ORLANDO, FLA. — Cilansetron is safe and effective and improves health-related quality of life in patients with diarrhea-predominant irritable bowel syndrome, according to two studies presented at the annual meeting of the American College of Gastroenterology.
In one double-blind, randomized, placebo-controlled study, a 2-mg dose of the 5-hydroxytryptamine (HT)3 receptor antagonist used three times daily was well tolerated and significantly improved symptoms in both men and women treated for up to 3 months.
A total of 692 patients were enrolled in the study. Adequate relief during at least half of the study weeks was reported by 49% of those in the treatment group and 28% of those in the placebo group, reported Philip B. Miner, M.D., president and medical director of the Oklahoma Foundation for Digestive Research, Oklahoma City.
Those in the treatment group reported significantly more relief from abdominal pain and discomfort (52% vs. 37%), and from abnormal bowel habits (51% vs. 26%) during the study. Solvay Pharmaceuticals GmbH, which is developing the drug for the treatment of IBS, sponsored this research.
Adverse events causing withdrawal from the study occurred in 12% of patients in the treatment group and 6% of those in the placebo group. Constipation, abdominal pain, and headache were the most common complaints leading to withdrawal from the treatment group, but no serious complications resulted from treatment, Dr. Miner said.
In another double-blind study, cilansetron improved health-related quality of life.
A total of 792 patients were randomized to receive placebo or treatment with 2 mg cilansetron three times daily for 6 months. A 34-item IBS-specific quality of life measure (the IBS-QOL) was administered at baseline and at the end of the study, Douglas A. Drossman, M.D., of the University of North Carolina, Chapel Hill, reported in a poster.
The baseline mean overall IBS-QOL scores were 55 in the treatment group and 55.5 in the placebo group. Higher scores on the 100-point scale indicate better quality of life; at the end-of-study assessment, scores had increased by about 18 points in the treatment group, which was a significantly greater jump than was the 10-point increase in the placebo group.
The differences in baseline and end-of-study scores for the cilansetron vs. the placebo groups were significant for seven of eight subscales, with the greatest differences seen in the scales measuring interference with activity (22-point vs. 11-point increase), food avoidance (19-point vs. 8-point increase), and dysphoria (22-point vs. 13-point increase). These measures showed the lowest levels of quality of life at baseline, with scores ranging from 44 to 49 points.
Only the subscale measuring the sexual effects of IBS showed no significant improvement with treatment vs. placebo (7-point vs. 4-point increase). This measure had the highest quality of life score at baseline at 76 points in both groups, Dr. Drossman noted.
The findings suggest that cilansetron improves overall health-related quality of life in addition to relieving specific symptoms of IBS, he said.