CILANSETRON IMPROVES HEALTH RELATED QUALITY OF LIFE IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA PREDOMINANCE (IBS-D): 849

Purpose: Patients with irritable bowel syndrome with diarrhea predominance (IBS-D) have been shown to have impaired health-related quality of life (HRQOL). Cilansetron is a novel 5-HT3receptor antagonist being developed for the treatment of IBS-D. Results from clinical trials have demonstrated that cilansetron is well tolerated and is efficacious in treating the symptoms of IBS-D in men and women. This study investigates the effect of cilansetron 2 mg TID compared to placebo on HRQOL as measured by the IBS-QOL. Methods: In a double-blind, placebo-controlled, 6-month multinational trial, subjects meeting the Rome criteria for IB S-D were randomized to cilansetron 2 mg TID or placebo (P). The IBS-QOL, a 34-item IBS-specific quality-of-life measure for IBS consisting of 8 subscales (Drossman et al, Am J Gastroenterol 2000), was administered at baseline and end of study (EOS) with high scores indicating better quality of life (QoL). Results: The intent-to-treat population consisted of 792 subjects. The IBS-QOL sub-sample size was 168 (91F, 77M) for cilansetron and 170 (90F, 80M) for P. Baseline mean overall IBS-QOL scores were 55.0 for cilansetron and 55.5 for P. Subjects showed improvements of 17.7 for cilansetron and 9.6 for P at EOS (p <0.005). Cilansetron was statistically significant to P (p <0.005) for all subscales except sexual, which showed the highest scores at baseline. The largest improvements were observed for the interference with activity, food avoidance, and dysphoria subscales which had the lowest levels of QoL at baseline.Table: Mean Changes From Baseline to EOSConclusions: Cilansetron treatment resulted in a significant improvement in HRQOL compared to placebo in IBS-D patients treated over a period of 6 months. These data support the ability of cilansetron to improve overall HRQOL in addition to relieving specific symptoms of IBS-D.