Clinical moderators of response to nalmefene in alcohol dependence: Results from a randomized controlled trial in Japan.

Prior identification of patients who may respond well to nalmefene well could maximize the effectiveness of treatment. It would also provide clinicians with clinical guideline that would enable them to appropriately prescribe nalmefene to patients who could benefit from it, leading to the rise of prescription rates. The unique circumstances in Japan, where only nalmefene is the only available opioid antagonist medication that can be used for alcohol dependence justifies research to identify patients who may benefit from the medication.The purpose of this study is to identify clinical moderators that affect treatment responsiveness of nalmefene for alcoholism by sub-analyzing the dataset from a multicenter, randomized, controlled, double-blind, phase 3 study conducted in Japanese alcohol-dependent patients19. This study showed the effect of nalmefene in reducing heavy drinking days (HDD) and average total alcohol consumption (TAC) among alcoholics with a high Drinking Risk Level (DRL) and a very high DRL, as defined by the WHO.