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Ramosetron reduced diarrhea, overall symptoms in IBS patients
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Ramosetron improved stool consistency, overall irritable bowel syndrome symptoms and quality of life in men who were IBS-diarrhea predominant, according to recent study data.
In a multicenter, double blind, placebo-controlled trial conducted in Japan from October 2010 to August 2011, 296 patients (aged 20 to 60 years) with IBS-D were randomly assigned placebo (n=149) or 5 mcg oral ramosetron (n=147), a serotonin (5-hydroxytryptamine)-3 receptor antagonist, once daily for 12 weeks.
Patients were evaluated for inclusion during a 1-week baseline period, and met criteria if they had a mean score of ≥0.7 for severity of abdominal pain/discomfort on a 5-point scale, had no type 1 or 2 stools as scored by the Bristol Stool Form Scale (BSFS), and had bowel movements for at least 5 days with a mean BSFS score of >5. Treatment efficacy, drug compliance and adverse events were assessed at 2, 4, 8 and 12 weeks.
In the first month, improved stool consistency was reported more often among the ramosetron group (50.3%; 95% CI, 42-58.7) compared with placebo (19.6%; 95% CI, 13.5-26.9). Weekly improvement of abdominal pain/discomfort was greater in the ramosetron group vs. placebo patients, with the most significant reduction at week 5 (–0.7 ± 0.73 vs. –0.48 ± 0.75; P=.012).
The ramosetron group also showed significantly greater IBS-related quality of life scores at 4 weeks (13.7; 95% CI, 12-15.4), 8 weeks (15.9; 95% CI, 13.9-17.9), 12 weeks (17.5; 95% CI, 15.4-19.6), and last point (16.8; 95% CI, 14.7-18.8) compared with placebo (9.2; 95% CI, 7.5-10.8; 11.7; 95% CI, 9.7-13.7; 13.3; 95% CI, 11.1-15.4; 12.4; 95% CI, 10.4-14.4; respectively).
“Its high potential, high selectivity, clear efficacy, and lower incidence of serious adverse events suggest that ramosetron is the most promising therapeutic agent for IBS-D,” the researchers concluded.
Disclosure: See the study for a full list of relevant financial disclosures.
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