Use of Nalmefene in Routine Practice: Results from a French Prospective Cohort Study and a National Database Analysis

Alcohol Alcohol. 2021 Aug 30;56(5):545-555. doi: 10.1093/alcalc/agab029.

Abstract

Aims: Two complementary studies were used to assess the real-life use of nalmefene in alcohol-dependent patients and its impact on alcohol use health status.

Methods: USE-PACT was a prospective cohort study designed to evaluate the real-life effectiveness of nalmefene in the management of alcohol dependence, as assessed by total alcohol consumption (TAC) and number of heavy drinking days (HDD) at 1 year. USE-AM was a cohort study using data from the French nationwide claims database and was used to evaluate the external validity of the population in the prospective study.

Results: Overall, 256 of 700 new nalmefene users enrolled in the USE-PACT study had valid data at 1 year. After 1 year, patients treated with nalmefene showed a mean ± SD reduction from baseline in TAC (-41.5 ± 57.4 g/day) and number of HDD (-10.7 ± 11.7 days/4 weeks). Patients took a mean ± SD of 20.0 ± 12.0 tablets/4 weeks (median of 1 tablet/day) for the first 3 months and then reduced the dose. The proportion of patients who no longer took nalmefene gradually increased from 5% at 1 month to 52% at 1 year. The USE-AM study identified 486 patients with a first reimbursement for nalmefene in 2016; baseline characteristics confirmed external validity of the USE-PACT study. Overall, 46.3% of initial USE-AM prescriptions were made by GPs; most (91.8%) patients stopped treatment during follow-up. However, 15.2% of patients resumed treatment after stopping.

Conclusions: In this analysis of French routine practice, patients with alcohol dependence treated with nalmefene showed reduced alcohol consumption, and nalmefene was generally well tolerated.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Alcoholism / drug therapy*
  • Female
  • Humans
  • Insurance Claim Review
  • Male
  • Middle Aged
  • Naltrexone / analogs & derivatives*
  • Naltrexone / therapeutic use
  • Narcotic Antagonists / therapeutic use*
  • Prospective Studies
  • Treatment Outcome
  • Young Adult

Substances

  • Narcotic Antagonists
  • Naltrexone
  • nalmefene

Grant support