EPA-0255 – Clinical Relevance of as-Needed Treatment with Nalmefene in Alcohol Dependent Patients

Abstract

Introduction:

The opioid system modulator nalmefeneis the first pharmacological therapy approved in the European Union for reduction of alcohol consumption.

Objectives:

To evaluate the clinical relevance of the reduction of alcohol consumption in patients with at least high drinking risk level at screening and randomisation from the two, identically designed, randomised controlled 6-month studies ESENSE1 (NCT00811720) and ESENSE2 (NCT00812461) of nalmefene versus placebo.

Methods:

Study medication was taken as-needed. All patients received a motivational and adherence-enhancing intervention (BRENDA). Response criteria were based on alcohol consumption at month 6 and Clinical Global Impression – Severity of Illness/Improvement (CGI-S/I), Short Form Health Survey version 2 (SF-36) mental component summary(MCS) scores at week 24. Clinical relevance was also studied using the Drinker Inventory of Consequences (DrInC), Alcohol Dependence Scale (ADS), and liver function variables.

Results:

Pooled study population: 667 patients (placebo N=332; nalmefene N=335). The proportion of responders was higher in the nalmefene group than in the placebo group with odds ratios for response consistently significantly (p<0.05) in favour of nalmefene. The difference in the proportions of responders translated to numbers-needed-to-treat ranging from 6 to 10. Significant differences to placebo (p<0.05) in the SF-36 MCS and physical component summary score, ADS, DrInC, CGI-I/S and liver enzymes further supported the clinical relevance of the treatment effect.

Conclusions:

In view of the immense alcohol-related burden to society, the harm to the individual and the large treatment gap partly due to a reluctance to engage in abstinence, the effect of nalmefene is clearly clinically relevant.