A Placebo-Controlled Randomized Trial of Vigabatrin in the Management of Acute Alcohol Withdrawal. (24th September 2022)

• Record Type: Journal Article
• Authors: Williams, James; Collins, Lisa; Norman, Amanda; O'Neill, Helen; Lloyd-Jones, Martyn; Ogden, Edward; Bonomo, Yvonne; Pastor, Adam
• Is Part Of: Alcohol and alcoholism. Volume 58:Number 1(2023)
• Page Start: 40
• Page End: 45
• Publication Date: 2022-09-24
• Subjects: Alcoholism -- Periodicals; 616.861005
• DOI: 10.1093/alcalc/agac044
• Languages: English
• ISSNs: 0735-0414

Abstract

Abstract: Objective: To undertake a double blinded randomised placebo-controlled trial to assess the efficacy of vigabatrin, a GABA-transaminase inhibitor, as a benzodiazepine sparing agent in the management of acute alcohol withdrawal syndrome in a residential setting. Methods: We enrolled 120 patients with alcohol use disorder who were randomly assigned to either treatment with vigabatrin (2g/day for 4 days) or placebo. The primary outcome was defined as the number of participants in each treatment arm needing diazepam for withdrawal management. A secondary outcome prespecified was the total dose of diazepam received by participants in each treatment arm. Participants were recruited on admission to a residential withdrawal unit at St Vincent's Hospital Melbourne from December 2014 to April 2019. Results: No significant difference was observed in the number of participants requiring benzodiazepines during their residential withdrawal stay with 44 participants (78.6%) in placebo arm requiring at least one dose of diazepam compared to 38 (66.7%) in vigabatrin arm ( p = .156). An 18.1% difference was observed between the proportion of participants who received a total dose of >100mg of diazepam during their residential withdrawal stay in placebo arm (32.1%), compared to vigabatrin arm (14.0%, p = .022). There were higher rates of reported adverse events in placebo arm with nine (15.0%) participants reporting adverse events compared with two (3.3%) participants in vigabatrin arm (p = .027). Conclusion: Vigabatrin significantly reduced the number of participants requiring >100mg diazepam over the course of their alcohol withdrawal and was associated with a reduction in adverse effects when compared to placebo.