Summary

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• Ravicti (glycerol phenylbutyrate) is indicated for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements.
• This summary is based on the review of one systematic review(s)/meta-analysis(es). ^[1]
• Glycerol phenylbutyrate demonstrated a beneficial effect in reducing hepatic encephalopathy compared to placebo (RR 0.57, 95% CI 0.36 to 0.90; 178 participants) and significantly reduced blood ammonia levels (MD -12.00, 95% CI -23.37 to -0.63; 178 participants).
• Polyethylene glycol was more effective than lactulose in reducing hepatic encephalopathy (RR 0.19, 95% CI 0.08 to 0.44; 190 participants).
• Sodium benzoate, ornithine phenylacetate, and AST-120 showed no beneficial effects on hepatic encephalopathy compared to their respective controls.
• Serious Adverse Events: No significant differences in serious adverse events were observed between glycerol phenylbutyrate and placebo (RR 1.63, 95% CI 0.85 to 3.13; 178 participants) or between other drugs (sodium benzoate, ornithine phenylacetate, AST-120, polyethylene glycol) and their respective controls.
• Non-Serious Adverse Events: No significant differences in non-serious adverse events were reported between glycerol phenylbutyrate and placebo, as well as between other drugs and their respective controls.
• There is no population types or subgroups information available in the reviewed studies.