†Study Design2: In a randomized, placebo-controlled, double-blind, multicenter, multinational, 6-month study, the efficacy of XIFAXAN 550 mg (taken orally twice a day) was evaluated in 299 adult subjects. Inclusion criteria: currently in remission (Conn score of 0 or 1) from HE and ≥2 episodes of HE associated with chronic liver disease in the previous 6 months. Lactulose was used concomitantly by 91% of patients. The primary endpoint was the time to first breakthrough overt HE episode, defined as a marked deterioration in neurological function (an increase of Conn score to grade ≥2 or an increase in Conn score and asterixis grade of 1 each if subject entered study at grade 0). Overt HE hospitalization was a key secondary endpoint.
NNT–4 patients would need to take XIFAXAN 550 mg twice daily for 6 months to reduce
the risk of 1 episode of overt HE.3
‡Lactulose was used concomitantly by 91% of patients in both arms of the study.2