A Joint Drug Utilisation Study (DUS) of valproate and related substances, in Europe, using databases

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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 SEMISODIUM

  VALPROMIDE

  VALPROIC ACID
• Medical condition to be studied:
  Pregnancy

  Contraception

Population studied

• Short description of the study population:
  All female patients receiving valproate prescriptions during the predefined pre- and post- implementation periods in the selected databases of target countries.
• 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:
  30000

Study design details

• Main study objective:
  The primary study objective is to describe prescribing patterns in the outpatient setting during the pre- and post-implementation periods, with the description of:- Demographic characteristics of female users of valproate in oral form.- Valproate treatment characteristics, medical history prior to valproate initiation, prior and concomitant medications with valproate related to the indication
• Outcomes:
  The assessment of the effectiveness of the risk minimisation measures in the outpatient setting will take into account the number of patients with at least one medication used prior the valproate initiation and related to the valproate indication (epilepsy, bipolar troubles, migraine headaches and other) within 12 months before the index date. To describe the prescribing practices of valproate before and after the dissemination of risk minimisation measures in the outpatient setting, the following parameters will be considered:- Demographic characteristics of initiated valproate users:o Age of included patients- Medical history related to valproate initiation up to 2 years before the index date (epilepsy, bipolar troubles, ...
• Data analysis plan:
  The main analysis will compare the prescribing patterns of valproate during the pre- and post- implementation periods in females and in the outpatient settings, to meet the primary study objective. The analysis will be descriptive in nature. Descriptive statistics will be provided for the patients, treatments and diagnosis characteristics. Categorical variables will be presented as counts (n), proportions (%) and confidence interval (CI) when relevant . Continuous variables will be presented as means with standard deviation (SD) and as medians with inter quartile range (IQR) as appropriate.Results will be displayed by period before and after the implementation of RMMs, and by country. The main periods in the pre- and post-implementation periods will be considered as primary analysis and the transition periods will be considered for sensitivity analysis.