Use of Nalmefene in Routine Practice: Results from a French Prospective Cohort Study and a National Database Analysis. (10th May 2021)

• Record Type: Journal Article
• Authors: Aubin, Henri-Jean; Dureau-Pournin, Caroline; Falissard, Bruno; Paille, François; Rigaud, Alain; Micon, Sophie; Pénichon, Marine; Andersohn, Frank; Truchi, Christine; Blin, Patrick
• Is Part Of: Alcohol and alcoholism. Volume 56:Number 5(2021)
• Page Start: 545
• Page End: 555
• Publication Date: 2021-05-10
• Subjects: Alcoholism -- Periodicals; 616.861005
• DOI: 10.1093/alcalc/agab029
• Languages: English
• ISSNs: 0735-0414

Abstract

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. Abstract : Short Summary: Two studies were used to evaluate how nalmefene is used in the management of alcohol dependence in France. After 1 year, new nalmefene users had substantially reduced alcohol consumption. Insurance data confirmed external validity of the population sample and the observation that patients often discontinue treatment over 1 year.