Use of Nalmefene in Routine Practice: Results from a French Prospective Cohort Study and a National Database Analysis
| Autor: | Bruno Falissard, François Paille, S. Micon, Henri-Jean Aubin, Patrick Blin, Caroline Dureau-Pournin, Alain Rigaud, Frank Andersohn, Christine Truchi, Marine Pénichon |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Narcotic Antagonists Population Routine practice Article External validity Insurance Claim Review Young Adult 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Humans AcademicSubjects/MED00860 Prospective Studies Medical prescription Prospective cohort study education Nalmefene Aged Aged 80 and over education.field_of_study business.industry Alcohol dependence General Medicine Middle Aged Naltrexone 030227 psychiatry Alcoholism Treatment Outcome Female Corrigendum business 030217 neurology & neurosurgery Cohort study medicine.drug |
| Zdroj: | Alcohol and Alcoholism (Oxford, Oxfordshire) |
| ISSN: | 1464-3502 0735-0414 |
| DOI: | 10.1093/alcalc/agab029 |
| Popis: | 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. 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|