DARWIN EU® - Association of venous thromboembolism with non-steroidal anti-inflammatory drug use in women 15-49 years using hormonal contraceptives

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Anti-inflammatory and antirheumatic products, non-steroids (NSAIDS) Defined by all M01A group except M01AX05, M01AX12, M01AX25 and M01AX26
• Medical condition to be studied:
  Venous thrombosis

Population studied

• Short description of the study population:
  Objective 1: Drug utilisation of NSAIDs. ; The study population will be women aged 15-49 who initiate oral NSAIDs of ibuprofen, diclofenac and naproxen on or after 2014 while using hormonal contraceptives, defined using a 90-day washout window. We will require at least 365 days of data availability before NSAIDs use. ; Objective 2 and 3: Incidence of VTE; The source population will be women of reproductive age using hormonal contraceptives or therapies. ; We will not limited to medication with contraceptive as indication, but also medications as a combination of estrogen and progestin for other indications. ; For example, the DIANE®-35, which contains ethinylestradiol and cyproterone acetate, is a treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism in women of reproductive age, will be included in this study. ; The study population will include women aged 15-49, using hormonal contraceptives, and with no history of venous or arterial thromboembolism, cancer (except non-melanoma skin cancer), thrombophilia, hysterectomy, bilateral oophorectomy, sterilisation or infertility treatment. ;
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)

Study design details

• Study design:
  Drug/Vaccine Safety Studies; Patient-level DUS;
• Main study objective:
  1. To characterise the use of NSAIDs among women aged 15-49. ; 2. To measure the association of any NSAID use and the incidence of VTE among 15-49 years old women on high, medium, and low risk hormonal contraceptives.; 3. To measure the association of ibuprofen, diclofenac and naproxen use on the incidence of VTE among 15-49 years old women on high, medium, and low risk hormonal contraceptives.;