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Study documents obesity-related defecation disorders
, as well as clinically significant rectocele and increased anal resting and rectal pressures.
The study, which was published in the American Journal of Gastroenterology and led by Pam Chaichanavichkij, MBChB, MRCS, of Queen Mary University, London, included 1,155 patients (84% female, median age 52) who were obese (31.7%), overweight (34.8%), or of normal weight 33.5%).
“These results support the notion that rectal evacuation disorder/incomplete evacuation may be an important underlying mechanism for fecal incontinence in obese patients,” the authors wrote.
Obese patients had higher odds of fecal incontinence to liquid stools (69.9 vs. 47.8%; odds ratio, 1.96 [confidence interval, 1.43-2.70]), use of containment products (54.6% vs. 32.6%; OR, 1.81 [CI, 1.31-2.51]), fecal urgency (74.6% vs. 60.7%; OR, 1.54 [CI, 1.11-2.14]), urge fecal incontinence (63.4% vs. 47.3%, OR, 1.68 [CI, 1.23-2.29]), and vaginal digitation (18.0% vs. 9.7%; OR, 2.18 [CI, 1.26-3.86]).
Obese patients were also more likely to have functional constipation (50.3%), compared with overweight (44.8%) and normal weight patients (41.1%).
There was a positive linear association between body mass index (BMI) and anal resting pressure (beta 0.45; R2, 0.25, P = 0.0003), though the odds of anal hypertension were not significantly higher after Benjamini-Hochberg correction. Obese patients more often had a large clinically significant rectocele (34.4% vs. 20.6%; OR, 2.62 [CI, 1.51-4.55]), compared with normal BMI patients.
The data showed higher rates of gynecological surgery, cholecystectomy, diabetes, and self-reported use of opioids, antidepressants, and anticholinergic medications in the obese group, compared with the others.
In morphological differences measured by x-ray defecography, obese patients had more than two-fold higher odds of having a rectocele and even greater odds of the rectocele being large and clinically significant. Anal and rectal resting pressures were linearly related to increasing BMI, the authors report.
Because most patients in the study were female, the findings may not be generalizable to the general population or male patients. Also, diet and exercise, two factors that may affect defecation disorders, were not accounted for in this study.
Dr. Chaichanavichkij reported no disclosures. Two other authors reported financial relationships with Medtronic Inc. and MMS/Laborie.
, as well as clinically significant rectocele and increased anal resting and rectal pressures.
The study, which was published in the American Journal of Gastroenterology and led by Pam Chaichanavichkij, MBChB, MRCS, of Queen Mary University, London, included 1,155 patients (84% female, median age 52) who were obese (31.7%), overweight (34.8%), or of normal weight 33.5%).
“These results support the notion that rectal evacuation disorder/incomplete evacuation may be an important underlying mechanism for fecal incontinence in obese patients,” the authors wrote.
Obese patients had higher odds of fecal incontinence to liquid stools (69.9 vs. 47.8%; odds ratio, 1.96 [confidence interval, 1.43-2.70]), use of containment products (54.6% vs. 32.6%; OR, 1.81 [CI, 1.31-2.51]), fecal urgency (74.6% vs. 60.7%; OR, 1.54 [CI, 1.11-2.14]), urge fecal incontinence (63.4% vs. 47.3%, OR, 1.68 [CI, 1.23-2.29]), and vaginal digitation (18.0% vs. 9.7%; OR, 2.18 [CI, 1.26-3.86]).
Obese patients were also more likely to have functional constipation (50.3%), compared with overweight (44.8%) and normal weight patients (41.1%).
There was a positive linear association between body mass index (BMI) and anal resting pressure (beta 0.45; R2, 0.25, P = 0.0003), though the odds of anal hypertension were not significantly higher after Benjamini-Hochberg correction. Obese patients more often had a large clinically significant rectocele (34.4% vs. 20.6%; OR, 2.62 [CI, 1.51-4.55]), compared with normal BMI patients.
The data showed higher rates of gynecological surgery, cholecystectomy, diabetes, and self-reported use of opioids, antidepressants, and anticholinergic medications in the obese group, compared with the others.
In morphological differences measured by x-ray defecography, obese patients had more than two-fold higher odds of having a rectocele and even greater odds of the rectocele being large and clinically significant. Anal and rectal resting pressures were linearly related to increasing BMI, the authors report.
Because most patients in the study were female, the findings may not be generalizable to the general population or male patients. Also, diet and exercise, two factors that may affect defecation disorders, were not accounted for in this study.
Dr. Chaichanavichkij reported no disclosures. Two other authors reported financial relationships with Medtronic Inc. and MMS/Laborie.
, as well as clinically significant rectocele and increased anal resting and rectal pressures.
The study, which was published in the American Journal of Gastroenterology and led by Pam Chaichanavichkij, MBChB, MRCS, of Queen Mary University, London, included 1,155 patients (84% female, median age 52) who were obese (31.7%), overweight (34.8%), or of normal weight 33.5%).
“These results support the notion that rectal evacuation disorder/incomplete evacuation may be an important underlying mechanism for fecal incontinence in obese patients,” the authors wrote.
Obese patients had higher odds of fecal incontinence to liquid stools (69.9 vs. 47.8%; odds ratio, 1.96 [confidence interval, 1.43-2.70]), use of containment products (54.6% vs. 32.6%; OR, 1.81 [CI, 1.31-2.51]), fecal urgency (74.6% vs. 60.7%; OR, 1.54 [CI, 1.11-2.14]), urge fecal incontinence (63.4% vs. 47.3%, OR, 1.68 [CI, 1.23-2.29]), and vaginal digitation (18.0% vs. 9.7%; OR, 2.18 [CI, 1.26-3.86]).
Obese patients were also more likely to have functional constipation (50.3%), compared with overweight (44.8%) and normal weight patients (41.1%).
There was a positive linear association between body mass index (BMI) and anal resting pressure (beta 0.45; R2, 0.25, P = 0.0003), though the odds of anal hypertension were not significantly higher after Benjamini-Hochberg correction. Obese patients more often had a large clinically significant rectocele (34.4% vs. 20.6%; OR, 2.62 [CI, 1.51-4.55]), compared with normal BMI patients.
The data showed higher rates of gynecological surgery, cholecystectomy, diabetes, and self-reported use of opioids, antidepressants, and anticholinergic medications in the obese group, compared with the others.
In morphological differences measured by x-ray defecography, obese patients had more than two-fold higher odds of having a rectocele and even greater odds of the rectocele being large and clinically significant. Anal and rectal resting pressures were linearly related to increasing BMI, the authors report.
Because most patients in the study were female, the findings may not be generalizable to the general population or male patients. Also, diet and exercise, two factors that may affect defecation disorders, were not accounted for in this study.
Dr. Chaichanavichkij reported no disclosures. Two other authors reported financial relationships with Medtronic Inc. and MMS/Laborie.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
Bulevirtide shows promise in chronic hepatitis D
shows an ongoing phase 3 study conducted in the United States and four other countries.
The findings were published in the New England Journal of Medicine.
Led by Heiner Wedemeyer, MD, of Hannover Medical School in Germany, the study included 150 patients with HDV, with and without compensated cirrhosis (mean age, 42 years; 57% male; 83% White). They were randomly assigned to receive 2 mg or 10 mg of bulevirtide subcutaneously daily for 144 weeks or, as a control group, receive no treatment for 48 weeks, followed by 10 mg of bulevirtide daily for 96 weeks. All patients were followed for 96 weeks after treatment ends.
For the primary endpoint, the combined viral and ALT response at week 48 was similar in the 2-mg (45%) and 10-mg (48%) groups, compared with 2% in the control group (one patient). Twelve percent of patients in the 2-mg group and 20% of patients in the 10-mg group had a clinical benefit, compared with none of the patients in the control group.
Among those with a combined response, normalization of the ALT level occurred in most patients by week 24, while the HDV RNA level continued to decline between week 24 and week 48, the authors wrote.
“This surrogate end point is considered to be a reasonably likely predictor of improved clinical outcomes in patients with HDV; however, longer-term data are needed to confirm the clinical benefit of bulevirtide,” the investigators wrote.
The results offer a glimmer of hope, Marc Ghany, MD, MHSc, of the National Institute of Diabetes and Digestive and Kidney Diseases wrote in an accompanying editorial. “The goal of HDV therapy is to improve patient survival by preventing progression to cirrhosis, liver failure, and liver cancer,” he wrote.
In safety results, headache, pruritus, fatigue, and eosinophilia were more common in the bulevirtide groups than in the control group. All adverse events were mild to moderate.
HDV infects about 5% of people with chronic HBV and relies on HBV surface antigen (HBsAg) for transmission and infectivity. Bulevirtide is derived from a region of the large envelope protein of HBsAg and irreversibly binds to the hepatocyte entry receptor for both HDV and HBV.
Bulevirtide has received conditional approval in the European Union. In 2022, the Food and Drug Administration declined to approve bulevirtide over concerns about production and delivery of the drug. There are no approved treatments for HDV in the United States.
The study was supported by Gilead Sciences. Dr. Wedemeyer disclosed research funding, acting as a consultant to, and giving paid lectures on behalf of Gilead Sciences. He and other coauthors disclosed financial relationships with Gilead and other pharmaceutical companies.
shows an ongoing phase 3 study conducted in the United States and four other countries.
The findings were published in the New England Journal of Medicine.
Led by Heiner Wedemeyer, MD, of Hannover Medical School in Germany, the study included 150 patients with HDV, with and without compensated cirrhosis (mean age, 42 years; 57% male; 83% White). They were randomly assigned to receive 2 mg or 10 mg of bulevirtide subcutaneously daily for 144 weeks or, as a control group, receive no treatment for 48 weeks, followed by 10 mg of bulevirtide daily for 96 weeks. All patients were followed for 96 weeks after treatment ends.
For the primary endpoint, the combined viral and ALT response at week 48 was similar in the 2-mg (45%) and 10-mg (48%) groups, compared with 2% in the control group (one patient). Twelve percent of patients in the 2-mg group and 20% of patients in the 10-mg group had a clinical benefit, compared with none of the patients in the control group.
Among those with a combined response, normalization of the ALT level occurred in most patients by week 24, while the HDV RNA level continued to decline between week 24 and week 48, the authors wrote.
“This surrogate end point is considered to be a reasonably likely predictor of improved clinical outcomes in patients with HDV; however, longer-term data are needed to confirm the clinical benefit of bulevirtide,” the investigators wrote.
The results offer a glimmer of hope, Marc Ghany, MD, MHSc, of the National Institute of Diabetes and Digestive and Kidney Diseases wrote in an accompanying editorial. “The goal of HDV therapy is to improve patient survival by preventing progression to cirrhosis, liver failure, and liver cancer,” he wrote.
In safety results, headache, pruritus, fatigue, and eosinophilia were more common in the bulevirtide groups than in the control group. All adverse events were mild to moderate.
HDV infects about 5% of people with chronic HBV and relies on HBV surface antigen (HBsAg) for transmission and infectivity. Bulevirtide is derived from a region of the large envelope protein of HBsAg and irreversibly binds to the hepatocyte entry receptor for both HDV and HBV.
Bulevirtide has received conditional approval in the European Union. In 2022, the Food and Drug Administration declined to approve bulevirtide over concerns about production and delivery of the drug. There are no approved treatments for HDV in the United States.
The study was supported by Gilead Sciences. Dr. Wedemeyer disclosed research funding, acting as a consultant to, and giving paid lectures on behalf of Gilead Sciences. He and other coauthors disclosed financial relationships with Gilead and other pharmaceutical companies.
shows an ongoing phase 3 study conducted in the United States and four other countries.
The findings were published in the New England Journal of Medicine.
Led by Heiner Wedemeyer, MD, of Hannover Medical School in Germany, the study included 150 patients with HDV, with and without compensated cirrhosis (mean age, 42 years; 57% male; 83% White). They were randomly assigned to receive 2 mg or 10 mg of bulevirtide subcutaneously daily for 144 weeks or, as a control group, receive no treatment for 48 weeks, followed by 10 mg of bulevirtide daily for 96 weeks. All patients were followed for 96 weeks after treatment ends.
For the primary endpoint, the combined viral and ALT response at week 48 was similar in the 2-mg (45%) and 10-mg (48%) groups, compared with 2% in the control group (one patient). Twelve percent of patients in the 2-mg group and 20% of patients in the 10-mg group had a clinical benefit, compared with none of the patients in the control group.
Among those with a combined response, normalization of the ALT level occurred in most patients by week 24, while the HDV RNA level continued to decline between week 24 and week 48, the authors wrote.
“This surrogate end point is considered to be a reasonably likely predictor of improved clinical outcomes in patients with HDV; however, longer-term data are needed to confirm the clinical benefit of bulevirtide,” the investigators wrote.
The results offer a glimmer of hope, Marc Ghany, MD, MHSc, of the National Institute of Diabetes and Digestive and Kidney Diseases wrote in an accompanying editorial. “The goal of HDV therapy is to improve patient survival by preventing progression to cirrhosis, liver failure, and liver cancer,” he wrote.
In safety results, headache, pruritus, fatigue, and eosinophilia were more common in the bulevirtide groups than in the control group. All adverse events were mild to moderate.
HDV infects about 5% of people with chronic HBV and relies on HBV surface antigen (HBsAg) for transmission and infectivity. Bulevirtide is derived from a region of the large envelope protein of HBsAg and irreversibly binds to the hepatocyte entry receptor for both HDV and HBV.
Bulevirtide has received conditional approval in the European Union. In 2022, the Food and Drug Administration declined to approve bulevirtide over concerns about production and delivery of the drug. There are no approved treatments for HDV in the United States.
The study was supported by Gilead Sciences. Dr. Wedemeyer disclosed research funding, acting as a consultant to, and giving paid lectures on behalf of Gilead Sciences. He and other coauthors disclosed financial relationships with Gilead and other pharmaceutical companies.
FROM NEW ENGLAND JOURNAL OF MEDICINE