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Nalmefene: a new approach to the treatment of alcohol dependence.

ABSTRACT: Reduction of alcohol consumption is not yet a widely accepted treatment objective for alcohol-dependent patients, as abstinence is often considered to be the only possible objective in this situation. However, various studies have demonstrated the value of proposing these two options to such patients. Firstly, reduction of alcohol consumption very significantly reduces the risk of alcohol-related damage, and also modifies the patient's and the doctor's perception of the disease, resulting in improved access to care and better patient adherence with the proposed treatment objective and consequently better clinical results. Recent studies have shown that some medicinal products can help patients reduce their alcohol consumption. One such product, nalmefene, has been granted European marketing authorization and is now being released onto the market in various countries. The ESENSE 1 and 2 studies in alcohol-dependent patients showed that, in combination with BRENDA, a psychosocial intervention focusing on reinforcement of motivation and treatment adherence, nalmefene significantly reduced the number of heavy drinking days and mean daily total alcohol consumption versus placebo. This reduction was more marked in the marketing authorization target population, ie, patients with a high or very high drinking risk level according to World Health Organization criteria. Another original feature of this molecule is that it can be used as needed if the patient perceives a risk of drinking, which is a more flexible approach and more likely to ensure the patient's active involvement in the treatment of his/her disease. This molecule opens up interesting and original therapeutic prospects in the treatment of alcohol dependence.

SUBMITTER: Paille F

PROVIDER: S-EPMC4133028 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Nalmefene: a new approach to the treatment of alcohol dependence.

Paille François F Martini Hervé H

Substance abuse and rehabilitation 20140808

Reduction of alcohol consumption is not yet a widely accepted treatment objective for alcohol-dependent patients, as abstinence is often considered to be the only possible objective in this situation. However, various studies have demonstrated the value of proposing these two options to such patients. Firstly, reduction of alcohol consumption very significantly reduces the risk of alcohol-related damage, and also modifies the patient's and the doctor's perception of the disease, resulting in imp ...[more]

PMID: 25187751

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Project description:BackgroundNalmefene is a recent option in alcohol dependence treatment. Its approval was controversial. We conducted a systematic review and meta-analysis of the aggregated data (registered as PROSPERO 2014:CRD42014014853) to compare the harm/benefit of nalmefene versus placebo or active comparator in this indication.Methods and findingsThree reviewers searched for published and unpublished studies in Medline, the Cochrane Library, Embase, ClinicalTrials.gov, Current Controlled Trials, and bibliographies and by mailing pharmaceutical companies, the European Medicines Agency (EMA), and the US Food and Drug Administration. Double-blind randomized clinical trials evaluating nalmefene to treat adult alcohol dependence, irrespective of the comparator, were included if they reported (1) health outcomes (mortality, accidents/injuries, quality of life, somatic complications), (2) alcohol consumption outcomes, (3) biological outcomes, or (4) treatment safety outcomes, at 6 mo and/or 1 y. Three authors independently screened the titles and abstracts of the trials identified. Relevant trials were evaluated in full text. The reviewers independently assessed the included trials for methodological quality using the Cochrane Collaboration tool for assessing risk of bias. On the basis of the I2 index or the Cochrane's Q test, fixed or random effect models were used to estimate risk ratios (RRs), mean differences (MDs), or standardized mean differences (SMDs) with 95% CIs. In sensitivity analyses, outcomes for participants who were lost to follow-up were included using baseline observation carried forward (BOCF); for binary measures, patients lost to follow-up were considered equal to failures (i.e., non-assessed patients were recorded as not having responded in both groups). Five randomized controlled trials (RCTs) versus placebo, with a total of 2,567 randomized participants, were included in the main analysis. None of these studies was performed in the specific population defined by the EMA approval of nalmefene, i.e., adults with alcohol dependence who consume more than 60 g of alcohol per day (for men) or more than 40 g per day (for women). No RCT compared nalmefene with another medication. Mortality at 6 mo (RR = 0.39, 95% CI [0.08; 2.01]) and 1 y (RR = 0.98, 95% CI [0.04; 23.95]) and quality of life at 6 mo (SF-36 physical component summary score: MD = 0.85, 95% CI [-0.32; 2.01]; SF-36 mental component summary score: MD = 1.01, 95% CI [-1.33; 3.34]) were not different across groups. Other health outcomes were not reported. Differences were encountered for alcohol consumption outcomes such as monthly number of heavy drinking days at 6 mo (MD = -1.65, 95% CI [-2.41; -0.89]) and at 1 y (MD = -1.60, 95% CI [-2.85; -0.35]) and total alcohol consumption at 6 mo (SMD = -0.20, 95% CI [-0.30; -0.10]). An attrition bias could not be excluded, with more withdrawals for nalmefene than for placebo, including more withdrawals for safety reasons at both 6 mo (RR = 3.65, 95% CI [2.02; 6.63]) and 1 y (RR = 7.01, 95% CI [1.72; 28.63]). Sensitivity analyses showed no differences for alcohol consumption outcomes between nalmefene and placebo, but the weight of these results should not be overestimated, as the BOCF approach to managing withdrawals was used.ConclusionsThe value of nalmefene for treatment of alcohol addiction is not established. At best, nalmefene has limited efficacy in reducing alcohol consumption.

Project description:BackgroundThe tradition of consuming alcohol has long been a part of Italian culture and is responsible for a large health burden. This burden may be reduced with effective interventions, one of the more important of which is treatment for Alcohol Dependence (AD). The aim of this article is to estimate the burden of disease in Italy attributable to alcohol consumption, heavy alcohol consumption, and AD. An additional aim of this paper is to examine the effects of increasing the coverage of treatment for AD on the alcohol-attributable burden of disease.MethodsAlcohol-attributable deaths and the effects of treatments for AD were estimated using alcohol-attributable fractions and simulations. Deaths, potential years of life lost, years lived with disability, and disability adjusted life years lost were obtained for 2004 for Italy and for the European Union from the Global Burden of Disease study. Alcohol consumption data were obtained from the Global Information System on Alcohol and Health. The prevalences of current drinkers, former drinkers, and lifetime abstainers were obtained from the GENder Alcohol and Culture International Study. The prevalence of AD was obtained from the World Mental Health Survey. Alcohol relative risks were obtained from various meta-analyses.Results5,320 deaths (1,530 female deaths; 3,790 male deaths) or 5.9% of all deaths (4.9% of all female deaths; 6.3% of all male deaths) of people 15 to 64 years of age were estimated to be alcohol-attributable. Of these deaths, 74.5% (61.3% for females; 79.8% for males) were attributable to heavy drinking, and 26.9% (25.6% for females; 27.5% for males) were attributable to AD. Increasing pharmacological AD treatment coverage to 40% would result in an estimated reduction of 3.3% (50 deaths/year) of all female and 7.6% (287 deaths/year) of all male alcohol-attributable deaths.ConclusionsAlcohol was responsible for a large proportion of the burden of disease in Italy in 2004. Increasing treatment coverage for AD in Italy could reduce that country's alcohol-attributable burden of disease.

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Nalmefene: a new approach to the treatment of alcohol dependence.

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Nalmefene: a new approach to the treatment of alcohol dependence.

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