HONOLULU — The use of tegaserod in women with constipation-predominant irritable bowel syndrome resulted in improved work attendance and productivity in a large, open-label, naturalistic study designed to reflect actual clinical practice, Dr. Nigel Flook reported at the annual meeting of the American College of Gastroenterology.
These findings, from the observational Zelnorm Advancing Quality of life (ZAQ) study, have important implications in terms of both quality of life and health economics. An earlier study showed that individuals with irritable bowel syndrome (IBS) miss three times as many work days as colleagues without IBS, according to Dr. Flook of the University of Alberta, Edmonton.
He reported on 2,381 women with symptoms of abdominal pain and discomfort, bloating, and constipation who participated in the Novartis-sponsored ZAQ study. Three-quarters were at least 40 years old; one-quarter were over age 60 years. Overall, 78% reported at least a 2-year history of IBS symptoms, and 30% said they had lived with IBS for longer than 10 years.
The major caveat regarding the ZAQ study data concerns the possibility of selection bias. Only 20% of participants completed the study by returning their week-12 questionnaires, Dr. Flook noted; data were collected at baseline and 12 weeks.
Baseline use of prescription and over-the-counter medications to treat gastrointestinal symptoms was extremely common: 28% of participants were taking more than one prescription drug, and 40% were on more than one OTC drug for their IBS symptoms.
All participants were placed on 6 mg b.i.d. of tegaserod, a selective serotonin receptor agonist that acts as a promotility agent and is the first drug approved for irritable bowel syndrome.
Analysis of self-reported questionnaire data obtained after 12 weeks of treatment with tegaserod showed that 27% of patients missed fewer days at work or school, although 7% missed more days, compared with baseline. Also, 50% indicated they experienced improvement in what they accomplished at work, school, or home, and 40% reported fewer canceled or rescheduled activities.