Hepatic function in alcoholics throughout 5 days of maximal therapeutic dosing of acetaminophen (APAP)

• Published in: Clinical toxicology (Philadelphia, Pa.) Pa.), 2005-10, Vol.43 (6), p.683-683
• Main Authors: Green, J L, Kuffner, E K, Bogdan, G M, Dart, R C
• Format: Article
• Language: English
• ISSN: 1556-3650

The use of APAP in alcoholic patients remains contentious despite prospective studies indicating safety during 2 or 3 days of APAP administration. One concern has been the duration of APAP treatment and its use in patients with preexisting liver disease (e.g. alcoholic hepatitis, hepatitis C). The half-life of CYP2E1 induction in humans is about 1.5 days. The objective of this study was to evaluate hepatic function in alcoholic patients given acetaminophen for 5 consecutive days. This is a randomized, double-blind, placebo-controlled trial of active alcoholics. Exclusion criteria included a baseline serum APAP>20 mcg/ml, AST or ALT>200 IU/L, or INR>1.5. Laboratory measures were obtained at baseline and days 2, 4, 6, and 7. Patients were randomized 1:1 to APAP (1 g every 4 hr for 4 doses, for 5 days) or placebo. 100 patients completed the trial (49 APAP group, 51 placebo group). No significant differences were found between the treatment groups in demographics, nutritional status or baseline measures (p>0.05). Baseline ALT>40 IU/L (upper limit normal) were reported for 17 (35%) patients in APAP group and 20 (39%) in placebo (p>0.05). 23 (45%) patients in placebo group and 18 (37%) patients in APAP were reactive for hepatitis C virus (HCV) antibody (p>0.05). Change in ALT, AST and INR measures were not significantly different between treatment groups or between groups with baseline ALT within or above normal limit. ALT levels in HCV positive patients were significantly higher throughout the study than HCV negative patients (p