Zelnorm® May Be Safe and Effective for Some IBS Patients With Mixed Bowel Pattern

LOS ANGELES -- Novartis announced study results showing promise for Zelnorm® (tegaserod maleate) as a safe and efficacious medical treatment for patients with irritable bowel syndrome (IBS) with a mixed bowel pattern (IBS-M). This is the first study to identify a potential treatment option for patients who suffer from IBS-M. The findings were presented at Digestive Disease Week 2006.

IBS is a dysmotility and sensory disorder characterized by abdominal pain or discomfort, bloating, and altered bowel function. Based on Rome II criteria, IBS patients are classified based on their primary bowel complaint as either IBS with Constipation (IBS-C) or IBS with Diarrhea (IBS-D). Those IBS sufferers who do not fulfill scientifically based standards for either IBS-C or IBS-D can exhibit a mixed bowel pattern, or IBS-Mixed (IBS-M). A recent study of IBS sufferers published in Gastroenterology revealed that nearly one third of participants experienced IBS-M.¹

"IBS patients who suffer with a mixed bowel pattern are in need of an effective treatment option," said William Chey, MD, associate professor of medicine and director of the GI Physiology Laboratory at the University of Michigan Health System. "These study results are promising as Zelnorm was shown to provide a statistically significant improvement in satisfactory relief of IBS symptoms in both the IBS-C and IBS-M groups. More than 50 percent of the IBS-M patients experienced a response to tegaserod."

Zelnorm is the first and only prescription medication approved by the U.S. Food and Drug Administration (FDA) for both Chronic Idiopathic Constipation and IBS with Constipation.

IBS-M Study Results
The study was designed to determine whether Zelnorm was safe and effective for the treatment of IBS-M. At present, no medical therapy has been demonstrated to be effective in IBS-M patients.

The randomized, double-blind, placebo-controlled, multicenter study evaluated 661 women with IBS-C (337) or IBS-M (324). Study participants were asked to provide an assessment of satisfactory relief over four weeks of treatment with Zelnorm 6 mg b.i.d. or placebo. Also assessed, were the proportion of patients reporting satisfactory relief for greater than or equal to 3 out of 4 treatment weeks (75 percent rule) and improvement during each of the 4 weeks in individual IBS symptoms. Baseline symptom assessment clearly distinguished between IBS-C and IBS-M cohorts.

Overall, Zelnorm provided statistically significant improvement in satisfactory relief of IBS symptoms over a four-week treatment for the IBS-C and IBS-M cohorts. In the two cohorts, the percentage of patients experiencing satisfactory relief of IBS symptoms (75 percent rule) was significantly higher for Zelnorm compared to placebo (IBS-C: 43.3 percent vs 28.9 percent, p=0.008 and IBS-M: 52.3 percent vs 36.3 percent, p=0.010). Zelnorm was significantly superior to placebo at improving weekly bowel movement frequency, stool consistency and straining.

Source: PR Newswire

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