Prantera C et al. – Administration of 800 mg rifaximin–extended intestinal release (EIR) twice daily for 12 weeks induced remission with few adverse events in patients with moderately active Crohn's disease (CD).Methods
- The authors performed a multicenter, randomized, double-blind trial of the efficacy and safety of 400, 800, and 1200 mg rifaximin-EIR, given twice daily to 402 patients with moderately active CD for 12 weeks.
- Data from patients given rifaximin-EIR were compared with those from individuals given placebo, and collected during a 12-week follow-up period.
- The primary end point was remission (Crohn's Disease Activity Index <150) at the end of the treatment period.
- At the end of the 12-week treatment period, 62% of patients who received the 800-mg dosage of rifaximin-EIR (61 of 98) were in remission, compared with 43% of patients who received placebo (43 of 101) (P = .005).
- A difference was maintained throughout the 12-week follow-up period (45% [40 of 89] vs 29% [28 of 98]; P = .02).
- Remission was achieved by 54% (56 of 104) and 47% (47 of 99) of the patients given the 400-mg and 1200-mg dosages of rifaximin-EIR, respectively; these rates did not differ from those of placebo.
- Patients given the 400-mg and 800-mg dosages of rifaximin-EIR had low rates of withdrawal from the study because of adverse events; rates were significantly higher among patients given the 1200-mg dosage (16% [16 of 99]).