OBJECTIVE: to examine the long-term effect (up to 30 months) of rifaximin-α use on safety, survival and hospitalisations.
Safety and hospitalisations data were compared between the group receiving rifaximin-α in the OLM and the groups receiving rifaximin-α or placebo in the RCT.
Adapted from Mullen et al. 2014
Long-term safety 1
During long-term rifaximin-α treatment:
- AE rates did not increase compared with those observed in the rifaximin-α or placebo arm in the pivotal RCT
- No new serious AEs emerged
- Mortality rate was similar to that observed in the placebo arm of the pivotal RCT and no deaths were attributed to rifaximin-α
- Infection rates were lower than those reported in the rifaximin-α or placebo arm in the pivotal RCT
- Incidence of gastrointestinal-related AEs was significantly higher with rifaximin-α plus lactulose (N=352) compared with rifaximin-α alone (N=40) (69.6% vs 47.5%; p<0.001)
- Six patients treated with rifaximin-α developed C difficile infection: 2 in the RCT and 4 in the OLM (event rate 0.012)