OBJECTIVES: This article evaluates the characteristics and treatment patterns of female patients with severe diarrhea-predominant irritable bowel syndrome (IBS-D) who were treated with alosetron under a risk management program.
METHODS: Patients prescribed alosetron (2002-2009) and who voluntarily enrolled in the follow-up study were evaluated. Questionnaires were administered at baseline, Wk 5, Wk 10, and quarterly thereafter for ≤1 year. Subgroup analyses were conducted in female patients with IBS-D ≥6 months, stratified by IBS-D severity criteria met (1-3) from the alosetron prescribing information (treatment recommended in female patients meeting ≥1 severity criterion). The voluntary and observational nature of the study are potential limitations, such that eligible patients in the clinical practice setting may have had more severe IBS-D, possibly representing a more motivated and homogeneous subpopulation of patients than the broader IBS-D population.
RESULTS: A total of 7841 patients enrolled in the study; 92.4% were adult females; 79.4% (n = 6229) met label criteria. Mean follow-up time was ∼10.3 months; 50.3% completed 1 year. Of the 6229 female patients, 76.9% met 3/3 severity criteria; 21.5% met 2/3 severity criteria; 1.4% met 1/3 severity criteria. The most common complaint was restriction of daily activities, followed by accidents/fecal incontinence, and stomach cramps/bloating. One-year treatment continuation was ≥64% across IBS-D severity groups.
CONCLUSIONS: One-year treatment continuation with alosetron was high, irrespective of the number of IBS-D severity criteria met. Restriction of daily activities was the primary indicator of disease severity. These findings demonstrate that alosetron continues to be safely and effectively used under the risk management program, and appears to provide long-term benefit in appropriate patients with IBS-D.
