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Aliment. Pharmacol. Ther. · Sep 2005
Randomized Controlled Trial Multicenter Study Clinical TrialEffect of tegaserod on work and daily activity in irritable bowel syndrome with constipation.
- M C Reilly, V Barghout, C R McBurney, and T E Niecko.
- Margaret Reilly Associates, Inc., New York, NY, USA. mreilly@reillyassociates.net
- Aliment. Pharmacol. Ther. 2005 Sep 1; 22 (5): 373-80.
BackgroundTegaserod is a promotility agent with proven efficacy and safety in patients with irritable bowel syndrome with constipation.AimTo assess tegaserod's effect on work productivity and daily activity.MethodsWomen, 18-65 years old and meeting Rome II criteria for irritable bowel syndrome with constipation, were randomized to a double-blind, placebo-controlled, multicentre study of tegaserod 6 mg b.d. or placebo. Productivity loss and daily activity impairment because of irritable bowel syndrome were measured with the Work Productivity and Activity Impairment questionnaire for irritable bowel syndrome, modified to exclude diarrhoea as a symptom. Assessments were made at baseline, weeks 2 and 4.ResultsA total of 2660 women were randomized and, of these, 1675 [tegaserod (n = 1363), placebo (n = 312)] were employed and completed Work Productivity and Activity Impairment for irritable bowel syndrome questionnaires. Compared with placebo, tegaserod significantly reduced work and daily activity impairment at weeks 2 and 4. Tegaserod reduced absenteeism by 2.6% (P = 0.004), presenteeism by 5.4% (P < 0.0001), overall work productivity loss by 6.3% (P < 0.0001), and activity impairment by 5.8% (P < 0.0001) at week 4 (vs. baseline). Assuming a 40-h workweek, tegaserod reduced work productivity loss by 2.5 h/week.ConclusionsTegaserod significantly reduced work productivity loss and daily activity impairment at 2 weeks, and this benefit was maintained at 4 weeks.
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