title: Drospirenone plus estradiol and the risk of serious cardiovascular events in postmenopausal women.
abstract: OBJECTIVE
  To compare incidence rates of serious cardiovascular events, particularly arterial thromboembolic events (ATE), in users of hormone replacement therapy (HRT), particularly oral continuous combined preparations.
  
  
  METHODS
  Prospective, controlled cohort study with four arms: women using (1) drospirenone (DRSP)/estradiol, (2) other oral continuous combined HRT (HRTcc), (3) all other oral HRTs, and (4) non-oral HRT. The study population consisted of women aged 40+ years in seven European countries who were new users of HRT at the time of inclusion. All patient-reported outcomes of interest were validated by the treating physicians. A multifaceted, four-level follow-up procedure ensured low loss to follow-up rates. The final analysis is based on Cox regression models comparing the cohorts.
  
  
  RESULTS
  In total, 30 597 women were recruited by 1052 study centers. Follow-up reflects 101 715 woman-years of observation. Loss to follow-up was about 2.8%. Risk estimates for general serious adverse events were similar for all cohorts. Incidence rates for serious cardiovascular events were 98.4 (DRSP/estradiol) and 169.7 (HRTcc) per 10 000 woman-years. The corresponding incidence rates for ATE were 10.9 and 29.7 events per 10 000 woman-years with an adjusted hazard ratio of 0.5 (95% confidence interval 0.3-0.8). The initiation rate for antihypertensive treatment after start of HRT was substantially lower for women using DRSP/estradiol compared to the other cohorts.
  
  
  CONCLUSIONS
  DRSP/estradiol is associated with general health risks similar to other oral and non-oral HRT but is probably associated with lower ATE risk.
  
  
  BACKGROUND
  NCT00214903, US National Library of Medicine.
authors.affiliation: a Pharmacoepidemiology Berlin , Berlin , Germany ;
authors.forename: J
authors.initials: J
authors.lastname: Dinger
authors.affiliation: b ZEG, Berlin Center for Epidemiology and Health Research , Berlin , Germany.
authors.forename: K
authors.initials: K
authors.lastname: Bardenheuer
authors.affiliation: b ZEG, Berlin Center for Epidemiology and Health Research , Berlin , Germany.
authors.forename: K
authors.initials: K
authors.lastname: Heinemann
mesh_terms: D000736:Androstenes / Q000008:administration & dosage / Q000009:adverse effects*; D000959:Antihypertensive Agents / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000453:epidemiology; D004359:Drug Therapy, Combination; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects*; D015914:Estrogen Replacement Therapy / Q000009:adverse effects* / Q000379:methods; D004967:Estrogens / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage / Q000009:adverse effects*; D017698:Postmenopause / Q000187:drug effects; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012044:Regression Analysis; D012307:Risk Factors; D016037:Single-Blind Method; D013923:Thromboembolism / Q000139:chemically induced
chemical_list: D000736:Androstenes; D000959:Antihypertensive Agents; D004967:Estrogens; D000451:Mineralocorticoid Receptor Antagonists; D004958:Estradiol; C035144:drospirenone
keywords: HRT; arterial thromboembolic events; drospirenone; serious cardiovascular events; venous thromoembolism