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Patients with Irritable Bowel Syndrome and Constipation Unhappy with Conventional Treatments Because of Side Effects and Lack of Efficacy: Presented at ASHP

By Maury M. Breecher, PhD, MPH

SAN DIEGO, CA -- June 9, 2003 -- Physicians and other healthcare providers should be aware that patients with irritable bowel syndrome and constipation (IBS-C) are likely to experience an average of three different side effects related to their treatment, according to a study presented here June 2^nd at the American Society of Health-System Pharmacists annual summer meeting.

The study involved a 20-minute online survey of 504 individuals diagnosed IBS-C, according to study authors M. Stelwagon, MBA.

Irritable bowel syndrome is a common gastrointestinal disorder that affects 10% to 15% of the U.S. population. Although traditional treatments relieve single symptoms for some patients, most patients "are dissatisfied with their efficacy and complain of adverse effects," according to the presentation.

On average, patients in the survey experienced 3.3 moderate to severe adverse effects related to medication use. Those adverse effects were reported by 60% of the survey respondents taking prescription laxatives, over-the-counter laxatives, or antidepressants, by 51% of the survey respondents who were taking antispasmodics, and by 38% of those taking fiber supplements, with patients often taking two or more medications.

According to the study, prescription laxatives were most likely to cause adverse effects, including drowsiness, dizziness, insomnia, nausea, abdominal cramps, abdominal pain, abdominal discomfort, bloating, dry mouth, headache, decreased sexual interest, constipation and diarrhoea.

Side effects impacted the lifestyles of 32% of the respondents so severely that they sought further medical attention, changed their medications, or refrained from daily activities. Discontinuation of therapy was reported by 131 survey participants, mostly due to adverse effects and lack of efficacy, the researchers pointed out. The reason the largest number of patients (n=25) of that group stopped using medications was because the treatments "did not work," according to the authors.

According to the poster presentation, "Healthcare providers can proactively monitor for treatment-related side effects, helping IBS-C patients better manage their condition and improve satisfaction with therapy."

"There is an unmet need for effective, well-tolerated treatments for patients with IBS plus constipation," the authors concluded.

The study was co-authored by K. A. Bergman, PhD, M. Shetzline, MD, and T. McCourt, PhD, and sponsored by Novartis Pharmaceuticals Corporation, of East Hanover, New Jersey.


[Study title: The Side Effects of Conventional Drug Treatments for IBS/C. Abstract P-12E]

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