Alosetron Treatment Led to Fewer Physician Contacts and Fewer Days of Lost Work Productivity Compared to Treatment with Traditional Therapy for Diarrhea-Predominant IBS (IBS-D)

Abstract

Purpose: To compare the impact of alosetron treatment with that of traditional therapy for IBS-D on healthcare resource use, productivity, and quality of life (QoL). Methods: Female patients with IBS-D were enrolled in a randomized, openlabel study to evaluate health care resource use, QoL, and productivity following treatment with alosetron (1 mg BID) versus traditional therapy for 24 weeks. Healthcare resource use was primarily measured as number of physician contacts and number of medications used during the treatment period. Improvement in IBS symptoms was assessed using the Global Improvement Scale (GIS) and QoL was assessed using the IBS-related QoL instrument. Total Lost Work Productivity was computed as: Days missed due to IBS + (Total days with IBS symptoms * (1 - % Effectiveness)). Results: Of 2,456 patients enrolled, 2,256 were evaluable with a mean age of 48.8 yrs and mean duration of 12.2 yrs for IBS. Relative to traditional therapy, alosetron-treated patients reported significantly fewer physician contacts (P=0.032) for any health problem. Although the difference in total number of medications used during the treatment period was not statistically significant between groups, the alosetron group used fewer medications on average compared to the traditional therapy group (9.1 vs. 9.5). Compared to patients treated with traditional therapy, alosetron-treated patients reported significantly greater improvement in all 9 domains of the IBSQoL (P<0.001), and a significantly greater proportion of alosetron-treated patients were responders on the GIS (P<0.001). In both cases, benefit was evident at 4 weeks and sustained throughout the 6-month treatment period. The majority of patients (>70%) on traditional therapy were non-responders at the end of the study. Moreover, patients treated with traditional therapy missed more days from work (3.0 vs. 1.9 days; P<0.001) and lost more days of work productivity (5.0 vs. 3.2 days, P<0.001), compared to alosetron-treated patients. Alosetron-treated patients also reported significantly less restrictions on outdoor activities and attendance at social gatherings compared to patients on traditional therapy (P<0.001). With the exception of GI adverse events (AEs) of constipation and GI pain and discomfort, the incidence of other AEs was similar in both groups, and most of the AEs were mild or moderate. Conclusion: Alosetron therapy led to significantly greater improvements in IBS symptoms and QoL compared to traditional therapy. Subjects treated with traditional therapy used more healthcare resources in terms of physician time, missed more days of work, and reported significantly greater lost productivity time compared to alosetron-treated patients. Disclosure: The manufacturer / provider for Alosetron is Prometheus Laboratories Inc. Dr Olden - Consultant and Speakers Bureau: Prometheus Laboratories Inc. Dr Shringarpure, Dr Nicandro and Dr Chuang - Employees and stockholders: Prometheus Laboratories Inc.