Alosetron versus traditional pharmacotherapy in clinical practice: effects on resource use, health-related quality of life, safety and symptom improvement in women with severe diarrhea-predominant irritable bowel syndrome

Olden KW1, Chey WD2, Shringarpure R3, Nicandro JP3, Chuang E3, Earnest DL3. Curr Med Res Opin. 2018 Oct 8:1-29. doi: 10.1080/03007995.2018.1533456. [Epub ahead of print]

Author information

1 a Department of Medicine , St Joseph's Hospital and Medical Center , Phoenix , AZ , USA.

2 b Division of Gastroenterology , University of Michigan Health System , Ann Arbor , MI , USA.

3 c Prometheus Laboratories Inc. , San Diego , CA , USA.


OBJECTIVE: Severe diarrhea-predominant irritable bowel syndrome (IBS-D) is associated with decreased health-related quality of life (HRQOL) and increased health care costs. Treatment recommendations for IBS-D often start with traditional pharmacotherapy (TP), with escalation to alosetron, rifaximin or eluxadoline if there is no success. There has been no previous head-to-head clinical trial comparing IBS-D treatment outcome for alosetron versus TP. This study evaluated resource use, work productivity, health-related quality of life, and global symptom response in women with IBS-D who were treated with alosetron or TP. GSK protocol S3B30020.

METHODS: 1956 patients who met criteria for severe IBS-D were randomized to treatment with alosetron 1 mg twice daily (BID) or only TP for up to 24 weeks. Work productivity and resource use were evaluated by standard questionnaires, HRQOL by the IBS-QOL instrument, and IBS symptoms by the Global Improvement Scale (GIS).

RESULTS: Compared to only TP, alosetron-treated patients reported: (1) fewer clinic/office visits for any health problem (p = 0.0181) or for IBS-D (p = 0.0004); (2) reduced use of over-the-counter medications for IBS-D (p < 0.0001); (3) fewer days of lost work productivity (p < 0.0001); (4) decreased restriction of social and outdoor activities (p < 0.0001); and (5) greater global improvement in IBS-D symptoms (p < 0.0001). Alosetron treatment improved HRQOL scores for all domains (p < 0.0001). Incidence of adverse events during alosetron use was not remarkable and similar to that previously reported.

CONCLUSIONS: Alosetron 1 mg BID significantly reduced healthcare utilization and lost productivity and significantly improved global IBS symptoms, HRQOL, and participation in outdoor and social activities compared with treatment response to TP.

© Copyright 2013-2022 GI Health Foundation. All rights reserved.
This site is maintained as an educational resource for US healthcare providers only. Use of this website is governed by the GIHF terms of use and privacy statement.