Purpose: Alosetron was reintroduced for treatment of female patients with severe, chronic diarrhea-predominant irritable bowel syndrome (IBS-D) under a risk management program (RMP) in Nov 2002. The RMP is intended to assure safe use of alosetron, but it may be inadvertently limiting use to only the most severe patients. This study evaluates the characteristics and treatment patterns of female patients with chronic IBS-D from the alosetron follow-up survey by patient-reported severity.
Methods: Patients prescribed alosetron (2002-2009) and voluntarily enrolled in the survey were analyzed. Questionnaires were administered at predefined timepoints (Baseline, Wk 5, Wk 10, and quarterly, up to 1 year) and understanding of alosetron risks/benefits and dosages were evaluated. Subgroup analysis was limited to females with IBS-D ≥6 months and stratified by number of IBS-D severity criteria (3 total) that were met from the alosetron prescribing information, namely stomach cramps/bloating, accidents/fecal incontinence, and/or restriction of daily activities (3/3=Group A, 2/3=Group B, or 1/3=Group C). Only 1 severity criterion had to be met to be eligible for treatment.
Results: A total of 7851 patients enrolled in the study; 92% were adult females and 79% met label criteria for alosetron use (n=6229). The majority of female patients reported experiencing all 3 severity criteria (Group A: 77%; Group B: 22%; Group C: 1%); almost all patients (≥94%) had inadequate relief of symptoms from prior medications. Most patients in Groups A and B complained of restriction of daily activities (≥91%) while there were none in Group C. Only 36% and 71% of Group B patients and 55% and 29% of Group C patients had stomach cramps/bloating and accidents/fecal incontinence, respectively. Treatment continuation with alosetron was high and similar across groups at 6 months and 1 year (≥75% and ≥64%). For patients discontinuing alosetron in Groups A, B, and C, mean (SD) treatment duration was 6.6±4.8, 6.5±5.1, and 7.0±4.4 months, respectively. Dosages of alosetron reported at maintenance and discontinuation were similar; the most commonly used dosages were 1 mg QD and BID.
Conclusion: Alosetron has mainly been prescribed to the most severe subgroup of female IBS-D patients. Six-month and 1-year treatment continuation with alosetron was high, suggesting that patients are experiencing long-term benefits of therapy irrespective of number of IBS-D severity criteria. Disability or restriction of daily activities was the most common indicator of disease severity in female patients who met >1 IBS-D severity criterion.
