Relative Risks for Non-fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction in Users of ORTHO EVRA(Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared to Levonorgestrel-containing Oral Contraceptives.
Condition: Contraception; Female Contraception; Fertility Control
MeSH terms: Ischemic Stroke; Myocardial Infarction; Thromboembolism; Venous Thromboembolism; Infarction
Study type: Observational

Summary: 
      This study uses the PharMetrics and MarketScan US health care insurance claims database to
      estimate relative risks for non-fatal venous thromboembolism (including cerebral venous sinus
      thrombosis), ischemic stroke, and acute myocardial infarction (heart attack), in current
      users of ORTHO EVRA (norelgestromin and ethinyl estradiol contraceptive patch) compared to
      current users of oral levonorgestrel-containing oral contraceptives with 30 micrograms
      ethinyl estradiol, with special attention to duration of use.
    

Detailed description: 
      This observational, retrospective study uses the PharMetrics and MarketScan US health care
      claim insurance database to assess the occurrence of venous thromboembolism (including
      cerebral venous sinus thrombosis), ischemic stroke, and acute myocardial infarction in
      current users of ORTHO EVRA (norelgestromin and ethinyl estradiol transdermal contraceptive
      patch) compared to current users of levonorgestrel-containing oral contraceptives with 30
      micrograms ethinyl estradiol, with special attention to duration of use. PharMetrics is a
      United States based, ongoing longitudinal database with information on around 55 million
      covered lives going back as far as 1995. It is made up of data contributed by managed care
      plans throughout the United States and it contains information on paid claims for
      pharmaceuticals, medical diagnoses and procedures as well as demographic information on all
      subjects. There will be 3 sets of cases reflecting women who have a first-time recorded claim
      for an ICD-9 diagnosis of the following during the study period: (1) deep vein thrombosis
      (blood clot), pulmonary embolism, or cerebral venous sinus thrombosis, venous thrombotic
      event (VTE) with hospitalization, a visit to the emergency room or positive indication of VTE
      from diagnostic test results, at any time during the study period and who had subsequent
      multiple claims for anticoagulant treatment. The requirement for multiple prescriptions for
      anticoagulation therapy was used to provide evidence that the original diagnosis of VTE was
      confirmed. (2) ischemic stroke and who were hospitalized, or (3) acute myocardial infarction
      (heart attack) or acute coronary revascularization and who were hospitalized. Three separate
      sets of controls will be identified for each outcome. Planned analysis will estimate the
      relative risk of idiopathic (unknown cause) ischemic stroke or myocardial infarction, and
      another analysis will estimate the relative risk of idiopathic VTE. Conditional logistic
      regression will be used. Analyses will be stratified by calendar year. The analyses will be
      repeated including non-idiopathic cases of VTE, ischemic stroke, and acute myocardial
      infarction. Each transdermal patch containing 6 milligrams norelgestromin and 0.75 milligram
      ethinyl estradiol is worn for 1 week for 3 consecutive weeks; the fourth week is patch-free.
      Triphasic levonorgestrel-containing oral contraceptives with 30 micrograms ethinyl estradiol
      is taken for 21 consecutive days followed by no pill or an inert pill for 7 days. Duration of
      use can vary. NOTE: The study was conducted in two parts. This study, CR014383, represents
      the first portion of the study. Study CR012022, NCT00377988, represents the second portion of
      the extended study.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        PharmaMetrics and MarketScan US health care claims database identified women 15-44 who were
        users of ORTHO EVRA or first time users of levonorgestrel-containing oral contraceptive
        with 30 micrograms ethinyl estradiol between April 1, 2002 and March 31, 2006
      
Keywords: Contraception; Hormonal contraception; Oral contraception; Ethinyl estradiol, Levonorgestrel, Contraception; Transdermal; Venous thromboembolism; Norelgestromin