Utilisation of antiepileptic medicines in girls and women of childbearing potential - a study in three European countries

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

• Anatomical Therapeutic Chemical (ATC) code:
  (N03A) ANTIEPILEPTICS

  ANTIEPILEPTICS

Population studied

• Short description of the study population:
  All females aged between 10 and 50 years during the study period in each of the databases. In order to be eligible, females must have contributed a minimum of 365 days to the database. The cohort entry date will be the latest of the date when they joined the database + 365 days, the date of their 10th birthday or 1-Jan-2007. The cohort exit date will be the earliest of the date they left the database, the date of their 51st birthday or 31-Dec-2016.
• 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:
  5439534

Study design details

• Main study objective:
  To characterise the prescription patterns of antiepileptic drugs (AEDs) in girls and women of childbearing potential between January 2007 and December 2016, using electronic healthcare data from the United Kingdom (UK), France and Italy.
• Data analysis plan:
  The prevalence of AED prescribing (overall and for specific AEDs) will be calculated per 1,000 female population with 95% confidence intervals (CI95). This will be calculated stratified by calendar year, age at prescription and indication for prescribing. The incidence of AED prescribing (new users) (overall and for specific AEDs) will be calculated per 10,000 person-years with CI95 stratified by calendar year, age at prescription and indication for prescribingThe prevalence of AED prescribing will be calculated during the 6 months before pregnancy (broken into 3-month time periods) and during each of the pregnancy trimesters. The prevalence of prescribing will be calculated stratified by pregnancy outcome, calendar year at pregnancy start and indication for prescribingThe percentage of women prescribed AEDs who initiate a switch in treatment will be calculated (overall and for each specific AED) stratified by calendar year, age at first switch and indication for prescribing.