A pragmatic trial of acamprosate in the treatment of alcohol dependence in primary care.

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 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.

[1]  N. W. Pedigo,et al.  The neurotoxicity induced by ethanol withdrawal in mature organotypic hippocampal slices might involve cross-talk between metabotropic glutamate type 5 receptors and N-methyl-D-aspartate receptors. , 2003, Alcoholism, clinical and experimental research.

[2]  N. W. Pedigo,et al.  Acamprosate inhibits the binding and neurotoxic effects of trans-ACPD, suggesting a novel site of action at metabotropic glutamate receptors. , 2002, Alcoholism, clinical and experimental research.

[3]  M. Morgan,et al.  The European NEAT program: an integrated approach using acamprosate and psychosocial support for the prevention of relapse in alcohol-dependent patients with a statistical modeling of therapy success prediction. , 2002, Alcoholism, clinical and experimental research.

[4]  P. Godeau.  Conférence de consensus , 2000 .

[5]  K. Lohr,et al.  Pharmacological treatment of alcohol dependence: a review of the evidence. , 1999, JAMA.

[6]  B. Burnand,et al.  MOS-SF-36 in evaluating health-related quality of life in alcohol-dependent patients. , 1998, The American journal of drug and alcohol abuse.

[7]  S. Cantor,et al.  Alcohol use disorders, consumption patterns, and health-related quality of life of primary care patients. , 1997, Alcoholism, clinical and experimental research.

[8]  B. Ritson,et al.  The SECCAT survey: I. The costs and consequences of alcoholism. , 1996, Alcohol and alcoholism.

[9]  J. Guelfi,et al.  Double-blind randomized multicentre trial of acamprosate in maintaining abstinence from alcohol. , 1995, Alcohol and alcoholism.

[10]  C. Sherbourne,et al.  The MOS 36-Item Short-Form Health Survey (SF-36) , 1992 .

[11]  D. Rund,et al.  Orthopaedic trauma in men: the relative risk among drinkers and the prevalence of problem drinking in male orthopaedic admissions. , 1991, Annals of the Royal College of Surgeons of England.

[12]  K. Macrae.  Pragmatic Versus Explanatory Trials , 1989, International Journal of Technology Assessment in Health Care.

[13]  M. Morgan,et al.  Improvement in quality of life after treatment for alcohol dependence with acamprosate and psychosocial support. , 2004, Alcoholism, clinical and experimental research.

[14]  K. Mann,et al.  The efficacy of acamprosate in the maintenance of abstinence in alcohol-dependent individuals: results of a meta-analysis. , 2004, Alcoholism, clinical and experimental research.

[15]  U. Preuss,et al.  Use of Acamprosate and Different Kinds of Psychosocial Support in Relapse Prevention of Alcoholism , 2002, Drugs in R&D.

[16]  B. Mason,et al.  Treatment of alcohol-dependent outpatients with acamprosate: a clinical review. , 2001, The Journal of clinical psychiatry.

[17]  M. Stein,et al.  The functioning and well being of persons who seek treatment for drug and alcohol use. , 1998, Journal of substance abuse.

[18]  Numérisation de documents anciens mathématiques,et al.  Journal de la Société de statistique de Paris , 1998 .

[19]  P. Kiritze-Topor.  ANALYSE, SUR DEUX ANS, DU SUIVI DE PATIENTS ALCOOLO-DEPENDANTS EN CABINET DE MEDECINE GENERALE , 1998 .

[20]  B. Ritson,et al.  The SECCAT Survey: II. The Alcohol Related Problems Questionnaire as a proxy for resource costs and quality of life in alcoholism treatment. Study of Socio-Economic Consequences and Costs of Alcoholism and Treatment. , 1997, Alcohol and alcoholism.

[21]  B. Ritson,et al.  THE SECCAT SURVEY: II. THE ALCOHOL RELATED PROBLEIN QUESTIONNAIRE AS A PROXY FOR RESOURCE COSTS AND QUA OF LIFE IN ALCOHOLISM TREATMENT , 1997 .

[22]  H. Allemand,et al.  SUIVI ET ASSIDUITE A UN AN DES MALADES DE L'ALCOOL EN MEDECINE GENERALE , 1996 .

[23]  D. Schwartz.  Connaissance ou décision. Attitude explicative: attitude pragmatique , 1994 .