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New Drug Therapy May Improve Irritable Bowel Syndrome With Diarrhea: Presented at ACG

By Mike Fillon

ORLANDO, FL -- November 3, 2004 -- Treatment with cilansetron resulted in significant improvement of health-related quality of life in patients suffering from irritable bowel syndrome with diarrhea (IBS-D), according to results from a recently completed phase 3, 6-month, multinational trial.

"Effective symptom control is critical to improving quality of life for the men and women who struggle with this condition on a daily basis," said lead researcher Kevin W. Olden, MD, professor of medicine and psychiatry, Digestive Health Center, division of gastroenterology, University of South Alabama, Mobile, Alabama.

Results of the study were displayed in a poster presentation at the American College of Gastroenterology 69th Annual Scientific Meeting, held here October 29 to November 3.

Irritable bowel syndrome is one of the most common gastrointestinal disorders in the United States, affecting more than 58 million Americans. It is a functional disorder of the intestines and its nerves, and it may be caused by abnormal motility of the intestinal muscles or abnormally sensitive nerves in the intestines, known as visceral hypersensitivity.

In Dr. Olden's double-blind, placebo-controlled study, patients were randomized to cilansetron 2 mg 3 times a day, or placebo. The researchers gave participants the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire at baseline and the end of treatment. Higher scores on IBS-QOL indicate better quality of life, Dr. Olden said.

The sample included 168 patients treated with cilansetron and 170 on placebo. At baseline, mean overall IBS-QOL scores were 55.0 for cilansetron and 55.5 for placebo. Patients on cilansetron improved by 17.7 points compared to 9.6 for patients on placebo (P <.005).

Cilansetron showed statistically significant improvements for all subscales (P <.005), except sexual, which showed the highest scores at baseline, at 75.5 points, and increased by 7.4 points. The largest improvements were observed for interference with activity, food avoidance, and dysphoria, which had the lowest levels of QOL at baseline, 47.9, and increased by 22 points (P <.005).

"These results show that cilansetron is well tolerated and efficacious in treating IBS with diarrhea in men and women," Dr. Olden said. "Cilansetron improves overall health-related quality of life and relieves specific symptoms of IBS with diarrhea."

Cilansetron is a novel 5-HT3 receptor antagonist. The cause of abnormal intestinal motility and visceral hypersensitivity in IBS is not precisely known. Most scientists believe that serotonin -- also known as 5-hydroxytryptamine (5-HT) -- plays an important role in stimulating muscle contractions in the intestines and increasing the sensitivity of the intestines to pain. It is believed that abnormal amounts of serotonin or 5-HT receptors, or abnormal binding of serotonin to the 5-HT receptors might cause symptoms in patients with IBS.

Patients with IBS typically complain of recurrent abdominal pain, bloating, and alteration in bowel habit. Some IBS patients are prone to constipation, some are prone to diarrhea, and some have periods of constipation alternating with periods of diarrhea. IBS is a chronic condition; symptoms can come and go over months, years, or even decades.

While IBS is not life threatening, symptoms of IBS can have a significant impact on quality of life and can even be debilitating, according to the researchers.

Dr. Olden serves as consultant to Solvay Pharmaceuticals, Marietta, Georgia, and his fellow researchers included employees of Solvay, developer of cilansetron.


[Presentation title: Cilansetron Improves Health Related Quality of Life in Patients With Irritable Bowel Syndrome With Diarrhea Predominance (IBS-D). Abstract 227]

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