Long-term safety and efficacy of nalmefene in Japanese patients with alcohol dependence.

Abstract

AIM:

The safety and efficacy of nalmefene in Japanese patients with high or very high World Health Organization drinking risk level of alcohol dependence were assessed in a multicenter, randomized, double-blind, placebo-controlled, phase 3 (lead-in) study. Here, the long-term safety and efficacy of nalmefene in an open-label extension of the lead-in study are presented.

METHODS:

Patients who completed the 24-week lead-in study were eligible for the extension study, where they were treated with nalmefene 20 mg as needed for 24 weeks. The long-term safety and efficacy of nalmefene 20 mg during the total 48-week period were evaluated. Treatment-emergent adverse events during the study period were recorded and change from baseline in the number of heavy drinking days and total alcohol consumption were calculated.

RESULTS:

Overall, long-term nalmefene 20 mg was well tolerated; the main treatment-emergent adverse events reported in ≥5% of patients included nasopharyngitis (37.2%), nausea (36.5%), somnolence (21.2%), dizziness (16.8%), malaise (14.6%), and vomiting (12.4%). The number of heavy drinking days and total alcohol consumption decreased from baseline to 48 weeks (mixed model for repeated measures, least squares mean ± standard error, -15.09 ± 0.77 days/month and -53.20 ± 2.29 g/day, respectively) during the study.

CONCLUSION:

This long-term evaluation in Japanese patients with high or very high drinking risk levels of alcohol dependence indicated that nalmefene was safe, well tolerated, and efficacious.

• Authors: Susumu Higuchi, Masayoshi Takahashi, Yoshiyuki Murai, Kana Tsuneyoshi, Izuru Nakamura, Didier Meulien, Hisatsugu Miyata
• Journal: Psychiatry and clinical neurosciences (Psychiatry Clin Neurosci) Vol. 74 Issue 8 Pg. 431-438 (Aug 2020) ISSN: 1440-1819 [Electronic] Australia
• PMID: 32359104 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2020 The Authors Psychiatry and Clinical Neurosciences published by John Wiley & Sons Australia, Ltd on behalf of Japanese Society of Psychiatry and Neurology.

Chemical References

• Narcotic Antagonists
• Naltrexone
• nalmefene

Topics

• Adult
• Alcohol Drinking (drug therapy)
• Alcoholism (drug therapy)
• Double-Blind Method
• Female
• Humans
• Japan
• Male
• Middle Aged
• Naltrexone (administration & dosage, adverse effects, analogs & derivatives, pharmacology)
• Narcotic Antagonists (administration & dosage, adverse effects, pharmacology)
• Outcome Assessment, Health Care
• Time Factors