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

Date of Approval
Application Number
16_139
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.

Collaborators

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 & Développement
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

Linkages

HES Admitted Patient Care;ONS Death Registration Data