PATTERN OF USE AND SAFETY PROFILE OF BRANDED VS GENERIC ANTIEPILEPTIC DRUGS

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 data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N03) ANTIEPILEPTICS

Population studied

• Short description of the study population:
  The source population corresponds to all subjects active into the database at January the 1, 2015 and that, at this date, had at least 365 days of look-back period. Within such population, all subjects with ≥1 prescription of any AEDs (ATC: N03*) will be identified. For each subject, the first AED prescription (ATC: N03*) in the study period will be considered as the index prescription, and its date will be considered as the index date. ; Subjects prescribed with AEDs in the 12 months before the index date (look-back period) will be excluded. In addition, we will exclude all subjects with active neoplasia or with history of neoplasia, identified as presence of prescription records and/or hospitalizations related to neoplasia during the look-back (i.e. use of antineoplastic drug (ATC: L01*), and/or hospital discharge records with a diagnosis of neoplasia (ICD-9-CM codes: 140*-208*; 230*-239*) in primary or secondary diagnosis field).
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  30000

Study design details

• Main study objective:
  - describe the therapeutic pattern of generic vs branded antiepileptics (AEDs). - assess the risk profile of generic vs branded AEDs . -to describe the most frequent AEDs- related ADRs among users of generic vs branded AEDs.
• Outcomes:
  All hospitalization and/or access to ED occurring during follow-up. All hospitalization and/or access to ED occurring during follow-up with a diagnosis of possible AEDs-related ADRs in primary or secondary diagnosis field.
• Data analysis plan:
  - Descriptive analysis will be used to describe the most frequently prescribed active principles and exposure classes, proportions of switching, and the most frequent AEDs- related ADRs. - Propensity Score (PS) calculation: we will use PS matching to balance the baseline characteristics between subjects treated with brand vs generic AEDs. PS will be calculated on demographic, socio-economic and clinical variables, using the Stata routine PSmatch2 to perform nearest number matching with a caliper of 0.2. of the SD of PS. - Statistical analysis: Adjusted Cox regression models will be fitted to estimate the risk of hospitalization and/or access to ED for any cause and for AEDs-related ADRs among subjects exposed to generic vs branded AEDs. Analysis will be stratified according to different ATC codes.

Documents

Study, other information

EUPAS24224_publication