DARWIN EU® Drug utilisation of valproate-containing medicinal products in women of childbearing potential

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  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:
  SODIUM VALPROATE

  VALPROATE MAGNESIUM

  VALPROATE SEMISODIUM

  VALPROIC ACID

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

  valproic acid

  (N03AG02) valpromide

  valpromide

Population studied

• Short description of the study population:
  The study included women aged 12-55 years old using vaproic acid/valproate-containing medicines between January 2010 and December 2021, with at least 365 days of prior history. The study also included new users with at least 365 days of visibility prior to their first VPA prescription and no previous VPA use.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women

  Women of childbearing potential using contraception
• Estimated number of subjects:
  20000

Study design details

• Main study objective:
  1.To characterise the prevalence and incidence of use of valproate, valproate containing medicines, and alternative antiepileptic therapies among women aged 12-55 years of age, stratified by calendar year and age; 2.To characterise the use of valproic acid or valproate containing medicines
• Outcomes:
  1) Prevalence and incidence of valproate-containing medication and alternative treatments. ; 2) Patient-level drug utilisation
• Data analysis plan:
  The study will be carried out as a Federated Network Analysis Project. All analyses will be conducted separately for each database. The data partners locally execute the analytics and review and approve the by default aggregated results before returning them to the DARWIN EU Coordination Centre. For all analyses a minimum cell count of 5 will be used when reporting results, with any smaller counts obscured. Population level cohort study: Annual prevalence of valproate use and alternative treatments will be estimated, as will annual incidence rates per 100,000 person years. New user cohort study: Large-scale patient-level characterisation will be conducted. Index date will be the date of the first VPA prescription for each person.