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Glycerol phenylbutyrate reduced hepatic encephalopathy in cirrhotic patients
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Patients with cirrhosis and hepatic encephalopathy who were assigned glycerol phenylbutyrate experienced fewer hepatic encephalopathy events and lower ammonia levels than those receiving placebo in a recent trial.
Researchers enrolled 178 cirrhotic patients with at least two episodes of hepatic encephalopathy (HE) in the previous 6 months in a multicenter, randomized double blind, placebo-controlled trial. Fifty-nine of the patients had been taking rifaximin. Ninety patients (mean age, 53.8 years; 50% men) were assigned 6 mL glycerol phenylbutyrate (GPB) twice daily for 16 weeks; the remainder (mean age, 55.4 years; 67% men) received placebo. Measured endpoints included the percentage of patients experiencing HE events, time to first event, HE-related hospitalizations and the safety profile of GPB.
The proportion of patients randomly assigned GPB had fewer HE events (21% vs. 36%; P=.02) than placebo patients, a delayed time to first HE event (HR=0.56; 95% CI, 0.32-0.99) and a smaller total number of HE events (35 vs. 57; P=.04). HE hospitalizations also occurred less frequently for the GPB patients (13 vs. 25; P=.06). In patients not taking rifaximin at enrollment, GPB resulted in a smaller percentage of patients having an HE event (10% vs. 32%; P<.01) and total events (7 vs. 31; P<.01).
Plasma ammonia levels also were reduced in the GPB cohort (46 mcmol/L week vs. 58 mcmol/L week; P=.04), which researchers said, “provides evidence that elevated blood ammonia plays an important role in the development of hepatic encephalopathy.”
Seventy-nine percent of GPB patients reported adverse events compared with 76% of placebo patients.
“The results demonstrate that GPB reduced the likelihood of HE events in patients with preexisting HE, and we conclude … it deserves further study as a potential therapeutic for these patients,” the investigators wrote. “The results further suggest that elevated blood ammonia plays an important role in the pathogenesis of recurrent overt HE.”
Disclosure: See the study for a full list of relevant financial disclosures.