A 24-month, open-label maintenance (OLM)1 study of rifaximin-α 550mg twice daily in patients with recurrent HE who participated in the pivotal RCT2 or newly enrolled patients.
OBJECTIVE: To examine the long-term effect (up to 30 months†) of rifaximin-α use on safety, survival, underlying disease and hospitalizations.
† The ‘All rifaximin-α’ group included patients who used rifaximin-α in the 6 month RCT and who were then enrolled in the 24 month OLM
† The ‘All rifaximin-α’ group included patients who used rifaximin-α in the 6 month RCT and who were then enrolled in the 24 month OLM
Adapted from Mullen et al. 2014
Long-term safety 1
Adverse event (AE) rates did not increase over the long-term
1
, compared with those observed in pivotal RCT.
2
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)
