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Long-term efficacy, tolerability and safety of nalmefene as-needed in patients with alcohol dependence: A 1-year, randomised controlled study

Wim van den Brink, Per Sørensen, Lars Torup, Karl Mann, Antoni Gual, for the SENSE Study Group

Journal of Psychopharmacology 2014, Volume 28, pages 733–744

In this study conducted in 10 European countries to assess long-term efficacy, tolerability and safety of nalmefene, 675 alcohol-dependent patients were randomized to nalmefene-as-needed or placebo. 62% of the nalmefene-treated patients in the total population completed the 1-year study, indicating that the drug was well tolerated. In a subgroup of patients with high/very high drinking risk levels, there was a significant effect in favour of nalmefene on the reduction of total alcohol consumption at month 6, and on the number of heavy drinking days and total alcohol consumption at month 13. These findings further support that nalmefene as-needed is effective in patients with high/very high drinking risk levels at the start of treatment, and has the potential to engage alcohol-dependent patients in a treatment aimed at reducing their alcohol consumption.

Abstract
This study evaluated the long-term efficacy and safety of nalmefene treatment in reducing alcohol consumption. We randomised (1:3) 675 alcohol-dependent patients ≥ 18 years of age to 52 weeks of as-needed treatment with placebo or nalmefene 18 mg/day: A total of 112 patients (68%) in the placebo group and 310 (62%) in the nalmefene group completed the study. At month 6, the co-primary outcome variables showed no statistically-significant differences between the treatment groups; but at month 13, nalmefene was more effective than placebo, both in the reduction of the number of heavy drinking days (HDDs) (− 1.6 days/month (95% CI − 2.9; − 0.3); p = 0.017) and the reduction of total alcohol consumption (TAC) (− 6.5 g/day last month (95% CI − 12.5; − 0.4); p = 0.036). In a subgroup analysis of patients with high/very high drinking risk levels at screening and at randomisation (the target population), there was a significant effect in favour of nalmefene on TAC at month 6, and on both HDD and TAC at month 13. Improvements in Clinical Global Impression and liver enzymes were greater with nalmefene, compared to placebo. Most adverse events were mild or moderate, and transient; adverse events, including those leading to dropout, were more common with nalmefene. This study provides evidence for the long-term safety and efficacy of nalmefene as-needed in alcohol-dependent patients whom continue to drink heavily, following a brief intervention.

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