Clinician Reviews

VANCOUVER – With treatment with a bisphosphonate following sequential use of teriparatide (Forteo) and denosumab (Prolia) for premenopausal women with idiopathic osteoporosis, bone mineral density (BMD) was maintained over the first year following denosumab cessation, according to results from a small, nonrandomized extension of a phase 2 study.

Bisphosphonates are recommended for patients after they have completed a course of denosumab because cessation of the bone resorption blocker is known to increase bone turnover markers, decrease BMD, and raise the risk of vertebral fractures. Although there is evidence to support this treatment sequence for postmenopausal women, there was no evidence regarding premenopausal women with idiopathic osteoporosis, said Adi Cohen, MD, who presented the results of the study at the annual meeting of the American Society for Bone and Mineral Research.

In the extension study, neither length of treatment with denosumab nor transition to menopause affected BMD results. Weekly doses of alendronate (ALN) better suppressed C-terminal telopeptide (CTX) than did zoledronic acid (ZOL) and led to better maintenance of BMD than did a single dose of ZOL. The researchers suggested that single-dose ZOL may not prevent bone loss for an entire year.

It is too early to call the results practice changing, said Dr. Cohen, professor of medicine and endocrinology at Columbia University Irving Medical Center, New York, but she noted, “It’s important just to provide information about how sequences of osteoporosis medications might be used in a rare but certainly understudied group of premenopausal women with osteoporosis who need treatment, and these data hopefully will help make some treatment decisions.”

In the early 2000s, researchers initially believed that premenopausal women with low BMD had experienced some kind of temporary event and that they would likely improve on their own over time. “I think we now recognize that whatever it is that causes this is an ongoing issue and that this is a problem they’re going to have to deal with for the rest of their lives. This is something that they have to stay on top of,” said coauthor Elizabeth Shane, MD, who is a professor of medicine at CUIMC.

However, there are no practice guidelines for the management of osteoporosis in premenopausal women, according to Dr. Shane. She noted that there is controversy as to whether to treat women with low bone density who do not have a history of fractures. “I think that there’s pretty much agreement that anybody who has a lot of fractures has an early-onset form of osteoporosis. The controversy is what to do about the person who just has a low bone density and hasn’t yet fractured and what is the utility of trying to treat them at that point and perhaps prevent a fracture. I don’t think we have enough data to address that,” Dr. Shane said.

Still, the research has provided some clarity in her own practice. “I think if somebody would come to my office who had very low bone density, I would probably treat them. If they have fractures, I would definitely treat them. I think that our work has provided a framework for people to approach that,” she said.

The study was an extension of a sequential treatment approach that began with 2 years of teriparatide (20 mcg daily) followed by an extension study of 2–3 years of treatment with denosumab (60 mg every 6 months). Seven months after the last dose of denosumab, patients underwent 1 year of treatment with ALN (70 mg weekly; n = 18) or a single dose of ZOL (5 mg IV; n = 6), according to patient choice.

The original phase 2 study started with 41 women. At 24 months, teriparatide treatment led to BMD increases of 13% in the lumbar spine (LS), 5% in the total hip (TH), and 5% in the femoral neck (FN). There was a 2% decline in BMD in the forearm (distal radius [DR]). A group of 32 of the women participated in an extension study and took denosumab for 12 months. Of those patients, 29 continued to take it for another 12 months. At 12 months, BMD increased 5% in the LS, 3% in the TH, 3% in the FN, and 1% in the DR (P < .05 for all). At 24 months, BMD rose by 22%, 10%, and 10% at the first three of those locations. BMD in the DR remained stable, compared with the baseline after taking teriparatide.

The bisphosphonate phase of the extension study included 24 women (mean age, 43 years). The mean body mass index of the patients was 23.0 kg/m². The patients had experienced a mean of 3.0 fractures in adulthood, and 38% of patients had a history of vertebral fracture.

Over 12 months of follow-up, the researchers found no statistically significant difference in BMD in the LS, TH, or FN, compared with bisphosphonate extension baseline. There was also no statistically significant change in serum CTX. There was evidence that, among patients with higher rates of bone turnover, there were higher rates of LS and FN bone loss during bisphosphonate treatment.

Among patients taking ZOL, at 12 months there was a statistically significant rise in CTX levels, but not among patients taking ALN. There were no new vertebral fractures among any participants during the bisphosphonate extension period.

The results represent critical data for an understudied population, according to Yumie Rhee, MD, PhD, who was comoderator of the session in which the study was presented. “They are showing that by using a bisphosphonate [patients] have this just slight decrease, but within error, so it’s maintaining the BMD, at least. I think it’s very important. It will be fascinating to see next year’s follow-up,” said Dr. Rhee, a professor of endocrinology at Yonsei University College of Medicine in Seoul, South Korea. “The problem with premenopausal osteoporosis is that we don’t have good evidence. Even though this study is very small, we’re just following that data, all of us.”

Comoderator Maria Zanchetta, MD, a professor of osteology at the Institute of Diagnostics and Metabolic Research, Universidad del Salvador, Buenos Aires, agreed. “We know what to do when we stop denosumab in postmenopausal women. We didn’t have any work about what to do when we stopped in premenopausal women. You can think that probably it’s going to be the same, but this is the first time you have the evidence that if you give bisphosphonate, you will maintain BMD.”

Limitations to the study include its small size and the lack of a placebo-treated control group. In addition, the bisphosphonate extension was not randomized.

The studies were funded by the U.S. Food and Drug Administration and Amgen. Dr. Cohen and Dr. Shane received research funding from Amgen. Dr. Rhee and Dr. Zanchetta have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

VANCOUVER – With treatment with a bisphosphonate following sequential use of teriparatide (Forteo) and denosumab (Prolia) for premenopausal women with idiopathic osteoporosis, bone mineral density (BMD) was maintained over the first year following denosumab cessation, according to results from a small, nonrandomized extension of a phase 2 study.

Bisphosphonates are recommended for patients after they have completed a course of denosumab because cessation of the bone resorption blocker is known to increase bone turnover markers, decrease BMD, and raise the risk of vertebral fractures. Although there is evidence to support this treatment sequence for postmenopausal women, there was no evidence regarding premenopausal women with idiopathic osteoporosis, said Adi Cohen, MD, who presented the results of the study at the annual meeting of the American Society for Bone and Mineral Research.

In the extension study, neither length of treatment with denosumab nor transition to menopause affected BMD results. Weekly doses of alendronate (ALN) better suppressed C-terminal telopeptide (CTX) than did zoledronic acid (ZOL) and led to better maintenance of BMD than did a single dose of ZOL. The researchers suggested that single-dose ZOL may not prevent bone loss for an entire year.

It is too early to call the results practice changing, said Dr. Cohen, professor of medicine and endocrinology at Columbia University Irving Medical Center, New York, but she noted, “It’s important just to provide information about how sequences of osteoporosis medications might be used in a rare but certainly understudied group of premenopausal women with osteoporosis who need treatment, and these data hopefully will help make some treatment decisions.”

In the early 2000s, researchers initially believed that premenopausal women with low BMD had experienced some kind of temporary event and that they would likely improve on their own over time. “I think we now recognize that whatever it is that causes this is an ongoing issue and that this is a problem they’re going to have to deal with for the rest of their lives. This is something that they have to stay on top of,” said coauthor Elizabeth Shane, MD, who is a professor of medicine at CUIMC.

However, there are no practice guidelines for the management of osteoporosis in premenopausal women, according to Dr. Shane. She noted that there is controversy as to whether to treat women with low bone density who do not have a history of fractures. “I think that there’s pretty much agreement that anybody who has a lot of fractures has an early-onset form of osteoporosis. The controversy is what to do about the person who just has a low bone density and hasn’t yet fractured and what is the utility of trying to treat them at that point and perhaps prevent a fracture. I don’t think we have enough data to address that,” Dr. Shane said.

Still, the research has provided some clarity in her own practice. “I think if somebody would come to my office who had very low bone density, I would probably treat them. If they have fractures, I would definitely treat them. I think that our work has provided a framework for people to approach that,” she said.

The study was an extension of a sequential treatment approach that began with 2 years of teriparatide (20 mcg daily) followed by an extension study of 2–3 years of treatment with denosumab (60 mg every 6 months). Seven months after the last dose of denosumab, patients underwent 1 year of treatment with ALN (70 mg weekly; n = 18) or a single dose of ZOL (5 mg IV; n = 6), according to patient choice.

The original phase 2 study started with 41 women. At 24 months, teriparatide treatment led to BMD increases of 13% in the lumbar spine (LS), 5% in the total hip (TH), and 5% in the femoral neck (FN). There was a 2% decline in BMD in the forearm (distal radius [DR]). A group of 32 of the women participated in an extension study and took denosumab for 12 months. Of those patients, 29 continued to take it for another 12 months. At 12 months, BMD increased 5% in the LS, 3% in the TH, 3% in the FN, and 1% in the DR (P < .05 for all). At 24 months, BMD rose by 22%, 10%, and 10% at the first three of those locations. BMD in the DR remained stable, compared with the baseline after taking teriparatide.

The bisphosphonate phase of the extension study included 24 women (mean age, 43 years). The mean body mass index of the patients was 23.0 kg/m². The patients had experienced a mean of 3.0 fractures in adulthood, and 38% of patients had a history of vertebral fracture.

Over 12 months of follow-up, the researchers found no statistically significant difference in BMD in the LS, TH, or FN, compared with bisphosphonate extension baseline. There was also no statistically significant change in serum CTX. There was evidence that, among patients with higher rates of bone turnover, there were higher rates of LS and FN bone loss during bisphosphonate treatment.

Among patients taking ZOL, at 12 months there was a statistically significant rise in CTX levels, but not among patients taking ALN. There were no new vertebral fractures among any participants during the bisphosphonate extension period.

The results represent critical data for an understudied population, according to Yumie Rhee, MD, PhD, who was comoderator of the session in which the study was presented. “They are showing that by using a bisphosphonate [patients] have this just slight decrease, but within error, so it’s maintaining the BMD, at least. I think it’s very important. It will be fascinating to see next year’s follow-up,” said Dr. Rhee, a professor of endocrinology at Yonsei University College of Medicine in Seoul, South Korea. “The problem with premenopausal osteoporosis is that we don’t have good evidence. Even though this study is very small, we’re just following that data, all of us.”

Comoderator Maria Zanchetta, MD, a professor of osteology at the Institute of Diagnostics and Metabolic Research, Universidad del Salvador, Buenos Aires, agreed. “We know what to do when we stop denosumab in postmenopausal women. We didn’t have any work about what to do when we stopped in premenopausal women. You can think that probably it’s going to be the same, but this is the first time you have the evidence that if you give bisphosphonate, you will maintain BMD.”

Limitations to the study include its small size and the lack of a placebo-treated control group. In addition, the bisphosphonate extension was not randomized.

The studies were funded by the U.S. Food and Drug Administration and Amgen. Dr. Cohen and Dr. Shane received research funding from Amgen. Dr. Rhee and Dr. Zanchetta have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

VANCOUVER – With treatment with a bisphosphonate following sequential use of teriparatide (Forteo) and denosumab (Prolia) for premenopausal women with idiopathic osteoporosis, bone mineral density (BMD) was maintained over the first year following denosumab cessation, according to results from a small, nonrandomized extension of a phase 2 study.

Bisphosphonates are recommended for patients after they have completed a course of denosumab because cessation of the bone resorption blocker is known to increase bone turnover markers, decrease BMD, and raise the risk of vertebral fractures. Although there is evidence to support this treatment sequence for postmenopausal women, there was no evidence regarding premenopausal women with idiopathic osteoporosis, said Adi Cohen, MD, who presented the results of the study at the annual meeting of the American Society for Bone and Mineral Research.

In the extension study, neither length of treatment with denosumab nor transition to menopause affected BMD results. Weekly doses of alendronate (ALN) better suppressed C-terminal telopeptide (CTX) than did zoledronic acid (ZOL) and led to better maintenance of BMD than did a single dose of ZOL. The researchers suggested that single-dose ZOL may not prevent bone loss for an entire year.

It is too early to call the results practice changing, said Dr. Cohen, professor of medicine and endocrinology at Columbia University Irving Medical Center, New York, but she noted, “It’s important just to provide information about how sequences of osteoporosis medications might be used in a rare but certainly understudied group of premenopausal women with osteoporosis who need treatment, and these data hopefully will help make some treatment decisions.”

In the early 2000s, researchers initially believed that premenopausal women with low BMD had experienced some kind of temporary event and that they would likely improve on their own over time. “I think we now recognize that whatever it is that causes this is an ongoing issue and that this is a problem they’re going to have to deal with for the rest of their lives. This is something that they have to stay on top of,” said coauthor Elizabeth Shane, MD, who is a professor of medicine at CUIMC.

However, there are no practice guidelines for the management of osteoporosis in premenopausal women, according to Dr. Shane. She noted that there is controversy as to whether to treat women with low bone density who do not have a history of fractures. “I think that there’s pretty much agreement that anybody who has a lot of fractures has an early-onset form of osteoporosis. The controversy is what to do about the person who just has a low bone density and hasn’t yet fractured and what is the utility of trying to treat them at that point and perhaps prevent a fracture. I don’t think we have enough data to address that,” Dr. Shane said.

Still, the research has provided some clarity in her own practice. “I think if somebody would come to my office who had very low bone density, I would probably treat them. If they have fractures, I would definitely treat them. I think that our work has provided a framework for people to approach that,” she said.

The study was an extension of a sequential treatment approach that began with 2 years of teriparatide (20 mcg daily) followed by an extension study of 2–3 years of treatment with denosumab (60 mg every 6 months). Seven months after the last dose of denosumab, patients underwent 1 year of treatment with ALN (70 mg weekly; n = 18) or a single dose of ZOL (5 mg IV; n = 6), according to patient choice.

The original phase 2 study started with 41 women. At 24 months, teriparatide treatment led to BMD increases of 13% in the lumbar spine (LS), 5% in the total hip (TH), and 5% in the femoral neck (FN). There was a 2% decline in BMD in the forearm (distal radius [DR]). A group of 32 of the women participated in an extension study and took denosumab for 12 months. Of those patients, 29 continued to take it for another 12 months. At 12 months, BMD increased 5% in the LS, 3% in the TH, 3% in the FN, and 1% in the DR (P < .05 for all). At 24 months, BMD rose by 22%, 10%, and 10% at the first three of those locations. BMD in the DR remained stable, compared with the baseline after taking teriparatide.

The bisphosphonate phase of the extension study included 24 women (mean age, 43 years). The mean body mass index of the patients was 23.0 kg/m². The patients had experienced a mean of 3.0 fractures in adulthood, and 38% of patients had a history of vertebral fracture.

Over 12 months of follow-up, the researchers found no statistically significant difference in BMD in the LS, TH, or FN, compared with bisphosphonate extension baseline. There was also no statistically significant change in serum CTX. There was evidence that, among patients with higher rates of bone turnover, there were higher rates of LS and FN bone loss during bisphosphonate treatment.

Among patients taking ZOL, at 12 months there was a statistically significant rise in CTX levels, but not among patients taking ALN. There were no new vertebral fractures among any participants during the bisphosphonate extension period.

The results represent critical data for an understudied population, according to Yumie Rhee, MD, PhD, who was comoderator of the session in which the study was presented. “They are showing that by using a bisphosphonate [patients] have this just slight decrease, but within error, so it’s maintaining the BMD, at least. I think it’s very important. It will be fascinating to see next year’s follow-up,” said Dr. Rhee, a professor of endocrinology at Yonsei University College of Medicine in Seoul, South Korea. “The problem with premenopausal osteoporosis is that we don’t have good evidence. Even though this study is very small, we’re just following that data, all of us.”

Comoderator Maria Zanchetta, MD, a professor of osteology at the Institute of Diagnostics and Metabolic Research, Universidad del Salvador, Buenos Aires, agreed. “We know what to do when we stop denosumab in postmenopausal women. We didn’t have any work about what to do when we stopped in premenopausal women. You can think that probably it’s going to be the same, but this is the first time you have the evidence that if you give bisphosphonate, you will maintain BMD.”

Limitations to the study include its small size and the lack of a placebo-treated control group. In addition, the bisphosphonate extension was not randomized.

The studies were funded by the U.S. Food and Drug Administration and Amgen. Dr. Cohen and Dr. Shane received research funding from Amgen. Dr. Rhee and Dr. Zanchetta have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Endoscopic sleeve gastroplasty (ESG) is safe and effective for weight loss in adults with class I, II, or III obesity, according to real-world data from a large U.S. study.

METHODOLOGY:

• Researchers conducted a retrospective analysis of 1,506 adults (85% female, 70% White) with severe obesity (501 class I, 546 class II, and 459 class III) who underwent ESG at seven academic and private U.S. centers from 2013 to 2022.
• Average percent total body weight loss (%TBWL) was evaluated at 6, 12, 18, and 24 months after the procedure.
• Weight loss and safety outcomes were evaluated according to obesity class.

TAKEAWAY:

• At 12 months, 83.2% of patients achieved ≥10% TBWL and 60.9% achieved ≥15% TBWL across all obesity classes.
• There was a significant difference in TBWL by baseline obesity class, with average weight loss significantly greater in class III than classes I and II at all time points. At 24 months, class III patients had mean TBWL of 20.4%, compared with 13.3% for class I and 13.6% for class II patients.
• As early as 6 months post-ESG, patients in all BMI classes were able to drop to the next lower BMI class and remained there through 2 years. However, ongoing improvement in BMI until the end of follow-up was seen only in class III patients. Notably, class III patients were significantly younger and taller than class I and class II patients.
• There were no differences in adverse events between obesity classes. Only 2.6% of patients had an adverse event requiring hospitalization. Most of these events (86%) were for symptom management and/or fluid replacement.

IN PRACTICE:

“Traditionally, ESG has been proposed as a treatment choice for patients with class I and II obesity because of its modest weight loss outcomes. However, our data show a %TBWL crossing 20% in patients with class III disease, which may push the envelope of perceived utility of ESG,” the authors write.

SOURCE:

The study, with first author Khushboo Gala, MBBS, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn., was published online in Clinical and Translational Gastroenterology.

LIMITATIONS:

Limitations include the retrospective design, with outcomes only out to 2 years, and loss of follow-up, with only 339 of the 1506 patients evaluated at 2 years.

DISCLOSURES:

The study had no financial support. Several study authors reported ties to industry. The full list can be found with the original article.

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

TOPLINE:

Endoscopic sleeve gastroplasty (ESG) is safe and effective for weight loss in adults with class I, II, or III obesity, according to real-world data from a large U.S. study.

METHODOLOGY:

• Researchers conducted a retrospective analysis of 1,506 adults (85% female, 70% White) with severe obesity (501 class I, 546 class II, and 459 class III) who underwent ESG at seven academic and private U.S. centers from 2013 to 2022.
• Average percent total body weight loss (%TBWL) was evaluated at 6, 12, 18, and 24 months after the procedure.
• Weight loss and safety outcomes were evaluated according to obesity class.

TAKEAWAY:

• At 12 months, 83.2% of patients achieved ≥10% TBWL and 60.9% achieved ≥15% TBWL across all obesity classes.
• There was a significant difference in TBWL by baseline obesity class, with average weight loss significantly greater in class III than classes I and II at all time points. At 24 months, class III patients had mean TBWL of 20.4%, compared with 13.3% for class I and 13.6% for class II patients.
• As early as 6 months post-ESG, patients in all BMI classes were able to drop to the next lower BMI class and remained there through 2 years. However, ongoing improvement in BMI until the end of follow-up was seen only in class III patients. Notably, class III patients were significantly younger and taller than class I and class II patients.
• There were no differences in adverse events between obesity classes. Only 2.6% of patients had an adverse event requiring hospitalization. Most of these events (86%) were for symptom management and/or fluid replacement.

IN PRACTICE:

“Traditionally, ESG has been proposed as a treatment choice for patients with class I and II obesity because of its modest weight loss outcomes. However, our data show a %TBWL crossing 20% in patients with class III disease, which may push the envelope of perceived utility of ESG,” the authors write.

SOURCE:

The study, with first author Khushboo Gala, MBBS, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn., was published online in Clinical and Translational Gastroenterology.

LIMITATIONS:

Limitations include the retrospective design, with outcomes only out to 2 years, and loss of follow-up, with only 339 of the 1506 patients evaluated at 2 years.

DISCLOSURES:

The study had no financial support. Several study authors reported ties to industry. The full list can be found with the original article.

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

TOPLINE:

Endoscopic sleeve gastroplasty (ESG) is safe and effective for weight loss in adults with class I, II, or III obesity, according to real-world data from a large U.S. study.

METHODOLOGY:

• Researchers conducted a retrospective analysis of 1,506 adults (85% female, 70% White) with severe obesity (501 class I, 546 class II, and 459 class III) who underwent ESG at seven academic and private U.S. centers from 2013 to 2022.
• Average percent total body weight loss (%TBWL) was evaluated at 6, 12, 18, and 24 months after the procedure.
• Weight loss and safety outcomes were evaluated according to obesity class.

TAKEAWAY:

• At 12 months, 83.2% of patients achieved ≥10% TBWL and 60.9% achieved ≥15% TBWL across all obesity classes.
• There was a significant difference in TBWL by baseline obesity class, with average weight loss significantly greater in class III than classes I and II at all time points. At 24 months, class III patients had mean TBWL of 20.4%, compared with 13.3% for class I and 13.6% for class II patients.
• As early as 6 months post-ESG, patients in all BMI classes were able to drop to the next lower BMI class and remained there through 2 years. However, ongoing improvement in BMI until the end of follow-up was seen only in class III patients. Notably, class III patients were significantly younger and taller than class I and class II patients.
• There were no differences in adverse events between obesity classes. Only 2.6% of patients had an adverse event requiring hospitalization. Most of these events (86%) were for symptom management and/or fluid replacement.

IN PRACTICE:

“Traditionally, ESG has been proposed as a treatment choice for patients with class I and II obesity because of its modest weight loss outcomes. However, our data show a %TBWL crossing 20% in patients with class III disease, which may push the envelope of perceived utility of ESG,” the authors write.

SOURCE:

The study, with first author Khushboo Gala, MBBS, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn., was published online in Clinical and Translational Gastroenterology.

LIMITATIONS:

Limitations include the retrospective design, with outcomes only out to 2 years, and loss of follow-up, with only 339 of the 1506 patients evaluated at 2 years.

DISCLOSURES:

The study had no financial support. Several study authors reported ties to industry. The full list can be found with the original article.

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

The Food and Drug Administration is considering banning chemicals used in hair straightening products that have been linked to cancer.

The proposal specifies that formaldehyde would be banned, as well as other chemicals that release formaldehyde, such as methylene glycol. Using hair smoothing products containing formaldehyde and formaldehyde-releasing chemicals “is linked to short-term adverse health effects, such as sensitization reactions and breathing problems, and long-term adverse health effects, including an increased risk of certain cancers,” the proposal states.

One study published last year showed that repeated use of hair straightening products, also called relaxers, could more than double the risk of uterine cancer. Although that study didn’t find that the uterine cancer risk varied based on a person’s race, the researchers noted that women who are Black are among the most likely to use the products and tend to start using them at younger ages, compared with people of other races and ethnicities.

Hair straightening products have also been linked to elevated risks of hormone-sensitive cancers, such as breast cancer and ovarian cancer.

Rep. Ayanna Pressley (D-Mass.) and Rep. Shontel Brown (D-Ohio) applauded the proposed rule in a statement issued jointly on Oct. 6. “The FDA’s proposal to ban these harmful chemicals in hair straighteners and relaxers is a win for public health – especially the health of Black women who are disproportionately put at risk by these products as a result of systemic racism and anti–Black hair sentiment,” Rep. Pressley said The two congresswomen wrote a letter to the FDA earlier this year requesting the topic be investigated.

“Regardless of how we wear our hair, we should be allowed to show up in the world without putting our health at risk. I applaud the FDA for being responsive to our calls and advancing a rule that will help prevent manufacturers from making a profit at the expense of our health,” Rep. Pressley said in the statement. “The administration should finalize this rule without delay.”



A version of this article appeared on WebMD.com

The Food and Drug Administration is considering banning chemicals used in hair straightening products that have been linked to cancer.

The proposal specifies that formaldehyde would be banned, as well as other chemicals that release formaldehyde, such as methylene glycol. Using hair smoothing products containing formaldehyde and formaldehyde-releasing chemicals “is linked to short-term adverse health effects, such as sensitization reactions and breathing problems, and long-term adverse health effects, including an increased risk of certain cancers,” the proposal states.

One study published last year showed that repeated use of hair straightening products, also called relaxers, could more than double the risk of uterine cancer. Although that study didn’t find that the uterine cancer risk varied based on a person’s race, the researchers noted that women who are Black are among the most likely to use the products and tend to start using them at younger ages, compared with people of other races and ethnicities.

Hair straightening products have also been linked to elevated risks of hormone-sensitive cancers, such as breast cancer and ovarian cancer.

Rep. Ayanna Pressley (D-Mass.) and Rep. Shontel Brown (D-Ohio) applauded the proposed rule in a statement issued jointly on Oct. 6. “The FDA’s proposal to ban these harmful chemicals in hair straighteners and relaxers is a win for public health – especially the health of Black women who are disproportionately put at risk by these products as a result of systemic racism and anti–Black hair sentiment,” Rep. Pressley said The two congresswomen wrote a letter to the FDA earlier this year requesting the topic be investigated.

“Regardless of how we wear our hair, we should be allowed to show up in the world without putting our health at risk. I applaud the FDA for being responsive to our calls and advancing a rule that will help prevent manufacturers from making a profit at the expense of our health,” Rep. Pressley said in the statement. “The administration should finalize this rule without delay.”



A version of this article appeared on WebMD.com

The Food and Drug Administration is considering banning chemicals used in hair straightening products that have been linked to cancer.

The proposal specifies that formaldehyde would be banned, as well as other chemicals that release formaldehyde, such as methylene glycol. Using hair smoothing products containing formaldehyde and formaldehyde-releasing chemicals “is linked to short-term adverse health effects, such as sensitization reactions and breathing problems, and long-term adverse health effects, including an increased risk of certain cancers,” the proposal states.

One study published last year showed that repeated use of hair straightening products, also called relaxers, could more than double the risk of uterine cancer. Although that study didn’t find that the uterine cancer risk varied based on a person’s race, the researchers noted that women who are Black are among the most likely to use the products and tend to start using them at younger ages, compared with people of other races and ethnicities.

Hair straightening products have also been linked to elevated risks of hormone-sensitive cancers, such as breast cancer and ovarian cancer.

Rep. Ayanna Pressley (D-Mass.) and Rep. Shontel Brown (D-Ohio) applauded the proposed rule in a statement issued jointly on Oct. 6. “The FDA’s proposal to ban these harmful chemicals in hair straighteners and relaxers is a win for public health – especially the health of Black women who are disproportionately put at risk by these products as a result of systemic racism and anti–Black hair sentiment,” Rep. Pressley said The two congresswomen wrote a letter to the FDA earlier this year requesting the topic be investigated.

“Regardless of how we wear our hair, we should be allowed to show up in the world without putting our health at risk. I applaud the FDA for being responsive to our calls and advancing a rule that will help prevent manufacturers from making a profit at the expense of our health,” Rep. Pressley said in the statement. “The administration should finalize this rule without delay.”



A version of this article appeared on WebMD.com

GLASGOW – Amitriptyline, titrated at low dose, was superior to placebo as a second-line treatment for irritable bowel syndrome (IBS) across multiple outcomes in what the researchers call the largest randomized controlled trial (RCT) of a tricyclic antidepressant in the condition.

Patients who took low-dose amitriptyline were almost twice as likely to report an overall improvement in symptoms as those taking placebo, according to investigators of the Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment (ATLANTIS) trial. Low-dose amitriptyline appeared safe and well tolerated, they reported.

Hazel Everitt, PhD, professor of primary care research at the University of Southampton, England, presented the findings at the annual conference of the Royal College of General Practitioners.

The data were also published in The Lancet and were presented at the recent United European Gastroenterology Week 2023.

Clinicians “should offer low-dose amitriptyline to patients with IBS whose symptoms do not improve with first-line therapies, with appropriate support to guide patient-led dose titration,” the researchers wrote in the journal article.

Despite first-line treatments such as diet, fiber, and antispasmodics, many patients with IBS continue to have troublesome symptoms, Dr. Everitt said in an interview. “GPs haven’t often prescribed amitriptyline for IBS – probably because of the lack of research evidence for its use in primary care.”

Dr. Everitt added that primary care physicians and patients interviewed for the study welcomed low-dose amitriptyline as a potential additional option, especially with increased patient-led care. “The dose titration document that was developed with patients specifically for the trial enables patients to be more empowered to manage their IBS by helping them to titrate their dose up or down depending on their symptoms and side effects.”

Judith Danby, MBBS, a retired GP who moderated the session at which the ATLANTIS results were presented, said, “Self-titration of the dose equals patient empowerment, and if patients can be helped to manage their own medication, then they will also be more empowered to think about lifestyle change, too.”
 

RCT across 55 practices

The U.K.’s National Institute for Health and Care Excellence guidance for the management of IBS in primary care says clinicians should “consider” using low-dose tricyclic antidepressants as a second-line treatment but highlight the need for an RCT of these drugs carried out solely in primary care.

The ATLANTIS trial was conducted across 55 general practices in England and included adults with Rome IV IBS of any subtype and ongoing symptoms (IBS Severity Scoring System [IBS-SSS] score ≥ 75 points) despite dietary changes and first-line therapies. Participants had normal full blood counts and C-reactive protein measures, negative celiac serology, and no evidence of suicidal ideation. The mean age was 48.5 years, and 68% were female. The mean IBS-SSS score in all participants was 272.8 at baseline.

Patients were randomly assigned in a 1:1 ratio to receive either low-dose oral amitriptyline (10 mg once daily; n = 232) with dose titration over 3 weeks (up to a maximum dose of 30 mg once daily) as determined by a participant’s symptoms and tolerability; or placebo (n = 231). Both groups participated for 6 months. The primary outcome was the IBS-SSS score at 6 months.
 

Amitriptyline

Three-quarters of participants adhered to the therapy over the 6 months, which was particularly notable given that the trial was conducted during the COVID-19 pandemic, according to the researchers.

An intent-to-treat analysis found that at 6 months, amitriptyline was superior to placebo, with a significant mean difference in IBS-SSS score between groups of –27.0 (95% confidence interval, –46.9 to –7.1; P = .0079; mean IBS-SSS, 170.4 vs. 200.1 with amitriptyline and placebo). A secondary outcome showed an increased likelihood of relief of IBS symptoms by subjective global assessment (odds ratio, 1.78; 95% CI. 1.19-2.66; P = .0050).

At 3 months, the difference in mean change in IBS-SSS score between groups was also significant, at –23.3 (95% CI, –42.0 to –4.6; P = .014), the researchers reported.

People who took the drug were 70% more likely to report relief of symptoms on SGA than those who took placebo (P = .08), according to the researchers.

The researchers reported no effect of low-dose amitriptyline on psychiatric symptoms, such as distressing thoughts, anxiety, and depression, during the 6-month follow-up, nor was there any effect on ability to work or go about social activities.

“This was a pragmatic trial performed in a large number of participants with IBS, with an average duration of symptoms of 10 years and with 80% having moderate to severe symptoms at baseline,” Alexander Ford, MD, professor of gastroenterology at the University of Leeds, England, and a coinvestigator on the study, told this news organization. “The fact that amitriptyline showed such a strong effect over placebo in this group of patients, with a mean decrease in IBS-SSS of almost 100 points at both 3 and 6 months, is therefore all the more impressive.”

Mild adverse events, such as dry mouth and drowsiness, were more frequent with low-dose amitriptyline than with placebo,

Dr. Everitt said the ATLANTIS findings could change practice. Previous trials of low-dose amitriptyline for IBS had mostly been small and were conducted in secondary care settings such as gastroenterology clinics with relatively short follow-up times.

“This is a problem for a long-term condition that fluctuates over time and is diagnosed and managed mostly in primary care,” she said. “The ATLANTIS trial is the largest trial of low-dose amitriptyline for IBS undertaken worldwide and was rigorously conducted with 6 months follow-up, providing reliable results that can help inform GPs and patients’ treatment decision-making in usual clinical practice.”

On a pragmatic level, the research group developed a dose titration document for use by patients and GPs. “Both the GPs and participants found the ATLANTIS dose titration document acceptable and helpful,” Dr. Everitt pointed out. She noted, “We’ve made the dose titration document freely available to support patients and clinicians to try low-dose amitriptyline for IBS.”

Dr. Ford and Dr. Everitt received grant funding (institutional) from the National Institute for Health and Care Research.

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

GLASGOW – Amitriptyline, titrated at low dose, was superior to placebo as a second-line treatment for irritable bowel syndrome (IBS) across multiple outcomes in what the researchers call the largest randomized controlled trial (RCT) of a tricyclic antidepressant in the condition.

Patients who took low-dose amitriptyline were almost twice as likely to report an overall improvement in symptoms as those taking placebo, according to investigators of the Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment (ATLANTIS) trial. Low-dose amitriptyline appeared safe and well tolerated, they reported.

Hazel Everitt, PhD, professor of primary care research at the University of Southampton, England, presented the findings at the annual conference of the Royal College of General Practitioners.

The data were also published in The Lancet and were presented at the recent United European Gastroenterology Week 2023.

Clinicians “should offer low-dose amitriptyline to patients with IBS whose symptoms do not improve with first-line therapies, with appropriate support to guide patient-led dose titration,” the researchers wrote in the journal article.

Despite first-line treatments such as diet, fiber, and antispasmodics, many patients with IBS continue to have troublesome symptoms, Dr. Everitt said in an interview. “GPs haven’t often prescribed amitriptyline for IBS – probably because of the lack of research evidence for its use in primary care.”

Dr. Everitt added that primary care physicians and patients interviewed for the study welcomed low-dose amitriptyline as a potential additional option, especially with increased patient-led care. “The dose titration document that was developed with patients specifically for the trial enables patients to be more empowered to manage their IBS by helping them to titrate their dose up or down depending on their symptoms and side effects.”

Judith Danby, MBBS, a retired GP who moderated the session at which the ATLANTIS results were presented, said, “Self-titration of the dose equals patient empowerment, and if patients can be helped to manage their own medication, then they will also be more empowered to think about lifestyle change, too.”
 

RCT across 55 practices

The U.K.’s National Institute for Health and Care Excellence guidance for the management of IBS in primary care says clinicians should “consider” using low-dose tricyclic antidepressants as a second-line treatment but highlight the need for an RCT of these drugs carried out solely in primary care.

The ATLANTIS trial was conducted across 55 general practices in England and included adults with Rome IV IBS of any subtype and ongoing symptoms (IBS Severity Scoring System [IBS-SSS] score ≥ 75 points) despite dietary changes and first-line therapies. Participants had normal full blood counts and C-reactive protein measures, negative celiac serology, and no evidence of suicidal ideation. The mean age was 48.5 years, and 68% were female. The mean IBS-SSS score in all participants was 272.8 at baseline.

Patients were randomly assigned in a 1:1 ratio to receive either low-dose oral amitriptyline (10 mg once daily; n = 232) with dose titration over 3 weeks (up to a maximum dose of 30 mg once daily) as determined by a participant’s symptoms and tolerability; or placebo (n = 231). Both groups participated for 6 months. The primary outcome was the IBS-SSS score at 6 months.
 

Amitriptyline

Three-quarters of participants adhered to the therapy over the 6 months, which was particularly notable given that the trial was conducted during the COVID-19 pandemic, according to the researchers.

An intent-to-treat analysis found that at 6 months, amitriptyline was superior to placebo, with a significant mean difference in IBS-SSS score between groups of –27.0 (95% confidence interval, –46.9 to –7.1; P = .0079; mean IBS-SSS, 170.4 vs. 200.1 with amitriptyline and placebo). A secondary outcome showed an increased likelihood of relief of IBS symptoms by subjective global assessment (odds ratio, 1.78; 95% CI. 1.19-2.66; P = .0050).

At 3 months, the difference in mean change in IBS-SSS score between groups was also significant, at –23.3 (95% CI, –42.0 to –4.6; P = .014), the researchers reported.

People who took the drug were 70% more likely to report relief of symptoms on SGA than those who took placebo (P = .08), according to the researchers.

The researchers reported no effect of low-dose amitriptyline on psychiatric symptoms, such as distressing thoughts, anxiety, and depression, during the 6-month follow-up, nor was there any effect on ability to work or go about social activities.

“This was a pragmatic trial performed in a large number of participants with IBS, with an average duration of symptoms of 10 years and with 80% having moderate to severe symptoms at baseline,” Alexander Ford, MD, professor of gastroenterology at the University of Leeds, England, and a coinvestigator on the study, told this news organization. “The fact that amitriptyline showed such a strong effect over placebo in this group of patients, with a mean decrease in IBS-SSS of almost 100 points at both 3 and 6 months, is therefore all the more impressive.”

Mild adverse events, such as dry mouth and drowsiness, were more frequent with low-dose amitriptyline than with placebo,

Dr. Everitt said the ATLANTIS findings could change practice. Previous trials of low-dose amitriptyline for IBS had mostly been small and were conducted in secondary care settings such as gastroenterology clinics with relatively short follow-up times.

“This is a problem for a long-term condition that fluctuates over time and is diagnosed and managed mostly in primary care,” she said. “The ATLANTIS trial is the largest trial of low-dose amitriptyline for IBS undertaken worldwide and was rigorously conducted with 6 months follow-up, providing reliable results that can help inform GPs and patients’ treatment decision-making in usual clinical practice.”

On a pragmatic level, the research group developed a dose titration document for use by patients and GPs. “Both the GPs and participants found the ATLANTIS dose titration document acceptable and helpful,” Dr. Everitt pointed out. She noted, “We’ve made the dose titration document freely available to support patients and clinicians to try low-dose amitriptyline for IBS.”

Dr. Ford and Dr. Everitt received grant funding (institutional) from the National Institute for Health and Care Research.

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

GLASGOW – Amitriptyline, titrated at low dose, was superior to placebo as a second-line treatment for irritable bowel syndrome (IBS) across multiple outcomes in what the researchers call the largest randomized controlled trial (RCT) of a tricyclic antidepressant in the condition.

Patients who took low-dose amitriptyline were almost twice as likely to report an overall improvement in symptoms as those taking placebo, according to investigators of the Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment (ATLANTIS) trial. Low-dose amitriptyline appeared safe and well tolerated, they reported.

Hazel Everitt, PhD, professor of primary care research at the University of Southampton, England, presented the findings at the annual conference of the Royal College of General Practitioners.

The data were also published in The Lancet and were presented at the recent United European Gastroenterology Week 2023.

Clinicians “should offer low-dose amitriptyline to patients with IBS whose symptoms do not improve with first-line therapies, with appropriate support to guide patient-led dose titration,” the researchers wrote in the journal article.

Despite first-line treatments such as diet, fiber, and antispasmodics, many patients with IBS continue to have troublesome symptoms, Dr. Everitt said in an interview. “GPs haven’t often prescribed amitriptyline for IBS – probably because of the lack of research evidence for its use in primary care.”

Dr. Everitt added that primary care physicians and patients interviewed for the study welcomed low-dose amitriptyline as a potential additional option, especially with increased patient-led care. “The dose titration document that was developed with patients specifically for the trial enables patients to be more empowered to manage their IBS by helping them to titrate their dose up or down depending on their symptoms and side effects.”

Judith Danby, MBBS, a retired GP who moderated the session at which the ATLANTIS results were presented, said, “Self-titration of the dose equals patient empowerment, and if patients can be helped to manage their own medication, then they will also be more empowered to think about lifestyle change, too.”
 

RCT across 55 practices

The U.K.’s National Institute for Health and Care Excellence guidance for the management of IBS in primary care says clinicians should “consider” using low-dose tricyclic antidepressants as a second-line treatment but highlight the need for an RCT of these drugs carried out solely in primary care.

The ATLANTIS trial was conducted across 55 general practices in England and included adults with Rome IV IBS of any subtype and ongoing symptoms (IBS Severity Scoring System [IBS-SSS] score ≥ 75 points) despite dietary changes and first-line therapies. Participants had normal full blood counts and C-reactive protein measures, negative celiac serology, and no evidence of suicidal ideation. The mean age was 48.5 years, and 68% were female. The mean IBS-SSS score in all participants was 272.8 at baseline.

Patients were randomly assigned in a 1:1 ratio to receive either low-dose oral amitriptyline (10 mg once daily; n = 232) with dose titration over 3 weeks (up to a maximum dose of 30 mg once daily) as determined by a participant’s symptoms and tolerability; or placebo (n = 231). Both groups participated for 6 months. The primary outcome was the IBS-SSS score at 6 months.
 

Amitriptyline

Three-quarters of participants adhered to the therapy over the 6 months, which was particularly notable given that the trial was conducted during the COVID-19 pandemic, according to the researchers.

An intent-to-treat analysis found that at 6 months, amitriptyline was superior to placebo, with a significant mean difference in IBS-SSS score between groups of –27.0 (95% confidence interval, –46.9 to –7.1; P = .0079; mean IBS-SSS, 170.4 vs. 200.1 with amitriptyline and placebo). A secondary outcome showed an increased likelihood of relief of IBS symptoms by subjective global assessment (odds ratio, 1.78; 95% CI. 1.19-2.66; P = .0050).

At 3 months, the difference in mean change in IBS-SSS score between groups was also significant, at –23.3 (95% CI, –42.0 to –4.6; P = .014), the researchers reported.

People who took the drug were 70% more likely to report relief of symptoms on SGA than those who took placebo (P = .08), according to the researchers.

The researchers reported no effect of low-dose amitriptyline on psychiatric symptoms, such as distressing thoughts, anxiety, and depression, during the 6-month follow-up, nor was there any effect on ability to work or go about social activities.

“This was a pragmatic trial performed in a large number of participants with IBS, with an average duration of symptoms of 10 years and with 80% having moderate to severe symptoms at baseline,” Alexander Ford, MD, professor of gastroenterology at the University of Leeds, England, and a coinvestigator on the study, told this news organization. “The fact that amitriptyline showed such a strong effect over placebo in this group of patients, with a mean decrease in IBS-SSS of almost 100 points at both 3 and 6 months, is therefore all the more impressive.”

Mild adverse events, such as dry mouth and drowsiness, were more frequent with low-dose amitriptyline than with placebo,

Dr. Everitt said the ATLANTIS findings could change practice. Previous trials of low-dose amitriptyline for IBS had mostly been small and were conducted in secondary care settings such as gastroenterology clinics with relatively short follow-up times.

“This is a problem for a long-term condition that fluctuates over time and is diagnosed and managed mostly in primary care,” she said. “The ATLANTIS trial is the largest trial of low-dose amitriptyline for IBS undertaken worldwide and was rigorously conducted with 6 months follow-up, providing reliable results that can help inform GPs and patients’ treatment decision-making in usual clinical practice.”

On a pragmatic level, the research group developed a dose titration document for use by patients and GPs. “Both the GPs and participants found the ATLANTIS dose titration document acceptable and helpful,” Dr. Everitt pointed out. She noted, “We’ve made the dose titration document freely available to support patients and clinicians to try low-dose amitriptyline for IBS.”

Dr. Ford and Dr. Everitt received grant funding (institutional) from the National Institute for Health and Care Research.

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

TOPLINE:

Climbing more than five flights of stairs daily is associated with a reduced risk of atherosclerotic cardiovascular disease (ASCVD) of about 20%, new observational data suggest.

METHODOLOGY:

• The prospective cohort study used data from 458,860 adults in the UK Biobank cohort who were 38-73 years old at baseline (2006-2010).
• Information about stair climbing, sociodemographic, and lifestyle factors was collected at baseline and 5 years later.
• Cases of ASCVD – defined as coronary artery disease (CAD), ischemic stroke, or acute complications – were identified via hospital records and death registry.
• Associations between stair climbing and ASCVD were examined as hazard ratios from Cox proportional hazards model. Analyses were stratified by susceptibility to ASCVD based on family history, genetic risk, and established risk factors.

TAKEAWAY:

• A total of 39,043 ASCVD, 30,718 CAD, and 10,521 ischemic stroke cases were recorded during a median follow-up of 12.5 years.
• Compared with no-stair climbing, climbing 6-10 flights of stairs daily was associated with a 7% lower ASCVD risk (multivariable-adjusted HR, 0.93; 95% confidence interval, 0.90-0.96) and climbing 16-20 flights daily was associated with a 10% lower risk (HR, 0.90; 95% CI, 0.85-0.94).
• The benefits plateaued at 20 flights daily; comparable results were obtained for CAD and ischemic stroke; the protective effect of stair climbing was attenuated by increasing levels of disease susceptibility.
• Adults who stopped climbing stairs daily during the study had a 32% higher risk of ASCVD (HR, 1.32; 95% CI,1.06-1.65), compared with peers who never reported stair climbing.

IN PRACTICE:

“These findings highlight the potential advantages of stair climbing as a primary preventive measure for ASCVD in the general population. Short bursts of high-intensity stair climbing are a time-efficient way to improve cardiorespiratory fitness and lipid profile, especially among those unable to achieve the current physical activity recommendations,” study author Lu Qi, with Tulane University, New Orleans, said in a news release.

SOURCE:

The study was published online in Atherosclerosis.

LIMITATIONS:

The observational design limits causal inferences. Stair climbing was self-reported via questionnaires and recall bias is a possibility. The UK Biobank participants do not represent the entire population of the country, with a healthy volunteer selection bias previously reported.

DISCLOSURES:

The study was supported by grants from the National Key R&D Program of China. The authors disclosed no relevant financial relationships.

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

TOPLINE:

Climbing more than five flights of stairs daily is associated with a reduced risk of atherosclerotic cardiovascular disease (ASCVD) of about 20%, new observational data suggest.

METHODOLOGY:

• The prospective cohort study used data from 458,860 adults in the UK Biobank cohort who were 38-73 years old at baseline (2006-2010).
• Information about stair climbing, sociodemographic, and lifestyle factors was collected at baseline and 5 years later.
• Cases of ASCVD – defined as coronary artery disease (CAD), ischemic stroke, or acute complications – were identified via hospital records and death registry.
• Associations between stair climbing and ASCVD were examined as hazard ratios from Cox proportional hazards model. Analyses were stratified by susceptibility to ASCVD based on family history, genetic risk, and established risk factors.

TAKEAWAY:

• A total of 39,043 ASCVD, 30,718 CAD, and 10,521 ischemic stroke cases were recorded during a median follow-up of 12.5 years.
• Compared with no-stair climbing, climbing 6-10 flights of stairs daily was associated with a 7% lower ASCVD risk (multivariable-adjusted HR, 0.93; 95% confidence interval, 0.90-0.96) and climbing 16-20 flights daily was associated with a 10% lower risk (HR, 0.90; 95% CI, 0.85-0.94).
• The benefits plateaued at 20 flights daily; comparable results were obtained for CAD and ischemic stroke; the protective effect of stair climbing was attenuated by increasing levels of disease susceptibility.
• Adults who stopped climbing stairs daily during the study had a 32% higher risk of ASCVD (HR, 1.32; 95% CI,1.06-1.65), compared with peers who never reported stair climbing.

IN PRACTICE:

“These findings highlight the potential advantages of stair climbing as a primary preventive measure for ASCVD in the general population. Short bursts of high-intensity stair climbing are a time-efficient way to improve cardiorespiratory fitness and lipid profile, especially among those unable to achieve the current physical activity recommendations,” study author Lu Qi, with Tulane University, New Orleans, said in a news release.

SOURCE:

The study was published online in Atherosclerosis.

LIMITATIONS:

The observational design limits causal inferences. Stair climbing was self-reported via questionnaires and recall bias is a possibility. The UK Biobank participants do not represent the entire population of the country, with a healthy volunteer selection bias previously reported.

DISCLOSURES:

The study was supported by grants from the National Key R&D Program of China. The authors disclosed no relevant financial relationships.

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

TOPLINE:

Climbing more than five flights of stairs daily is associated with a reduced risk of atherosclerotic cardiovascular disease (ASCVD) of about 20%, new observational data suggest.

METHODOLOGY:

• The prospective cohort study used data from 458,860 adults in the UK Biobank cohort who were 38-73 years old at baseline (2006-2010).
• Information about stair climbing, sociodemographic, and lifestyle factors was collected at baseline and 5 years later.
• Cases of ASCVD – defined as coronary artery disease (CAD), ischemic stroke, or acute complications – were identified via hospital records and death registry.
• Associations between stair climbing and ASCVD were examined as hazard ratios from Cox proportional hazards model. Analyses were stratified by susceptibility to ASCVD based on family history, genetic risk, and established risk factors.

TAKEAWAY:

• A total of 39,043 ASCVD, 30,718 CAD, and 10,521 ischemic stroke cases were recorded during a median follow-up of 12.5 years.
• Compared with no-stair climbing, climbing 6-10 flights of stairs daily was associated with a 7% lower ASCVD risk (multivariable-adjusted HR, 0.93; 95% confidence interval, 0.90-0.96) and climbing 16-20 flights daily was associated with a 10% lower risk (HR, 0.90; 95% CI, 0.85-0.94).
• The benefits plateaued at 20 flights daily; comparable results were obtained for CAD and ischemic stroke; the protective effect of stair climbing was attenuated by increasing levels of disease susceptibility.
• Adults who stopped climbing stairs daily during the study had a 32% higher risk of ASCVD (HR, 1.32; 95% CI,1.06-1.65), compared with peers who never reported stair climbing.

IN PRACTICE:

“These findings highlight the potential advantages of stair climbing as a primary preventive measure for ASCVD in the general population. Short bursts of high-intensity stair climbing are a time-efficient way to improve cardiorespiratory fitness and lipid profile, especially among those unable to achieve the current physical activity recommendations,” study author Lu Qi, with Tulane University, New Orleans, said in a news release.

SOURCE:

The study was published online in Atherosclerosis.

LIMITATIONS:

The observational design limits causal inferences. Stair climbing was self-reported via questionnaires and recall bias is a possibility. The UK Biobank participants do not represent the entire population of the country, with a healthy volunteer selection bias previously reported.

DISCLOSURES:

The study was supported by grants from the National Key R&D Program of China. The authors disclosed no relevant financial relationships.

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

VANCOUVER – In patients with type 2 diabetes, sodium-glucose cotransporter 2 (SGLT2) inhibitors as an adjunct to metformin were not associated with an increase in fracture risk, according to a new real-world study.

There have been some reports of an increase in fracture risk associated with SGLT2 inhibitors, and it was observed in the phase 3 CANVAS trial of canagliflozin (Invokana), which led to a Food and Drug Administration warning of fracture risks associated with canagliflozin use. Some ensuing studies did not show an increased risk, but these studies were generally less than a year in duration and may have missed longer-term risk, according to Veerle van Hulten, MSc.

“Fracture risk is something that takes a long time to develop, so we wanted to have a longer follow-up. We looked into the CPRD [Clinical Practice Research Datalink], which is a beautiful database containing real-world data from primary care practices,” said Ms. van Hulten, a PhD student at Maastricht (the Netherlands) University, who presented the study at the annual meeting of the American Society for Bone and Mineral Research.

Ms. van Hulten and colleagues compared SGLT2 inhibitors with dipeptidyl peptidase–4 (DPP-4) inhibitors because the latter are used in similar populations and have been shown to have no effect on fracture risk.

“What we found is that SGLT2 inhibitors are not associated with an increased fracture risk. Even with a duration of use of over 811 days, we did not observe an increased hazard ratio for fractures when compared DPP-4 inhibitor users,” Ms. van Hulten said.

SGLT2 inhibitors reduce blood sugar by increasing elimination of sugar in the urine. They also increase phosphate, reduce calcium, and increase parathyroid hormone, which could in turn negatively affect bone turnover, according to Ms. van Hulten.

In the new study, conducted between January 2013 and June 2020, the researchers used propensity score matching to compare adult patients, including 13,807 who were prescribed SGLT2 inhibitors and 28,524 who were prescribed DPP-4 inhibitors for the first time. They matched patients based on demographics, comorbidities, comedication, and lifestyle factors.

There was no association between SGLT2 inhibitor use and overall fracture risk or major osteoporotic, hip, vertebral, humerus, radius, or ulna fractures. There was no difference in risk for any duration of use, even with the longest duration of use of 811 days (adjusted hazard ratio, 1.0). There were no differences among specific SGLT2 inhibitors, including canagliflozin (aHR, 1.12; 95% confidence interval, 0.73-1.72). Analyses by sex and age also revealed no statistically significant differences between the two drug classes.

During the Q&A session after the presentation, Sarah Berry, MD, MPH, an associate professor of medicine at Harvard Medical School and a clinical researcher at the Marcus Institute for Aging Research, both in Boston, noted the trend toward an increase in fracture risk in the first 90 days. “It looked like there was something going on in the first 90 days, and then after that the results were much closer to the null. I would put out maybe another potential mechanism whereby the SGLT2 inhibitors might cause fracture, and that’s falls. They cause polyuria, and any drug you give that causes women to rush to the bathroom may well cause fractures, particularly in the short term,” Dr. Berry said.

Ms. van Hulten agreed, and also brought up that the drugs can cause osmotic diuresis. That can lead to hypovolemia, the symptoms of which include weakness, fatigue, and dizziness. “And increased falls, of course, increases fracture risk. We do not expect anything to happen to bone metabolism in the first 90 days. I think we can agree that there would be more time needed to alter the bone enough to increase fracture risk, so we expect that this trend toward an increased risk might be attributable to that increased fall risk that might occur with SGLT2 inhibitor use,” she said.

It’s possible that such a mechanism explains increased fracture risk seen in some earlier short-term studies, she added.

Overall, Ms. van Hulten said that the results should provide some confidence in SGLT2 inhibitors, though more work needs to be done. “I think we provide reassurance that SGLT2 inhibitors are safe to use. However, we still only have a median follow-up of 1.6 years. It’s not as long as we maybe would like, but it’s the best we can do with the data available, since the SGLT2 inhibitors have only been used since 2013. So maybe it’s best to prescribe it and keep [fall risk] in mind and look into the effects later on again, but it seems to be safe to use.”

The study received funding from the Novo Nordisk Foundation. Ms. van Hulten and Dr. Berry reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

VANCOUVER – In patients with type 2 diabetes, sodium-glucose cotransporter 2 (SGLT2) inhibitors as an adjunct to metformin were not associated with an increase in fracture risk, according to a new real-world study.

There have been some reports of an increase in fracture risk associated with SGLT2 inhibitors, and it was observed in the phase 3 CANVAS trial of canagliflozin (Invokana), which led to a Food and Drug Administration warning of fracture risks associated with canagliflozin use. Some ensuing studies did not show an increased risk, but these studies were generally less than a year in duration and may have missed longer-term risk, according to Veerle van Hulten, MSc.

“Fracture risk is something that takes a long time to develop, so we wanted to have a longer follow-up. We looked into the CPRD [Clinical Practice Research Datalink], which is a beautiful database containing real-world data from primary care practices,” said Ms. van Hulten, a PhD student at Maastricht (the Netherlands) University, who presented the study at the annual meeting of the American Society for Bone and Mineral Research.

Ms. van Hulten and colleagues compared SGLT2 inhibitors with dipeptidyl peptidase–4 (DPP-4) inhibitors because the latter are used in similar populations and have been shown to have no effect on fracture risk.

“What we found is that SGLT2 inhibitors are not associated with an increased fracture risk. Even with a duration of use of over 811 days, we did not observe an increased hazard ratio for fractures when compared DPP-4 inhibitor users,” Ms. van Hulten said.

SGLT2 inhibitors reduce blood sugar by increasing elimination of sugar in the urine. They also increase phosphate, reduce calcium, and increase parathyroid hormone, which could in turn negatively affect bone turnover, according to Ms. van Hulten.

In the new study, conducted between January 2013 and June 2020, the researchers used propensity score matching to compare adult patients, including 13,807 who were prescribed SGLT2 inhibitors and 28,524 who were prescribed DPP-4 inhibitors for the first time. They matched patients based on demographics, comorbidities, comedication, and lifestyle factors.

There was no association between SGLT2 inhibitor use and overall fracture risk or major osteoporotic, hip, vertebral, humerus, radius, or ulna fractures. There was no difference in risk for any duration of use, even with the longest duration of use of 811 days (adjusted hazard ratio, 1.0). There were no differences among specific SGLT2 inhibitors, including canagliflozin (aHR, 1.12; 95% confidence interval, 0.73-1.72). Analyses by sex and age also revealed no statistically significant differences between the two drug classes.

During the Q&A session after the presentation, Sarah Berry, MD, MPH, an associate professor of medicine at Harvard Medical School and a clinical researcher at the Marcus Institute for Aging Research, both in Boston, noted the trend toward an increase in fracture risk in the first 90 days. “It looked like there was something going on in the first 90 days, and then after that the results were much closer to the null. I would put out maybe another potential mechanism whereby the SGLT2 inhibitors might cause fracture, and that’s falls. They cause polyuria, and any drug you give that causes women to rush to the bathroom may well cause fractures, particularly in the short term,” Dr. Berry said.

Ms. van Hulten agreed, and also brought up that the drugs can cause osmotic diuresis. That can lead to hypovolemia, the symptoms of which include weakness, fatigue, and dizziness. “And increased falls, of course, increases fracture risk. We do not expect anything to happen to bone metabolism in the first 90 days. I think we can agree that there would be more time needed to alter the bone enough to increase fracture risk, so we expect that this trend toward an increased risk might be attributable to that increased fall risk that might occur with SGLT2 inhibitor use,” she said.

It’s possible that such a mechanism explains increased fracture risk seen in some earlier short-term studies, she added.

Overall, Ms. van Hulten said that the results should provide some confidence in SGLT2 inhibitors, though more work needs to be done. “I think we provide reassurance that SGLT2 inhibitors are safe to use. However, we still only have a median follow-up of 1.6 years. It’s not as long as we maybe would like, but it’s the best we can do with the data available, since the SGLT2 inhibitors have only been used since 2013. So maybe it’s best to prescribe it and keep [fall risk] in mind and look into the effects later on again, but it seems to be safe to use.”

The study received funding from the Novo Nordisk Foundation. Ms. van Hulten and Dr. Berry reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

VANCOUVER – In patients with type 2 diabetes, sodium-glucose cotransporter 2 (SGLT2) inhibitors as an adjunct to metformin were not associated with an increase in fracture risk, according to a new real-world study.

There have been some reports of an increase in fracture risk associated with SGLT2 inhibitors, and it was observed in the phase 3 CANVAS trial of canagliflozin (Invokana), which led to a Food and Drug Administration warning of fracture risks associated with canagliflozin use. Some ensuing studies did not show an increased risk, but these studies were generally less than a year in duration and may have missed longer-term risk, according to Veerle van Hulten, MSc.

“Fracture risk is something that takes a long time to develop, so we wanted to have a longer follow-up. We looked into the CPRD [Clinical Practice Research Datalink], which is a beautiful database containing real-world data from primary care practices,” said Ms. van Hulten, a PhD student at Maastricht (the Netherlands) University, who presented the study at the annual meeting of the American Society for Bone and Mineral Research.

Ms. van Hulten and colleagues compared SGLT2 inhibitors with dipeptidyl peptidase–4 (DPP-4) inhibitors because the latter are used in similar populations and have been shown to have no effect on fracture risk.

“What we found is that SGLT2 inhibitors are not associated with an increased fracture risk. Even with a duration of use of over 811 days, we did not observe an increased hazard ratio for fractures when compared DPP-4 inhibitor users,” Ms. van Hulten said.

SGLT2 inhibitors reduce blood sugar by increasing elimination of sugar in the urine. They also increase phosphate, reduce calcium, and increase parathyroid hormone, which could in turn negatively affect bone turnover, according to Ms. van Hulten.

In the new study, conducted between January 2013 and June 2020, the researchers used propensity score matching to compare adult patients, including 13,807 who were prescribed SGLT2 inhibitors and 28,524 who were prescribed DPP-4 inhibitors for the first time. They matched patients based on demographics, comorbidities, comedication, and lifestyle factors.

There was no association between SGLT2 inhibitor use and overall fracture risk or major osteoporotic, hip, vertebral, humerus, radius, or ulna fractures. There was no difference in risk for any duration of use, even with the longest duration of use of 811 days (adjusted hazard ratio, 1.0). There were no differences among specific SGLT2 inhibitors, including canagliflozin (aHR, 1.12; 95% confidence interval, 0.73-1.72). Analyses by sex and age also revealed no statistically significant differences between the two drug classes.

During the Q&A session after the presentation, Sarah Berry, MD, MPH, an associate professor of medicine at Harvard Medical School and a clinical researcher at the Marcus Institute for Aging Research, both in Boston, noted the trend toward an increase in fracture risk in the first 90 days. “It looked like there was something going on in the first 90 days, and then after that the results were much closer to the null. I would put out maybe another potential mechanism whereby the SGLT2 inhibitors might cause fracture, and that’s falls. They cause polyuria, and any drug you give that causes women to rush to the bathroom may well cause fractures, particularly in the short term,” Dr. Berry said.

Ms. van Hulten agreed, and also brought up that the drugs can cause osmotic diuresis. That can lead to hypovolemia, the symptoms of which include weakness, fatigue, and dizziness. “And increased falls, of course, increases fracture risk. We do not expect anything to happen to bone metabolism in the first 90 days. I think we can agree that there would be more time needed to alter the bone enough to increase fracture risk, so we expect that this trend toward an increased risk might be attributable to that increased fall risk that might occur with SGLT2 inhibitor use,” she said.

It’s possible that such a mechanism explains increased fracture risk seen in some earlier short-term studies, she added.

Overall, Ms. van Hulten said that the results should provide some confidence in SGLT2 inhibitors, though more work needs to be done. “I think we provide reassurance that SGLT2 inhibitors are safe to use. However, we still only have a median follow-up of 1.6 years. It’s not as long as we maybe would like, but it’s the best we can do with the data available, since the SGLT2 inhibitors have only been used since 2013. So maybe it’s best to prescribe it and keep [fall risk] in mind and look into the effects later on again, but it seems to be safe to use.”

The study received funding from the Novo Nordisk Foundation. Ms. van Hulten and Dr. Berry reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

SARS-CoV-2 infection is linked in men with increased incidence of urinary retention, urinary tract infection (UTI), and blood in the urine, a new study finds.

Authors of the study, led by Alex Qinyang Liu, of S.H. Ho Urology Centre, at The Chinese University of Hong Kong, highlighted the clinical implications.

“Clinicians should be aware of the significantly higher incidence of LUTS [lower urinary tract symptoms] complications with COVID-19 in this patient group and understand that these urological manifestations can occur regardless of COVID-19 severity,” the authors wrote.

Findings were published online in the Journal of Internal Medicine.

“This is the largest study demonstrating the detrimental urological effects of SARS-CoV-2 infection,” the authors wrote. They explained that current literature has included only small case series and observational studies assessing the connection between COVID-19 and male LUTS.
 

Nearly 18,000 patients in study

Included in this study were all male patients who used the public health care system in Hong Kong who received alpha-blocker monotherapy for LUTS from 2021 to 2022. After propensity score matching, 17,986 patients were included. Half had polymerase chain reaction–confirmed SARS-CoV-2 infection (n = 8,993).

The retrospective study compared urologic outcomes, including male benign prostatic hyperplasia (BPH) complications, and changes in medical treatment in the two groups. They compared male patients with SARS-CoV-2 infection who were taking baseline alpha blocker monotherapy for LUTS with a control group who had no SARS-CoV-2 infection.

They found that, compared with controls, the SARS-CoV-2–infected group had significantly higher incidence of retention of urine (4.55% vs. 0.86%, P < .001), hematuria (1.36% vs. 0.41%, P < .001), clinical UTI (4.31% vs. 1.49%, P < .001), culture-proven bacteriuria (9.02% vs. 1.97%, P < .001), and addition of 5-alpha reductase inhibitors (0.50% vs. 0.02%, P < .001).
 

Similar side effects even with asymptomatic infection

The researchers pointed out that similar incidence of retention of urine, hematuria, and addition of medication were seen even when patients had asymptomatic infection.

They added that their findings have biological plausibility because the coexpression of the proteins ACE2 and TMPRSS2 in the prostate makes it a target for SARS-CoV-2, which leads to inflammation and may help explain the primary outcomes.

“Given the high infectivity and unprecedented scale of the COVID-19 pandemic, these urological symptoms and complications represent a significant clinical burden that clinicians and urologists should be aware of,” the authors wrote.

The authors noted that the prevalence of BPH and LUTS rises with age and are among the most common urologic conditions affecting older men. “Incidentally, male patients of advanced age are also more significantly affected by COVID-19.”

The authors declare no relevant financial relationships.

SARS-CoV-2 infection is linked in men with increased incidence of urinary retention, urinary tract infection (UTI), and blood in the urine, a new study finds.

Authors of the study, led by Alex Qinyang Liu, of S.H. Ho Urology Centre, at The Chinese University of Hong Kong, highlighted the clinical implications.

“Clinicians should be aware of the significantly higher incidence of LUTS [lower urinary tract symptoms] complications with COVID-19 in this patient group and understand that these urological manifestations can occur regardless of COVID-19 severity,” the authors wrote.

Findings were published online in the Journal of Internal Medicine.

“This is the largest study demonstrating the detrimental urological effects of SARS-CoV-2 infection,” the authors wrote. They explained that current literature has included only small case series and observational studies assessing the connection between COVID-19 and male LUTS.
 

Nearly 18,000 patients in study

Included in this study were all male patients who used the public health care system in Hong Kong who received alpha-blocker monotherapy for LUTS from 2021 to 2022. After propensity score matching, 17,986 patients were included. Half had polymerase chain reaction–confirmed SARS-CoV-2 infection (n = 8,993).

The retrospective study compared urologic outcomes, including male benign prostatic hyperplasia (BPH) complications, and changes in medical treatment in the two groups. They compared male patients with SARS-CoV-2 infection who were taking baseline alpha blocker monotherapy for LUTS with a control group who had no SARS-CoV-2 infection.

They found that, compared with controls, the SARS-CoV-2–infected group had significantly higher incidence of retention of urine (4.55% vs. 0.86%, P < .001), hematuria (1.36% vs. 0.41%, P < .001), clinical UTI (4.31% vs. 1.49%, P < .001), culture-proven bacteriuria (9.02% vs. 1.97%, P < .001), and addition of 5-alpha reductase inhibitors (0.50% vs. 0.02%, P < .001).
 

Similar side effects even with asymptomatic infection

The researchers pointed out that similar incidence of retention of urine, hematuria, and addition of medication were seen even when patients had asymptomatic infection.

They added that their findings have biological plausibility because the coexpression of the proteins ACE2 and TMPRSS2 in the prostate makes it a target for SARS-CoV-2, which leads to inflammation and may help explain the primary outcomes.

“Given the high infectivity and unprecedented scale of the COVID-19 pandemic, these urological symptoms and complications represent a significant clinical burden that clinicians and urologists should be aware of,” the authors wrote.

The authors noted that the prevalence of BPH and LUTS rises with age and are among the most common urologic conditions affecting older men. “Incidentally, male patients of advanced age are also more significantly affected by COVID-19.”

The authors declare no relevant financial relationships.

SARS-CoV-2 infection is linked in men with increased incidence of urinary retention, urinary tract infection (UTI), and blood in the urine, a new study finds.

Authors of the study, led by Alex Qinyang Liu, of S.H. Ho Urology Centre, at The Chinese University of Hong Kong, highlighted the clinical implications.

“Clinicians should be aware of the significantly higher incidence of LUTS [lower urinary tract symptoms] complications with COVID-19 in this patient group and understand that these urological manifestations can occur regardless of COVID-19 severity,” the authors wrote.

Findings were published online in the Journal of Internal Medicine.

“This is the largest study demonstrating the detrimental urological effects of SARS-CoV-2 infection,” the authors wrote. They explained that current literature has included only small case series and observational studies assessing the connection between COVID-19 and male LUTS.
 

Nearly 18,000 patients in study

Included in this study were all male patients who used the public health care system in Hong Kong who received alpha-blocker monotherapy for LUTS from 2021 to 2022. After propensity score matching, 17,986 patients were included. Half had polymerase chain reaction–confirmed SARS-CoV-2 infection (n = 8,993).

The retrospective study compared urologic outcomes, including male benign prostatic hyperplasia (BPH) complications, and changes in medical treatment in the two groups. They compared male patients with SARS-CoV-2 infection who were taking baseline alpha blocker monotherapy for LUTS with a control group who had no SARS-CoV-2 infection.

They found that, compared with controls, the SARS-CoV-2–infected group had significantly higher incidence of retention of urine (4.55% vs. 0.86%, P < .001), hematuria (1.36% vs. 0.41%, P < .001), clinical UTI (4.31% vs. 1.49%, P < .001), culture-proven bacteriuria (9.02% vs. 1.97%, P < .001), and addition of 5-alpha reductase inhibitors (0.50% vs. 0.02%, P < .001).
 

Similar side effects even with asymptomatic infection

The researchers pointed out that similar incidence of retention of urine, hematuria, and addition of medication were seen even when patients had asymptomatic infection.

They added that their findings have biological plausibility because the coexpression of the proteins ACE2 and TMPRSS2 in the prostate makes it a target for SARS-CoV-2, which leads to inflammation and may help explain the primary outcomes.

“Given the high infectivity and unprecedented scale of the COVID-19 pandemic, these urological symptoms and complications represent a significant clinical burden that clinicians and urologists should be aware of,” the authors wrote.

The authors noted that the prevalence of BPH and LUTS rises with age and are among the most common urologic conditions affecting older men. “Incidentally, male patients of advanced age are also more significantly affected by COVID-19.”

The authors declare no relevant financial relationships.

Patients with obesity but without major depressive disorder or suicidal ideation within the previous 2 years attained meaningful weight loss with semaglutide, regardless of antidepressant use at baseline, in a post hoc analysis of the Semaglutide Treatment Effect in People with Obesity (STEP) program.

Adverse events, including psychiatric events, were slightly more usual in the patients on antidepressants, Robert Kushner, MD, noted, in an oral session at the annual meeting of the Obesity Society.  

“It is very common that patients who present for weight management are taking antidepressants for various reasons, including depression, anxiety, insomnia, or chronic pain,”Dr. Kushner, from Northwestern University in Chicago, said in an email. “We wanted to see if these participants responded differently to semaglutide, compared to those not on antidepressants.”

“We found that antidepressants do not blunt the effect of semaglutide for weight loss,” he said. “However, there is a slight increase in reported adverse effects.”

“Semaglutide 2.4 mg provides an effective treatment option for weight management, regardless of antidepressant use at baseline,” Dr. Kushner summarized. “Clinicians should be assured that we can use semaglutide in this population of patients.”

Jack Yanovski, MD, PhD, said this was a “great presentation,” noting that “it’s really important that we understand what goes on in patients with depression.”

“Of course, all these trials still had rules that prevent the folks with the most severe depressive symptoms or past suicidality to participate,” added Dr. Yanovski, chief of the Growth and Obesity Section, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md. “We need specific trials to know exactly how well we do.”

Dr. Kushner agreed, but also noted that, ever since some earlier antidepressants were associated with risk for suicidal ideation and death, strict guidelines were put in place that exclude certain patients from participating in clinical trials.

Dr. Yanovski suggested that now that the drugs are approved, it would be possible to study this, and the information would be important for clinicians.

Dr. Kushner said he hopes that such studies are forthcoming. In the meantime, “data like this will add some support and understanding,” he suggested.
 

36,000 Patients with obesity, 500 on antidepressants

Many people living with obesity report taking antidepressants for depression, anxiety, chronic pain, obsessive-compulsive disorder, sleep disturbance, neuropathy, panic disorder, or posttraumatic stress disorder, Dr. Kushner noted.

However, some of these medications can cause weight gain, and little is known about treatment outcomes for people with obesity who are on antidepressants, since most weight-loss studies exclude people with active major depressive disorder.

The researchers analyzed data from 1,961 patients in STEP 1 and 807 patients in STEP 2 as well as 611 patients in STEP 3 and 304 patients in STEP 5 – 3,683 participants in total, of which 539 were on antidepressants at baseline.

The patients were randomly assigned to 2.4 mg semaglutide vs. placebo plus a lifestyle intervention (STEP 1, 2, and 5) or intensive behavioral therapy (STEP 3 only), for 68 weeks, except STEP 5, which was 104 weeks.

Patients were included if they were aged 18 or older with a body mass index ≥30 kg/m², or ≥27 kg/m² with more than one weight-related complication (STEP 1, 3, and 5) or BMI ≥27 kg/m² with type 2 diabetes (STEP 2 only), and at least one self-reported unsuccessful effort to lose weight by diet.

They were excluded if they had active major depressive disorder within 2 years prior to screening (or other severe psychiatric disorders such as schizophrenia or bipolar disorder) or a Patient Health Questionnaire-9 score of 15 or higher (indicating moderately severe or severe depression), or suicide ideation (type 4 or 5 on the Columbia Suicide Severity Rating Scale) or suicide behavior, within 30 days of screening.

From baseline to week 68, patients on semaglutide (with/without baseline antidepressant use) had a significantly greater change in weight vs. patients on placebo (with/without baseline antidepressant use), respectively:

• STEP 1: –15.7% / –14.7% vs. –0.2% / –2.8%
• STEP 2: –10.7% / –9.5% vs. –3.3% / –3.4%
• STEP 3: –16.2% / –15.9% vs. –5.0% / –5.9%
• STEP 5: –19.0% / –14.1% vs. +1.6% / – 4.0%. 

The proportion of reported adverse events was generally slightly greater in patients receiving semaglutide (with/without baseline antidepressant use) than those on placebo (with/without baseline antidepressant use), respectively:

• STEP 1: 97.7% vs 88.6% and 92.9% vs. 86%
• STEP 2: 97.6% vs 86.5% and 88.6% vs. 77.2%
• STEP 3: 97.6% vs 95.3% and 100% vs. 95.8%
• STEP 5: 100% vs 94.8% and 95.5% vs. 89.2%.

Gastrointestinal adverse events were more frequently reported in the semaglutide group and in patients on antidepressants at baseline. The proportion of patients with psychiatric adverse events was greater in participants on antidepressants at baseline. There were no differences in suicidal ideation/behavior in patients with/without antidepressant use at baseline.

The STEP trials were funded by Novo Nordisk. Dr. Kushner discloses that he served as a consultant for Novo Nordisk, WeightWatchers, Eli Lilly, and Pfizer, and received a research grant from Epitomee.

A version of this article appeared on Medscape.com.

Patients with obesity but without major depressive disorder or suicidal ideation within the previous 2 years attained meaningful weight loss with semaglutide, regardless of antidepressant use at baseline, in a post hoc analysis of the Semaglutide Treatment Effect in People with Obesity (STEP) program.

Adverse events, including psychiatric events, were slightly more usual in the patients on antidepressants, Robert Kushner, MD, noted, in an oral session at the annual meeting of the Obesity Society.  

“It is very common that patients who present for weight management are taking antidepressants for various reasons, including depression, anxiety, insomnia, or chronic pain,”Dr. Kushner, from Northwestern University in Chicago, said in an email. “We wanted to see if these participants responded differently to semaglutide, compared to those not on antidepressants.”

“We found that antidepressants do not blunt the effect of semaglutide for weight loss,” he said. “However, there is a slight increase in reported adverse effects.”

“Semaglutide 2.4 mg provides an effective treatment option for weight management, regardless of antidepressant use at baseline,” Dr. Kushner summarized. “Clinicians should be assured that we can use semaglutide in this population of patients.”

Jack Yanovski, MD, PhD, said this was a “great presentation,” noting that “it’s really important that we understand what goes on in patients with depression.”

“Of course, all these trials still had rules that prevent the folks with the most severe depressive symptoms or past suicidality to participate,” added Dr. Yanovski, chief of the Growth and Obesity Section, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md. “We need specific trials to know exactly how well we do.”

Dr. Kushner agreed, but also noted that, ever since some earlier antidepressants were associated with risk for suicidal ideation and death, strict guidelines were put in place that exclude certain patients from participating in clinical trials.

Dr. Yanovski suggested that now that the drugs are approved, it would be possible to study this, and the information would be important for clinicians.

Dr. Kushner said he hopes that such studies are forthcoming. In the meantime, “data like this will add some support and understanding,” he suggested.
 

36,000 Patients with obesity, 500 on antidepressants

Many people living with obesity report taking antidepressants for depression, anxiety, chronic pain, obsessive-compulsive disorder, sleep disturbance, neuropathy, panic disorder, or posttraumatic stress disorder, Dr. Kushner noted.

However, some of these medications can cause weight gain, and little is known about treatment outcomes for people with obesity who are on antidepressants, since most weight-loss studies exclude people with active major depressive disorder.

The researchers analyzed data from 1,961 patients in STEP 1 and 807 patients in STEP 2 as well as 611 patients in STEP 3 and 304 patients in STEP 5 – 3,683 participants in total, of which 539 were on antidepressants at baseline.

The patients were randomly assigned to 2.4 mg semaglutide vs. placebo plus a lifestyle intervention (STEP 1, 2, and 5) or intensive behavioral therapy (STEP 3 only), for 68 weeks, except STEP 5, which was 104 weeks.

Patients were included if they were aged 18 or older with a body mass index ≥30 kg/m², or ≥27 kg/m² with more than one weight-related complication (STEP 1, 3, and 5) or BMI ≥27 kg/m² with type 2 diabetes (STEP 2 only), and at least one self-reported unsuccessful effort to lose weight by diet.

They were excluded if they had active major depressive disorder within 2 years prior to screening (or other severe psychiatric disorders such as schizophrenia or bipolar disorder) or a Patient Health Questionnaire-9 score of 15 or higher (indicating moderately severe or severe depression), or suicide ideation (type 4 or 5 on the Columbia Suicide Severity Rating Scale) or suicide behavior, within 30 days of screening.

From baseline to week 68, patients on semaglutide (with/without baseline antidepressant use) had a significantly greater change in weight vs. patients on placebo (with/without baseline antidepressant use), respectively:

• STEP 1: –15.7% / –14.7% vs. –0.2% / –2.8%
• STEP 2: –10.7% / –9.5% vs. –3.3% / –3.4%
• STEP 3: –16.2% / –15.9% vs. –5.0% / –5.9%
• STEP 5: –19.0% / –14.1% vs. +1.6% / – 4.0%. 

The proportion of reported adverse events was generally slightly greater in patients receiving semaglutide (with/without baseline antidepressant use) than those on placebo (with/without baseline antidepressant use), respectively:

• STEP 1: 97.7% vs 88.6% and 92.9% vs. 86%
• STEP 2: 97.6% vs 86.5% and 88.6% vs. 77.2%
• STEP 3: 97.6% vs 95.3% and 100% vs. 95.8%
• STEP 5: 100% vs 94.8% and 95.5% vs. 89.2%.

Gastrointestinal adverse events were more frequently reported in the semaglutide group and in patients on antidepressants at baseline. The proportion of patients with psychiatric adverse events was greater in participants on antidepressants at baseline. There were no differences in suicidal ideation/behavior in patients with/without antidepressant use at baseline.

The STEP trials were funded by Novo Nordisk. Dr. Kushner discloses that he served as a consultant for Novo Nordisk, WeightWatchers, Eli Lilly, and Pfizer, and received a research grant from Epitomee.

A version of this article appeared on Medscape.com.

Patients with obesity but without major depressive disorder or suicidal ideation within the previous 2 years attained meaningful weight loss with semaglutide, regardless of antidepressant use at baseline, in a post hoc analysis of the Semaglutide Treatment Effect in People with Obesity (STEP) program.

Adverse events, including psychiatric events, were slightly more usual in the patients on antidepressants, Robert Kushner, MD, noted, in an oral session at the annual meeting of the Obesity Society.  

“It is very common that patients who present for weight management are taking antidepressants for various reasons, including depression, anxiety, insomnia, or chronic pain,”Dr. Kushner, from Northwestern University in Chicago, said in an email. “We wanted to see if these participants responded differently to semaglutide, compared to those not on antidepressants.”

“We found that antidepressants do not blunt the effect of semaglutide for weight loss,” he said. “However, there is a slight increase in reported adverse effects.”

“Semaglutide 2.4 mg provides an effective treatment option for weight management, regardless of antidepressant use at baseline,” Dr. Kushner summarized. “Clinicians should be assured that we can use semaglutide in this population of patients.”

Jack Yanovski, MD, PhD, said this was a “great presentation,” noting that “it’s really important that we understand what goes on in patients with depression.”

“Of course, all these trials still had rules that prevent the folks with the most severe depressive symptoms or past suicidality to participate,” added Dr. Yanovski, chief of the Growth and Obesity Section, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md. “We need specific trials to know exactly how well we do.”

Dr. Kushner agreed, but also noted that, ever since some earlier antidepressants were associated with risk for suicidal ideation and death, strict guidelines were put in place that exclude certain patients from participating in clinical trials.

Dr. Yanovski suggested that now that the drugs are approved, it would be possible to study this, and the information would be important for clinicians.

Dr. Kushner said he hopes that such studies are forthcoming. In the meantime, “data like this will add some support and understanding,” he suggested.
 

36,000 Patients with obesity, 500 on antidepressants

Many people living with obesity report taking antidepressants for depression, anxiety, chronic pain, obsessive-compulsive disorder, sleep disturbance, neuropathy, panic disorder, or posttraumatic stress disorder, Dr. Kushner noted.

However, some of these medications can cause weight gain, and little is known about treatment outcomes for people with obesity who are on antidepressants, since most weight-loss studies exclude people with active major depressive disorder.

The researchers analyzed data from 1,961 patients in STEP 1 and 807 patients in STEP 2 as well as 611 patients in STEP 3 and 304 patients in STEP 5 – 3,683 participants in total, of which 539 were on antidepressants at baseline.

The patients were randomly assigned to 2.4 mg semaglutide vs. placebo plus a lifestyle intervention (STEP 1, 2, and 5) or intensive behavioral therapy (STEP 3 only), for 68 weeks, except STEP 5, which was 104 weeks.

Patients were included if they were aged 18 or older with a body mass index ≥30 kg/m², or ≥27 kg/m² with more than one weight-related complication (STEP 1, 3, and 5) or BMI ≥27 kg/m² with type 2 diabetes (STEP 2 only), and at least one self-reported unsuccessful effort to lose weight by diet.

They were excluded if they had active major depressive disorder within 2 years prior to screening (or other severe psychiatric disorders such as schizophrenia or bipolar disorder) or a Patient Health Questionnaire-9 score of 15 or higher (indicating moderately severe or severe depression), or suicide ideation (type 4 or 5 on the Columbia Suicide Severity Rating Scale) or suicide behavior, within 30 days of screening.

From baseline to week 68, patients on semaglutide (with/without baseline antidepressant use) had a significantly greater change in weight vs. patients on placebo (with/without baseline antidepressant use), respectively:

• STEP 1: –15.7% / –14.7% vs. –0.2% / –2.8%
• STEP 2: –10.7% / –9.5% vs. –3.3% / –3.4%
• STEP 3: –16.2% / –15.9% vs. –5.0% / –5.9%
• STEP 5: –19.0% / –14.1% vs. +1.6% / – 4.0%. 

The proportion of reported adverse events was generally slightly greater in patients receiving semaglutide (with/without baseline antidepressant use) than those on placebo (with/without baseline antidepressant use), respectively:

• STEP 1: 97.7% vs 88.6% and 92.9% vs. 86%
• STEP 2: 97.6% vs 86.5% and 88.6% vs. 77.2%
• STEP 3: 97.6% vs 95.3% and 100% vs. 95.8%
• STEP 5: 100% vs 94.8% and 95.5% vs. 89.2%.

Gastrointestinal adverse events were more frequently reported in the semaglutide group and in patients on antidepressants at baseline. The proportion of patients with psychiatric adverse events was greater in participants on antidepressants at baseline. There were no differences in suicidal ideation/behavior in patients with/without antidepressant use at baseline.

The STEP trials were funded by Novo Nordisk. Dr. Kushner discloses that he served as a consultant for Novo Nordisk, WeightWatchers, Eli Lilly, and Pfizer, and received a research grant from Epitomee.

A version of this article appeared on Medscape.com.

For women who are obese, daily life is wrought with landmines. Whether it’s the challenges of air travel because plane seats are too small, the need to shield themselves from the world’s discriminating eyes, or the great lengths many will go to achieve better health and the promise of longevity, navigating life as an obese person requires a thick skin.

So, it’s no wonder so many are willing to pay more than $1,000 a month out of pocket to get their hands on drugs like semaglutide (Ozempic and Wegovy) or tirzepatide (Mounjaro). The benefits of these drugs, which are part of a new class called glucagonlike peptide–1 (GLP-1) receptor agonists, include significant and rapid weight loss, blood sugar control, and improved life quality; they are unprecedented in a setting where surgery has long been considered the most effective long-term option.

On the flip side, the desire for rapid weight loss and better blood sugar control also comes with an unexpected cost. Many women living with obesity who take oral contraceptives are unaware that these drugs – especially Mounjaro – can interfere with the absorption of birth control pills and how well they work, making an unintended pregnancy more likely.

Neel Shah, MD, an endocrinologist and associate professor at the University of Texas Health Science Center at Houston, said he has had several patients become pregnant without intending to. 

“It was when Mounjaro came out on the market when we started using it,” he said of the drug the Food and Drug Administration approved for type 2 diabetes in 2022. “It [the warning] was in the product insert, but clinically speaking, I don’t know if it was at the top of providers’ minds when they were prescribing Mounjaro.”

When asked if he believed that we were going to be seeing a significant increase in so-called Mounjaro babies, Dr. Shah was sure in his response. 

“Absolutely. We will because the sheer volume [of patients] will increase,” he said.
 

It’s all in the gut

One of the ways that drugs like Mounjaro work is by delaying the time that it takes for food to move from the stomach to the small intestine. Although data are still evolving, it is believed that this process – delayed gastric emptying – may affect the absorption of birth control pills. 

Dr. Shah said another theory is that vomiting, which is a common side effect of these types of drugs, also affects the pills’ ability to prevent pregnancy. 

And “there’s a prolonged period of ramping up the dose because of the GI side effects,” said Pinar Kodaman, MD, PhD, a reproductive endocrinologist and assistant professor of gynecology at Yale University in New Haven, Conn. 

“Initially, at the lowest dose, there may not be a lot of potential effect on absorption and gastric emptying. But as the dose goes up, it becomes more common, and it can cause diarrhea, which is another condition that can affect the absorption of any medication,” she said.
 

Unanticipated outcomes, extra prevention

Roughly 42% of women in the United States are obese, 40% of whom are between the ages of 20 and 39. Although these new drugs can improve fertility outcomes for women who are obese (especially those with polycystic ovary syndrome, or PCOS), only one – Mounjaro – currently carries a warning about birth control pill effectiveness on its label. Unfortunately, it appears that some doctors are unaware or not counseling patients about this risk, and the data are unclear about whether other drugs in this class, like Ozempic and Wegovy, have the same risks. 

“To date, it hasn’t been a typical thing that we counsel about,” said Dr. Kodaman. “It’s all fairly new, but when we have patients on birth control pills, we do review other medications that they are on because some can affect efficacy, and it’s something to keep in mind.”

It’s also unclear if other forms of birth control – for example, birth control patches that deliver through the skin – might carry similar pregnancy risks. Dr. Shah said some of his patients who became pregnant without intending to were using these patches. This raises even more questions, since they deliver drugs through the skin directly into the bloodstream and not through the GI system. 

What can women do to help ensure that they don’t become pregnant while using these drugs? 

“I really think that if patients want to protect themselves from an unplanned pregnancy, that as soon as they start the GLP receptor agonists, it wouldn’t be a bad idea to use condoms, because the onset of action is pretty quick,” said Dr. Kodaman, noting also that “at the lowest dose there may not be a lot of potential effect on gastric emptying. But as the dose goes up, it becomes much more common or can cause diarrhea.” 

Dr. Shah said that in his practice he’s “been telling patients to add barrier contraception” 4 weeks before they start their first dose “and at any dose adjustment.”

Zoobia Chaudhry, an obesity medicine doctor and assistant professor of medicine at Johns Hopkins University in Baltimore, recommends that “patients just make sure that the injection and medication that they take are at least 1 hour apart.”

“Most of the time, patients do take birth control before bedtime, so if the two are spaced, it should be OK,” she said.

Another option is for women to speak to their doctors about other contraceptive options like IUDs or implantable rods, where gastric absorption is not going to be an issue. 

“There’s very little research on this class of drugs,” said Emily Goodstein, a 40-year-old small-business owner in Washington, who recently switched from Ozempic to Mounjaro. “Being a person who lives in a larger body is such a horrifying experience because of the way that the world discriminates against you.”

She appreciates the feeling of being proactive that these new drugs grant. It has “opened up a bunch of opportunities for me to be seen as a full individual by the medical establishment,” she said. “I was willing to take the risk, knowing that I would be on these drugs for the rest of my life.”

In addition to being what Dr. Goodstein refers to as a guinea pig, she said she made sure that her primary care doctor was aware that she was not trying or planning to become pregnant again. (She has a 3-year-old child.) Still, her doctor mentioned only the most common side effects linked to these drugs, like nausea, vomiting, and diarrhea, and did not mention the risk of pregnancy.

“Folks are really not talking about the reproductive implications,” she said, referring to members of a Facebook group on these drugs that she belongs to. 

Like patients themselves, many doctors are just beginning to get their arms around these agents. “Awareness, education, provider involvement, and having a multidisciplinary team could help patients achieve the goals that they set out for themselves,” said Dr. Shah. 

Clear conversations are key.

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

For women who are obese, daily life is wrought with landmines. Whether it’s the challenges of air travel because plane seats are too small, the need to shield themselves from the world’s discriminating eyes, or the great lengths many will go to achieve better health and the promise of longevity, navigating life as an obese person requires a thick skin.

So, it’s no wonder so many are willing to pay more than $1,000 a month out of pocket to get their hands on drugs like semaglutide (Ozempic and Wegovy) or tirzepatide (Mounjaro). The benefits of these drugs, which are part of a new class called glucagonlike peptide–1 (GLP-1) receptor agonists, include significant and rapid weight loss, blood sugar control, and improved life quality; they are unprecedented in a setting where surgery has long been considered the most effective long-term option.

On the flip side, the desire for rapid weight loss and better blood sugar control also comes with an unexpected cost. Many women living with obesity who take oral contraceptives are unaware that these drugs – especially Mounjaro – can interfere with the absorption of birth control pills and how well they work, making an unintended pregnancy more likely.

Neel Shah, MD, an endocrinologist and associate professor at the University of Texas Health Science Center at Houston, said he has had several patients become pregnant without intending to. 

“It was when Mounjaro came out on the market when we started using it,” he said of the drug the Food and Drug Administration approved for type 2 diabetes in 2022. “It [the warning] was in the product insert, but clinically speaking, I don’t know if it was at the top of providers’ minds when they were prescribing Mounjaro.”

When asked if he believed that we were going to be seeing a significant increase in so-called Mounjaro babies, Dr. Shah was sure in his response. 

“Absolutely. We will because the sheer volume [of patients] will increase,” he said.
 

It’s all in the gut

One of the ways that drugs like Mounjaro work is by delaying the time that it takes for food to move from the stomach to the small intestine. Although data are still evolving, it is believed that this process – delayed gastric emptying – may affect the absorption of birth control pills. 

Dr. Shah said another theory is that vomiting, which is a common side effect of these types of drugs, also affects the pills’ ability to prevent pregnancy. 

And “there’s a prolonged period of ramping up the dose because of the GI side effects,” said Pinar Kodaman, MD, PhD, a reproductive endocrinologist and assistant professor of gynecology at Yale University in New Haven, Conn. 

“Initially, at the lowest dose, there may not be a lot of potential effect on absorption and gastric emptying. But as the dose goes up, it becomes more common, and it can cause diarrhea, which is another condition that can affect the absorption of any medication,” she said.
 

Unanticipated outcomes, extra prevention

Roughly 42% of women in the United States are obese, 40% of whom are between the ages of 20 and 39. Although these new drugs can improve fertility outcomes for women who are obese (especially those with polycystic ovary syndrome, or PCOS), only one – Mounjaro – currently carries a warning about birth control pill effectiveness on its label. Unfortunately, it appears that some doctors are unaware or not counseling patients about this risk, and the data are unclear about whether other drugs in this class, like Ozempic and Wegovy, have the same risks. 

“To date, it hasn’t been a typical thing that we counsel about,” said Dr. Kodaman. “It’s all fairly new, but when we have patients on birth control pills, we do review other medications that they are on because some can affect efficacy, and it’s something to keep in mind.”

It’s also unclear if other forms of birth control – for example, birth control patches that deliver through the skin – might carry similar pregnancy risks. Dr. Shah said some of his patients who became pregnant without intending to were using these patches. This raises even more questions, since they deliver drugs through the skin directly into the bloodstream and not through the GI system. 

What can women do to help ensure that they don’t become pregnant while using these drugs? 

“I really think that if patients want to protect themselves from an unplanned pregnancy, that as soon as they start the GLP receptor agonists, it wouldn’t be a bad idea to use condoms, because the onset of action is pretty quick,” said Dr. Kodaman, noting also that “at the lowest dose there may not be a lot of potential effect on gastric emptying. But as the dose goes up, it becomes much more common or can cause diarrhea.” 

Dr. Shah said that in his practice he’s “been telling patients to add barrier contraception” 4 weeks before they start their first dose “and at any dose adjustment.”

Zoobia Chaudhry, an obesity medicine doctor and assistant professor of medicine at Johns Hopkins University in Baltimore, recommends that “patients just make sure that the injection and medication that they take are at least 1 hour apart.”

“Most of the time, patients do take birth control before bedtime, so if the two are spaced, it should be OK,” she said.

Another option is for women to speak to their doctors about other contraceptive options like IUDs or implantable rods, where gastric absorption is not going to be an issue. 

“There’s very little research on this class of drugs,” said Emily Goodstein, a 40-year-old small-business owner in Washington, who recently switched from Ozempic to Mounjaro. “Being a person who lives in a larger body is such a horrifying experience because of the way that the world discriminates against you.”

She appreciates the feeling of being proactive that these new drugs grant. It has “opened up a bunch of opportunities for me to be seen as a full individual by the medical establishment,” she said. “I was willing to take the risk, knowing that I would be on these drugs for the rest of my life.”

In addition to being what Dr. Goodstein refers to as a guinea pig, she said she made sure that her primary care doctor was aware that she was not trying or planning to become pregnant again. (She has a 3-year-old child.) Still, her doctor mentioned only the most common side effects linked to these drugs, like nausea, vomiting, and diarrhea, and did not mention the risk of pregnancy.

“Folks are really not talking about the reproductive implications,” she said, referring to members of a Facebook group on these drugs that she belongs to. 

Like patients themselves, many doctors are just beginning to get their arms around these agents. “Awareness, education, provider involvement, and having a multidisciplinary team could help patients achieve the goals that they set out for themselves,” said Dr. Shah. 

Clear conversations are key.

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

For women who are obese, daily life is wrought with landmines. Whether it’s the challenges of air travel because plane seats are too small, the need to shield themselves from the world’s discriminating eyes, or the great lengths many will go to achieve better health and the promise of longevity, navigating life as an obese person requires a thick skin.

So, it’s no wonder so many are willing to pay more than $1,000 a month out of pocket to get their hands on drugs like semaglutide (Ozempic and Wegovy) or tirzepatide (Mounjaro). The benefits of these drugs, which are part of a new class called glucagonlike peptide–1 (GLP-1) receptor agonists, include significant and rapid weight loss, blood sugar control, and improved life quality; they are unprecedented in a setting where surgery has long been considered the most effective long-term option.

On the flip side, the desire for rapid weight loss and better blood sugar control also comes with an unexpected cost. Many women living with obesity who take oral contraceptives are unaware that these drugs – especially Mounjaro – can interfere with the absorption of birth control pills and how well they work, making an unintended pregnancy more likely.

Neel Shah, MD, an endocrinologist and associate professor at the University of Texas Health Science Center at Houston, said he has had several patients become pregnant without intending to. 

“It was when Mounjaro came out on the market when we started using it,” he said of the drug the Food and Drug Administration approved for type 2 diabetes in 2022. “It [the warning] was in the product insert, but clinically speaking, I don’t know if it was at the top of providers’ minds when they were prescribing Mounjaro.”

When asked if he believed that we were going to be seeing a significant increase in so-called Mounjaro babies, Dr. Shah was sure in his response. 

“Absolutely. We will because the sheer volume [of patients] will increase,” he said.
 

It’s all in the gut

One of the ways that drugs like Mounjaro work is by delaying the time that it takes for food to move from the stomach to the small intestine. Although data are still evolving, it is believed that this process – delayed gastric emptying – may affect the absorption of birth control pills. 

Dr. Shah said another theory is that vomiting, which is a common side effect of these types of drugs, also affects the pills’ ability to prevent pregnancy. 

And “there’s a prolonged period of ramping up the dose because of the GI side effects,” said Pinar Kodaman, MD, PhD, a reproductive endocrinologist and assistant professor of gynecology at Yale University in New Haven, Conn. 

“Initially, at the lowest dose, there may not be a lot of potential effect on absorption and gastric emptying. But as the dose goes up, it becomes more common, and it can cause diarrhea, which is another condition that can affect the absorption of any medication,” she said.
 

Unanticipated outcomes, extra prevention

Roughly 42% of women in the United States are obese, 40% of whom are between the ages of 20 and 39. Although these new drugs can improve fertility outcomes for women who are obese (especially those with polycystic ovary syndrome, or PCOS), only one – Mounjaro – currently carries a warning about birth control pill effectiveness on its label. Unfortunately, it appears that some doctors are unaware or not counseling patients about this risk, and the data are unclear about whether other drugs in this class, like Ozempic and Wegovy, have the same risks. 

“To date, it hasn’t been a typical thing that we counsel about,” said Dr. Kodaman. “It’s all fairly new, but when we have patients on birth control pills, we do review other medications that they are on because some can affect efficacy, and it’s something to keep in mind.”

It’s also unclear if other forms of birth control – for example, birth control patches that deliver through the skin – might carry similar pregnancy risks. Dr. Shah said some of his patients who became pregnant without intending to were using these patches. This raises even more questions, since they deliver drugs through the skin directly into the bloodstream and not through the GI system. 

What can women do to help ensure that they don’t become pregnant while using these drugs? 

“I really think that if patients want to protect themselves from an unplanned pregnancy, that as soon as they start the GLP receptor agonists, it wouldn’t be a bad idea to use condoms, because the onset of action is pretty quick,” said Dr. Kodaman, noting also that “at the lowest dose there may not be a lot of potential effect on gastric emptying. But as the dose goes up, it becomes much more common or can cause diarrhea.” 

Dr. Shah said that in his practice he’s “been telling patients to add barrier contraception” 4 weeks before they start their first dose “and at any dose adjustment.”

Zoobia Chaudhry, an obesity medicine doctor and assistant professor of medicine at Johns Hopkins University in Baltimore, recommends that “patients just make sure that the injection and medication that they take are at least 1 hour apart.”

“Most of the time, patients do take birth control before bedtime, so if the two are spaced, it should be OK,” she said.

Another option is for women to speak to their doctors about other contraceptive options like IUDs or implantable rods, where gastric absorption is not going to be an issue. 

“There’s very little research on this class of drugs,” said Emily Goodstein, a 40-year-old small-business owner in Washington, who recently switched from Ozempic to Mounjaro. “Being a person who lives in a larger body is such a horrifying experience because of the way that the world discriminates against you.”

She appreciates the feeling of being proactive that these new drugs grant. It has “opened up a bunch of opportunities for me to be seen as a full individual by the medical establishment,” she said. “I was willing to take the risk, knowing that I would be on these drugs for the rest of my life.”

In addition to being what Dr. Goodstein refers to as a guinea pig, she said she made sure that her primary care doctor was aware that she was not trying or planning to become pregnant again. (She has a 3-year-old child.) Still, her doctor mentioned only the most common side effects linked to these drugs, like nausea, vomiting, and diarrhea, and did not mention the risk of pregnancy.

“Folks are really not talking about the reproductive implications,” she said, referring to members of a Facebook group on these drugs that she belongs to. 

Like patients themselves, many doctors are just beginning to get their arms around these agents. “Awareness, education, provider involvement, and having a multidisciplinary team could help patients achieve the goals that they set out for themselves,” said Dr. Shah. 

Clear conversations are key.

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

Obesity is a major factor affecting the health of many Americans. It is estimated by the Centers for Disease Control and Prevention that 41% of adults and 19.7% of children in our country now meet the criteria for being obese. Obesity costs the United States approximately $147 billion annually in health care costs. While these numbers are staggering, they continue to rise.

The recent craze over medications such as Ozempic, Wegovy, and Mounjaro shows how eager people are to lose weight. Yet, many of them face bias, not just in their daily lives, but from health care professionals who should do better. No one should feel stigmatized when they come for medical help. This just drives away patients who need us and who may then suffer more severe consequences of obesity-related illnesses.

Earlier this year, the American Association of Clinical Endocrinology issued a consensus statement on the role stigma and weight bias play in the management of obesity. They proposed a staging system to address the severity of obesity and suggested stigma and bias should be assessed in all patients.

While we are good at diagnosing obesity, many of us fail at addressing it empathetically with patients. I’ve seen many patients cry about past encounters they’ve had in the health care system. We need to address the emotional effect that obesity has as well as the physical complications.

Obesity is a major contributor to many diseases such as diabetes and heart disease, but we are finding it also plays a role in other diseases such as certain cancers. Treating obesity is imperative to prevent these diseases as well as to promote better treatment outcomes. We’ve all seen the diabetic patient lose weight and have their blood glucose levels come under control.

Many patients have tried hard to lose weight yet health care providers talk to them as if they haven’t made any efforts. This is very frustrating for patients. Simply telling a patient to diet and lose weight is a setup for failure. We need to address their past efforts and see what has worked and what hasn’t. Redoing the same thing over and over again is not a recipe for success.

Additionally, the focus on “diet and exercise” fails to account for emotional factors that may be contributing to a person’s obesity. Some people eat when they are stressed or depressed. It can become a habit or even an addiction. If this contributor to obesity isn’t fixed, nothing will work.

However, no medication will work well without the basic building blocks of diet and exercise. Routinely prescribing weight-loss medications without discussing diet and exercise will not result in much weight loss. Some patients simply don’t know how to eat healthfully or what they should do for exercise. A little education can go a long way. Ancillary staff, such as nutritionists or diabetic counselors, can help and free up the doctor’s time. In small practices, we can’t afford to provide those services in house but we should learn where patients can go for these services.

The AACE guidelines do a great job staging obesity. The guidelines make it easier to measure progress and decide on treatment plans. With this system, it is no longer necessary to use terms such as “excess weight” or “morbid obesity.” Patients already know they are overweight. What they need to know are clear steps so that they can reach goals. These guidelines greatly assist with providing those steps.

Most of us can do better when treating patients with obesity, We are probably not even aware of the times we have been guilty of stigmatization or weight bias. When we start treating obesity as a serious medical problem rather than something that’s the fault of the patient, it becomes much easier. When we remind ourselves what can happen to our patients when we fail to treat their obesity, we can become more serious about trying to help them reverse this critical medical problem. Bring an end to throwing out a “lose weight” or “eat healthier” suggestion to our already stressed patients. In order to address the obesity crisis that is here, we need to look inside ourselves and ask how we are going to contribute to the solution.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant of medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.

Obesity is a major factor affecting the health of many Americans. It is estimated by the Centers for Disease Control and Prevention that 41% of adults and 19.7% of children in our country now meet the criteria for being obese. Obesity costs the United States approximately $147 billion annually in health care costs. While these numbers are staggering, they continue to rise.

The recent craze over medications such as Ozempic, Wegovy, and Mounjaro shows how eager people are to lose weight. Yet, many of them face bias, not just in their daily lives, but from health care professionals who should do better. No one should feel stigmatized when they come for medical help. This just drives away patients who need us and who may then suffer more severe consequences of obesity-related illnesses.

Earlier this year, the American Association of Clinical Endocrinology issued a consensus statement on the role stigma and weight bias play in the management of obesity. They proposed a staging system to address the severity of obesity and suggested stigma and bias should be assessed in all patients.

While we are good at diagnosing obesity, many of us fail at addressing it empathetically with patients. I’ve seen many patients cry about past encounters they’ve had in the health care system. We need to address the emotional effect that obesity has as well as the physical complications.

Obesity is a major contributor to many diseases such as diabetes and heart disease, but we are finding it also plays a role in other diseases such as certain cancers. Treating obesity is imperative to prevent these diseases as well as to promote better treatment outcomes. We’ve all seen the diabetic patient lose weight and have their blood glucose levels come under control.

Many patients have tried hard to lose weight yet health care providers talk to them as if they haven’t made any efforts. This is very frustrating for patients. Simply telling a patient to diet and lose weight is a setup for failure. We need to address their past efforts and see what has worked and what hasn’t. Redoing the same thing over and over again is not a recipe for success.

Additionally, the focus on “diet and exercise” fails to account for emotional factors that may be contributing to a person’s obesity. Some people eat when they are stressed or depressed. It can become a habit or even an addiction. If this contributor to obesity isn’t fixed, nothing will work.

However, no medication will work well without the basic building blocks of diet and exercise. Routinely prescribing weight-loss medications without discussing diet and exercise will not result in much weight loss. Some patients simply don’t know how to eat healthfully or what they should do for exercise. A little education can go a long way. Ancillary staff, such as nutritionists or diabetic counselors, can help and free up the doctor’s time. In small practices, we can’t afford to provide those services in house but we should learn where patients can go for these services.

The AACE guidelines do a great job staging obesity. The guidelines make it easier to measure progress and decide on treatment plans. With this system, it is no longer necessary to use terms such as “excess weight” or “morbid obesity.” Patients already know they are overweight. What they need to know are clear steps so that they can reach goals. These guidelines greatly assist with providing those steps.

Most of us can do better when treating patients with obesity, We are probably not even aware of the times we have been guilty of stigmatization or weight bias. When we start treating obesity as a serious medical problem rather than something that’s the fault of the patient, it becomes much easier. When we remind ourselves what can happen to our patients when we fail to treat their obesity, we can become more serious about trying to help them reverse this critical medical problem. Bring an end to throwing out a “lose weight” or “eat healthier” suggestion to our already stressed patients. In order to address the obesity crisis that is here, we need to look inside ourselves and ask how we are going to contribute to the solution.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant of medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.

Obesity is a major factor affecting the health of many Americans. It is estimated by the Centers for Disease Control and Prevention that 41% of adults and 19.7% of children in our country now meet the criteria for being obese. Obesity costs the United States approximately $147 billion annually in health care costs. While these numbers are staggering, they continue to rise.

The recent craze over medications such as Ozempic, Wegovy, and Mounjaro shows how eager people are to lose weight. Yet, many of them face bias, not just in their daily lives, but from health care professionals who should do better. No one should feel stigmatized when they come for medical help. This just drives away patients who need us and who may then suffer more severe consequences of obesity-related illnesses.

Earlier this year, the American Association of Clinical Endocrinology issued a consensus statement on the role stigma and weight bias play in the management of obesity. They proposed a staging system to address the severity of obesity and suggested stigma and bias should be assessed in all patients.

While we are good at diagnosing obesity, many of us fail at addressing it empathetically with patients. I’ve seen many patients cry about past encounters they’ve had in the health care system. We need to address the emotional effect that obesity has as well as the physical complications.

Obesity is a major contributor to many diseases such as diabetes and heart disease, but we are finding it also plays a role in other diseases such as certain cancers. Treating obesity is imperative to prevent these diseases as well as to promote better treatment outcomes. We’ve all seen the diabetic patient lose weight and have their blood glucose levels come under control.

Many patients have tried hard to lose weight yet health care providers talk to them as if they haven’t made any efforts. This is very frustrating for patients. Simply telling a patient to diet and lose weight is a setup for failure. We need to address their past efforts and see what has worked and what hasn’t. Redoing the same thing over and over again is not a recipe for success.

Additionally, the focus on “diet and exercise” fails to account for emotional factors that may be contributing to a person’s obesity. Some people eat when they are stressed or depressed. It can become a habit or even an addiction. If this contributor to obesity isn’t fixed, nothing will work.

However, no medication will work well without the basic building blocks of diet and exercise. Routinely prescribing weight-loss medications without discussing diet and exercise will not result in much weight loss. Some patients simply don’t know how to eat healthfully or what they should do for exercise. A little education can go a long way. Ancillary staff, such as nutritionists or diabetic counselors, can help and free up the doctor’s time. In small practices, we can’t afford to provide those services in house but we should learn where patients can go for these services.

The AACE guidelines do a great job staging obesity. The guidelines make it easier to measure progress and decide on treatment plans. With this system, it is no longer necessary to use terms such as “excess weight” or “morbid obesity.” Patients already know they are overweight. What they need to know are clear steps so that they can reach goals. These guidelines greatly assist with providing those steps.

Most of us can do better when treating patients with obesity, We are probably not even aware of the times we have been guilty of stigmatization or weight bias. When we start treating obesity as a serious medical problem rather than something that’s the fault of the patient, it becomes much easier. When we remind ourselves what can happen to our patients when we fail to treat their obesity, we can become more serious about trying to help them reverse this critical medical problem. Bring an end to throwing out a “lose weight” or “eat healthier” suggestion to our already stressed patients. In order to address the obesity crisis that is here, we need to look inside ourselves and ask how we are going to contribute to the solution.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant of medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.