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Abstract
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, GSK protocol S3B30020, 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.
Methods: A total of 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 IBSQOL 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 = .0181) or for IBS-D (p = .0004); (2) reduced use of over-the-counter medications for IBS-D (p < .0001); (3) fewer days of lost work productivity (p < .0001); (4) decreased restriction of social and outdoor activities (p < .0001); and (5) greater global improvement in IBS-D symptoms (p < .0001). Alosetron treatment improved HRQOL scores for all domains (p < .0001). Incidence of adverse events during alosetron use was not remarkable and was similar to that previously reported.
Conclusions: Alosetron 1 mg BID significantly reduced health care utilization and lost productivity, and significantly improved global IBS symptoms, HRQOL, and participation in outdoor and social activities compared with treatment response to TP.
Transparency
Declaration of funding
This clinical trial was funded by GlaxoSmithKlein plc. The study report was funded by Prometheus Laboratories Inc.
Declaration of financial/other relationships
K.W.O. has disclosed that he has no significant relationships with or financial interests in any commercial companies related to this study or article. W.D.C. has disclosed that he has served as a consultant and has received honoraria for presentations and/or has served on speaker’s bureaus for AstraZeneca, Actavis/Allergan Inc., Ardelyx Inc., IM Health, Ironwood Pharmaceuticals, Nestlé Health Science, Prometheus Laboratories Inc., Sucampo Pharmaceuticals Inc., SK, Takeda Pharmaceuticals USA Inc. and QOL Medical LLC; he has received research funding from Ironwood Pharmaceuticals, Nestlé Health Science, Prometheus Laboratories Inc., Perrigo Company plc and Vibrant Pharma Inc.; he is co-founder and co-Chief Medical Officer at My Total Health. R.S., J.P.N. and E.C. have disclosed that they are former employees of Prometheus Laboratories Inc. R.S. has disclosed that she is a current employee of Intercept Pharmaceuticals Inc. J.P.N. has disclosed that he is a current employee of Allergan Inc. E.C. has disclosed that he is a current employee of Progenity Inc. D.L.E. has disclosed that he was a former consultant for Prometheus Laboratories Inc and currently is Emeritus Professor at The University of Arizona College of Medicine.
CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgements
Data analyses were conducted by GlaxoSmithKline plc and Prometheus Laboratories Inc. Writing support was provided by Dr. Anthony Stonehouse of Watson & Stonehouse Enterprises LLC and was funded by Prometheus Laboratories Inc.
Notes
1 Lotronex is a registered trade name of Sebela Pharmaceuticals Inc., Roswell, Georgia, USA