Use of Nalmefene (Selincro®) in European databases: Cohort design using longitudinal electronic medical records or claims databases

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Alcohol use

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  The primary objective of the database analysis is to describe the use of Selincro® in clinical practice, particularly in different sub-populations.
• Outcomes:
  age, gender,pregnancy, proportion of patients with increased (>3xULN) ALAT or ASAT, proportion of patients with psychiatric or somatic comorbidity, proportion of patients with history of seizure, the proportion of patients with concurrent prescription of CNS active medication, The use of Selincro® over more than one year and the occurrence of overdose.The use of Selincro® in patients outside the indication defined in the SmPC.
• Data analysis plan:
  In this non comparative study, only descriptive statistics will be used. Consequently, all variables will be summarised using descriptive techniques: summary statistics (mean, standard deviation, median, inter-quartile range, minimum and maximum values) will be presented for continuous variables, and countsand percentages will be presented for categorical and binary variables. Missing values will be displayed.