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Tegaserod (Zelnorm) Improves Quality-of-Life Measures Among IBS-With-Constipation Patients

By Bruce Sylvester

CHICAGO, IL -- May 20, 2005 -- Tegaserod (Zelnorm(R)), a promotility agent that acts at the serotonin 5-HT4 receptor, significantly improves quality-of-life measures in women with irritable bowel syndrome with a constipation agent (IBS-C), researchers reported here on May 16^th at Digestive Disease Week (DDW).

"The most important finding is that, using this quality-of-life evaluative tool, we identified significant positive effects on quality of life in various domains," said Christopher McBurney, PharmD, clinical researcher, Novartis Pharmaceuticals, Basel, Switzerland.

"While we already knew that this agent is very effective for IBS with constipation, this new data expands our awareness of its efficacy into other areas related to the disease, which are of great day-to-day concern to IBS-with-constipation patients," Dr. McBurney said.

United States Food and Drug Administration has already approved tegaserod for short-term management of severe, chronic irritable bowel syndrome in women who have constipation as their main bowel problem.

To determine the agent's effect on markers of quality of life, the investigators randomized women meeting Rome II criteria for IBS-C to a double-blind, placebo-controlled multicenter study. Women were randomized to tegaserod 6 mg twice daily or placebo. A 2-week baseline period and 2 4-week double-blind periods (phase 1 and phase 2) were separated by a tegaserod-free interval.

The researchers used the IBS-quality-of-life (IBS-QoL) questionnaire to evaluate the effect of tegaserod therapy on quality of life. Subjects completed the questionnaire at baseline and at the end of phase 1 and 2.

Dr. McBurney reported the phase 1 results in his presentation. Phase 2 results are being evaluated and will be published at a later date.

The researchers enrolled 2660 women who were 65 years of age or younger. They randomized 2135 women to tegaserod treatment and 525 to placebo. The mean age was 42 years (range 17-66) and mean duration of IBS symptoms was 13 years. Of these subjects, 1645 tegaserod and 402 placebo patients were evaluable for phase 1 QoL measures.

Tegaserod subjects reported statistically significant higher overall IBS-QoL scores than placebo subjects (P = .005). The scores were higher in the tegaserod arm in 5 of 8 areas: dysphoria (P = .0008), body image (P = .035), health worry (P = .0006), food avoidance (P = .037), and relationships (P = .0023). The other 3 dimensions (sexual concerns, interference in daily activities, and social reaction) showed trends in favor of tegaserod but were not statistically significant.

Tegaserod subjects who achieved 50% or higher relief in overall IBS symptoms showed improvements over placebo in all QoL dimensions.

"This study demonstrates that tegaserod significantly improves QoL in patients with IBS-C," the authors concluded.

The study was supported by Novartis Pharma AG.


[Presentation title: Tegaserod Significantly Improves Health-Related Quality Of Life and Patient Satisfaction in Patients With IBS-C. Abstract M994]

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