A double-blind, randomised placebo-controlled trial (RCT) investigating the efficacy and safety of XIFAXAN® 550 mg bd in cirrhotic patients with recurrent HE.
1
Patients with chronic liver disease and with Conn score 0 or 1 were randomised to treatment with either placebo (N=159) or XIFAXAN® 550 mg bd (N=140) for 6 months.*
*91% of patients (n=273) received concomitant lactulose during the study.
Patients with chronic liver disease and with Conn score 0 or 1 were randomised to treatment with either placebo (N=159) or XIFAXAN® 550 mg bd (N=140) for 6 months.*
*91% of patients (n=273) received concomitant lactulose during the study.
Proportion of patients experiencing breakthrough HE episodesPrimary end-point
Adapted from Bass et al. 2010ITT Population
- There was a significantly reduced relative risk of an episode of HE in the XIFAXAN® 550 mg bd group compared with the placebo group over a 6 month period
- Relative risk reduction 58% (calculated from hazard ratio with XIFAXAN®, 0.42; 95% confidence interval [CI], 0.28 to 0.64; p<0.001)
- There was a significantly reduced relative risk of hospitalisation related to HE in the XIFAXAN® 550 mg bd group compared with the placebo group over a 6 month period
- Relative risk reduction 50% (calculated from hazard ratio with XIFAXAN®, 0.50; 95% confidence interval [CI], 0.29 to 0.87; p=0.01)
Proportion of patients experiencing HE-related hospitalisationsSecondary end-point
Adapted from Bass et al. 2010ITT Population
GL-HEP-XIF-2000171 April 2021
