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Ramosetron improves symptoms, quality of life in women with IBS-D
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Ramosetron, a 5-hydroxytryptamine-3 antagonist used in Japan, Korea and Thailand to treat male patients with diarrhea-predominant irritable bowel syndrome, was found to reduce symptoms, increase stool consistency and improve quality of life in women in a recent phase 3 clinical trial.
Alosetron, another 5-hydroxytryptamine-3 (5-HT-3) antagonist, is approved in the U.S. for female patients, but there is “no logical explanation why 5-HT-3 antagonists would be effective solely in women with IBS-D in Western countries and only in men with IBS-D in Asian countries,” Shin Fukudo, MD, PhD, from the department of Behavioral Medicine at Tohoku University Graduate School of Medicine in Japan, and colleagues wrote. “Given the preceding context, it is natural to test the hypothesis that ramosetron could also be effective in female patients with IBS-D, in a study with a sufficient sample size.”
From February 2013 through February 2014, Fukudo and colleagues prospectively studied female outpatients aged 20 to 64 years with IBS-D who, after a 1-week baseline evaluation, were randomly assigned to receive 2.5 µg oral ramosetron hydrochloride (n = 292) or placebo (n = 284) once daily for 12 weeks at one of 70 Japanese academic centers. Patients recorded daily symptoms and were evaluated at 2, 3, 8 and 12 weeks, and the primary endpoints included monthly responder rates for overall IBS symptom relief and increased stool consistency at the last visit. Health-related quality of life was also evaluated every 4 weeks.
Overall symptom improvement was reported by 50.7% (95% CI, 44.8%-56.6%) of the treatment group compared with 32% (95% CI, 26.7%-37.8%) of the placebo group, for a difference of 18.6% (95% CI, 10.7%-26.5%). This corresponded to a relative risk of 1.58 (95% CI, 1.29-1.94) and a number needed to treat of 6 (95% CI, 4-10).
Increased stool consistency was reported by 40.8% (95% CI, 35.1%-46.6%) of the treatment group compared with 24.3% (95% CI, 19.4%-29.7%) of the placebo group, for a difference of 16.5% (95% CI, 8.9%-24%). This corresponded to a relative risk of 1.68 (95% CI, 1.31-2.15) and a number needed to treat of 7 (95% CI, 5-12).
Patients in the treatment group also had significant improvements in abdominal pain and discomfort (P = .001) and quality of life (P = .002) compared with patients in the placebo group. Adverse events were observed in 52.7% of the treatment group compared with 41.5% of the placebo group (P = .008); constipation occurred in 11% and 4.6%, respectively (P = .005), and hard stool occurred in 22.6% and 5.6%, respectively (P < .001).
“In conclusion, the study results suggest that 2.5 µg of ramosetron is useful for treating female patients with IBS-D,” the researchers wrote. “Based on this study and previous studies, ramosetron has been shown to be the most promising 5-HT-3 antagonist for treating patients with IBS-D regardless of gender.” – by Adam Leitenberger
Disclosures: This study was funded by Astellas Pharma. Fukudo and other researchers report they are medical consultants for Astellas, and other researchers report they are employees of Astellas.
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