A PRAGMATIC TRIAL OF ACAMPROSATE IN THE TREATMENT OF ALCOHOL DEPENDENCE IN PRIMARY CARE
Identifieur interne : 000B16 ( Istex/Curation ); précédent : 000B15; suivant : 000B17A PRAGMATIC TRIAL OF ACAMPROSATE IN THE TREATMENT OF ALCOHOL DEPENDENCE IN PRIMARY CARE
Auteurs : Paul Kiritze Topor [France] ; Dominique Huas [France] ; Claude Rosenzweig [France] ; Sylvie Comte [France] ; Franc Ois Paille [France] ; Philippe Lehert [Australie]Source :
- Alcohol and Alcoholism [ 0735-0414 ] ; 2004-NaN.
Descripteurs français
- Wicri :
- topic : Alcool, Alcoolisme, Santé mentale.
English descriptors
- KwdEn :
- Abstinence, Academic centres, Acamprosate, Acamprosate group, Acute detoxification, Additional patient, Adjunctive therapy, Adverse event, Alcohol, Alcohol alcoholism, Alcohol consumption, Alcohol dependence, Alcohol misuse, Alcoholdependent patients, Alcoholdependent subjects, Alcoholism, Ares, Ares study, Arpq, Arpq score, Baseline, Baseline score, Baseline variables, Better outcome, Bodily pain, Clinical effectiveness, Clinical trial methodology, Clinical trials, Community care, Confidence limits, Control group, Cumulative abstinence duration, Cumulative abstinence duration proportion, Detoxification, Diagnostic criteria, Drink diaries, Drinking behaviour, Drinking history, Employment situation, Entry criteria, Everyday practice, Exclusion criteria, Experimental research, Familial antecedents, French version, General population, General practice, General practitioner, General practitioners, Health problems, Health profile measure, Health transition, Inclusion, Inclusion bias, Investigator, Less problem, Medical care, Mental health, Multiple regression analysis, Neat study, Other hand, Outcome criteria, Outcome measure, Outcome measures, Patient characteristics, Patients consulting, Patients randomized, Placebo group, Possible scores, Potential source, Potential sources, Practitioner, Pragmatic, Pragmatic trial, Pragmatic trials, Previous detoxifications, Primary care, Primary care environment, Primary outcome, Primary outcome criterion, Problems questionnaire, Psychosocial, Psychosocial support, Psychosocial therapy, Randomization list, Randomized, Reference values, Regular visits, Rehabilitation programme, Relative benefit, Relative risk, Role limitation dimensions, Role limitations, Routine care, Same time, Seccat survey, Secondary efficacy variables, Secondary outcome measure, Significant difference, Significant differences, Social repercussions, Standard care, Standard care group, Standard practice, Study period, Such patients, Therapeutic objective, Total arpq score, Treatment arms, Treatment effect, Treatment failures, Treatment group, Treatment groups, Unused medication.
- Teeft :
- Abstinence, Academic centres, Acamprosate, Acamprosate group, Acute detoxification, Additional patient, Adjunctive therapy, Adverse event, Alcohol, Alcohol alcoholism, Alcohol consumption, Alcohol dependence, Alcohol misuse, Alcoholdependent patients, Alcoholdependent subjects, Alcoholism, Ares, Ares study, Arpq, Arpq score, Baseline, Baseline score, Baseline variables, Better outcome, Bodily pain, Clinical effectiveness, Clinical trial methodology, Clinical trials, Community care, Confidence limits, Control group, Cumulative abstinence duration, Cumulative abstinence duration proportion, Detoxification, Diagnostic criteria, Drink diaries, Drinking behaviour, Drinking history, Employment situation, Entry criteria, Everyday practice, Exclusion criteria, Experimental research, Familial antecedents, French version, General population, General practice, General practitioner, General practitioners, Health problems, Health profile measure, Health transition, Inclusion, Inclusion bias, Investigator, Less problem, Medical care, Mental health, Multiple regression analysis, Neat study, Other hand, Outcome criteria, Outcome measure, Outcome measures, Patient characteristics, Patients consulting, Patients randomized, Placebo group, Possible scores, Potential source, Potential sources, Practitioner, Pragmatic, Pragmatic trial, Pragmatic trials, Previous detoxifications, Primary care, Primary care environment, Primary outcome, Primary outcome criterion, Problems questionnaire, Psychosocial, Psychosocial support, Psychosocial therapy, Randomization list, Randomized, Reference values, Regular visits, Rehabilitation programme, Relative benefit, Relative risk, Role limitation dimensions, Role limitations, Routine care, Same time, Seccat survey, Secondary efficacy variables, Secondary outcome measure, Significant difference, Significant differences, Social repercussions, Standard care, Standard care group, Standard practice, Study period, Such patients, Therapeutic objective, Total arpq score, Treatment arms, Treatment effect, Treatment failures, Treatment group, Treatment groups, Unused medication.
Abstract
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.
Url:
DOI: 10.1093/alcalc/agh088
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<term>Academic centres</term>
<term>Acamprosate</term>
<term>Acamprosate group</term>
<term>Acute detoxification</term>
<term>Additional patient</term>
<term>Adjunctive therapy</term>
<term>Adverse event</term>
<term>Alcohol</term>
<term>Alcohol alcoholism</term>
<term>Alcohol consumption</term>
<term>Alcohol dependence</term>
<term>Alcohol misuse</term>
<term>Alcoholdependent patients</term>
<term>Alcoholdependent subjects</term>
<term>Alcoholism</term>
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<term>Ares study</term>
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<term>Arpq score</term>
<term>Baseline</term>
<term>Baseline score</term>
<term>Baseline variables</term>
<term>Better outcome</term>
<term>Bodily pain</term>
<term>Clinical effectiveness</term>
<term>Clinical trial methodology</term>
<term>Clinical trials</term>
<term>Community care</term>
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<term>Control group</term>
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<term>Cumulative abstinence duration proportion</term>
<term>Detoxification</term>
<term>Diagnostic criteria</term>
<term>Drink diaries</term>
<term>Drinking behaviour</term>
<term>Drinking history</term>
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<term>Experimental research</term>
<term>Familial antecedents</term>
<term>French version</term>
<term>General population</term>
<term>General practice</term>
<term>General practitioner</term>
<term>General practitioners</term>
<term>Health problems</term>
<term>Health profile measure</term>
<term>Health transition</term>
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<term>Inclusion bias</term>
<term>Investigator</term>
<term>Less problem</term>
<term>Medical care</term>
<term>Mental health</term>
<term>Multiple regression analysis</term>
<term>Neat study</term>
<term>Other hand</term>
<term>Outcome criteria</term>
<term>Outcome measure</term>
<term>Outcome measures</term>
<term>Patient characteristics</term>
<term>Patients consulting</term>
<term>Patients randomized</term>
<term>Placebo group</term>
<term>Possible scores</term>
<term>Potential source</term>
<term>Potential sources</term>
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<term>Pragmatic</term>
<term>Pragmatic trial</term>
<term>Pragmatic trials</term>
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<term>Primary care environment</term>
<term>Primary outcome</term>
<term>Primary outcome criterion</term>
<term>Problems questionnaire</term>
<term>Psychosocial</term>
<term>Psychosocial support</term>
<term>Psychosocial therapy</term>
<term>Randomization list</term>
<term>Randomized</term>
<term>Reference values</term>
<term>Regular visits</term>
<term>Rehabilitation programme</term>
<term>Relative benefit</term>
<term>Relative risk</term>
<term>Role limitation dimensions</term>
<term>Role limitations</term>
<term>Routine care</term>
<term>Same time</term>
<term>Seccat survey</term>
<term>Secondary efficacy variables</term>
<term>Secondary outcome measure</term>
<term>Significant difference</term>
<term>Significant differences</term>
<term>Social repercussions</term>
<term>Standard care</term>
<term>Standard care group</term>
<term>Standard practice</term>
<term>Study period</term>
<term>Such patients</term>
<term>Therapeutic objective</term>
<term>Total arpq score</term>
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<term>Treatment effect</term>
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<term>Academic centres</term>
<term>Acamprosate</term>
<term>Acamprosate group</term>
<term>Acute detoxification</term>
<term>Additional patient</term>
<term>Adjunctive therapy</term>
<term>Adverse event</term>
<term>Alcohol</term>
<term>Alcohol alcoholism</term>
<term>Alcohol consumption</term>
<term>Alcohol dependence</term>
<term>Alcohol misuse</term>
<term>Alcoholdependent patients</term>
<term>Alcoholdependent subjects</term>
<term>Alcoholism</term>
<term>Ares</term>
<term>Ares study</term>
<term>Arpq</term>
<term>Arpq score</term>
<term>Baseline</term>
<term>Baseline score</term>
<term>Baseline variables</term>
<term>Better outcome</term>
<term>Bodily pain</term>
<term>Clinical effectiveness</term>
<term>Clinical trial methodology</term>
<term>Clinical trials</term>
<term>Community care</term>
<term>Confidence limits</term>
<term>Control group</term>
<term>Cumulative abstinence duration</term>
<term>Cumulative abstinence duration proportion</term>
<term>Detoxification</term>
<term>Diagnostic criteria</term>
<term>Drink diaries</term>
<term>Drinking behaviour</term>
<term>Drinking history</term>
<term>Employment situation</term>
<term>Entry criteria</term>
<term>Everyday practice</term>
<term>Exclusion criteria</term>
<term>Experimental research</term>
<term>Familial antecedents</term>
<term>French version</term>
<term>General population</term>
<term>General practice</term>
<term>General practitioner</term>
<term>General practitioners</term>
<term>Health problems</term>
<term>Health profile measure</term>
<term>Health transition</term>
<term>Inclusion</term>
<term>Inclusion bias</term>
<term>Investigator</term>
<term>Less problem</term>
<term>Medical care</term>
<term>Mental health</term>
<term>Multiple regression analysis</term>
<term>Neat study</term>
<term>Other hand</term>
<term>Outcome criteria</term>
<term>Outcome measure</term>
<term>Outcome measures</term>
<term>Patient characteristics</term>
<term>Patients consulting</term>
<term>Patients randomized</term>
<term>Placebo group</term>
<term>Possible scores</term>
<term>Potential source</term>
<term>Potential sources</term>
<term>Practitioner</term>
<term>Pragmatic</term>
<term>Pragmatic trial</term>
<term>Pragmatic trials</term>
<term>Previous detoxifications</term>
<term>Primary care</term>
<term>Primary care environment</term>
<term>Primary outcome</term>
<term>Primary outcome criterion</term>
<term>Problems questionnaire</term>
<term>Psychosocial</term>
<term>Psychosocial support</term>
<term>Psychosocial therapy</term>
<term>Randomization list</term>
<term>Randomized</term>
<term>Reference values</term>
<term>Regular visits</term>
<term>Rehabilitation programme</term>
<term>Relative benefit</term>
<term>Relative risk</term>
<term>Role limitation dimensions</term>
<term>Role limitations</term>
<term>Routine care</term>
<term>Same time</term>
<term>Seccat survey</term>
<term>Secondary efficacy variables</term>
<term>Secondary outcome measure</term>
<term>Significant difference</term>
<term>Significant differences</term>
<term>Social repercussions</term>
<term>Standard care</term>
<term>Standard care group</term>
<term>Standard practice</term>
<term>Study period</term>
<term>Such patients</term>
<term>Therapeutic objective</term>
<term>Total arpq score</term>
<term>Treatment arms</term>
<term>Treatment effect</term>
<term>Treatment failures</term>
<term>Treatment group</term>
<term>Treatment groups</term>
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<front><div type="abstract" xml:lang="en">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.</div>
</front>
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