Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers.

ABSTRACT:

Background and aims

Nalmefene has been approved in Europe for the treatment of alcohol dependence and subsequently recommended by the UK National Institute for Health and Care Excellence (NICE). This study examines critically the evidence base underpinning both decisions and the issues arising.

Methods

Published studies of nalmefene were identified through a systematic search, with documents from the European Medicines Agency, the NICE appraisal and public clinical trial registries also examined to identify methodological issues.

Results

Efficacy data used to support the licensing of nalmefene suffer from risk of bias due to lack of specification of a priori outcome measures and sensitivity analyses, use of post-hoc sample refinement and the use of inappropriate compa

SUBMITTER: Fitzgerald N 

PROVIDER: S-EPMC5089629 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature