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1108 – Esense 2 - Randomised Controlled 6-month Study Of As-needed Nalmefene: Subgroup Analysis Of Alcohol Dependent Patients With High Drinking Risk Level

Published online by Cambridge University Press:  15 April 2020

W. van den Brink ,
H.-J. Aubin ,
P. Sørensen ,
L. Torup ,
K. Mann  and
A. Gual
W. van den Brink
Affiliation:
Department of Psychiatry, Amsterdam Institute for Addiction Research, University of Amsterdam, Amsterdam, The Netherlands
H.-J. Aubin
Affiliation:
Hôpital Paul Brousse, INSERM 669, Université Paris-Sud, Villejuif, France
P. Sørensen
Affiliation:
H. Lundbeck A/S, Valby, Denmark
L. Torup
Affiliation:
H. Lundbeck A/S, Valby, Denmark
K. Mann
Affiliation:
Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany
A. Gual
Affiliation:
Department of Psychiatry, Alcohol Unit, Institute of Neurosciences, Hospital Clinic, Barcelona, Spain

Abstract

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Introduction

We describe the efficacy and safety of as-needed use of nalmefene in the subgroup of patients with a high drinking risk level (DRL; men:>60g/day; women:>40g/day); i.e. a group of patients with a great unmet medical need for.

Objectives

To evaluate the 6 month efficacy and safety of as-needed use of nalmefene 18mg versus placebo in a subgroup of alcohol-dependent patients with high DRL from a randomised controlled trial [NCT00812461].

Methods

All patients received a motivational and adherence-enhancing intervention (BRENDA) in combination with either nalmefene or placebo. Number of heavy drinking days (HDDs) and total alcohol consumption (TAC) were measured using the Timeline Follow-back method. Additionally, data on clinical improvement, liver function and safety were collected throughout the study.

Results

The study population consisted of 317 patients: placebo N=162; nalmefene N=155 (mean age 44.8±10.3 years; 69% men; mean HDDs: 22±6.2/month; mean TAC 111±47.9g/day). Mean number of HDDs decreased to 10 days/month and mean TAC decreased to 43g/day at month 6 in the nalmefene group. There was a superior effect of nalmefene compared to placebo in reducing the number of HDDs (-2.7 [95% CI: -5.0;-0.3];p=0.0253) and TAC -10.3 [-20.2;-0.5];p=0.0404). Improvements in clinical status and alanine amino transferase were greater in the nalmefene group compared to the placebo group (p< 0.05). Adverse events were more common with nalmefene; incidence of adverse events leading to dropout was at the placebo level.

Conclusions

As-needed nalmefene was efficacious in reducing alcohol consumption in patients with high risk for alcoholrelated harm.

Type
Abstract
Information
European Psychiatry , Volume 28 , Issue S1: Abstracts of the 21th European Congress of Psychiatry , 2013 , 28-E501
Copyright
Copyright © European Psychiatric Association 2013
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