Randomized clinical trial: minesapride vs placebo for irritable bowel syndrome with predominant constipation

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Abstract

Agonists of 5-hydroxytryptamine 4 receptors are potential agents for irritable bowel syndrome with predominant constipation (IBS-C). However, only tegaserod has been approved for a very limited population in the US. The aim of the study was to evaluate the efficacy and safety of minesapride in patients with IBS-C.

A greater percentage of minesapride 40 mg-treated patients than placebo-treated patients met both responder requirements for ≥9/12 weeks and the stricter composite evaluation (P < 0.05). Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12). The most common adverse event was mild diarrhea.

Conclusions: Minesapride was safe and well-tolerated in patients with IBS. Although the primary endpoint was negative, minesapride 40 mg is likely to improve the stricter composite endpoint and SBM frequency.

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