Alosetron is Effective in the Management of Functional Diarrhea: 1318

Purpose: Alosetron has been shown to decrease pain and stool frequency in patients with irritable bowel syndrome - diarrhea predominant (IBS-D). Currently it is FDA approved to treat female patients with severe IBS-D. There is no uniformly accepted treatment for functional diarrhea. This study was undertaken to see if alosetron can improve the symptoms of functional diarrhea (FD). Methods: The study design was an observational, open-label cohort. The primary endpoints were decrease in stool frequency and increase in stool consistency. Inclusion criteria were patients between 18 and 75 years whom satisfied Rome III criteria for FD. Exclusions included IBS, IBD, intolerance to fructose or lactose, bacterial overgrowth, extensive abdominal surgery, past history of ischemic colitis, microscopic colitis, celiac disease or impaired cognition. Data was collected with regard to stool frequency, Bristol stool score, dose of drug, length of therapy, adverse events (AE) and serious adverse events (SAE's). All patients were started on 0.5 mg alosetron BID. Results: 20 patients (19 female; 1 male) met screening criteria and were followed for a mean time of 12 months (range 6-48 months). The average stool frequency at baseline was 5. After beginning therapy the average daily stool decreased to 2. The average pretreatment Bristol stool score was 6.0 that decreased to 3.2 during therapy. No SAE's were reported. The only AE observed was constipation in 6 patients. 3 returned to the study after brief cessation of drug (Average = 3 days) and 3 were unable to continue. Conclusion: 1. The primary endpoints of decrease in stool frequency and increase in stool consistency were met. 2. No SAE's were reported. 3. Constipation was the only AE, occurring in 30% of patients. 4. Alosetron is efficacious in managing functional diarrhea. Disclosure: Dr Randall - Consultant: Prometheus, Speakers Bureau.