Safety and Persistence of Nalmefene Treatment for Alcohol Dependence. Results from Two Post-authorisation Safety Studies.

ABSTRACT:

Aims

Two post-authorisation studies assessed the safety and persistence of patients' use of nalmefene.

Methods

The START study (EUPAS5678) was a non-interventional, multi-country, prospective, 18-month (8 follow-up visits) cohort study including outpatients initiating nalmefene for the first time. The multi-database retrospective cohort study (MDRC, EUPAS14083) included baseline and follow-up data from German, Swedish and UK healthcare databases. Both studies permitted 'all comers' without explicit exclusion criteria; predefined subgroups of interest included the elderly (≥65 years) as well as patients with significant psychiatric and/or somatic comorbidities.

Results

START study: Overall, the mean duration of nalmefene treatment was 10.3 ± 7.3 months (N = 1348), with

SUBMITTER: Chick J 

PROVIDER: S-EPMC8406067 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature