The drug zelnorm (tegaserod) is an effective, well-tolerated treatment for chronic constipation, according to findings from a large multinational trial.

Chronic constipation is one of the most common complaints and has a major healthcare impact. Effective treatments are limited.

In studies of patients with Irritable bowel syndrome involving constipation, zelnorm was shown to reduce straining during defecation, improve stool consistency, and increase the frequency of bowel movements.

Given these findings, Dr. Sophie Hugot-Cournez of Novartis Pharma, Basel, Switzerland, the maker of zelnorm, and colleagues decided to test the drug in 1,264 patients with chronic constipation.

They were randomly assigned to receive zelnorm, 2 or 6 milligrams twice daily, or placebo for 12 weeks.

Thirty-five percent of patients on low-dose zelnorm and 40 percent on high-dose zelnorm responded with an increase in complete spontaneous bowel movements during weeks 1 through 4, compared with only about 26 percent of those taking placebo.

High-dose zelnorm significantly reduced straining, abdominal bloating, and abdominal pain compared with placebo. Other benefits included an improvement in stool form and in the global assessment of bowel habits and constipation.

Zelnorm was well tolerated and the most common adverse events, headache and abdominal pain, actually occurred more often with placebo than with the drug.

Zelnorm “provided rapid, predictable, and effective relief of the multiple symptoms of chronic constipation,” the authors conclude.

The study was funded by Novartis Pharma.

SOURCE: American Journal of Gastroenterology February 2005.