Long-term efficacy and safety of ramosetron in the treatment of diarrhea-predominant irritable bowel syndrome

Figures & data

Table 1 Summary of clinical studies of ramosetron in the treatment of diarrhea-predominant irritable bowel syndrome (IBS)

Study	Study design	Sample size	Efficacy	Statistical analysis	Adverse events
Matsueda et al^Citation30	Randomized controlled trial	418	12-week IBS-symptom responders: 42.57% with 5 μg ramosetron, 43.01% with 10 μg ramosetron, 26.92% with placebo.	The responder rates in the ramosetron 5 and 10 μg groups were higher than placebo (P<0.05).	Neither ischemic colitis nor severe constipation was observed.
Matsueda et al^Citation23	Randomized controlled trial	539	12-week IBS-symptom responders: 47% with 5 μg ramosetron, 27% with placebo.	The responder rates in the ramosetron group were higher than placebo (P<0.001).	Hard stool occurred in 7.41% in ramosetron group compared with 0.74% in placebo (P<0.001). No adverse events were classified as severe.
Matsueda et al^Citation33	Nonrandomized, noncomparative study (postmarketing survey)	272	Responder rates for at least 28 weeks (up to 52 weeks) with ramosetron: 50.00% with 2.5 μg dose-reduction group, 35.71% with 5 μg dose-maintenance group, 22.50% with 10 μg dose increase group.(br/)The rate was further increased subsequently.	No statistical analysis was reported.	The lack of the delayed increase in the incidence of adverse events associated with long-term treatment was demonstrated.
Lee et al^Citation32	Multicenter, randomized, open-label design	343	Responder rates during 4-week treatment: 37% with ramosetron, 38% with mebeverine.	Responder rates for IBS symptoms in the ramosetron and mebeverine groups were increased compared with baselines (P<0.001). There were no significant differences in the responder rates between the ramosetron and mebeverine groups.	Neither severe constipation nor ischemic colitis was reported by ramosetrontreated patients.

MatsuedaKHarasawaSHongoMHiwatashiNSasakiDA phase II trial of the novel serotonin type 3 receptor antagonist ramosetron in Japanese male and female patients with diarrhea-predominant irritable bowel syndromeDigestion20087722523518667823

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MatsuedaKHarasawaSHongoMHiwatashiNSasakiDA randomized, double-blind, placebo-controlled clinical trial of the effectiveness of the novel serotonin type 3 receptor antagonist ramosetron in both male and female Japanese patients with diarrhea-predominant irritable bowel syndromeScand J Gastroenterol2008431202121118618371

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MatsuedaKArakawaTMatsumotoTSasakiDLong-term study of YM060 (ramosetron hydrochloride) in Japanese patients (male) with diarrhea-predominant irritable bowel syndromeRinsho Iyaku200824655678 Japanese with English abstract

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LeeKJKimNYKwonJKEfficacy of ramosetron in the treatment of male patients with irritable bowel syndrome with diarrhea: a multicenter, randomized clinical trial, compared with mebeverineNeurogastroenterol Motil2011231098110421920001

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