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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.
Aliment Pharmacol Ther. 2012 Sep; 36(5):437-48.AP

Abstract

BACKGROUND

Patients with irritable bowel syndrome with diarrhoea (IBS-D) experience restriction in daily activities and decreased health-related quality of life (QOL).

AIM

To investigate effects of alosetron on patient-reported health-related QOL, satisfaction and productivity in women with severe IBS-D.

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.

RESULTS

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.

CONCLUSIONS

In women with severe IBS-D, alosetron treatment, including 0.5 mg QD, resulted in statistically significant and clinically relevant improvements in health-related QOL, restriction of daily activities and treatment satisfaction over placebo. IBS symptom improvement corresponded with positive changes in IBSQOL, LWP and treatment satisfaction.

Authors+Show Affiliations

Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA02215, USA. fcremoni@bidmc.harvard.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22779693

Citation

Cremonini, F, et al. "Randomised Clinical Trial: Alosetron Improves Quality of Life and Reduces Restriction of Daily Activities in Women With Severe Diarrhoea-predominant IBS." Alimentary Pharmacology & Therapeutics, vol. 36, no. 5, 2012, pp. 437-48.
Cremonini F, Nicandro JP, Atkinson V, et al. Randomised clinical trial: alosetron improves quality of life and reduces restriction of daily activities in women with severe diarrhoea-predominant IBS. Aliment Pharmacol Ther. 2012;36(5):437-48.
Cremonini, F., Nicandro, J. P., Atkinson, V., Shringarpure, R., Chuang, E., & Lembo, A. (2012). Randomised clinical trial: alosetron improves quality of life and reduces restriction of daily activities in women with severe diarrhoea-predominant IBS. Alimentary Pharmacology & Therapeutics, 36(5), 437-48. https://doi.org/10.1111/j.1365-2036.2012.05208.x
Cremonini F, et al. Randomised Clinical Trial: Alosetron Improves Quality of Life and Reduces Restriction of Daily Activities in Women With Severe Diarrhoea-predominant IBS. Aliment Pharmacol Ther. 2012;36(5):437-48. PubMed PMID: 22779693.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomised clinical trial: alosetron improves quality of life and reduces restriction of daily activities in women with severe diarrhoea-predominant IBS. AU - Cremonini,F, AU - Nicandro,J P, AU - Atkinson,V, AU - Shringarpure,R, AU - Chuang,E, AU - Lembo,A, Y1 - 2012/07/10/ PY - 2012/04/25/received PY - 2012/05/21/revised PY - 2012/06/13/revised PY - 2012/06/16/accepted PY - 2012/7/12/entrez PY - 2012/7/12/pubmed PY - 2012/12/19/medline SP - 437 EP - 48 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 36 IS - 5 N2 - BACKGROUND: Patients with irritable bowel syndrome with diarrhoea (IBS-D) experience restriction in daily activities and decreased health-related quality of life (QOL). AIM: To investigate effects of alosetron on patient-reported health-related QOL, satisfaction and productivity in women with severe IBS-D. 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. RESULTS: 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. CONCLUSIONS: In women with severe IBS-D, alosetron treatment, including 0.5 mg QD, resulted in statistically significant and clinically relevant improvements in health-related QOL, restriction of daily activities and treatment satisfaction over placebo. IBS symptom improvement corresponded with positive changes in IBSQOL, LWP and treatment satisfaction. SN - 1365-2036 UR - https://www.unboundmedicine.com/medline/citation/22779693/Randomised_clinical_trial:_alosetron_improves_quality_of_life_and_reduces_restriction_of_daily_activities_in_women_with_severe_diarrhoea_predominant_IBS_ L2 - https://doi.org/10.1111/j.1365-2036.2012.05208.x DB - PRIME DP - Unbound Medicine ER -