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1107 – Esense 1 - 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 ,
A. Bladström ,
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
A. Bladström
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 treatment.

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 [NCT00811720].

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 350 patients: placebo N=170; nalmefene N=180 (mean age 51.9±9.4 years; 63% men; mean HDDs: 23±5.7/month; mean TAC: 101±41.7g/day). Mean number of HDDs decreased to 11 days/month and mean TAC decreased to 44g/day at month 6 in the nalmefene group. There was a superior effect of nalmefene compared to placebo in reducing the number of HDDs (-3.7 [95% CI: -5.9;-1.5];p=0.0010) and TAC (-18.3 [-26.9;-9.7];p< 0.0001) at month 6. Improvements in clinical status and liver parameters were greater in the nalmefene group compared to the placebo group (p< 0.05). Adverse events and adverse events leading to dropout were more common with nalmefene than placebo.

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-E500
Copyright
Copyright © European Psychiatric Association 2013
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