals. This difference translated to an odds ratio (OR) favoring semen strychni of 0.75 (P < .001).

In addition, the toxic compound was also associated with greater patient-reported improvement in the quality of life, as measured using the Leicester Cough Questionnaire, a 19-item scale that measures quality of life for people with chronic cough. Patients in the experimental arm had mean scores of 11.9 before treatment and 19 at the end of therapy compared with 12 and 15.1 points, respectively, among individuals in the control arm. This translated to an OR of 3.8 (P < .001) for patients on semen strychni.

The toxin appeared to be generally safe. There were no reported cases of pain, fainting, or bleeding in either study group, although there was one case of muscle twitching in the semen strychni group, Su reported.

There is evidence to suggest that semen strychni may have a calming effect on cough through action in the STAT3 pathway, considered to be a promising therapeutic target for musculoskeletal conditions, Su noted.
 

Not Ready for Prime Time

“My feeling is that these kinds of abstracts are welcome, but this is far from reality at this point,” said Vijay Balasubramanian, MD, clinical professor of medicine and director of the Pulmonary Hypertension Program at the University of California San Francisco.

“We need some kind of a regulated way of understanding dose characteristics and pharmacokinetics, and so it should be followed by more systematic studies,” he said in an interview.

Both Balasubramanian and his co-moderator Andrew R. Berman, MD, director of the Division of Pulmonary and Critical Care Medicine and Allergy and Rheumatology at Rutgers Health New Jersey Medical School in Newark, New Jersey, said that they sympathize with clinicians and their patients who seek out unusual therapies such as semen strychni.

“It’s very frustrating to treat chronic cough, especially associated with fibrotic lung disease, and the extent to which researchers will go to find that one product that perhaps can make a difference is understandable,” Berman told this news organization.

Su did not report a study funding source. Su, Balasubramanian, and Berman reported no relevant financial relationships.

 

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

PHILADELPHIA — Low-volume bowel preparation is noninferior in adequacy to standard-volume prep in hospitalized patients undergoing colonoscopy, according to a study presented at the annual meeting of the American College of Gastroenterology (ACG).

Patients who received MoviPrep (2L of polyethylene glycol and ascorbic acid) reported higher tolerability and willingness to repeat colonoscopy preparation in the future than those taking GoLYTELY (4L of polyethylene glycol and electrolytes). In addition, the rates of electrolyte abnormalities and acute kidney injury were low and similar between the two groups.

Yale School of Medicine

“Bowel preparation remains a challenge in the inpatient setting, where 20%-50% of all colonoscopies can have inadequate bowel preparation,” said lead author Karen Xiao, MD, assistant professor in the section of digestive diseases at Yale School of Medicine, New Haven, Connecticut.

Previous studies have indicated that low-volume (2L), split-dose preparations are noninferior to high-volume (4L), split-dose regimens, and patients generally prefer low-volume options, she said. However, the current standard of care for inpatients continues to include high-volume polyethylene glycol electrocyte lavage, which may be less tolerable.

“Similar to prior studies, our study supports that MoviPrep may be a suitable alternative to traditional high-volume bowel preparation in hospitalized patients undergoing colonoscopy,” she said.

In a single-blind, multi-site, randomized controlled trial, Xiao and colleagues in the Yale–New Haven Health System randomly assigned inpatients undergoing colonoscopy to MoviPrep or GoLYTELY between January 2022 and July 2024. They excluded patients with prior small or large bowel resection, foreign body removal, or medical contraindications, such as obstruction, pregnancy, phenylketonuria, or glucose-6-phosphate dehydrogenase deficiency.

After bowel prep but before colonoscopy, patients took the Mayo Clinic Bowel Preparation survey. Colonoscopies were then recorded, and videos were scored by a single-blinded central reviewer. The primary outcome included the adequacy of bowel prep as defined by a Boston Bowel Preparation Scale score of 6 or higher, with each segment scoring 2 or higher.

In the final analysis, 202 patients received MoviPrep and 210 received GoLYTELY. In both groups, the average age was 62; about 60% were men; and 66% were White, about 22% Black, and 13%-15% Hispanic. About 65% of patients in both arms had an American Society of Anesthesiologists (ASA) score of 3, with another 20% in each group having an ASA score of 4, “reflective of a sicker inpatient population,” Xiao said.

Inpatient colonoscopy was indicated for gastrointestinal bleeding (55%), diarrhea (15%-20%), abnormal imaging (10%-13%), inflammatory bowel disease (4%), or other (35%-41%). Patients could have more than one indication for colonoscopy.

Overall, bowel preparation was scored as adequate in 111 patients with MoviPrep (55%) and 111 patients with GoLYTELY (52.9%), and was inadequate in 91 patients with MoviPrep (45%) and 99 patients with GoLYTELY (47.1%). With a rate difference of 2.1% and a P value of .007, MoviPrep was considered noninferior to GoLYTELY for adequate bowel preparation.

In terms of secondary outcomes, there wasn’t a significant difference in the length of hospital stay, with a median stay of 6 days. Similarly, there were no differences in the rates of adverse events, including acute kidney injury and electrolyte abnormalities, with rates ranging from 1% to 9%. MoviPrep patients were slightly more likely to need additional bowel prep but also had a slightly shorter time to colonoscopy.
 

Ease of Use Is a Plus

On the basis of the Mayo Clinic Bowel Preparation survey, there wasn’t a difference between the groups in how much bowel prep solution was left in the bottle. However, more than twice as many patients who took MoviPrep said the prep was “easy,” and more MoviPrep patients called it “acceptable,” whereas more GoLYTELY patients said prep was “somewhat difficult” or “very difficult.”

In addition, significantly more MoviPrep patients (49.7% vs 33.7%) said they were “mostly willing” to drink the same prep again if they needed another colonoscopy in the future, while more GoLYTELY patients said they were “somewhat willing” (44.7% vs 34.6%) or “not willing at all” (21.6% vs 15.7%).

“Bowel prep, particularly in hospitals, is important because we do it so often. When you think about what our patients in the hospital are going through, they’re very sick and often have multiple comorbidities, so how can we give them a bowel prep that is safe for them, easiest for them, easy for our nursing staff who are experiencing shortages, and as good as the traditional bowel prep,” said the session’s moderator, Amy Oxentenko, MD, AGAF, professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota.

Mayo Clinic

“Here we’ve seen great data that we can provide half the volume of the prep, still get amazing results in terms of adequacy of preparation, and the patients had a better experience,” said Oxentenko, the incoming ACG president. “That’s important because they likely may need another colonoscopy in the future, and we would hate for the bowel prep in the hospital to potentially dissuade them from a future colonoscopy.”

Future studies could stratify patients on the basis of colonoscopy indication or patient history, including conditions such as chronic constipation or neurogenic bowel, where some patients may still need a high-volume prep, Oxentenko said.

“Also, in the hospital setting, we don’t always know when a patient is going to the endoscopy suite due to other patient cases that may get prolonged or pushed in,” she said. “So how do you time the second dose of the split dose in anticipation of when that patient will go to the endoscopy suite to maintain that great preparation with a smaller volume prep?”

The study was awarded the ACG Governors Award for Excellence in Clinical Research (Trainee). Xiao and Oxentenko reported no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Low-volume bowel preparation is noninferior in adequacy to standard-volume prep in hospitalized patients undergoing colonoscopy, according to a study presented at the annual meeting of the American College of Gastroenterology (ACG).

Patients who received MoviPrep (2L of polyethylene glycol and ascorbic acid) reported higher tolerability and willingness to repeat colonoscopy preparation in the future than those taking GoLYTELY (4L of polyethylene glycol and electrolytes). In addition, the rates of electrolyte abnormalities and acute kidney injury were low and similar between the two groups.

Yale School of Medicine

“Bowel preparation remains a challenge in the inpatient setting, where 20%-50% of all colonoscopies can have inadequate bowel preparation,” said lead author Karen Xiao, MD, assistant professor in the section of digestive diseases at Yale School of Medicine, New Haven, Connecticut.

Previous studies have indicated that low-volume (2L), split-dose preparations are noninferior to high-volume (4L), split-dose regimens, and patients generally prefer low-volume options, she said. However, the current standard of care for inpatients continues to include high-volume polyethylene glycol electrocyte lavage, which may be less tolerable.

“Similar to prior studies, our study supports that MoviPrep may be a suitable alternative to traditional high-volume bowel preparation in hospitalized patients undergoing colonoscopy,” she said.

In a single-blind, multi-site, randomized controlled trial, Xiao and colleagues in the Yale–New Haven Health System randomly assigned inpatients undergoing colonoscopy to MoviPrep or GoLYTELY between January 2022 and July 2024. They excluded patients with prior small or large bowel resection, foreign body removal, or medical contraindications, such as obstruction, pregnancy, phenylketonuria, or glucose-6-phosphate dehydrogenase deficiency.

After bowel prep but before colonoscopy, patients took the Mayo Clinic Bowel Preparation survey. Colonoscopies were then recorded, and videos were scored by a single-blinded central reviewer. The primary outcome included the adequacy of bowel prep as defined by a Boston Bowel Preparation Scale score of 6 or higher, with each segment scoring 2 or higher.

In the final analysis, 202 patients received MoviPrep and 210 received GoLYTELY. In both groups, the average age was 62; about 60% were men; and 66% were White, about 22% Black, and 13%-15% Hispanic. About 65% of patients in both arms had an American Society of Anesthesiologists (ASA) score of 3, with another 20% in each group having an ASA score of 4, “reflective of a sicker inpatient population,” Xiao said.

Inpatient colonoscopy was indicated for gastrointestinal bleeding (55%), diarrhea (15%-20%), abnormal imaging (10%-13%), inflammatory bowel disease (4%), or other (35%-41%). Patients could have more than one indication for colonoscopy.

Overall, bowel preparation was scored as adequate in 111 patients with MoviPrep (55%) and 111 patients with GoLYTELY (52.9%), and was inadequate in 91 patients with MoviPrep (45%) and 99 patients with GoLYTELY (47.1%). With a rate difference of 2.1% and a P value of .007, MoviPrep was considered noninferior to GoLYTELY for adequate bowel preparation.

In terms of secondary outcomes, there wasn’t a significant difference in the length of hospital stay, with a median stay of 6 days. Similarly, there were no differences in the rates of adverse events, including acute kidney injury and electrolyte abnormalities, with rates ranging from 1% to 9%. MoviPrep patients were slightly more likely to need additional bowel prep but also had a slightly shorter time to colonoscopy.
 

Ease of Use Is a Plus

On the basis of the Mayo Clinic Bowel Preparation survey, there wasn’t a difference between the groups in how much bowel prep solution was left in the bottle. However, more than twice as many patients who took MoviPrep said the prep was “easy,” and more MoviPrep patients called it “acceptable,” whereas more GoLYTELY patients said prep was “somewhat difficult” or “very difficult.”

In addition, significantly more MoviPrep patients (49.7% vs 33.7%) said they were “mostly willing” to drink the same prep again if they needed another colonoscopy in the future, while more GoLYTELY patients said they were “somewhat willing” (44.7% vs 34.6%) or “not willing at all” (21.6% vs 15.7%).

“Bowel prep, particularly in hospitals, is important because we do it so often. When you think about what our patients in the hospital are going through, they’re very sick and often have multiple comorbidities, so how can we give them a bowel prep that is safe for them, easiest for them, easy for our nursing staff who are experiencing shortages, and as good as the traditional bowel prep,” said the session’s moderator, Amy Oxentenko, MD, AGAF, professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota.

Mayo Clinic

“Here we’ve seen great data that we can provide half the volume of the prep, still get amazing results in terms of adequacy of preparation, and the patients had a better experience,” said Oxentenko, the incoming ACG president. “That’s important because they likely may need another colonoscopy in the future, and we would hate for the bowel prep in the hospital to potentially dissuade them from a future colonoscopy.”

Future studies could stratify patients on the basis of colonoscopy indication or patient history, including conditions such as chronic constipation or neurogenic bowel, where some patients may still need a high-volume prep, Oxentenko said.

“Also, in the hospital setting, we don’t always know when a patient is going to the endoscopy suite due to other patient cases that may get prolonged or pushed in,” she said. “So how do you time the second dose of the split dose in anticipation of when that patient will go to the endoscopy suite to maintain that great preparation with a smaller volume prep?”

The study was awarded the ACG Governors Award for Excellence in Clinical Research (Trainee). Xiao and Oxentenko reported no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Low-volume bowel preparation is noninferior in adequacy to standard-volume prep in hospitalized patients undergoing colonoscopy, according to a study presented at the annual meeting of the American College of Gastroenterology (ACG).

Patients who received MoviPrep (2L of polyethylene glycol and ascorbic acid) reported higher tolerability and willingness to repeat colonoscopy preparation in the future than those taking GoLYTELY (4L of polyethylene glycol and electrolytes). In addition, the rates of electrolyte abnormalities and acute kidney injury were low and similar between the two groups.

Yale School of Medicine

“Bowel preparation remains a challenge in the inpatient setting, where 20%-50% of all colonoscopies can have inadequate bowel preparation,” said lead author Karen Xiao, MD, assistant professor in the section of digestive diseases at Yale School of Medicine, New Haven, Connecticut.

Previous studies have indicated that low-volume (2L), split-dose preparations are noninferior to high-volume (4L), split-dose regimens, and patients generally prefer low-volume options, she said. However, the current standard of care for inpatients continues to include high-volume polyethylene glycol electrocyte lavage, which may be less tolerable.

“Similar to prior studies, our study supports that MoviPrep may be a suitable alternative to traditional high-volume bowel preparation in hospitalized patients undergoing colonoscopy,” she said.

In a single-blind, multi-site, randomized controlled trial, Xiao and colleagues in the Yale–New Haven Health System randomly assigned inpatients undergoing colonoscopy to MoviPrep or GoLYTELY between January 2022 and July 2024. They excluded patients with prior small or large bowel resection, foreign body removal, or medical contraindications, such as obstruction, pregnancy, phenylketonuria, or glucose-6-phosphate dehydrogenase deficiency.

After bowel prep but before colonoscopy, patients took the Mayo Clinic Bowel Preparation survey. Colonoscopies were then recorded, and videos were scored by a single-blinded central reviewer. The primary outcome included the adequacy of bowel prep as defined by a Boston Bowel Preparation Scale score of 6 or higher, with each segment scoring 2 or higher.

In the final analysis, 202 patients received MoviPrep and 210 received GoLYTELY. In both groups, the average age was 62; about 60% were men; and 66% were White, about 22% Black, and 13%-15% Hispanic. About 65% of patients in both arms had an American Society of Anesthesiologists (ASA) score of 3, with another 20% in each group having an ASA score of 4, “reflective of a sicker inpatient population,” Xiao said.

Inpatient colonoscopy was indicated for gastrointestinal bleeding (55%), diarrhea (15%-20%), abnormal imaging (10%-13%), inflammatory bowel disease (4%), or other (35%-41%). Patients could have more than one indication for colonoscopy.

Overall, bowel preparation was scored as adequate in 111 patients with MoviPrep (55%) and 111 patients with GoLYTELY (52.9%), and was inadequate in 91 patients with MoviPrep (45%) and 99 patients with GoLYTELY (47.1%). With a rate difference of 2.1% and a P value of .007, MoviPrep was considered noninferior to GoLYTELY for adequate bowel preparation.

In terms of secondary outcomes, there wasn’t a significant difference in the length of hospital stay, with a median stay of 6 days. Similarly, there were no differences in the rates of adverse events, including acute kidney injury and electrolyte abnormalities, with rates ranging from 1% to 9%. MoviPrep patients were slightly more likely to need additional bowel prep but also had a slightly shorter time to colonoscopy.
 

Ease of Use Is a Plus

On the basis of the Mayo Clinic Bowel Preparation survey, there wasn’t a difference between the groups in how much bowel prep solution was left in the bottle. However, more than twice as many patients who took MoviPrep said the prep was “easy,” and more MoviPrep patients called it “acceptable,” whereas more GoLYTELY patients said prep was “somewhat difficult” or “very difficult.”

In addition, significantly more MoviPrep patients (49.7% vs 33.7%) said they were “mostly willing” to drink the same prep again if they needed another colonoscopy in the future, while more GoLYTELY patients said they were “somewhat willing” (44.7% vs 34.6%) or “not willing at all” (21.6% vs 15.7%).

“Bowel prep, particularly in hospitals, is important because we do it so often. When you think about what our patients in the hospital are going through, they’re very sick and often have multiple comorbidities, so how can we give them a bowel prep that is safe for them, easiest for them, easy for our nursing staff who are experiencing shortages, and as good as the traditional bowel prep,” said the session’s moderator, Amy Oxentenko, MD, AGAF, professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota.

Mayo Clinic

“Here we’ve seen great data that we can provide half the volume of the prep, still get amazing results in terms of adequacy of preparation, and the patients had a better experience,” said Oxentenko, the incoming ACG president. “That’s important because they likely may need another colonoscopy in the future, and we would hate for the bowel prep in the hospital to potentially dissuade them from a future colonoscopy.”

Future studies could stratify patients on the basis of colonoscopy indication or patient history, including conditions such as chronic constipation or neurogenic bowel, where some patients may still need a high-volume prep, Oxentenko said.

“Also, in the hospital setting, we don’t always know when a patient is going to the endoscopy suite due to other patient cases that may get prolonged or pushed in,” she said. “So how do you time the second dose of the split dose in anticipation of when that patient will go to the endoscopy suite to maintain that great preparation with a smaller volume prep?”

The study was awarded the ACG Governors Award for Excellence in Clinical Research (Trainee). Xiao and Oxentenko reported no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Non-fasting breath gas patterns may help identify patients with irritable bowel syndrome (IBS) who are most likely to respond to a low fermentable oligo-, di-, monosaccharides and polyols (FODMAP) diet, according to a new study.

The low FODMAP diet is the most evidence-based dietary therapy for patients with IBS, but we know that “only about 50% of our patients respond to it,” said principal investigator Prashant Singh, MD, assistant professor at the University of Michigan in Ann Arbor, Michigan. “Exhaled breath gases represent bacterial fermentation of dietary carbohydrates. These measurements could provide a simple biomarker for response to low FODMAP diets.”

Even before starting the low FODMAP diet, “you could see notable differences in breath test patterns between responders and nonresponders,” he said. “We saw that low FODMAP responders had higher hydrogen (H2) and lower methane (CH4) at baseline than nonresponders and had a greater drop in hydrogen following FODMAP restriction vs nonresponders.”

He added that these results imply that responders to this diet may exhibit differences in baseline microbiota composition regarding saccharolytic capacity and/or methanogens. 

Singh presented the findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 
 

Breaths That Can Predict Response

To determine if pre-intervention non-fasting breath patterns are associated with a clinical response to low FODMAP diets, Singh and colleagues enrolled 284 self-selected participants (mean age, 45.2 years) with mild to moderate gastrointestinal (GI) symptoms. Participants used an app-connected breath analyzer to record hourly, non-fasting H2 and CH4 levels during waking hours, in addition to logging meal content and symptom severity (bloating, abdominal pain, and flatulence) on a 0-10 scale. 

Patients were directed to consume their habitual diet for 1 week, before following an app-directed low FODMAP diet for 1 week. Responders were defined as those with a ≥ 30% reduction in at least one mean symptom score. The researchers then compared average hourly H2 and CH4 levels and symptom scores at baseline between low FODMAP diet responders and nonresponders.

Of the participants, 111 were classified as responders and 173 as nonresponders. There were no significant differences between the groups in gender, age, body mass index, or FODMAP per calorie.

Following FODMAP restriction, responders had consistently lower abdominal pain throughout the day and lower bloating and flatulence predominantly in the latter part of the day. Nonresponders experienced no significant changes in key abdominal symptoms after adopting the low FODMAP diet. 

The researchers found that breath tests taken at baseline revealed predictive trends between the groups, even though average FODMAP consumption did not significantly differ between them. Baseline H2 levels were higher among responders than among nonresponders, especially in the morning and evening. However, responders had lower baseline CH4 levels throughout the day. 

Following FODMAP restrictions, responders had a significant drop in non-fasting H2 but not CH4, whereas nonresponders did not have a significant drop in either.

The study was limited by the fact that participants were not clinically diagnosed with IBS, their GI symptoms were mild overall, and no data were available on stool consistency/frequency or fecal microbiome composition for correlation with exhaled breath gas levels.
 

A Potential New Biomarker

Session co-moderator Kyle Staller, MD, MPH, director of the Gastrointestinal Motility Laboratory at Mass General and associate professor of medicine at Harvard Medical School in Boston, Massachusetts, said in an interview that if validated, these findings provide hope for better directing low FODMAP diets to those patients who may benefit. 

Massachusetts General Hospital

There are some patients who may or may not respond to a FODMAP diet, for reasons we don’t yet know, possibly related to fermentation of gas, and it’s helpful to know before starting treatment, he said. It may help us with more of “a precision medicine approach before we really torture people with diets that can be very difficult to adhere to.” 

Staller, who was not involved in the study, added that, “People tend to really focus on small intestinal bacteria overgrowth when it comes to hydrogen and methane production, but in reality, this is really a very agile day-to-day, meal-to-meal responsiveness. 

“It’s a different paradigm,” he continued. “I’d also like to see more data as to why we see the diurnal rhythm” and whether potential factors such as intestinal transit times are playing a role. 

Singh reported receiving royalties from UpToDate. Staller reported receiving research support from Ardelyx and Restasis and serving as a consultant to Anji, Ardelyx, GI Supply, Mahana, Restasis, and Sanofi. Funding associated with the study was not available at the time of publication.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Non-fasting breath gas patterns may help identify patients with irritable bowel syndrome (IBS) who are most likely to respond to a low fermentable oligo-, di-, monosaccharides and polyols (FODMAP) diet, according to a new study.

The low FODMAP diet is the most evidence-based dietary therapy for patients with IBS, but we know that “only about 50% of our patients respond to it,” said principal investigator Prashant Singh, MD, assistant professor at the University of Michigan in Ann Arbor, Michigan. “Exhaled breath gases represent bacterial fermentation of dietary carbohydrates. These measurements could provide a simple biomarker for response to low FODMAP diets.”

Even before starting the low FODMAP diet, “you could see notable differences in breath test patterns between responders and nonresponders,” he said. “We saw that low FODMAP responders had higher hydrogen (H2) and lower methane (CH4) at baseline than nonresponders and had a greater drop in hydrogen following FODMAP restriction vs nonresponders.”

He added that these results imply that responders to this diet may exhibit differences in baseline microbiota composition regarding saccharolytic capacity and/or methanogens. 

Singh presented the findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 
 

Breaths That Can Predict Response

To determine if pre-intervention non-fasting breath patterns are associated with a clinical response to low FODMAP diets, Singh and colleagues enrolled 284 self-selected participants (mean age, 45.2 years) with mild to moderate gastrointestinal (GI) symptoms. Participants used an app-connected breath analyzer to record hourly, non-fasting H2 and CH4 levels during waking hours, in addition to logging meal content and symptom severity (bloating, abdominal pain, and flatulence) on a 0-10 scale. 

Patients were directed to consume their habitual diet for 1 week, before following an app-directed low FODMAP diet for 1 week. Responders were defined as those with a ≥ 30% reduction in at least one mean symptom score. The researchers then compared average hourly H2 and CH4 levels and symptom scores at baseline between low FODMAP diet responders and nonresponders.

Of the participants, 111 were classified as responders and 173 as nonresponders. There were no significant differences between the groups in gender, age, body mass index, or FODMAP per calorie.

Following FODMAP restriction, responders had consistently lower abdominal pain throughout the day and lower bloating and flatulence predominantly in the latter part of the day. Nonresponders experienced no significant changes in key abdominal symptoms after adopting the low FODMAP diet. 

The researchers found that breath tests taken at baseline revealed predictive trends between the groups, even though average FODMAP consumption did not significantly differ between them. Baseline H2 levels were higher among responders than among nonresponders, especially in the morning and evening. However, responders had lower baseline CH4 levels throughout the day. 

Following FODMAP restrictions, responders had a significant drop in non-fasting H2 but not CH4, whereas nonresponders did not have a significant drop in either.

The study was limited by the fact that participants were not clinically diagnosed with IBS, their GI symptoms were mild overall, and no data were available on stool consistency/frequency or fecal microbiome composition for correlation with exhaled breath gas levels.
 

A Potential New Biomarker

Session co-moderator Kyle Staller, MD, MPH, director of the Gastrointestinal Motility Laboratory at Mass General and associate professor of medicine at Harvard Medical School in Boston, Massachusetts, said in an interview that if validated, these findings provide hope for better directing low FODMAP diets to those patients who may benefit. 

Massachusetts General Hospital

There are some patients who may or may not respond to a FODMAP diet, for reasons we don’t yet know, possibly related to fermentation of gas, and it’s helpful to know before starting treatment, he said. It may help us with more of “a precision medicine approach before we really torture people with diets that can be very difficult to adhere to.” 

Staller, who was not involved in the study, added that, “People tend to really focus on small intestinal bacteria overgrowth when it comes to hydrogen and methane production, but in reality, this is really a very agile day-to-day, meal-to-meal responsiveness. 

“It’s a different paradigm,” he continued. “I’d also like to see more data as to why we see the diurnal rhythm” and whether potential factors such as intestinal transit times are playing a role. 

Singh reported receiving royalties from UpToDate. Staller reported receiving research support from Ardelyx and Restasis and serving as a consultant to Anji, Ardelyx, GI Supply, Mahana, Restasis, and Sanofi. Funding associated with the study was not available at the time of publication.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Non-fasting breath gas patterns may help identify patients with irritable bowel syndrome (IBS) who are most likely to respond to a low fermentable oligo-, di-, monosaccharides and polyols (FODMAP) diet, according to a new study.

The low FODMAP diet is the most evidence-based dietary therapy for patients with IBS, but we know that “only about 50% of our patients respond to it,” said principal investigator Prashant Singh, MD, assistant professor at the University of Michigan in Ann Arbor, Michigan. “Exhaled breath gases represent bacterial fermentation of dietary carbohydrates. These measurements could provide a simple biomarker for response to low FODMAP diets.”

Even before starting the low FODMAP diet, “you could see notable differences in breath test patterns between responders and nonresponders,” he said. “We saw that low FODMAP responders had higher hydrogen (H2) and lower methane (CH4) at baseline than nonresponders and had a greater drop in hydrogen following FODMAP restriction vs nonresponders.”

He added that these results imply that responders to this diet may exhibit differences in baseline microbiota composition regarding saccharolytic capacity and/or methanogens. 

Singh presented the findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 
 

Breaths That Can Predict Response

To determine if pre-intervention non-fasting breath patterns are associated with a clinical response to low FODMAP diets, Singh and colleagues enrolled 284 self-selected participants (mean age, 45.2 years) with mild to moderate gastrointestinal (GI) symptoms. Participants used an app-connected breath analyzer to record hourly, non-fasting H2 and CH4 levels during waking hours, in addition to logging meal content and symptom severity (bloating, abdominal pain, and flatulence) on a 0-10 scale. 

Patients were directed to consume their habitual diet for 1 week, before following an app-directed low FODMAP diet for 1 week. Responders were defined as those with a ≥ 30% reduction in at least one mean symptom score. The researchers then compared average hourly H2 and CH4 levels and symptom scores at baseline between low FODMAP diet responders and nonresponders.

Of the participants, 111 were classified as responders and 173 as nonresponders. There were no significant differences between the groups in gender, age, body mass index, or FODMAP per calorie.

Following FODMAP restriction, responders had consistently lower abdominal pain throughout the day and lower bloating and flatulence predominantly in the latter part of the day. Nonresponders experienced no significant changes in key abdominal symptoms after adopting the low FODMAP diet. 

The researchers found that breath tests taken at baseline revealed predictive trends between the groups, even though average FODMAP consumption did not significantly differ between them. Baseline H2 levels were higher among responders than among nonresponders, especially in the morning and evening. However, responders had lower baseline CH4 levels throughout the day. 

Following FODMAP restrictions, responders had a significant drop in non-fasting H2 but not CH4, whereas nonresponders did not have a significant drop in either.

The study was limited by the fact that participants were not clinically diagnosed with IBS, their GI symptoms were mild overall, and no data were available on stool consistency/frequency or fecal microbiome composition for correlation with exhaled breath gas levels.
 

A Potential New Biomarker

Session co-moderator Kyle Staller, MD, MPH, director of the Gastrointestinal Motility Laboratory at Mass General and associate professor of medicine at Harvard Medical School in Boston, Massachusetts, said in an interview that if validated, these findings provide hope for better directing low FODMAP diets to those patients who may benefit. 

Massachusetts General Hospital

There are some patients who may or may not respond to a FODMAP diet, for reasons we don’t yet know, possibly related to fermentation of gas, and it’s helpful to know before starting treatment, he said. It may help us with more of “a precision medicine approach before we really torture people with diets that can be very difficult to adhere to.” 

Staller, who was not involved in the study, added that, “People tend to really focus on small intestinal bacteria overgrowth when it comes to hydrogen and methane production, but in reality, this is really a very agile day-to-day, meal-to-meal responsiveness. 

“It’s a different paradigm,” he continued. “I’d also like to see more data as to why we see the diurnal rhythm” and whether potential factors such as intestinal transit times are playing a role. 

Singh reported receiving royalties from UpToDate. Staller reported receiving research support from Ardelyx and Restasis and serving as a consultant to Anji, Ardelyx, GI Supply, Mahana, Restasis, and Sanofi. Funding associated with the study was not available at the time of publication.

A version of this article appeared on Medscape.com.

PHILADELPHIA — The use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) is associated with a significant decrease in the risk for early-onset colorectal cancer (EO-CRC) in patients with type 2 diabetes (T2D), according to the results of a retrospective study.

“This is the first large study to investigate the impact of GLP-1 RA use on EO-CRC risk,” principal investigator Temitope Olasehinde, MD, resident physician at the University Hospitals Cleveland Medical Center, Case Western Reserve University in Cleveland, Ohio, said in an interview.

The results indicate the GLP-1 RAs have a potentially protective role to play in combating EO-CRC, the incidence of which is notably rising in younger adults, with a corresponding increase in associated mortality.

Previous studies investigating the link between GLP-1 RAs and CRC did not capture patients aged younger than 50 years; thus, it was unknown if these results could be extrapolated to a younger age group, said Olasehinde.

The researcher presented the findings at the annual meeting of the American College of Gastroenterology.
 

Retrospective Database Analysis

Olasehinde and colleagues analyzed data from TriNetX, a large federated deidentified health research network, to identify patients (age ≤ 49 years) with diagnosed T2D subsequently prescribed antidiabetic medications who had not received a prior diagnosis of CRC. Additionally, patients were stratified on the basis of first-time GLP-1 RA use.

They identified 2,025,034 drug-naive patients with T2D; of these, 284,685 were subsequently prescribed GLP-1 RAs, and 1,740,349 remained in the non–GLP-1 RA cohort. Following propensity score matching, there were 86,186 patients in each cohort.

Patients who received GLP-1 RAs had significantly lower odds of developing EO-CRC than those who received non–GLP-1 RAs (0.6% vs 0.9%; P < .001; odds ratio [OR], 0.61; 95% CI, 0.54-068).

Furthermore, a sub-analysis revealed that patients who were obese and taking GLP-1 RAs had significantly lower odds of developing EO-CRC than patients who were obese but not taking GLP-1 RAs (0.7% vs 1.1%; P < .001; OR, 0.58; 95% CI, 0.50-067).
 

A Proposed Protective Effect

Although GLP-1 RAs are indicated for the treatment of T2D and obesity, recent evidence suggests that they may play a role in reducing the risk for CRC as well. This protective effect may be produced not only by addressing T2D and obesity — both important risk factors for CRC — but also via cellular mechanisms, Olasehinde noted.

“GLP-1 receptors are widely expressed throughout the gastrointestinal tract, with various effects on tissues in the stomach, small intestine, and colon,” she explained. Specifically, activation of these receptors in the proximal and distal colon promotes the release of “important factors that protect and facilitate healing of the intestinal epithelium” and “regulate the gut microbiome.”

This is particularly relevant in EO-CRC, she added, given its greater association with T2D and obesity, both factors that “have been shown to create dysbiosis in the gut microbiome and low-grade inflammation via release of free radicals/inflammatory cytokines.”

These results provide more evidence that EO-CRC “is clinically and molecularly distinct from late-onset colorectal cancer,” which is important for both clinicians and patients to understand, said Olasehinde.

“It is imperative that we are all aware of the specific signs and symptoms this population presents with and the implications of this diagnosis in younger age groups,” she added. “Patients should continue making informed dietary and lifestyle modifications/choices to help reduce the burden of EO-CRC.”

Hypothesis-Generating Results

Aasma Shaukat, MD, MPH, who was not affiliated with the research, called the results promising but — at this stage — primarily useful for stimulating future research. 

"We do need more studies such as this to generate hypotheses that can be studied prospectively," Shaukat, professor of medicine and population health, and director of GI Outcomes Research at NYU Langone Health in New York City, told Medscape Medical News. 

She referred to another study, published in JAMA Oncology, that also used the TriNetX research network, which showed that GLP-1 RAs were associated with reduced CRC risk in drug-naive patients with T2D. 

Shaukat also noted that the current analysis has limitations that should be considered. "The study is retrospective, and confounding is a possibility,” she said. 

“How the groups that did and did not receive GLP-1 RAs differ in other risk factors that could be the drivers of the cancers is not known. Whether cancers were detected through screening or symptoms, stage, and other features that may differ are not known. Finally, since we don’t know who did or did not have colonoscopy, undiagnosed cancers are not known," she explained. 

Shaukat, who was the lead author of the ACG 2021 Colorectal Cancer Screening Guidelines, added that the field would benefit from studies providing "biological plausibility information, such as animal studies to understand how GLP-1 RAs may modulate risk of colon cancer; other population-based cohort studies on the incidence of colon cancer among GLP-1 RA users and non-users; and prospective trials on chemoprevention." 

The study had no specific funding. Olasehinde reported no relevant financial relationships. Shaukat reported serving as a consultant for Freenome, Medtronic, and Motus GI, as well as an advisory board member for Iterative Scopes Inc.

A version of this article appeared on Medscape.com.

PHILADELPHIA — The use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) is associated with a significant decrease in the risk for early-onset colorectal cancer (EO-CRC) in patients with type 2 diabetes (T2D), according to the results of a retrospective study.

“This is the first large study to investigate the impact of GLP-1 RA use on EO-CRC risk,” principal investigator Temitope Olasehinde, MD, resident physician at the University Hospitals Cleveland Medical Center, Case Western Reserve University in Cleveland, Ohio, said in an interview.

The results indicate the GLP-1 RAs have a potentially protective role to play in combating EO-CRC, the incidence of which is notably rising in younger adults, with a corresponding increase in associated mortality.

Previous studies investigating the link between GLP-1 RAs and CRC did not capture patients aged younger than 50 years; thus, it was unknown if these results could be extrapolated to a younger age group, said Olasehinde.

The researcher presented the findings at the annual meeting of the American College of Gastroenterology.
 

Retrospective Database Analysis

Olasehinde and colleagues analyzed data from TriNetX, a large federated deidentified health research network, to identify patients (age ≤ 49 years) with diagnosed T2D subsequently prescribed antidiabetic medications who had not received a prior diagnosis of CRC. Additionally, patients were stratified on the basis of first-time GLP-1 RA use.

They identified 2,025,034 drug-naive patients with T2D; of these, 284,685 were subsequently prescribed GLP-1 RAs, and 1,740,349 remained in the non–GLP-1 RA cohort. Following propensity score matching, there were 86,186 patients in each cohort.

Patients who received GLP-1 RAs had significantly lower odds of developing EO-CRC than those who received non–GLP-1 RAs (0.6% vs 0.9%; P < .001; odds ratio [OR], 0.61; 95% CI, 0.54-068).

Furthermore, a sub-analysis revealed that patients who were obese and taking GLP-1 RAs had significantly lower odds of developing EO-CRC than patients who were obese but not taking GLP-1 RAs (0.7% vs 1.1%; P < .001; OR, 0.58; 95% CI, 0.50-067).
 

A Proposed Protective Effect

Although GLP-1 RAs are indicated for the treatment of T2D and obesity, recent evidence suggests that they may play a role in reducing the risk for CRC as well. This protective effect may be produced not only by addressing T2D and obesity — both important risk factors for CRC — but also via cellular mechanisms, Olasehinde noted.

“GLP-1 receptors are widely expressed throughout the gastrointestinal tract, with various effects on tissues in the stomach, small intestine, and colon,” she explained. Specifically, activation of these receptors in the proximal and distal colon promotes the release of “important factors that protect and facilitate healing of the intestinal epithelium” and “regulate the gut microbiome.”

This is particularly relevant in EO-CRC, she added, given its greater association with T2D and obesity, both factors that “have been shown to create dysbiosis in the gut microbiome and low-grade inflammation via release of free radicals/inflammatory cytokines.”

These results provide more evidence that EO-CRC “is clinically and molecularly distinct from late-onset colorectal cancer,” which is important for both clinicians and patients to understand, said Olasehinde.

“It is imperative that we are all aware of the specific signs and symptoms this population presents with and the implications of this diagnosis in younger age groups,” she added. “Patients should continue making informed dietary and lifestyle modifications/choices to help reduce the burden of EO-CRC.”

Hypothesis-Generating Results

Aasma Shaukat, MD, MPH, who was not affiliated with the research, called the results promising but — at this stage — primarily useful for stimulating future research. 

"We do need more studies such as this to generate hypotheses that can be studied prospectively," Shaukat, professor of medicine and population health, and director of GI Outcomes Research at NYU Langone Health in New York City, told Medscape Medical News. 

She referred to another study, published in JAMA Oncology, that also used the TriNetX research network, which showed that GLP-1 RAs were associated with reduced CRC risk in drug-naive patients with T2D. 

Shaukat also noted that the current analysis has limitations that should be considered. "The study is retrospective, and confounding is a possibility,” she said. 

“How the groups that did and did not receive GLP-1 RAs differ in other risk factors that could be the drivers of the cancers is not known. Whether cancers were detected through screening or symptoms, stage, and other features that may differ are not known. Finally, since we don’t know who did or did not have colonoscopy, undiagnosed cancers are not known," she explained. 

Shaukat, who was the lead author of the ACG 2021 Colorectal Cancer Screening Guidelines, added that the field would benefit from studies providing "biological plausibility information, such as animal studies to understand how GLP-1 RAs may modulate risk of colon cancer; other population-based cohort studies on the incidence of colon cancer among GLP-1 RA users and non-users; and prospective trials on chemoprevention." 

The study had no specific funding. Olasehinde reported no relevant financial relationships. Shaukat reported serving as a consultant for Freenome, Medtronic, and Motus GI, as well as an advisory board member for Iterative Scopes Inc.

A version of this article appeared on Medscape.com.

PHILADELPHIA — The use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) is associated with a significant decrease in the risk for early-onset colorectal cancer (EO-CRC) in patients with type 2 diabetes (T2D), according to the results of a retrospective study.

“This is the first large study to investigate the impact of GLP-1 RA use on EO-CRC risk,” principal investigator Temitope Olasehinde, MD, resident physician at the University Hospitals Cleveland Medical Center, Case Western Reserve University in Cleveland, Ohio, said in an interview.

The results indicate the GLP-1 RAs have a potentially protective role to play in combating EO-CRC, the incidence of which is notably rising in younger adults, with a corresponding increase in associated mortality.

Previous studies investigating the link between GLP-1 RAs and CRC did not capture patients aged younger than 50 years; thus, it was unknown if these results could be extrapolated to a younger age group, said Olasehinde.

The researcher presented the findings at the annual meeting of the American College of Gastroenterology.
 

Retrospective Database Analysis

Olasehinde and colleagues analyzed data from TriNetX, a large federated deidentified health research network, to identify patients (age ≤ 49 years) with diagnosed T2D subsequently prescribed antidiabetic medications who had not received a prior diagnosis of CRC. Additionally, patients were stratified on the basis of first-time GLP-1 RA use.

They identified 2,025,034 drug-naive patients with T2D; of these, 284,685 were subsequently prescribed GLP-1 RAs, and 1,740,349 remained in the non–GLP-1 RA cohort. Following propensity score matching, there were 86,186 patients in each cohort.

Patients who received GLP-1 RAs had significantly lower odds of developing EO-CRC than those who received non–GLP-1 RAs (0.6% vs 0.9%; P < .001; odds ratio [OR], 0.61; 95% CI, 0.54-068).

Furthermore, a sub-analysis revealed that patients who were obese and taking GLP-1 RAs had significantly lower odds of developing EO-CRC than patients who were obese but not taking GLP-1 RAs (0.7% vs 1.1%; P < .001; OR, 0.58; 95% CI, 0.50-067).
 

A Proposed Protective Effect

Although GLP-1 RAs are indicated for the treatment of T2D and obesity, recent evidence suggests that they may play a role in reducing the risk for CRC as well. This protective effect may be produced not only by addressing T2D and obesity — both important risk factors for CRC — but also via cellular mechanisms, Olasehinde noted.

“GLP-1 receptors are widely expressed throughout the gastrointestinal tract, with various effects on tissues in the stomach, small intestine, and colon,” she explained. Specifically, activation of these receptors in the proximal and distal colon promotes the release of “important factors that protect and facilitate healing of the intestinal epithelium” and “regulate the gut microbiome.”

This is particularly relevant in EO-CRC, she added, given its greater association with T2D and obesity, both factors that “have been shown to create dysbiosis in the gut microbiome and low-grade inflammation via release of free radicals/inflammatory cytokines.”

These results provide more evidence that EO-CRC “is clinically and molecularly distinct from late-onset colorectal cancer,” which is important for both clinicians and patients to understand, said Olasehinde.

“It is imperative that we are all aware of the specific signs and symptoms this population presents with and the implications of this diagnosis in younger age groups,” she added. “Patients should continue making informed dietary and lifestyle modifications/choices to help reduce the burden of EO-CRC.”

Hypothesis-Generating Results

Aasma Shaukat, MD, MPH, who was not affiliated with the research, called the results promising but — at this stage — primarily useful for stimulating future research. 

"We do need more studies such as this to generate hypotheses that can be studied prospectively," Shaukat, professor of medicine and population health, and director of GI Outcomes Research at NYU Langone Health in New York City, told Medscape Medical News. 

She referred to another study, published in JAMA Oncology, that also used the TriNetX research network, which showed that GLP-1 RAs were associated with reduced CRC risk in drug-naive patients with T2D. 

Shaukat also noted that the current analysis has limitations that should be considered. "The study is retrospective, and confounding is a possibility,” she said. 

“How the groups that did and did not receive GLP-1 RAs differ in other risk factors that could be the drivers of the cancers is not known. Whether cancers were detected through screening or symptoms, stage, and other features that may differ are not known. Finally, since we don’t know who did or did not have colonoscopy, undiagnosed cancers are not known," she explained. 

Shaukat, who was the lead author of the ACG 2021 Colorectal Cancer Screening Guidelines, added that the field would benefit from studies providing "biological plausibility information, such as animal studies to understand how GLP-1 RAs may modulate risk of colon cancer; other population-based cohort studies on the incidence of colon cancer among GLP-1 RA users and non-users; and prospective trials on chemoprevention." 

The study had no specific funding. Olasehinde reported no relevant financial relationships. Shaukat reported serving as a consultant for Freenome, Medtronic, and Motus GI, as well as an advisory board member for Iterative Scopes Inc.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Researchers have developed an artificial intelligence (AI) tool capable of detecting and differentiating cystic and solid pancreatic lesions during endoscopic ultrasound (EUS) with high accuracy.

This was a transatlantic collaborative effort involving researchers in Portugal, Spain, the United States, and Brazil, and the AI tool “works on different platforms and different devices,” Miguel Mascarenhas, MD, PhD, with Centro Hospitalar Universitário de São João, Porto, Portugal, said in a presentation at the annual meeting of the American College of Gastroenterology.

Mascarenhas noted that pancreatic cystic lesions (PCLs) are a common incidental finding during imaging and are differentiated by whether they’re mucinous PCLs (M-PCLs) or non-mucinous PCLs (NM-PCLs). The malignancy risk is almost exclusive of PCL with a mucinous phenotype.

Pancreatic solid lesions are also prevalent, and differentiation is challenging. Pancreatic ductal adenocarcinoma (P-DAC) is the most common pancreatic solid lesion and has a poor prognosis because of late-stage disease at diagnosis. Pancreatic neuroendocrine tumors (P-NETs) are less common but have malignant potential.

EUS is the “gold standard” for pancreatic lesion evaluation, but its diagnostic accuracy is suboptimal, particularly for lesions < 10 mm, Mascarenhas noted.

With an eye toward improving diagnostic accuracy, he and colleagues developed a convolutional neural network for detecting and differentiating cystic (M-PCL and NM-PCL) and solid (P-DAC and P-NET) pancreatic lesions.

They leveraged data from 378 EUS exams with 126,000 still images — 19,528 M-PCL, 8175 NM-PCL, 64,286 P-DAC, 29,153 P-NET, and 4858 normal pancreas images.

The AI tool demonstrated 99.1% accuracy for identifying normal pancreatic tissue, and it showed 99% and 99.8% accuracy for M-PCL and NM-PCL, respectively.

For pancreatic solid lesions, P-DAC and P-NET were distinguished with 94% accuracy, with 98.7% and 83.6% sensitivity for P-DAC and P-NET, respectively.
 

Real-Time Validation Next

“AI is delivering promising results throughout medicine, but particularly in gastroenterology, which is one of the most fertile areas of AI research. This comes mostly from the deployment of deep-learning models, most of them convolutional neural networks, which are highly efficient for image analysis,” Mascarenhas told attendees.

This is the “first worldwide convolutional neural network” capable of detecting and differentiating both cystic and solid pancreatic lesions. The use of a large dataset from four centers in two continents helps minimize the impact of demographic bias, Mascarenhas added.

The study is based on still images, not full videos, he noted. As a next step, the team is conducting a multicenter study focused on real-time clinical validation of the model during EUS procedures.

“AI has the potential to improve the diagnostic accuracy of endoscopic ultrasound. We’re just on the tip of the iceberg. There is enormous potential to harness AI, and we welcome all the groups that might want to join our research,” Mascarenhas said.

Brennan Spiegel, MD, MSHS, AGAF, director of Health Services Research at Cedars-Sinai Medical Center, Los Angeles, who wasn’t involved in the study, is optimistic about emerging applications for AI.

“AI holds incredible promise in gastroenterology, especially for diagnosing complex pancreatic lesions where early, accurate differentiation can be lifesaving,” Spiegel said in an interview.

“This study’s high accuracy across diverse datasets is encouraging; however, as a retrospective analysis, it leaves the real-time clinical impact still to be proven. Prospective studies will be essential to confirm AI’s role in enhancing our diagnostic capabilities,” Spiegel cautioned.

“More generally, AI is rapidly transforming gastroenterology by enhancing our ability to detect, differentiate, and monitor conditions with unprecedented precision. From improving early cancer detection to guiding complex diagnostic procedures, AI stands to become an invaluable tool that complements clinical expertise. As we refine these technologies, the potential for AI to elevate both diagnostic accuracy and patient outcomes in GI is truly remarkable,” Spiegel said.

The study had no specific funding. Mascarenhas and Spiegel have declared no conflicts of interest.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Researchers have developed an artificial intelligence (AI) tool capable of detecting and differentiating cystic and solid pancreatic lesions during endoscopic ultrasound (EUS) with high accuracy.

This was a transatlantic collaborative effort involving researchers in Portugal, Spain, the United States, and Brazil, and the AI tool “works on different platforms and different devices,” Miguel Mascarenhas, MD, PhD, with Centro Hospitalar Universitário de São João, Porto, Portugal, said in a presentation at the annual meeting of the American College of Gastroenterology.

Mascarenhas noted that pancreatic cystic lesions (PCLs) are a common incidental finding during imaging and are differentiated by whether they’re mucinous PCLs (M-PCLs) or non-mucinous PCLs (NM-PCLs). The malignancy risk is almost exclusive of PCL with a mucinous phenotype.

Pancreatic solid lesions are also prevalent, and differentiation is challenging. Pancreatic ductal adenocarcinoma (P-DAC) is the most common pancreatic solid lesion and has a poor prognosis because of late-stage disease at diagnosis. Pancreatic neuroendocrine tumors (P-NETs) are less common but have malignant potential.

EUS is the “gold standard” for pancreatic lesion evaluation, but its diagnostic accuracy is suboptimal, particularly for lesions < 10 mm, Mascarenhas noted.

With an eye toward improving diagnostic accuracy, he and colleagues developed a convolutional neural network for detecting and differentiating cystic (M-PCL and NM-PCL) and solid (P-DAC and P-NET) pancreatic lesions.

They leveraged data from 378 EUS exams with 126,000 still images — 19,528 M-PCL, 8175 NM-PCL, 64,286 P-DAC, 29,153 P-NET, and 4858 normal pancreas images.

The AI tool demonstrated 99.1% accuracy for identifying normal pancreatic tissue, and it showed 99% and 99.8% accuracy for M-PCL and NM-PCL, respectively.

For pancreatic solid lesions, P-DAC and P-NET were distinguished with 94% accuracy, with 98.7% and 83.6% sensitivity for P-DAC and P-NET, respectively.
 

Real-Time Validation Next

“AI is delivering promising results throughout medicine, but particularly in gastroenterology, which is one of the most fertile areas of AI research. This comes mostly from the deployment of deep-learning models, most of them convolutional neural networks, which are highly efficient for image analysis,” Mascarenhas told attendees.

This is the “first worldwide convolutional neural network” capable of detecting and differentiating both cystic and solid pancreatic lesions. The use of a large dataset from four centers in two continents helps minimize the impact of demographic bias, Mascarenhas added.

The study is based on still images, not full videos, he noted. As a next step, the team is conducting a multicenter study focused on real-time clinical validation of the model during EUS procedures.

“AI has the potential to improve the diagnostic accuracy of endoscopic ultrasound. We’re just on the tip of the iceberg. There is enormous potential to harness AI, and we welcome all the groups that might want to join our research,” Mascarenhas said.

Brennan Spiegel, MD, MSHS, AGAF, director of Health Services Research at Cedars-Sinai Medical Center, Los Angeles, who wasn’t involved in the study, is optimistic about emerging applications for AI.

“AI holds incredible promise in gastroenterology, especially for diagnosing complex pancreatic lesions where early, accurate differentiation can be lifesaving,” Spiegel said in an interview.

“This study’s high accuracy across diverse datasets is encouraging; however, as a retrospective analysis, it leaves the real-time clinical impact still to be proven. Prospective studies will be essential to confirm AI’s role in enhancing our diagnostic capabilities,” Spiegel cautioned.

“More generally, AI is rapidly transforming gastroenterology by enhancing our ability to detect, differentiate, and monitor conditions with unprecedented precision. From improving early cancer detection to guiding complex diagnostic procedures, AI stands to become an invaluable tool that complements clinical expertise. As we refine these technologies, the potential for AI to elevate both diagnostic accuracy and patient outcomes in GI is truly remarkable,” Spiegel said.

The study had no specific funding. Mascarenhas and Spiegel have declared no conflicts of interest.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Researchers have developed an artificial intelligence (AI) tool capable of detecting and differentiating cystic and solid pancreatic lesions during endoscopic ultrasound (EUS) with high accuracy.

This was a transatlantic collaborative effort involving researchers in Portugal, Spain, the United States, and Brazil, and the AI tool “works on different platforms and different devices,” Miguel Mascarenhas, MD, PhD, with Centro Hospitalar Universitário de São João, Porto, Portugal, said in a presentation at the annual meeting of the American College of Gastroenterology.

Mascarenhas noted that pancreatic cystic lesions (PCLs) are a common incidental finding during imaging and are differentiated by whether they’re mucinous PCLs (M-PCLs) or non-mucinous PCLs (NM-PCLs). The malignancy risk is almost exclusive of PCL with a mucinous phenotype.

Pancreatic solid lesions are also prevalent, and differentiation is challenging. Pancreatic ductal adenocarcinoma (P-DAC) is the most common pancreatic solid lesion and has a poor prognosis because of late-stage disease at diagnosis. Pancreatic neuroendocrine tumors (P-NETs) are less common but have malignant potential.

EUS is the “gold standard” for pancreatic lesion evaluation, but its diagnostic accuracy is suboptimal, particularly for lesions < 10 mm, Mascarenhas noted.

With an eye toward improving diagnostic accuracy, he and colleagues developed a convolutional neural network for detecting and differentiating cystic (M-PCL and NM-PCL) and solid (P-DAC and P-NET) pancreatic lesions.

They leveraged data from 378 EUS exams with 126,000 still images — 19,528 M-PCL, 8175 NM-PCL, 64,286 P-DAC, 29,153 P-NET, and 4858 normal pancreas images.

The AI tool demonstrated 99.1% accuracy for identifying normal pancreatic tissue, and it showed 99% and 99.8% accuracy for M-PCL and NM-PCL, respectively.

For pancreatic solid lesions, P-DAC and P-NET were distinguished with 94% accuracy, with 98.7% and 83.6% sensitivity for P-DAC and P-NET, respectively.
 

Real-Time Validation Next

“AI is delivering promising results throughout medicine, but particularly in gastroenterology, which is one of the most fertile areas of AI research. This comes mostly from the deployment of deep-learning models, most of them convolutional neural networks, which are highly efficient for image analysis,” Mascarenhas told attendees.

This is the “first worldwide convolutional neural network” capable of detecting and differentiating both cystic and solid pancreatic lesions. The use of a large dataset from four centers in two continents helps minimize the impact of demographic bias, Mascarenhas added.

The study is based on still images, not full videos, he noted. As a next step, the team is conducting a multicenter study focused on real-time clinical validation of the model during EUS procedures.

“AI has the potential to improve the diagnostic accuracy of endoscopic ultrasound. We’re just on the tip of the iceberg. There is enormous potential to harness AI, and we welcome all the groups that might want to join our research,” Mascarenhas said.

Brennan Spiegel, MD, MSHS, AGAF, director of Health Services Research at Cedars-Sinai Medical Center, Los Angeles, who wasn’t involved in the study, is optimistic about emerging applications for AI.

“AI holds incredible promise in gastroenterology, especially for diagnosing complex pancreatic lesions where early, accurate differentiation can be lifesaving,” Spiegel said in an interview.

“This study’s high accuracy across diverse datasets is encouraging; however, as a retrospective analysis, it leaves the real-time clinical impact still to be proven. Prospective studies will be essential to confirm AI’s role in enhancing our diagnostic capabilities,” Spiegel cautioned.

“More generally, AI is rapidly transforming gastroenterology by enhancing our ability to detect, differentiate, and monitor conditions with unprecedented precision. From improving early cancer detection to guiding complex diagnostic procedures, AI stands to become an invaluable tool that complements clinical expertise. As we refine these technologies, the potential for AI to elevate both diagnostic accuracy and patient outcomes in GI is truly remarkable,” Spiegel said.

The study had no specific funding. Mascarenhas and Spiegel have declared no conflicts of interest.

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — The rationale for using obesity medications in pediatric patients is that it’s using “a biological intervention to treat a biologically based disease,” according to Claudia Fox, MD, MPH, an associate professor of pediatrics and codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota, Minneapolis. At the annual meeting of the American Academy of Pediatrics (AAP), Fox provided an overview of what obesity medications are approved for in youth and how to determine which medications may be best for different patients.

“This field is changing so rapidly that even over the course of the last 3 or 4 months, the verbiage around what we should be calling these interventions has changed,” Fox noted. Instead of “anti-obesity” medications, “most of us are now using the term obesity medications to highlight or to reduce chances of stigma and bias that can come along with this topic.”

Jessica Ivers, MD, a pediatrician at Swedish Pediatrics in Seattle, Washington, said she found the session very informative, particularly because she doesn’t think many pediatricians currently feel very comfortable prescribing obesity medications.

“It answered questions that any general pediatrician would have, and it’s kind of a new field that people are learning about,” Ivers said. “I think we just need more education. It’s just too new, and people haven’t had the education and the support from colleagues to [use the medications].”

Fox first reminded attendees of precisely what obesity is: A chronic, relapsing, multifactorial, neurobehavioral disease that involves the accumulation and/or distribution of excess body fat that results in impaired health. AAP clinical practice guidelines currently advise that youth aged 12 years or older who have obesity be offered weight loss pharmacotherapy as an adjunct to lifestyle treatment, taking into consideration the indications, risks, and benefits of each medication.

That doesn’t necessarily mean every child aged 12 years or older with a body mass index (BMI) of at least the 95th percentile should be prescribed one of these medications, Fox said. But pediatricians should start becoming familiar with the options and recognize that part of reducing the stigma of this disease is emphasizing that these medications are prescribed not for “weight loss” but to treat the disease of obesity, Fox said. The guidelines advise “early, intensive care” and focusing on the whole child, “using a family-centered and nonstigmatizing approach that acknowledges obesity’s biologic, social, and structural drivers.”
 

Offer the Full Spectrum of Care Early On

Early intervention means starting obesity treatment at diagnosis, without watchful waiting or the previously recommended staged approach. Instead of trying lifestyle therapy for 3-6 months, then considering the addition of medication, and then considering bariatric surgery, “we should be offering the full spectrum of obesity care as appropriate for that individual patient,” Fox said.

Some children with severe obesity may need the combination of lifestyle therapy and pharmacotherapy right up front, whereas another might be able to try lifestyle therapy alone for a while first. “What we know is that, for most interventions, whether it is lifestyle therapy, a medication, or bariatric surgery, early response typically predicts longer-term response,” Fox said. A study conducted by her group, for example, found that a 3% BMI reduction after 1 month with lifestyle therapy was very predictive of clinically meaningful BMI reduction at 1 year.

As with any medical treatment, physicians need to weigh the risks of the medication — short-term side effects and unknown long-term risks (or benefits) — against the risks of not treating. Because obesity is a progressive disease, “if we don’t treat it, most will develop comorbid conditions, or worsening of their already present comorbid conditions, and this does indeed lead to shortened life expectancy,” Fox said. Those who should be treated with medication are obviously those in whom the benefits outweigh the risks, Fox said, which depends on their age, their comorbidities, the severity of obesity, and the safety and efficacy of medication options.

“If I have a patient who has maybe class 2 obesity but no other comorbid conditions, I may be less inclined to start an obesity medication than a kid who has class 1 obesity and obstructive sleep apnea, for instance,” Fox said. “Some of the medications are very, very potent and effective. If you have a kid who maybe has less severe forms of obesity, perhaps they don’t need something that’s so potent.”

BMI trajectory is also a factor to consider. She said she may not be too concerned about a 16-year-old who has always been at the 95th percentile and is otherwise healthy, but the situation is different for a 16-year-old who used to be in the 25th percentile and has rapidly progressed to the 50th and then 75th percentiles in a trajectory heading straight up.

Another factor that may come into play is the patient and family preferences, though Fox noted that weight bias and stigma often interfere here. If obesity medications are brought up, the family may bring up the need for more exercise and better meal prep at home.

“They have this sense that they just need to try harder, that if they did that, the obesity would somehow get better on its own,” Fox said. “That’s an internalized bias that it’s somehow their fault, rather than realizing that this is indeed a biological disorder.”

Finally, clinicians may want to consider the child’s response to lifestyle therapy and whether they have already had bariatric surgery because these medications can be prescribed in people who did not have an adequate response to surgery.
 

Overview of the Medications

There are currently six obesity medications approved by the Food and Drug Administration (FDA) for use in youth: Phentermine, orlistat, liraglutide, phentermine/topiramate, semaglutide, and setmelanotide.

Of these, orlistat is rarely used now because it results in the least amount of change in BMI (about a 3% loss change in BMI), has a lot of gastrointestinal side effects, often is not covered by insurance, and is expensive out of pocket. Setmelanotide is indicated only in those aged 6 years or older who have obesity because of Bardet-Biedl syndrome or one of three other rare genetic conditions: a POMC, LEPR, or PCSK1 deficiency. Fox therefore focused on the other medications besides these two.

While nearly all the currently available obesity medications are only approved in those aged 12 years or older, Fox noted that studies are ongoing at younger ages, so some of these medications may receive approval in younger populations in the future. The only one currently available for a younger age is liraglutide, which is approved down to 6 years old in children with type 2 diabetes.

“Very young kids who have very severe forms of obesity need intervention, and unfortunately, at this point, we really don’t have much to offer them,” Fox said.

Fox highlighted six key factors to consider in selecting a medication for those aged 12 years or older, though one of these, in the US healthcare system, can tend to trump all the others. Those factors are mechanism of action, side effect profile, effects on other diagnoses, patient/family preferences, provider comfort, and finally — the potentially overruling one — insurance coverage and access.

“These days, insurance coverage and access are really the No. 1 driver when I’m seeing a patient,” Fox said. “The first thing I do is look at their insurance and then also look at what kind of updates our pharmacist has given us about which medication is currently in stock.”

Each medication has different properties that should be considered with the child’s health profile. For example, topiramate is a carbonic anhydrase inhibitor so likely shouldn’t be prescribed in a child who is taking any other carbonic anhydrase inhibitor. Fox said she probably wouldn’t prescribe phentermine in a child with severe anxiety because it might enhance the anxiety effect. But if a child has migraines, she may be more inclined to try phentermine/topiramate first because the topiramate may help with the migraines. Similarly, if a child has type 2 diabetes or prediabetes, she may lean toward one of the glucagon-like peptide 1 (GLP-1) agonist drugs.
 

Liraglutide and Semaglutide

Liraglutide and semaglutide are both GLP-1 receptor agonists administered subcutaneously to reduce appetite, increase satiety, slow gastric emptying, and reduce the food reward response in the brain. Liraglutide can result in up to 4.5%-5% change in BMI, and semaglutide, the most potent of all the medications, can result in up to a 17% change in BMI.

Liraglutide and semaglutide are both approved for patients aged 12 years or older who weigh at least 60 kg and have a BMI of at least the 95th percentile. Liraglutide is also approved for those aged 10 years or older with type 2 diabetes. Both are contraindicated in those with a family history of medullary thyroid cancer or multiple endocrine neoplasia II. The risks to watch for include pancreatitis and gallbladder disease. Also keep in mind if you have a patient with type 1 diabetes and insulin resistance; prescribing a GLP-1 agonist is appropriate, but their insulin needs will decrease, necessitating close monitoring of their blood glucose, Fox noted.

These GLP-1 medications can be considered for those who have insurance coverage for them, who have diabetes or prediabetes, who are comfortable with daily (liraglutide) or weekly (semaglutide) injections, who have food cravings, and who have poor satiety or satiation. Without insurance, these medications are very expensive.

The most common side effects include injection site reactions and nausea, vomiting, and diarrhea, though all these usually fade and can be minimized with small portions and slower eating if needed. Less common possible side effects can include abdominal pain, constipation, headache, dizziness, fatigue, and hypoglycemia. If patients develop severe belly pain that radiates to their back, they should be assessed for pancreatitis.

It’s also important to demonstrate for patients how to do the injections, Fox said. Liraglutide dosing begins at 0.6 mg daily for a week, followed by a week at 1.2 mg, a week at 1.8 mg, a week at 2.4 mg, and then 3 mg daily. Semaglutide dosing starts at 0.25 mg weekly for 4 weeks, then going up each subsequent month as needed to 0.5 mg, then 1 mg, then 1.7 mg, and finally 2.4 mg. Though there’s no standard follow-up schedule for these medications, Fox suggested considering monthly visits for the first 3 months and then every 2-3 months to assess heart rate and blood pressure, the injection site, adherence, side effects, and the effect on BMI and eating.

“Are they getting appetite suppression, but not too much appetite suppression?” Fox said. “Just like in eating disorder treatment, we want our patients to eat regularly spaced meals. If their appetite is so suppressed that they are hardly eating anything, that’s a problem.”

Fox also offered the following additional pearls about these medications:

• Though manufacturers have struggled to keep up with demand, the shortages of these medications are improving. However, beware the compounding pharmacies filling the gap because compounded medications are not FDA approved, and quality control issues are a concern.
• Prior authorizations are usually needed, and common reasons for denial to anticipate include lack of documentation on not having contraindications, the patient not following a low-calorie diet or engaging in physical activity, and the patient not having seen a registered dietitian.
• Patients should expect gastrointestinal side effects, but ondansetron can be prescribed to lessen the intensity.

Phentermine/Topiramate

Phentermine/topiramate extended-release is a once-daily oral tablet, with the phentermine acting to reduce appetite (by simulating the release of norepinephrine) and the topiramate reducing caloric intake and food reward response (by increasing gamma-aminobutyric acid activity). It’s approved for those aged 12 years or older with a BMI of at least the 95th percentile and should be considered in those with strong hunger, low energy, binge eating disorder, or migraines, as well as those who have insurance coverage for it. It can result in up to a 10% change in BMI.

Contraindications include pregnancy, substance use, cardiovascular disease (though it’s okay in patients with controlled hypertension), hyperthyroidism, glaucoma, and monoamine oxidase inhibitor (MAOI) use. Fox emphasized the teratogenic effects, so patients capable of pregnancy need to be on reliable birth control. The most common side effects include paresthesia, dizziness, dysgeusia, insomnia, and constipation.

A risk of topiramate is kidney stones, so patients should drink a lot of water, especially in hot weather, Fox said. Other risks can include metabolic acidosis, suicidality, poor cognitive function, high blood pressure, and renal impairment.

“If your patient is struggling academically, I might use this medication a bit more cautiously, particularly when the dose gets above 100 mg a day,” Fox said. “That’s when the cognitive effects tend to emerge more strongly.”

Patients with congenital heart disease should meet with their cardiologist before starting this medication, and although patients taking selective serotonin reuptake inhibitors (SSRIs) can take this, there is a potential increased risk for serotonin syndrome because phentermine has a little bit of serotonergic activity, she said.

Before prescribing, do an exam to ensure the patient doesn’t have a heart murmur, isn’t hypertensive, isn’t pregnant, has normal kidney function, and has bicarbonate in a reasonable range. Dosing begins with a daily 3.75/23-mg capsule for 2 weeks, followed by 2 weeks at 7.5 mg/46 mg. As with the GLP-1 drugs, Fox advises considering monthly follow-ups for the first 3 months and then visits every 2-3 months. Each visit should include the assessment of cardiovascular health, heart rate, blood pressure, side effects, pregnancy risk, and the medication’s effect on BMI and eating. If the patient is tolerating a dose of 7.5 mg/46 mg, it can be increased to 11.25 mg/69 mg for 2 weeks and then to 15 mg/92 mg. Bicarbonate and creatinine should be checked every 6-12 months; if bicarbonate < 18 mEq/L, the dose should be reduced and then bicarbonate should be checked again a month later.

Fox noted that this drug is expected to go off patent in late 2024 or in 2025, which will substantially reduce the cost. It’s also possible to prescribe phentermine and topiramate separately, which may reduce costs or help with insurance coverage and can allow for evening dosing of topiramate.
 

Phentermine

Phentermine alone is only approved for those older than 16 years who have a BMI of at least 30, or at least 27 with weight-related comorbidities, and it’s not approved for use longer than 12 weeks. It results in a BMI change of up to 5%. It should be considered in those with strong hunger and low energy and in those who don’t have adequate insurance coverage because out-of-pocket costs can be as little as $5/mo.

Contraindications are the same as those for the combined pill above: Substance use, cardiovascular disease, hyperthyroidism, glaucoma, MAOI use, and agitation. Again, take caution with patients who have hypertension, have congenital heart disease, or take SSRIs or insulin.

Side effects can include palpitations, tachycardia, dry mouth, headache, insomnia, and anxiety. The dose starts at 15 mg daily, and Fox advises following a similar follow-up as with the other medications, at which clinicians should assess BMI, the medication’s effect on eating, cardiovascular health, and side effects and have a discussion about off-label use. Off-label use refers to prescriptions lasting longer than 12 weeks, but it’s arguably safer than attention-deficit/hyperactivity disorder stimulants because of the lower addiction potential, Fox said.
 

What Else to Know

Because obesity is a chronic disease, treatment will be ongoing, Fox noted. A lot of people will ask when or where the “off-ramp” for these medications is, but many people will need these medications long term just as someone with other chronic diseases requires lifetime pharmacotherapy. The treatment intensity will vary based on disease severity and individual characteristics, Fox said.

For those feeling overwhelmed by the options, Fox advises clinicians to start by picking one medication to learn and then spending the time to read the FDA package insert in full. Get samples and then closely follow patients to learn that medication well before moving on to learn another. She also noted the opportunity for pediatricians to see a pediatric obesity medicine fellowship.

No external funding was used for the presentation. Fox is a site principal investigator for clinical trials sponsored by Novo Nordisk and Eli Lilly. Ivers had no disclosures.

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

ORLANDO, FLORIDA — The rationale for using obesity medications in pediatric patients is that it’s using “a biological intervention to treat a biologically based disease,” according to Claudia Fox, MD, MPH, an associate professor of pediatrics and codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota, Minneapolis. At the annual meeting of the American Academy of Pediatrics (AAP), Fox provided an overview of what obesity medications are approved for in youth and how to determine which medications may be best for different patients.

“This field is changing so rapidly that even over the course of the last 3 or 4 months, the verbiage around what we should be calling these interventions has changed,” Fox noted. Instead of “anti-obesity” medications, “most of us are now using the term obesity medications to highlight or to reduce chances of stigma and bias that can come along with this topic.”

Jessica Ivers, MD, a pediatrician at Swedish Pediatrics in Seattle, Washington, said she found the session very informative, particularly because she doesn’t think many pediatricians currently feel very comfortable prescribing obesity medications.

“It answered questions that any general pediatrician would have, and it’s kind of a new field that people are learning about,” Ivers said. “I think we just need more education. It’s just too new, and people haven’t had the education and the support from colleagues to [use the medications].”

Fox first reminded attendees of precisely what obesity is: A chronic, relapsing, multifactorial, neurobehavioral disease that involves the accumulation and/or distribution of excess body fat that results in impaired health. AAP clinical practice guidelines currently advise that youth aged 12 years or older who have obesity be offered weight loss pharmacotherapy as an adjunct to lifestyle treatment, taking into consideration the indications, risks, and benefits of each medication.

That doesn’t necessarily mean every child aged 12 years or older with a body mass index (BMI) of at least the 95th percentile should be prescribed one of these medications, Fox said. But pediatricians should start becoming familiar with the options and recognize that part of reducing the stigma of this disease is emphasizing that these medications are prescribed not for “weight loss” but to treat the disease of obesity, Fox said. The guidelines advise “early, intensive care” and focusing on the whole child, “using a family-centered and nonstigmatizing approach that acknowledges obesity’s biologic, social, and structural drivers.”
 

Offer the Full Spectrum of Care Early On

Early intervention means starting obesity treatment at diagnosis, without watchful waiting or the previously recommended staged approach. Instead of trying lifestyle therapy for 3-6 months, then considering the addition of medication, and then considering bariatric surgery, “we should be offering the full spectrum of obesity care as appropriate for that individual patient,” Fox said.

Some children with severe obesity may need the combination of lifestyle therapy and pharmacotherapy right up front, whereas another might be able to try lifestyle therapy alone for a while first. “What we know is that, for most interventions, whether it is lifestyle therapy, a medication, or bariatric surgery, early response typically predicts longer-term response,” Fox said. A study conducted by her group, for example, found that a 3% BMI reduction after 1 month with lifestyle therapy was very predictive of clinically meaningful BMI reduction at 1 year.

As with any medical treatment, physicians need to weigh the risks of the medication — short-term side effects and unknown long-term risks (or benefits) — against the risks of not treating. Because obesity is a progressive disease, “if we don’t treat it, most will develop comorbid conditions, or worsening of their already present comorbid conditions, and this does indeed lead to shortened life expectancy,” Fox said. Those who should be treated with medication are obviously those in whom the benefits outweigh the risks, Fox said, which depends on their age, their comorbidities, the severity of obesity, and the safety and efficacy of medication options.

“If I have a patient who has maybe class 2 obesity but no other comorbid conditions, I may be less inclined to start an obesity medication than a kid who has class 1 obesity and obstructive sleep apnea, for instance,” Fox said. “Some of the medications are very, very potent and effective. If you have a kid who maybe has less severe forms of obesity, perhaps they don’t need something that’s so potent.”

BMI trajectory is also a factor to consider. She said she may not be too concerned about a 16-year-old who has always been at the 95th percentile and is otherwise healthy, but the situation is different for a 16-year-old who used to be in the 25th percentile and has rapidly progressed to the 50th and then 75th percentiles in a trajectory heading straight up.

Another factor that may come into play is the patient and family preferences, though Fox noted that weight bias and stigma often interfere here. If obesity medications are brought up, the family may bring up the need for more exercise and better meal prep at home.

“They have this sense that they just need to try harder, that if they did that, the obesity would somehow get better on its own,” Fox said. “That’s an internalized bias that it’s somehow their fault, rather than realizing that this is indeed a biological disorder.”

Finally, clinicians may want to consider the child’s response to lifestyle therapy and whether they have already had bariatric surgery because these medications can be prescribed in people who did not have an adequate response to surgery.
 

Overview of the Medications

There are currently six obesity medications approved by the Food and Drug Administration (FDA) for use in youth: Phentermine, orlistat, liraglutide, phentermine/topiramate, semaglutide, and setmelanotide.

Of these, orlistat is rarely used now because it results in the least amount of change in BMI (about a 3% loss change in BMI), has a lot of gastrointestinal side effects, often is not covered by insurance, and is expensive out of pocket. Setmelanotide is indicated only in those aged 6 years or older who have obesity because of Bardet-Biedl syndrome or one of three other rare genetic conditions: a POMC, LEPR, or PCSK1 deficiency. Fox therefore focused on the other medications besides these two.

While nearly all the currently available obesity medications are only approved in those aged 12 years or older, Fox noted that studies are ongoing at younger ages, so some of these medications may receive approval in younger populations in the future. The only one currently available for a younger age is liraglutide, which is approved down to 6 years old in children with type 2 diabetes.

“Very young kids who have very severe forms of obesity need intervention, and unfortunately, at this point, we really don’t have much to offer them,” Fox said.

Fox highlighted six key factors to consider in selecting a medication for those aged 12 years or older, though one of these, in the US healthcare system, can tend to trump all the others. Those factors are mechanism of action, side effect profile, effects on other diagnoses, patient/family preferences, provider comfort, and finally — the potentially overruling one — insurance coverage and access.

“These days, insurance coverage and access are really the No. 1 driver when I’m seeing a patient,” Fox said. “The first thing I do is look at their insurance and then also look at what kind of updates our pharmacist has given us about which medication is currently in stock.”

Each medication has different properties that should be considered with the child’s health profile. For example, topiramate is a carbonic anhydrase inhibitor so likely shouldn’t be prescribed in a child who is taking any other carbonic anhydrase inhibitor. Fox said she probably wouldn’t prescribe phentermine in a child with severe anxiety because it might enhance the anxiety effect. But if a child has migraines, she may be more inclined to try phentermine/topiramate first because the topiramate may help with the migraines. Similarly, if a child has type 2 diabetes or prediabetes, she may lean toward one of the glucagon-like peptide 1 (GLP-1) agonist drugs.
 

Liraglutide and Semaglutide

Liraglutide and semaglutide are both GLP-1 receptor agonists administered subcutaneously to reduce appetite, increase satiety, slow gastric emptying, and reduce the food reward response in the brain. Liraglutide can result in up to 4.5%-5% change in BMI, and semaglutide, the most potent of all the medications, can result in up to a 17% change in BMI.

Liraglutide and semaglutide are both approved for patients aged 12 years or older who weigh at least 60 kg and have a BMI of at least the 95th percentile. Liraglutide is also approved for those aged 10 years or older with type 2 diabetes. Both are contraindicated in those with a family history of medullary thyroid cancer or multiple endocrine neoplasia II. The risks to watch for include pancreatitis and gallbladder disease. Also keep in mind if you have a patient with type 1 diabetes and insulin resistance; prescribing a GLP-1 agonist is appropriate, but their insulin needs will decrease, necessitating close monitoring of their blood glucose, Fox noted.

These GLP-1 medications can be considered for those who have insurance coverage for them, who have diabetes or prediabetes, who are comfortable with daily (liraglutide) or weekly (semaglutide) injections, who have food cravings, and who have poor satiety or satiation. Without insurance, these medications are very expensive.

The most common side effects include injection site reactions and nausea, vomiting, and diarrhea, though all these usually fade and can be minimized with small portions and slower eating if needed. Less common possible side effects can include abdominal pain, constipation, headache, dizziness, fatigue, and hypoglycemia. If patients develop severe belly pain that radiates to their back, they should be assessed for pancreatitis.

It’s also important to demonstrate for patients how to do the injections, Fox said. Liraglutide dosing begins at 0.6 mg daily for a week, followed by a week at 1.2 mg, a week at 1.8 mg, a week at 2.4 mg, and then 3 mg daily. Semaglutide dosing starts at 0.25 mg weekly for 4 weeks, then going up each subsequent month as needed to 0.5 mg, then 1 mg, then 1.7 mg, and finally 2.4 mg. Though there’s no standard follow-up schedule for these medications, Fox suggested considering monthly visits for the first 3 months and then every 2-3 months to assess heart rate and blood pressure, the injection site, adherence, side effects, and the effect on BMI and eating.

“Are they getting appetite suppression, but not too much appetite suppression?” Fox said. “Just like in eating disorder treatment, we want our patients to eat regularly spaced meals. If their appetite is so suppressed that they are hardly eating anything, that’s a problem.”

Fox also offered the following additional pearls about these medications:

• Though manufacturers have struggled to keep up with demand, the shortages of these medications are improving. However, beware the compounding pharmacies filling the gap because compounded medications are not FDA approved, and quality control issues are a concern.
• Prior authorizations are usually needed, and common reasons for denial to anticipate include lack of documentation on not having contraindications, the patient not following a low-calorie diet or engaging in physical activity, and the patient not having seen a registered dietitian.
• Patients should expect gastrointestinal side effects, but ondansetron can be prescribed to lessen the intensity.

Phentermine/Topiramate

Phentermine/topiramate extended-release is a once-daily oral tablet, with the phentermine acting to reduce appetite (by simulating the release of norepinephrine) and the topiramate reducing caloric intake and food reward response (by increasing gamma-aminobutyric acid activity). It’s approved for those aged 12 years or older with a BMI of at least the 95th percentile and should be considered in those with strong hunger, low energy, binge eating disorder, or migraines, as well as those who have insurance coverage for it. It can result in up to a 10% change in BMI.

Contraindications include pregnancy, substance use, cardiovascular disease (though it’s okay in patients with controlled hypertension), hyperthyroidism, glaucoma, and monoamine oxidase inhibitor (MAOI) use. Fox emphasized the teratogenic effects, so patients capable of pregnancy need to be on reliable birth control. The most common side effects include paresthesia, dizziness, dysgeusia, insomnia, and constipation.

A risk of topiramate is kidney stones, so patients should drink a lot of water, especially in hot weather, Fox said. Other risks can include metabolic acidosis, suicidality, poor cognitive function, high blood pressure, and renal impairment.

“If your patient is struggling academically, I might use this medication a bit more cautiously, particularly when the dose gets above 100 mg a day,” Fox said. “That’s when the cognitive effects tend to emerge more strongly.”

Patients with congenital heart disease should meet with their cardiologist before starting this medication, and although patients taking selective serotonin reuptake inhibitors (SSRIs) can take this, there is a potential increased risk for serotonin syndrome because phentermine has a little bit of serotonergic activity, she said.

Before prescribing, do an exam to ensure the patient doesn’t have a heart murmur, isn’t hypertensive, isn’t pregnant, has normal kidney function, and has bicarbonate in a reasonable range. Dosing begins with a daily 3.75/23-mg capsule for 2 weeks, followed by 2 weeks at 7.5 mg/46 mg. As with the GLP-1 drugs, Fox advises considering monthly follow-ups for the first 3 months and then visits every 2-3 months. Each visit should include the assessment of cardiovascular health, heart rate, blood pressure, side effects, pregnancy risk, and the medication’s effect on BMI and eating. If the patient is tolerating a dose of 7.5 mg/46 mg, it can be increased to 11.25 mg/69 mg for 2 weeks and then to 15 mg/92 mg. Bicarbonate and creatinine should be checked every 6-12 months; if bicarbonate < 18 mEq/L, the dose should be reduced and then bicarbonate should be checked again a month later.

Fox noted that this drug is expected to go off patent in late 2024 or in 2025, which will substantially reduce the cost. It’s also possible to prescribe phentermine and topiramate separately, which may reduce costs or help with insurance coverage and can allow for evening dosing of topiramate.
 

Phentermine

Phentermine alone is only approved for those older than 16 years who have a BMI of at least 30, or at least 27 with weight-related comorbidities, and it’s not approved for use longer than 12 weeks. It results in a BMI change of up to 5%. It should be considered in those with strong hunger and low energy and in those who don’t have adequate insurance coverage because out-of-pocket costs can be as little as $5/mo.

Contraindications are the same as those for the combined pill above: Substance use, cardiovascular disease, hyperthyroidism, glaucoma, MAOI use, and agitation. Again, take caution with patients who have hypertension, have congenital heart disease, or take SSRIs or insulin.

Side effects can include palpitations, tachycardia, dry mouth, headache, insomnia, and anxiety. The dose starts at 15 mg daily, and Fox advises following a similar follow-up as with the other medications, at which clinicians should assess BMI, the medication’s effect on eating, cardiovascular health, and side effects and have a discussion about off-label use. Off-label use refers to prescriptions lasting longer than 12 weeks, but it’s arguably safer than attention-deficit/hyperactivity disorder stimulants because of the lower addiction potential, Fox said.
 

What Else to Know

Because obesity is a chronic disease, treatment will be ongoing, Fox noted. A lot of people will ask when or where the “off-ramp” for these medications is, but many people will need these medications long term just as someone with other chronic diseases requires lifetime pharmacotherapy. The treatment intensity will vary based on disease severity and individual characteristics, Fox said.

For those feeling overwhelmed by the options, Fox advises clinicians to start by picking one medication to learn and then spending the time to read the FDA package insert in full. Get samples and then closely follow patients to learn that medication well before moving on to learn another. She also noted the opportunity for pediatricians to see a pediatric obesity medicine fellowship.

No external funding was used for the presentation. Fox is a site principal investigator for clinical trials sponsored by Novo Nordisk and Eli Lilly. Ivers had no disclosures.

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

ORLANDO, FLORIDA — The rationale for using obesity medications in pediatric patients is that it’s using “a biological intervention to treat a biologically based disease,” according to Claudia Fox, MD, MPH, an associate professor of pediatrics and codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota, Minneapolis. At the annual meeting of the American Academy of Pediatrics (AAP), Fox provided an overview of what obesity medications are approved for in youth and how to determine which medications may be best for different patients.

“This field is changing so rapidly that even over the course of the last 3 or 4 months, the verbiage around what we should be calling these interventions has changed,” Fox noted. Instead of “anti-obesity” medications, “most of us are now using the term obesity medications to highlight or to reduce chances of stigma and bias that can come along with this topic.”

Jessica Ivers, MD, a pediatrician at Swedish Pediatrics in Seattle, Washington, said she found the session very informative, particularly because she doesn’t think many pediatricians currently feel very comfortable prescribing obesity medications.

“It answered questions that any general pediatrician would have, and it’s kind of a new field that people are learning about,” Ivers said. “I think we just need more education. It’s just too new, and people haven’t had the education and the support from colleagues to [use the medications].”

Fox first reminded attendees of precisely what obesity is: A chronic, relapsing, multifactorial, neurobehavioral disease that involves the accumulation and/or distribution of excess body fat that results in impaired health. AAP clinical practice guidelines currently advise that youth aged 12 years or older who have obesity be offered weight loss pharmacotherapy as an adjunct to lifestyle treatment, taking into consideration the indications, risks, and benefits of each medication.

That doesn’t necessarily mean every child aged 12 years or older with a body mass index (BMI) of at least the 95th percentile should be prescribed one of these medications, Fox said. But pediatricians should start becoming familiar with the options and recognize that part of reducing the stigma of this disease is emphasizing that these medications are prescribed not for “weight loss” but to treat the disease of obesity, Fox said. The guidelines advise “early, intensive care” and focusing on the whole child, “using a family-centered and nonstigmatizing approach that acknowledges obesity’s biologic, social, and structural drivers.”
 

Offer the Full Spectrum of Care Early On

Early intervention means starting obesity treatment at diagnosis, without watchful waiting or the previously recommended staged approach. Instead of trying lifestyle therapy for 3-6 months, then considering the addition of medication, and then considering bariatric surgery, “we should be offering the full spectrum of obesity care as appropriate for that individual patient,” Fox said.

Some children with severe obesity may need the combination of lifestyle therapy and pharmacotherapy right up front, whereas another might be able to try lifestyle therapy alone for a while first. “What we know is that, for most interventions, whether it is lifestyle therapy, a medication, or bariatric surgery, early response typically predicts longer-term response,” Fox said. A study conducted by her group, for example, found that a 3% BMI reduction after 1 month with lifestyle therapy was very predictive of clinically meaningful BMI reduction at 1 year.

As with any medical treatment, physicians need to weigh the risks of the medication — short-term side effects and unknown long-term risks (or benefits) — against the risks of not treating. Because obesity is a progressive disease, “if we don’t treat it, most will develop comorbid conditions, or worsening of their already present comorbid conditions, and this does indeed lead to shortened life expectancy,” Fox said. Those who should be treated with medication are obviously those in whom the benefits outweigh the risks, Fox said, which depends on their age, their comorbidities, the severity of obesity, and the safety and efficacy of medication options.

“If I have a patient who has maybe class 2 obesity but no other comorbid conditions, I may be less inclined to start an obesity medication than a kid who has class 1 obesity and obstructive sleep apnea, for instance,” Fox said. “Some of the medications are very, very potent and effective. If you have a kid who maybe has less severe forms of obesity, perhaps they don’t need something that’s so potent.”

BMI trajectory is also a factor to consider. She said she may not be too concerned about a 16-year-old who has always been at the 95th percentile and is otherwise healthy, but the situation is different for a 16-year-old who used to be in the 25th percentile and has rapidly progressed to the 50th and then 75th percentiles in a trajectory heading straight up.

Another factor that may come into play is the patient and family preferences, though Fox noted that weight bias and stigma often interfere here. If obesity medications are brought up, the family may bring up the need for more exercise and better meal prep at home.

“They have this sense that they just need to try harder, that if they did that, the obesity would somehow get better on its own,” Fox said. “That’s an internalized bias that it’s somehow their fault, rather than realizing that this is indeed a biological disorder.”

Finally, clinicians may want to consider the child’s response to lifestyle therapy and whether they have already had bariatric surgery because these medications can be prescribed in people who did not have an adequate response to surgery.
 

Overview of the Medications

There are currently six obesity medications approved by the Food and Drug Administration (FDA) for use in youth: Phentermine, orlistat, liraglutide, phentermine/topiramate, semaglutide, and setmelanotide.

Of these, orlistat is rarely used now because it results in the least amount of change in BMI (about a 3% loss change in BMI), has a lot of gastrointestinal side effects, often is not covered by insurance, and is expensive out of pocket. Setmelanotide is indicated only in those aged 6 years or older who have obesity because of Bardet-Biedl syndrome or one of three other rare genetic conditions: a POMC, LEPR, or PCSK1 deficiency. Fox therefore focused on the other medications besides these two.

While nearly all the currently available obesity medications are only approved in those aged 12 years or older, Fox noted that studies are ongoing at younger ages, so some of these medications may receive approval in younger populations in the future. The only one currently available for a younger age is liraglutide, which is approved down to 6 years old in children with type 2 diabetes.

“Very young kids who have very severe forms of obesity need intervention, and unfortunately, at this point, we really don’t have much to offer them,” Fox said.

Fox highlighted six key factors to consider in selecting a medication for those aged 12 years or older, though one of these, in the US healthcare system, can tend to trump all the others. Those factors are mechanism of action, side effect profile, effects on other diagnoses, patient/family preferences, provider comfort, and finally — the potentially overruling one — insurance coverage and access.

“These days, insurance coverage and access are really the No. 1 driver when I’m seeing a patient,” Fox said. “The first thing I do is look at their insurance and then also look at what kind of updates our pharmacist has given us about which medication is currently in stock.”

Each medication has different properties that should be considered with the child’s health profile. For example, topiramate is a carbonic anhydrase inhibitor so likely shouldn’t be prescribed in a child who is taking any other carbonic anhydrase inhibitor. Fox said she probably wouldn’t prescribe phentermine in a child with severe anxiety because it might enhance the anxiety effect. But if a child has migraines, she may be more inclined to try phentermine/topiramate first because the topiramate may help with the migraines. Similarly, if a child has type 2 diabetes or prediabetes, she may lean toward one of the glucagon-like peptide 1 (GLP-1) agonist drugs.
 

Liraglutide and Semaglutide

Liraglutide and semaglutide are both GLP-1 receptor agonists administered subcutaneously to reduce appetite, increase satiety, slow gastric emptying, and reduce the food reward response in the brain. Liraglutide can result in up to 4.5%-5% change in BMI, and semaglutide, the most potent of all the medications, can result in up to a 17% change in BMI.

Liraglutide and semaglutide are both approved for patients aged 12 years or older who weigh at least 60 kg and have a BMI of at least the 95th percentile. Liraglutide is also approved for those aged 10 years or older with type 2 diabetes. Both are contraindicated in those with a family history of medullary thyroid cancer or multiple endocrine neoplasia II. The risks to watch for include pancreatitis and gallbladder disease. Also keep in mind if you have a patient with type 1 diabetes and insulin resistance; prescribing a GLP-1 agonist is appropriate, but their insulin needs will decrease, necessitating close monitoring of their blood glucose, Fox noted.

These GLP-1 medications can be considered for those who have insurance coverage for them, who have diabetes or prediabetes, who are comfortable with daily (liraglutide) or weekly (semaglutide) injections, who have food cravings, and who have poor satiety or satiation. Without insurance, these medications are very expensive.

The most common side effects include injection site reactions and nausea, vomiting, and diarrhea, though all these usually fade and can be minimized with small portions and slower eating if needed. Less common possible side effects can include abdominal pain, constipation, headache, dizziness, fatigue, and hypoglycemia. If patients develop severe belly pain that radiates to their back, they should be assessed for pancreatitis.

It’s also important to demonstrate for patients how to do the injections, Fox said. Liraglutide dosing begins at 0.6 mg daily for a week, followed by a week at 1.2 mg, a week at 1.8 mg, a week at 2.4 mg, and then 3 mg daily. Semaglutide dosing starts at 0.25 mg weekly for 4 weeks, then going up each subsequent month as needed to 0.5 mg, then 1 mg, then 1.7 mg, and finally 2.4 mg. Though there’s no standard follow-up schedule for these medications, Fox suggested considering monthly visits for the first 3 months and then every 2-3 months to assess heart rate and blood pressure, the injection site, adherence, side effects, and the effect on BMI and eating.

“Are they getting appetite suppression, but not too much appetite suppression?” Fox said. “Just like in eating disorder treatment, we want our patients to eat regularly spaced meals. If their appetite is so suppressed that they are hardly eating anything, that’s a problem.”

Fox also offered the following additional pearls about these medications:

• Though manufacturers have struggled to keep up with demand, the shortages of these medications are improving. However, beware the compounding pharmacies filling the gap because compounded medications are not FDA approved, and quality control issues are a concern.
• Prior authorizations are usually needed, and common reasons for denial to anticipate include lack of documentation on not having contraindications, the patient not following a low-calorie diet or engaging in physical activity, and the patient not having seen a registered dietitian.
• Patients should expect gastrointestinal side effects, but ondansetron can be prescribed to lessen the intensity.

Phentermine/Topiramate

Phentermine/topiramate extended-release is a once-daily oral tablet, with the phentermine acting to reduce appetite (by simulating the release of norepinephrine) and the topiramate reducing caloric intake and food reward response (by increasing gamma-aminobutyric acid activity). It’s approved for those aged 12 years or older with a BMI of at least the 95th percentile and should be considered in those with strong hunger, low energy, binge eating disorder, or migraines, as well as those who have insurance coverage for it. It can result in up to a 10% change in BMI.

Contraindications include pregnancy, substance use, cardiovascular disease (though it’s okay in patients with controlled hypertension), hyperthyroidism, glaucoma, and monoamine oxidase inhibitor (MAOI) use. Fox emphasized the teratogenic effects, so patients capable of pregnancy need to be on reliable birth control. The most common side effects include paresthesia, dizziness, dysgeusia, insomnia, and constipation.

A risk of topiramate is kidney stones, so patients should drink a lot of water, especially in hot weather, Fox said. Other risks can include metabolic acidosis, suicidality, poor cognitive function, high blood pressure, and renal impairment.

“If your patient is struggling academically, I might use this medication a bit more cautiously, particularly when the dose gets above 100 mg a day,” Fox said. “That’s when the cognitive effects tend to emerge more strongly.”

Patients with congenital heart disease should meet with their cardiologist before starting this medication, and although patients taking selective serotonin reuptake inhibitors (SSRIs) can take this, there is a potential increased risk for serotonin syndrome because phentermine has a little bit of serotonergic activity, she said.

Before prescribing, do an exam to ensure the patient doesn’t have a heart murmur, isn’t hypertensive, isn’t pregnant, has normal kidney function, and has bicarbonate in a reasonable range. Dosing begins with a daily 3.75/23-mg capsule for 2 weeks, followed by 2 weeks at 7.5 mg/46 mg. As with the GLP-1 drugs, Fox advises considering monthly follow-ups for the first 3 months and then visits every 2-3 months. Each visit should include the assessment of cardiovascular health, heart rate, blood pressure, side effects, pregnancy risk, and the medication’s effect on BMI and eating. If the patient is tolerating a dose of 7.5 mg/46 mg, it can be increased to 11.25 mg/69 mg for 2 weeks and then to 15 mg/92 mg. Bicarbonate and creatinine should be checked every 6-12 months; if bicarbonate < 18 mEq/L, the dose should be reduced and then bicarbonate should be checked again a month later.

Fox noted that this drug is expected to go off patent in late 2024 or in 2025, which will substantially reduce the cost. It’s also possible to prescribe phentermine and topiramate separately, which may reduce costs or help with insurance coverage and can allow for evening dosing of topiramate.
 

Phentermine

Phentermine alone is only approved for those older than 16 years who have a BMI of at least 30, or at least 27 with weight-related comorbidities, and it’s not approved for use longer than 12 weeks. It results in a BMI change of up to 5%. It should be considered in those with strong hunger and low energy and in those who don’t have adequate insurance coverage because out-of-pocket costs can be as little as $5/mo.

Contraindications are the same as those for the combined pill above: Substance use, cardiovascular disease, hyperthyroidism, glaucoma, MAOI use, and agitation. Again, take caution with patients who have hypertension, have congenital heart disease, or take SSRIs or insulin.

Side effects can include palpitations, tachycardia, dry mouth, headache, insomnia, and anxiety. The dose starts at 15 mg daily, and Fox advises following a similar follow-up as with the other medications, at which clinicians should assess BMI, the medication’s effect on eating, cardiovascular health, and side effects and have a discussion about off-label use. Off-label use refers to prescriptions lasting longer than 12 weeks, but it’s arguably safer than attention-deficit/hyperactivity disorder stimulants because of the lower addiction potential, Fox said.
 

What Else to Know

Because obesity is a chronic disease, treatment will be ongoing, Fox noted. A lot of people will ask when or where the “off-ramp” for these medications is, but many people will need these medications long term just as someone with other chronic diseases requires lifetime pharmacotherapy. The treatment intensity will vary based on disease severity and individual characteristics, Fox said.

For those feeling overwhelmed by the options, Fox advises clinicians to start by picking one medication to learn and then spending the time to read the FDA package insert in full. Get samples and then closely follow patients to learn that medication well before moving on to learn another. She also noted the opportunity for pediatricians to see a pediatric obesity medicine fellowship.

No external funding was used for the presentation. Fox is a site principal investigator for clinical trials sponsored by Novo Nordisk and Eli Lilly. Ivers had no disclosures.

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

VIENNA — A diet high in ultraprocessed foods (UPFs) increases the risk for clinical relapse in patients with Crohn’s disease (CD) who are in remission, results of a new study suggested.

Certain subgroups of UPFs, specifically bread, pastries, and starch as well as oil and spreads, exhibited the strongest association with relapse risks of approximately threefold.

“In addition to treating active inflammatory bowel disease (IBD), we want to maintain remission for the long term,” Chen Sarbagili Shabat, PhD, clinical dietitian from Tel Aviv Medical Center in Israel, said in an interview. “It’s highly important. We know environmental factors are associated with the disease, which is why we can treat active disease with diet. Likewise, we can manage CD in a remission state with diet.”

This is the first prospective study of this particular level of UPFs in people with Crohn’s disease who are in remission, noted Shabat, who presented the findings at United European Gastroenterology (UEG) Week 2024.

Previously, a meta-analysis of prospective cohort studies showed that a diet high in UPFs is associated with a 70% increased risk for development of CD, and a longitudinal study showed that “Western” dietary patterns were associated with relapse risk in patients with IBD, Shabat reported.
 

Effect of High vs Low Intake of UPFs

The current single-center, prospective cohort study, followed 111 patients with CD every 3 months until relapse for up to 1 year.

Participants were aged 18-75 years (mean age, 38 years), with a median disease duration of 8.7 years. They were required to have maintained steroid-free clinical remission (Harvey-Bradshaw Index (HBI), < 5) for 3 months or more. The median duration of clinical remission at recruitment was 3 years.

Data collection included HBI level, medication type and dosage to ensure constant therapy and full compliance, and a stool sample for fecal calprotectin measurement.

The primary outcome comprised a clinical relapse HBI ≥ 5 over the 12-month follow-up or a change in disease activity requiring a change in medication, hospitalization, or any IBD-related surgery.

Participants were asked to complete a processed food questionnaire to assess the intake of UPFs and a food frequency questionnaire to assess the total intake of energy, macronutrients, and micronutrients. UPFs were divided into high and low intakes using a median cutoff of 3.6 servings/day.

The low intake group included 57 participants, and the high intake group included 54.

A total of 24 patients (21.6%) experienced a clinical relapse event, 7 in the low intake group vs 17 in the high intake group (hazard ratio [HR], 3.86; 95% CI, 1.30-11.47; P = .015 after adjustments).

In a subset of 97 patients with baseline fecal calprotectin measurements, 6 (n = 50) in the low intake group experienced a clinical relapse vs 15 (n = 47) in the high intake group (HR, 4.32; 95% CI, 1.36-13.73; P = .013 after adjustments).

Fecal calprotectin results were also suggestive of an association between high intake of UPFs and gut inflammation, Shabat reported.
 

Food Groups and Emulsifiers

UPFs were divided into subgroups: Bread, pastries, and starch; oils and spreads; ultraprocessed meat; sweet products and desserts; and ultraprocessed beverages.

The highest associations with relapse were in the subgroup of bread, pastries, and starch (HR, 3.37; 95% CI, 1.26-8.25) and the subgroup of oils and spreads (HR, 2.76; 95% CI, 1.02-7.45).

“The selection of healthy food is highly important, especially since we know that certain food ingredients can contribute to the pathogenesis of CD,” Shabat said. Patients can use partial enteral nutrition to provide 40%-50% of daily caloric intake in order to maintain remission, but she acknowledged it can be really difficult to adhere to.

She concluded by asserting that the study results, along with future research, should contribute to establishing nutritional guidelines to reduce UPF consumption in patients with CD in order to maintain remission.

Commenting on the study, Kevin Whelan, PhD, professor of dietetics and head of the Department of Nutritional Sciences at King’s College London in England, said that he was intrigued by the subgroup analysis that showed breads, pastries, oils, and spreads as having the strongest association with relapse risk.

He also remarked that these foods almost ubiquitously contain emulsifiers, and so the association might have less to do with UPFs in general and more to do with emulsifiers.

Concurring, Shabat noted that, while emulsifiers can negatively influence the microbiota and the gut barrier function, as well as contribute to intestinal inflammation, further mechanistic studies are required to understand these effects.

We need to determine if all additives have the same effect on the inflammatory process and also need studies looking at UPFs alone, she added.

Shabat reported receiving personal fees from Nestle Health Science (Wolfson Medical Center IP) for consulting and speaking and from Takeda and Ferring for speaking. Whelan reported no relevant disclosures.

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

VIENNA — A diet high in ultraprocessed foods (UPFs) increases the risk for clinical relapse in patients with Crohn’s disease (CD) who are in remission, results of a new study suggested.

Certain subgroups of UPFs, specifically bread, pastries, and starch as well as oil and spreads, exhibited the strongest association with relapse risks of approximately threefold.

“In addition to treating active inflammatory bowel disease (IBD), we want to maintain remission for the long term,” Chen Sarbagili Shabat, PhD, clinical dietitian from Tel Aviv Medical Center in Israel, said in an interview. “It’s highly important. We know environmental factors are associated with the disease, which is why we can treat active disease with diet. Likewise, we can manage CD in a remission state with diet.”

This is the first prospective study of this particular level of UPFs in people with Crohn’s disease who are in remission, noted Shabat, who presented the findings at United European Gastroenterology (UEG) Week 2024.

Previously, a meta-analysis of prospective cohort studies showed that a diet high in UPFs is associated with a 70% increased risk for development of CD, and a longitudinal study showed that “Western” dietary patterns were associated with relapse risk in patients with IBD, Shabat reported.
 

Effect of High vs Low Intake of UPFs

The current single-center, prospective cohort study, followed 111 patients with CD every 3 months until relapse for up to 1 year.

Participants were aged 18-75 years (mean age, 38 years), with a median disease duration of 8.7 years. They were required to have maintained steroid-free clinical remission (Harvey-Bradshaw Index (HBI), < 5) for 3 months or more. The median duration of clinical remission at recruitment was 3 years.

Data collection included HBI level, medication type and dosage to ensure constant therapy and full compliance, and a stool sample for fecal calprotectin measurement.

The primary outcome comprised a clinical relapse HBI ≥ 5 over the 12-month follow-up or a change in disease activity requiring a change in medication, hospitalization, or any IBD-related surgery.

Participants were asked to complete a processed food questionnaire to assess the intake of UPFs and a food frequency questionnaire to assess the total intake of energy, macronutrients, and micronutrients. UPFs were divided into high and low intakes using a median cutoff of 3.6 servings/day.

The low intake group included 57 participants, and the high intake group included 54.

A total of 24 patients (21.6%) experienced a clinical relapse event, 7 in the low intake group vs 17 in the high intake group (hazard ratio [HR], 3.86; 95% CI, 1.30-11.47; P = .015 after adjustments).

In a subset of 97 patients with baseline fecal calprotectin measurements, 6 (n = 50) in the low intake group experienced a clinical relapse vs 15 (n = 47) in the high intake group (HR, 4.32; 95% CI, 1.36-13.73; P = .013 after adjustments).

Fecal calprotectin results were also suggestive of an association between high intake of UPFs and gut inflammation, Shabat reported.
 

Food Groups and Emulsifiers

UPFs were divided into subgroups: Bread, pastries, and starch; oils and spreads; ultraprocessed meat; sweet products and desserts; and ultraprocessed beverages.

The highest associations with relapse were in the subgroup of bread, pastries, and starch (HR, 3.37; 95% CI, 1.26-8.25) and the subgroup of oils and spreads (HR, 2.76; 95% CI, 1.02-7.45).

“The selection of healthy food is highly important, especially since we know that certain food ingredients can contribute to the pathogenesis of CD,” Shabat said. Patients can use partial enteral nutrition to provide 40%-50% of daily caloric intake in order to maintain remission, but she acknowledged it can be really difficult to adhere to.

She concluded by asserting that the study results, along with future research, should contribute to establishing nutritional guidelines to reduce UPF consumption in patients with CD in order to maintain remission.

Commenting on the study, Kevin Whelan, PhD, professor of dietetics and head of the Department of Nutritional Sciences at King’s College London in England, said that he was intrigued by the subgroup analysis that showed breads, pastries, oils, and spreads as having the strongest association with relapse risk.

He also remarked that these foods almost ubiquitously contain emulsifiers, and so the association might have less to do with UPFs in general and more to do with emulsifiers.

Concurring, Shabat noted that, while emulsifiers can negatively influence the microbiota and the gut barrier function, as well as contribute to intestinal inflammation, further mechanistic studies are required to understand these effects.

We need to determine if all additives have the same effect on the inflammatory process and also need studies looking at UPFs alone, she added.

Shabat reported receiving personal fees from Nestle Health Science (Wolfson Medical Center IP) for consulting and speaking and from Takeda and Ferring for speaking. Whelan reported no relevant disclosures.

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

VIENNA — A diet high in ultraprocessed foods (UPFs) increases the risk for clinical relapse in patients with Crohn’s disease (CD) who are in remission, results of a new study suggested.

Certain subgroups of UPFs, specifically bread, pastries, and starch as well as oil and spreads, exhibited the strongest association with relapse risks of approximately threefold.

“In addition to treating active inflammatory bowel disease (IBD), we want to maintain remission for the long term,” Chen Sarbagili Shabat, PhD, clinical dietitian from Tel Aviv Medical Center in Israel, said in an interview. “It’s highly important. We know environmental factors are associated with the disease, which is why we can treat active disease with diet. Likewise, we can manage CD in a remission state with diet.”

This is the first prospective study of this particular level of UPFs in people with Crohn’s disease who are in remission, noted Shabat, who presented the findings at United European Gastroenterology (UEG) Week 2024.

Previously, a meta-analysis of prospective cohort studies showed that a diet high in UPFs is associated with a 70% increased risk for development of CD, and a longitudinal study showed that “Western” dietary patterns were associated with relapse risk in patients with IBD, Shabat reported.
 

Effect of High vs Low Intake of UPFs

The current single-center, prospective cohort study, followed 111 patients with CD every 3 months until relapse for up to 1 year.

Participants were aged 18-75 years (mean age, 38 years), with a median disease duration of 8.7 years. They were required to have maintained steroid-free clinical remission (Harvey-Bradshaw Index (HBI), < 5) for 3 months or more. The median duration of clinical remission at recruitment was 3 years.

Data collection included HBI level, medication type and dosage to ensure constant therapy and full compliance, and a stool sample for fecal calprotectin measurement.

The primary outcome comprised a clinical relapse HBI ≥ 5 over the 12-month follow-up or a change in disease activity requiring a change in medication, hospitalization, or any IBD-related surgery.

Participants were asked to complete a processed food questionnaire to assess the intake of UPFs and a food frequency questionnaire to assess the total intake of energy, macronutrients, and micronutrients. UPFs were divided into high and low intakes using a median cutoff of 3.6 servings/day.

The low intake group included 57 participants, and the high intake group included 54.

A total of 24 patients (21.6%) experienced a clinical relapse event, 7 in the low intake group vs 17 in the high intake group (hazard ratio [HR], 3.86; 95% CI, 1.30-11.47; P = .015 after adjustments).

In a subset of 97 patients with baseline fecal calprotectin measurements, 6 (n = 50) in the low intake group experienced a clinical relapse vs 15 (n = 47) in the high intake group (HR, 4.32; 95% CI, 1.36-13.73; P = .013 after adjustments).

Fecal calprotectin results were also suggestive of an association between high intake of UPFs and gut inflammation, Shabat reported.
 

Food Groups and Emulsifiers

UPFs were divided into subgroups: Bread, pastries, and starch; oils and spreads; ultraprocessed meat; sweet products and desserts; and ultraprocessed beverages.

The highest associations with relapse were in the subgroup of bread, pastries, and starch (HR, 3.37; 95% CI, 1.26-8.25) and the subgroup of oils and spreads (HR, 2.76; 95% CI, 1.02-7.45).

“The selection of healthy food is highly important, especially since we know that certain food ingredients can contribute to the pathogenesis of CD,” Shabat said. Patients can use partial enteral nutrition to provide 40%-50% of daily caloric intake in order to maintain remission, but she acknowledged it can be really difficult to adhere to.

She concluded by asserting that the study results, along with future research, should contribute to establishing nutritional guidelines to reduce UPF consumption in patients with CD in order to maintain remission.

Commenting on the study, Kevin Whelan, PhD, professor of dietetics and head of the Department of Nutritional Sciences at King’s College London in England, said that he was intrigued by the subgroup analysis that showed breads, pastries, oils, and spreads as having the strongest association with relapse risk.

He also remarked that these foods almost ubiquitously contain emulsifiers, and so the association might have less to do with UPFs in general and more to do with emulsifiers.

Concurring, Shabat noted that, while emulsifiers can negatively influence the microbiota and the gut barrier function, as well as contribute to intestinal inflammation, further mechanistic studies are required to understand these effects.

We need to determine if all additives have the same effect on the inflammatory process and also need studies looking at UPFs alone, she added.

Shabat reported receiving personal fees from Nestle Health Science (Wolfson Medical Center IP) for consulting and speaking and from Takeda and Ferring for speaking. Whelan reported no relevant disclosures.

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