P-81SECONDARY BENEFITS OF ALCOHOL REDUCTION WITH NALMEFENE

Abstract

The opioid system modulator nalmefene reduce average daily total alcohol consumption, number of heavy drinking days, and improve liver function and clinical status in alcohol-dependent patients. We in-vestigated the effect of alcohol reduction with nalmefene 18 mg on alcohol dependence features, drinking consequences, and mood in two 6-month randomized, double-blind, placebo-controlled, studies (NCT00811720; NCT00812461) in alcohol-dependent patients. The Alcohol Dependence Scale (ADS), the Drinker Inventory of Con-sequences (DrInC-2R) and the Profiles of Mood States (POMS) were administered. Post-hoc analyses of change from baseline at 24 weeks using ANCOVA (ADS) and mixed model repeated measures (DrInC-2R and POMS) were performed in the pooled subgroup of patients with high drinking risk level (men: > 60g/day; women: > 40g/day). At baseline, the sample comprised 322 (placebo) and 319 (nalmefene) patients. For the ADS the mean change from baseline for nalmefene versus placebo for the three components: Loss of behavioral control and heavy drinking, Obsessive-compulsive drinking style and Psycho-perceptual and psychophysical withdrawal were-0.5 ± 0.2 (p = 0.0080),-0.5 ± 0.2 (p = 0.0005) and-0.5 ± 0.1 (p = 0.0003) respect-ively. For the DrInC the mean change from baseline for nalmefene versus placebo for the Physical and Inter-personal subscales were-0.9 ± 0.3 (p = 0.0067) and-1.1 ± 0.4 (p = 0.0097) respectively. For the POMS the mean change from baseline for nalmefene versus placebo for the mood profiles Depression, Fatigue and Confusion were-2.0 ± 0.8 (p = 0.0138),-0.9 ± 0.5 (p = 0.0422), and-0.7 ± 0.3 (p = 0.0465), respectively. Other subscales of DrInC and POMS did not differ between nalmefene and placebo. In conclusion, the reduction in alcohol consumption with nalmefene resulted in significant improvements in alcohol dependence features, drinking consequences, and mood.