Characterizing Repatha use among adult pregnant women, adult women of childbearing age and within the adult general population (NA)

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

• Name of medicine:
  REPATHA
• Anatomical Therapeutic Chemical (ATC) code:
  (C10AX13) evolocumab

  evolocumab

Population studied

• Short description of the study population:
  We will identify three cohorts of patients. The first is a cohort of adult (>16 years of age) pregnant women. The second is a cohort of adult women of childbearing age (ages 16-54 years). The third is a cohort of adults in the general population.; Inclusion Criteria:; ; Pregnant Women Cohort; 1. Female; 2. 16 years of age or older (as of August 27, 2015 or July 17, 2015); 3. Have at least one birth (live or non-live) claim during the study period (August 27, 2015 or July 17, 2015 until the end of available data); 4. Have continuous medical and pharmacy health insurance coverage during the 480 days (includes up to 300 pregnancy days + 180 days prior to the estimated date of conception) prior to the birth claim, with an allowable 45-day gap in coverage. ; ; Women of Childbearing Age Cohort; 1. Female; 2. 16 to 54 years of age (as of August 27, 2015 or July 17, 2015); ; General Population Cohort; 1. 16 years of age or older (as of August 27, 2015 or July 17, 2015)
• Age groups:
  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:
  Pregnant women

  Women of childbearing potential not using contraception

  Women of childbearing potential using contraception
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  Characterizing Repatha use among adult pregnant women, adult women of childbearing age and within the adult general population
• Data analysis plan:
  To estimate the number of exposures, duration of each exposure(s) and frequency of dosing of Repatha among pregnant women, women of childbearing age and in the general population. Among those exposed to Repatha, we will further characterize these patients by age, calendar year of exposure(s), history of ASCVD (yes/no), gender (for the general population only) and by trimester of exposure(s) (for the pregnant women cohort only).

Documents

Study results

20190050 ORSR Abstract_FINAL_2