Alcohol and Alcoholism Advance Access originally published online on August 10, 2004
Alcohol and Alcoholism 2004 39(6):520-527; doi:10.1093/alcalc/agh088
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Alcohol & Alcoholism Vol. 39, No. 6 © Medical Council on Alcohol 2004; all rights reserved
A PRAGMATIC TRIAL OF ACAMPROSATE IN THE TREATMENT OF ALCOHOL DEPENDENCE IN PRIMARY CARE
1 11 avenue du Grain d'Or, 49600 Beaupreau, France. 2 Department of General Practice, Xavier Bichat University, 75018 Paris, France. 3 Le Clos Macé, 35850 Geveze, France. 4 Merck Santé, 37 rue Saint-Romain, 69379 Lyon cedex 08, France. 5 Hôpital Villemin, 17 rue de Nabecor, 54000 Nancy, France and 6 Statistics Department, University of Mons, FuCam, Mons, Belgium and Faculty of Medicine, University of Melbourne, Melbourne, Australia
* Author to whom correspondence should be addressed at: 11 avenue du Grain d'Or 49600 Beaupréau, France. Tel.: 02 41 63 00 07; Fax: 02 41 63 35 42; E-mail: pkiritze001{at}cegetel.rss.fr
(Received 12 May 2003; first review notified 13 June 2003; in revised form 15 July 2004; accepted 15 July 2004)
Aims: To assess the effectiveness of pharmacotherapy with acamprosate in alcohol-dependent patients treated in a naturalistic setting in primary care in France. Methods: The ARES (Acamprosate et Répercussions Économiques et Sociales; Acamprosate and Economic and Social Repercussions) study was performed by 149 general practitioners interested in treating alcohol use disorders in France who included patients fulfilling DSM-IV criteria for alcohol dependence. The only exclusion criteria concerned contra-indications to acamprosate, co-medication with naltrexone and multiple substance abuse. Eligible patients were randomized to one of two treatment arms, either standard care alone or standard care with acamprosate, using an open-label design and followed up quarterly for a period of 1 year. The primary outcome variable was the change from baseline on the Alcohol-Related Problems Questionnaire. Secondary efficacy variables were abstinence, Clinical Global Impression, quality of life measured with the SF-36 and incidence of adverse events. An intent-to-treat population was used for outcome analysis. Results: 422 patients were included, of whom 348 (82%) completed the protocol as planned. At the end of the study, patients randomized to the acamprosate group had significantly better outcomes in terms of total ARPQ score, change from baseline (–2.61 vs –3.44) and number of subjects with no alcohol-related problem. On average, patients treated with acamprosate had one less alcohol-related problem than did the controls. The number needed to treat in order to save one additional patient from alcohol-related problems compared to standard care was 7.14. Statistically significant differences in favour of the acamprosate group were observed for all secondary efficacy outcome measures including quality of life. Conclusions: Adjunctive therapy with acamprosate in primary care is associated with significantly better functional outcome. Pragmatic trials in alcohol dependence are both feasible and informative.