- Fecal Incontinence
|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]
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.