New Data for Zelnorm® Demonstrate Relief of Multiple Symptoms of Dysmotility-Type Dyspepsia

LAS VEGAS -- Zelnorm (tegaserod maleate) has demonstrated potential to treat the multiple symptoms of dysmotility-type dyspepsia, according to new data being presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, held Oct. 20-25, 2006.

Dysmotility-type dyspepsia is a common digestive condition characterized by discomfort and bloating that occurs in the abdominal area. Dysmotility-type dyspepsia is a subgroup of functional dyspepsia, a condition that affects an estimated 25 percent of the adult population, or more than 52 million Americans, and costs an average of $2.5 billion annually in direct and indirect healthcare costs. There are no prescription medications approved to treat dysmotility-type dyspepsia or the symptoms associated with the condition.

"These multiple symptoms have a very significant impact on patients' lives," said Loren Laine, MD, professor of medicine, University of Southern California School of Medicine. "For patients with moderate to severe symptoms, the results of these studies are promising and suggest a benefit for tegaserod."

Pooled data from two pivotal studies (n = 2,667) show a positive benefit of Zelnorm treatment versus placebo for women with dysmotility-type dyspepsia symptoms, including early satiety (extreme sensation of fullness soon after starting a normal sized meal that makes it difficult to finish the meal), post-prandial fullness (uncomfortable feeling of fullness after a meal) and bloating. The data showed statistically significant treatment benefit of Zelnorm (p<0.05) for the primary endpoints -- percent of days with satisfactory relief of dyspepsia symptoms and improvement in composite average daily symptom score.

In patients with more severe baseline dyspepsia symptoms, Zelnorm showed a greater treatment effect versus placebo. Although Zelnorm improves dysmotility and reduces visceral hypersensitivity in the lower gastrointestinal tract, further research is needed to assess the mechanism of action of Zelnorm in potentially relieving post-prandial fullness, early satiety and bloating associated with dysmotility-type dyspepsia.

About the Studies
A total of 2,667 women, at least 18 years of age, were randomized in the two studies. Study participants were enrolled in accordance with ROME criteria for dysmotility-type dyspepsia. The co-primary endpoints for each study were the percentage of days with satisfactory relief of dyspepsia symptoms and the composite average daily symptom score (CADSS). The symptom score endpoints were measured using a 7-point Likert scale ("1 = no discomfort at all" to "7 = very severe discomfort"). Patients were excluded from these studies if they had concomitant heartburn, IBS or GERD. All patients included had to have at least mild dyspepsia.

Study 1 showed a statistically significant improvement with Zelnorm treatment for the endpoints of percentage of days with satisfactory relief (tegaserod 32.24 percent vs. placebo 26.63 percent) and composite average daily symptom score (tegaserod 3.14 vs. placebo 3.35) compared to placebo (p=0.0002, p<0.0001 respectively). Study 2 showed a trend in favor of Zelnorm as compared with placebo for both endpoints, percentage of days with satisfactory relief (tegaserod 31.87 percent vs. placebo 29.36 percent) and composite average daily symptom score (tegaserod 3.15 vs. placebo 3.23) compared to placebo, but statistical significance was not achieved (p=0.0662, p=0.0936). In both studies, tegaserod showed greater benefit over placebo. Pooled data demonstrated a statistically significant benefit of tegaserod over placebo for both primary endpoints.

The adverse event profiles in both studies were consistent with the established safety and tolerability profile of Zelnorm. The most common adverse event was diarrhea, which occurred in about 19 percent of Zelnorm-treated patients as compared with 4 percent to 5 percent of placebo patients. In Zelnorm-treated patients experiencing moderate to severe symptoms, the rate of diarrhea was 13.6 percent as compared with 3 percent of placebo treated patients. These events tended to occur in the first week of therapy, were transient, self-limiting and usually did not require discontinuation. (Discontinuation rate for diarrhea was 3-5 percent for Zelnorm. Discontinuation due to diarrhea was 0.1 percent to 0.5 percent for placebo.) There were no serious consequences of diarrhea reported in the pivotal studies.

Source: Novartis

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