Minesapride beneficial to patients with irritable bowel syndrome
Treatment with minesapride in patients with irritable bowel syndrome with constipation (IBS-C) is well tolerated and helps improve stool frequency, as well as abdominal and overall symptoms, according to the results of a phase II study from Japan.
Researchers randomized 171 patients with Rome III-defined IBS-C to receive minesapride (1, 4, 12, or 40 mg) or placebo once daily for 4 weeks. The modified intention-to-treat population included 171 patients (mean age, 38.5 years; 83.6 percent female). Mean disease duration was 10.7 years, and the mean weekly frequency of complete spontaneous bowel movements (CSBMs) was 0.6.
At week 4, the weekly frequency of CSBMs was greater in all minesapride groups than in the placebo group, with a significant difference between the latter and the 40-mg dose group (p=0.040). Moreover, the abdominal symptoms score markedly improved with minesapride 40 mg.
All treatment groups showed a reduction in the overall IBS severity index score from baseline to week 4, and the decrease was especially pronounced in the 12-mg and 40-mg dose vs placebo groups (p=0.048 and p<0.001, respectively).
Active treatment was well tolerated. Treatment-emergent adverse events (TEAEs) occurred in 55 percent of patients in the pooled minesapride groups and in 60 percent in the placebo group. The most common TEAE was diarrhoea (42.9 percent and 37.1 percent, respectively).
The present data underscore the utility of minesapride for treating patients with IBS-C, the researchers said.