title: Clinical relevance of as-needed treatment with nalmefene in alcohol-dependent patients.
abstract: Nalmefene is the first drug approved for reduction of alcohol consumption. The aim of this study was to evaluate the clinical relevance of treatment with nalmefene in alcohol-dependent patients with a high drinking risk level from two randomised placebo-controlled 6-month studies (NCT00811720 and NCT00812461). Response criteria were based on alcohol consumption, Clinical Global Impression, and Short Form Health Survey mental component summary scores at month 6, analysed using logistic regression. The proportion of responders was higher in the nalmefene group than in the placebo group with odds ratios significantly in favour of nalmefene for all responder criteria; numbers-needed-to-treat ranged from 6 to 10. Significant differences from placebo in clinician-rated and patient-reported outcomes, and liver enzymes further supported the clinical relevance of the treatment effect. In conclusion, this study supports the clinical relevance of nalmefene treatment in patients with alcohol dependence. Nalmefene may help to reduce the alcohol-related burden and the large treatment gap, with currently less than 10% of alcohol-dependent patients in Europe receiving treatment.
authors.forename: Henri-Jean
authors.initials: HJ
authors.lastname: Aubin
authors.forename: Jens
authors.initials: J
authors.lastname: Reimer
authors.forename: David J
authors.initials: DJ
authors.lastname: Nutt
authors.forename: Anna
authors.initials: A
authors.lastname: Bladström
authors.forename: Lars
authors.initials: L
authors.lastname: Torup
authors.forename: Clément
authors.initials: C
authors.lastname: François
authors.forename: Jonathan
authors.initials: J
authors.lastname: Chick
mesh_terms: D000328:Adult; D000428:Alcohol Drinking; D000437:Alcoholism / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D040261:Harm Reduction; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D009292:Narcotic Antagonists; D009271:Naltrexone; C038981:nalmefene