A pragmatic trial of acamprosate in the treatment of alcohol dependence in primary care.
OBJECTIVE
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 Repercussions Economiques 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.
11 avenue du Grain d'Or 49600 Beaupréau, France. pkiritze001@cegetel.rss.fr
Paul
P
Kiritzé-Topor
Dominique
D
Huas
Claude
C
Rosenzweig
Sylvie
S
Comte
François
F
Paille
Philippe
P
Lehert
D000077443:Acamprosate; D000427:Alcohol Deterrents / Q000627:therapeutic use*; D000437:Alcoholism / Q000188:drug therapy*; D016009:Chi-Square Distribution; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care; D012107:Research Design; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D013654:Taurine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
D000427:Alcohol Deterrents; D013654:Taurine; D000077443:Acamprosate