A Drug Utilisation Study extension (DUS ext.) of valproate and related substances, in Europe, using databases (VALNAC09343)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  VALPROIC ACID

  VALPROMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (N03AG01) valproic acid

  valproic acid

  (N03AG02) valpromide

  valpromide
• Medical condition to be studied:
  Epilepsy

  Bipolar disorder

  Pregnancy

Population studied

• Short description of the study population:
  The study population included WCBP (i.e. 13–49 years old women), receiving at least one valproate prescription or dispensation during the pre-implementation period and post-implementation period.
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  2304

Study design details

• Study design:
  This DUS ext. was a non-interventional longitudinal retrospective cohort study of WCBP exposed to valproate
• Main study objective:
  The primary objective is mentioned in study summary due to lack of space here. The aim of this study is to describe the prescribing practices before and after the dissemination of the new risk minimization measures (RMMs) (planned over Q2 2018 - Q4 2018, depending on approval by National Competent Authorities) in Europe and to assess the effectiveness of these measures.
• Setting:
  electronic medical records or administrative healthcare databases in France, Germany, the Netherlands, Spain, Sweden, and the United Kingdom (UK).
• Data analysis plan:
  Given the study objectives the analyses will be mainly descriptive and will be conducted by country, database, and study time periods (both pre-implementation periods and post-implementation period). Categorical variables will be presented as counts (n), proportions (%) with confidence interval (CI) where relevant. Continuous variables will be presented as means with standard deviation (SD) and as medians with interquartile range (IQR), where appropriate. The main analyses will compare the prescribing practices in WCBP receiving valproate during the pre- and post-implementation periods with respect to key elements of the PPP and will compare the incidence of valproate exposed pregnancies, and characteristics of exposed pregnancies during the same periods to meet the primary study objective.