Use of Nalmefene (Selincro) in the UK: Cohort design using longitudinal electronic medical records (EMR)

Date of Approval: 
2016-07-20 00:00:00
Lay Summary: 
Selincro (Nalmefene) is a medication indicated for the reduction of alcohol consumption in patients with alcohol dependence. It was commercialized in May 2013 in the UK. During the regulatory review process that led to the marketing authorization, additional studies were proposed to assess the real-life use of the drug. The main objective of these studies is to provide missing important information, such as the use in patients groups not represented in the previous clinical trials or long-term use. We proposed first, to investigate utilisation of Selincro and frequency of side effects, in routine clinical practice within 11 European countries by collecting patients' characteristics through their physicians. To complement this approach, European healthcare databases analyses were also proposed to describe drug utilisation patterns. These analyses will be conducted in 3 European countries including the UK, in which, the analysis of routinely collected health information will be done using the Clinical Practice Research Datalink (CPRD GOLD). The study findings will complement the knowledge about the right use and the safety of Selincro.
Technical Summary: 
The primary study objective is to describe the proportion of pre-defined sub-populations of interest in the overall population of patients initiating Selincro. The secondary objectives are to describe the proportion of patients treated with Selincro for more than one year, the percentage of patients with a number of Selincro prescriptions exceeding the daily intake (overdose), the percentage of women who are pregnant during the course of Selincro treatment, and the percentage of patients who are outside the licensed indication (off-label use) at the time of Selincro initiation. This study is an historical cohort using Clinical Practice Research Datalink (CPRD) GOLD, an Electronic Medical Record database held by a network of general practitioners (GPs). Patients with a first prescription record of Selincro between May 2013 and June 2016 are included. The study period for each patient will be 18 months. This analysis is purely descriptive and no statistical test will be performed. Missing values will be displayed when appropriate.
Health Outcomes to be Measured: 
Demographic and clinical characteristics including psychiatric disorders and somatic comorbidities.
Application Number: 

Lianna Ishihara - Chief Investigator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Celine Darricarrere - Corresponding Applicant - Lundbeck Limited
Celine Quelen - Collaborator - Creativ-Ceutical
Didier Meulien - Collaborator - Lundbeck Limited
Florence COSTE - Collaborator - Sanofi-aventis Recherche & Developpeme
Florence TUBACH - Collaborator - Paris Diderot University
Francoise Diamand - Collaborator - Not from an Organisation
Gitte Dyhr - Collaborator - Lundbeck Limited
Loan Honeywell - Collaborator - Lundbeck Limited
Per Sorensen - Collaborator - Lundbeck Limited
Sylvie Guillo - Collaborator - Hopital Bichat

HES Admitted Patient Care;ONS Death Registration Data