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

Niamh Fitzgerald, Kathryn Angus, Andrew Elders, Marisa de Andrade, Duncan Raistrick, Jim McCambridge, Nick Heather

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Abstract

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. 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.
Original languageEnglish
Pages (from-to)1477–1487
Number of pages11
JournalAddiction
Volume111
Issue number8
Early online date5 Jun 2016
DOIs
Publication statusPublished - Jul 2016

Keywords

  • addiction
  • alcohol
  • brief intervention
  • nalmefene
  • trial regulation
  • vested interests

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