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Randomised clinical trial: alosetron improves quality of life and reduces restriction of daily activities in women with severe diarrhoea-predominant IBS
Alimentary Pharmacology and Therapeutics, 07/16/2012
Clinical Article
Cremonini F et al. – In women with severe irritable bowel syndrome with diarrhoea (IBS–D), alosetron treatment, including 0.5 mg QD, resulted in statistically significant and clinically relevant improvements in health–related quality of life (QOL), restriction of daily activities and treatment satisfaction over placebo. IBS symptom improvement corresponded with positive changes in IBSQOL, LWP and treatment satisfaction.
Methods- A total of 705 women (severe IBS–D, Rome II criteria) randomised to alosetron 0.5 mg QD, 1 mg QD, 1 mg BID, or placebo for 12 weeks were studied.
- IBSQOL, treatment satisfaction, daily activities, and lost workplace productivity (LWP) were evaluated at randomisation and Week 12.
- One or more doses of alosetron significantly improved all IBSQOL domains except for sexual function from baseline vs. placebo.
- The magnitude of IBSQOL changes was consistent with a clinically meaningful effect.
- Alosetron 0.5 mg QD and 1 mg BID significantly reduced IBS interference with social/leisure activities and LWP from baseline vs. placebo [social/leisure (mean ±S.E.) days lost: –6.7 ± 0.8, –7.0 ± 0.9, P<0.01; LWP (mean ± S.E.) h lost: –11.0 ± 3.3, –21.1 ± 4.1, P<0.05 respectively].
- Significantly more patients treated with alosetron reported satisfaction vs. placebo.
- Improvements in IBSQOL, LWP, and treatment satisfaction significantly correlated with global improvement of IBS symptoms.
- The incidence of adverse events with alosetron was low with constipation being the most commonly reported event.
- A single case of ischaemic colitis occurred, in a patient receiving alosetron 0.5 mg QD.