Intravenous N-acetylcysteine improves transplant-free survival in early stage non-acetaminophen acute liver failure

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#acetaminophen #acetylcysteine #adolescent #adult #aged

Intravenous N-acetylcysteine improves transplant-free survival in early stage non-acetaminophen acute liver failure

Lee et al., 2009 | Gastroenterology | Rct

Citation

Lee William M, Hynan Linda S, ... Robuck Patricia R. Intravenous N-acetylcysteine improves transplant-free survival in early stage non-acetaminophen acute liver failure. Gastroenterology. 2009-Sep;137(3):856-64, 864.e1. doi:10.1053/j.gastro.2009.06.006

Abstract

BACKGROUND & AIMS: N-acetylcysteine (NAC), an antidote for acetaminophen poisoning, might benefit patients with non-acetaminophen-related acute liver failure. METHODS: In a prospective, double-blind trial, acute liver failure patients without clinical or historical evidence of acetaminophen overdose were stratified by site and coma grade and assigned randomly to groups that were given NAC or placebo (dextrose) infusion for 72 hours. The primary outcome was overall survival at 3 weeks. Secondary outcomes included transplant-free survival and rate of transplantation. RESULTS: A total of 173 patients received NAC (n = 81) or placebo (n = 92). Overall survival at 3 weeks was 70% for patients given NAC and 66% for patients given placebo (1-sided P = .283). Transplant-free survival was significantly better for NAC patients (40%) than for those given placebo (27%; 1-sided P = .043). The benefits of transplant-free survival were confined to the 114 patients with coma grades I-II who received NAC (52% compared with 30% for placebo; 1-sided P = .010); transplant-free survival for the 59 patients with coma grades III-IV was 9% in those given NAC and 22% in those given placebo (1-sided P = .912). The transplantation rate was lower in the NAC group but was not significantly different between groups (32% vs 45%; P = .093). Intravenous NAC generally was well tolerated; only nausea and vomiting occurred significantly more frequently in the NAC group (14% vs 4%; P = .031). CONCLUSIONS: Intravenous NAC improves transplant-free survival in patients with early stage non-acetaminophen-related acute liver failure. Patients with advanced coma grades do not benefit from NAC and typically require emergency liver transplantation.

Key Findings

A total of 173 patients received NAC (n = 81) or placebo (n = 92). Overall survival at 3 weeks was 70% for patients given NAC and 66% for patients given placebo (1-sided P = .283). Transplant-free survival was significantly better for NAC patients (40%) than for those given placebo (27%; 1-sided P = .043). The benefits of transplant-free survival were confined to the 114 patients with coma grades I-II who received NAC (52% compared with 30% for placebo; 1-sided P = .010); transplant-free surviva

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population non
Sample Size 81
Age Range See abstract
Condition See abstract

MeSH Terms

  • Acetaminophen
  • Acetylcysteine
  • Adolescent
  • Adult
  • Aged
  • Analgesics, Non-Narcotic
  • Double-Blind Method
  • Female
  • Hepatic Encephalopathy
  • Humans
  • Infusions, Intravenous
  • Liver Failure, Acute
  • Liver Transplantation
  • Male
  • Middle Aged
  • Survival Rate
  • Young Adult

Evidence Classification

  • Level: Rct
  • Publication Types: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.
  • Vertical: nac

Provenance

Source extracted via PubMed E-utilities API on 2026-04-10