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Rifaximin is approved by both the FDA and the EMA for the reduction of recurrence of overt hepatic encephalopathy (HE) in adults.
Both approvals were based on a large, double-blind, placebo-controlled Phase III clinical trial involving 299 subjects, which found:
Most participants (about 91%) used Lactulose concomitantly, and the benefit was consistent across subgroups.
Korvick 2010 Div…