To the Editor A systematic review and meta-analysis1 highlighted the current pharmacotherapy for outpatients affected by alcohol use disorders. However, regarding off-label drugs, some issues need more discussion, particularly those regarding nalmefene use.
Nalmefene is no longer an off-label drug in Europe. Nalmefene was approved in February 2013 by the European Medicines Agency and was granted market authorization in the European Union for the reduction of alcohol consumption in alcohol-dependent patients with a high drinking risk level (defined as >60 g/d for men and >40 g/d for women).2 As cited by Jonas and colleagues, 2 randomized, double-blind, placebo-controlled trials have been published in which patients with alcohol use disorders received nalmefene as needed (ie, in self-identified risk situations, when drinking is imminent, or as soon as possible after drinking) for 6 months. However, a post hoc analysis of these studies only including patients with at least a high drinking risk level both at screening and randomization showed more interesting results: nalmefene reduced the number of heavy drinking days (treatment difference: −3.2 days; P < .001) and total alcohol consumption (treatment difference: −14.3 g/d; P < .001) at month 6 significantly more than placebo.3
Caputo F, Domenicali M, Bernardi M. Medications for Alcohol Use Disorders. JAMA. 2014;312(13):1350-1351. doi:10.1001/jama.2014.10158