Source: American College of Gastroenterology Major new trial of Cilansetron shows promising results ORLANDO (November 1, 2004)-
-A new therapy under development for the treatment of irritable bowel syndrome with diarrhea predominance appears to provide significant improvements in measures of quality of life, according to a study presented at the 69th Annual Meeting of the American College of Gastroenterology. Cilansetron (Solvay Pharmaceuticals, Marietta, GA) is a novel 5-HT3 receptor antagonist.
Researchers Kevin W. Olden M.D., FACG of the University of South Alabama and Douglas A. Drossman, M.D., FACG of the University of North Carolina at Chapel Hill conducted a double-blind, placebo-controlled, 6-month multinational trial in which patients were randomized to cilansetron 2 mg three times a day or placebo. They gave participants a survey of IBS specific quality of life measures (IBS-QOL), developed by Dr. Drossman, at both the outset and the end of the study. Higher scores on IBS-QOL indicate better quality of life. The sample included 168 patients given cilansetron and 170 on placebo. At baseline, their mean overall IBS-QOL scores were 55.0 for cilansetron and 55.5 for placebo.
Overall, patients on cilansetron improved 17.7 on the scale compared to 9.6 for patients on placebo (p<0.005). Cilansetron showed statistically significant improvements for all subscales, except sexual, which showed the highest scores at baseline. The largest improvements were observed for interference with activity, food avoidance and poor mood (dysphoria), which had the lowest levels of QOL at baseline.
"These results show that cilansestron is well tolerated and efficacious in treating IBS with diarrhea in men and women," said Dr. Olden. "Cilansetron improves overall health- related quality of life and relieves specific symptoms of IBS with diarrhea." Both Dr. Olden and Dr. Drossman serve as consultants to Solvay, and their fellow researchers included employees of Solvay. The ACG was formed in 1932 to advance the scientific study and medical treatment of disorders of the gastrointestinal (GI) tract. The College promotes the highest standards in medical education and is guided by its commitment to meeting the needs of clinical gastroenterology practitioners.
EDITOR'S NOTE: This drug is not yet available to consumers. Here is a statement from the company that is developing it: "Cilansetron is a new compound developed by Solvay’s Research and Development Department. It is a selective 5HT3-antagonist which is in phase III clinical development for the indication of diarrhea predominant IBS. This means cilansetron is not yet on the market. The results from the first clinical studies are promising. We hope to tell you more about this product soon." For more information, please visit http://www.solvay-ibs.com/.