Efficacy and safety of XIFAXAN for IBS-D
Dr. Mark Pimentel
Executive Director, MAST Program at Cedars-Sinai Medical Center
Watch Dr. Pimentel discuss important safety information for XIFAXAN, as well as efficacy data based on clinical trials in adults with IBS-D.
- 44% of patients had improvement in both abdominal pain and diarrhea (n=1074/2438)
- 36% of responders had no symptom recurrence at 6 months (n=382/1074)
- Primary endpoint: 38% experienced significant improvement in stool consistency and abdominal pain (n=125/328, P<0.05) vs 31% for placebo (n=97/308)
- In clinical studies, the most common adverse reactions for XIFAXAN in IBS-D (≥2%) were nausea (3%) and ALT increased (2%)
IBS-D = irritable bowel syndrome with diarrhea
TARGET 3 Study Design1,2: XIFAXAN was evaluated in 2438 IBS-D patients. 44% (n=1074) experienced relief from an open-label course of treatment. Relief was defined as experiencing a ≥30% improvement from baseline in the weekly average abdominal pain score (based on daily self-reports) and a ≥50% reduction in the number of days in a week with a daily stool consistency of Bristol Stool Scale type 6 or 7 (mushy or watery) compared with baseline. If patients experienced a recurrence of either of their symptoms for 3 weeks of a rolling 4-week period, they entered the randomized, double-blind treatment phase. Randomized patients then received a repeat treatment with either XIFAXAN or placebo. The primary endpoint was the proportion of patients who experienced relief in both symptoms (defined exactly as in the open-label period) during the 4 weeks following repeat treatment.
References: 1. XIFAXAN [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals. 2. Lembo A, Pimentel M, Rao SS, et al. Repeat treatment with rifaximin is safe and effective in patients with diarrhea-predominant irritable bowel syndrome. Gastroenterology. 2016;151(6):1113-1121.