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Meta-analysis shows limited efficacy of nalmefene for alcohol addiction

A recently published meta-analysis suggests limited efficacy of nalmefene for the treatment of alcohol addiction

“Nalmefene, an opioid antagonist, was recently approved by the European Medicines Agency for the treatment of alcohol dependence in order to help reduce alcohol consumption in adults who consume more than 60 g of alcohol per day (for men) or more than 40 g per day (for women),” the researchers wrote. “The [United Kingdom] National Institute for Health and Care Excellence (NICE) initially recommended it as a ‘possible’ treatment for alcohol dependence, but, subsequently, the NICE evidence review group distanced itself from its earlier advice. The French National Authority for Health Transparency Committee was also cautious and considered that nalmefene provided a minor improvement in actual benefit compared to psychosocial support alone in the treatment of alcohol dependence.”

To compare harms and benefits of nalmefene vs. placebo or active comparator, researchers conducted a systematic review and meta-analysis of double-blind, randomized controlled trials evaluating nalmefene for adult alcohol dependence. Five trials with a total of 2,567 participants were included in the analysis.

Mortality at 6 months and quality of life at 6 months did not differ between treatment groups, according to researchers.

Other health outcomes were not reported.

Monthly number of heavy drinking days at 6 months and 1 year and total alcohol consumption at 6 months differed between treatment groups, with nalmefene demonstrating slight superiority.

There were more study withdrawals, including more withdrawals for safety reasons, at 6 months and 1 year among the nalmefene group.

Sensitivity analyses showed no differences in alcohol consumption outcomes between treatment groups.

“This review calls into question the decisions of some of the regulatory and advisory bodies that have approved nalmefene on the basis of this evidence. Given our results, certain conditions should be set by health authorities for the maintenance of nalmefene market approval. In our opinion, [randomized controlled trials] against placebo and naltrexone proving the superiority of nalmefene in the approved indication are needed,” the researchers wrote. “Clinicians must be aware that the value of nalmefene for the treatment of alcohol addiction is not established. At best, nalmefene has limited efficacy in reducing alcohol consumption.” – by Amanda Oldt

Disclosure: Palpacuer reports no relevant financial disclosures. Please see the full study for a list of all authors’ relevant financial disclosures.