Drug updated on 12/11/2024
| Dosage Form | Liquid (oral; 1.1 g/mL) |
| Drug Class | Nitrogen-binding agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
Latest News
Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Glycerol phenylbutyrate demonstrated a beneficial effect in reducing hepatic encephalopathy compared to placebo (relative risk (RR) 0.57, 95% confidence interval (CI) 0.36 to 0.90; 178 participants; 1 trial; number needed to treat for an additional beneficial outcome (NNTB) 6) and significantly reduced blood ammonia levels (mean difference (MD) -12.00, 95% CI -23.37 to -0.63; 178 participants; 1 trial).
- Polyethylene glycol showed a more pronounced beneficial effect in reducing hepatic encephalopathy than lactulose (RR 0.19, 95% CI 0.08 to 0.44; 190 participants; 3 trials; NNTB 4).
- No significant beneficial effects were observed for sodium benzoate, ornithine phenylacetate, and AST-120 (Kremezin) in reducing hepatic encephalopathy or mortality.
- Serious Adverse Events: No significant difference in the occurrence of serious adverse events between glycerol phenylbutyrate and placebo (RR 1.63, 95% CI 0.85 to 3.13; 178 participants; 1 trial).
- Non-serious Adverse Events: No significant difference in non-serious adverse events between glycerol phenylbutyrate and placebo or other pharmacotherapies.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ravicti (glycerol phenylbutyrate) Prescribing Information. | 2021 | Horizon Therapeutics USA, Inc., Deerfield, IL |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis | 2019 | The Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Suggested guidelines for the diagnosis and management of urea cycle disorders: first revision. | 2019 | Journal of Inherited Metabolic Disease |