COPENHAGEN, Denmark ― For patients undergoing treatment for high-risk alcohol consumption in primary care, alcohol consumption can be controlled or even stopped with baclofen (multiple brands), according to data from France, where the drug is widely used to treat alcohol dependence.
The study, which was presented here at the 13th World Congress of Biological Psychiatry, showed that 1 year of treatment with the drug significantly reduced alcohol consumption or increased rates of abstinence in comparison with placebo by almost 60% in a real-world population.
Lead researcher Philippe Jaury, MD, PhD, Department of General Medicine, University Paris Descartes, France, said the results were "in favor of baclofen."
"There are more adverse events and serious adverse events with baclofen, but they are expected. What we can say is that baclofen is not a placebo; there are adverse events, and they are well known...so it's easy to take care of that," Dr Jaury added.
The findings were presented here at the 13th World Congress of Biological Psychiatry.
Primary Care Setting
Dr Jaury noted the BACLOVILLE study is a pragmatic, therapeutic, randomized, double-blind trial of primary care patients to determine the efficacy and safety of high-dose baclofen vs placebo for the reduction of alcohol consumption.
The study included adult patients aged 18 to 65 years from 60 centers in France who met World Health Organization criteria for high-risk alcohol consumption at least twice a month for the past 3 months.
Patients with concomitant severe psychiatric pathologies or organic diseases could be included on the basis of judgement of the individual investigator. Thus, the study reflected the real-world patient population seen in primary care.
The drug was administered at a dose of 5 mg at least three times a day for the first 3 days, after which the dose could be increased to a maximum of 300 mg/day.
Patients were treated for a maximum of 52 consecutive weeks and were not asked to stop drinking. The duration of titration was flexible, and the dose of baclofen could be decreased in the event of intolerance. Patients recorded alcohol consumption in a diary.
Of 327 patients initially assessed for eligibility, 162 were randomly assigned to receive baclofen and 158 to receive placebo. Of patients who received baclofen, 113 were followed for 12 months; in the placebo arm, 105 were followed for that period.
Through the use of multiple imputation with chained equations, carried out before patient unblinding, all 162 baclofen patients and 158 placebo patients could be included in the efficacy analysis.
The median age of the patients was 46 years in the baclofen arm and 47 years in the placebo group. The majority (71% and 69%, respectively) were men. The mean daily alcohol consumption was 128 g in the baclofen group and 129 g in the placebo arm. Almost all patients (~94%) were deemed to be alcohol dependent on DSM-IV criteria.
Dr Jaury also noted that approximately 7% of patients in the two groups had bipolar disorder and that about 20% had attempted suicide. Regular consumption of cannabis was reported by 11% of baclofen patients and 7% of those in the placebo arm. Regular cocaine and heroin consumption was also reported.
The median daily baclofen dose was 180 mg during the 52 weeks, at a range of 15 mg to 420 mg.
The imputed percentage of patients with low-risk alcohol consumption or those who were abstinent at the end of follow-up was significantly greater with baclofen than with placebo, at 57% vs 36% (risk ratio, 1.59; P = .003). The results were confirmed in two sensitivity analyses.
More Research Needed
When the team compared the number of adverse events between the 223 patients in the overall study who were treated at some point with baclofen and the 158 assigned to placebo, they found that the overall adverse event rate was similar, at 86% and 80%, respectively.
However, the proportion of patients who experienced severe adverse events was significantly higher in the baclofen group in comparison with the placebo group, at 38% vs 23%, as was the total number of severe adverse events, at 298 vs 95.
There was also a significant difference in the number of severe adverse events deemed to be possibly treatment related, at 133 events in 16% of patients in the baclofen group vs 17 events in 3% of patients in the placebo group.
The most commonly reported adverse events were drowsiness, fatigue, vertigo, paresthesia, and tinnitus.
Session co-chair Fabricio Moreira, PhD, Department of Pharmacology, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil, told Medscape Medical News: "I think this is promising, particularly because, for alcohol consumption, we have very few drugs that are effective in treating patients with alcoholism.
"Any new type of treatment is very welcome. The main problem is we still don't know the mechanism of how baclofen works in this setting and or how safe it is.
"Based on this study, there seem to be very few side effects, but I think that we need more studies, and also to study other doses of baclofen so that we know the therapeutic window," Dr Moreira added.
The study was funded by the French Ministry of Health and through a private donation. The investigators have disclosed no relevant financial relationships.
13th World Congress of Biological Psychiatry. Abstract 1011, presented June 21, 2017.
Medscape Medical News © 2017
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