The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation.
OBJECTIVE
The study was conducted to compare risks of adverse cardiovascular and other events associated with the use of drospirenone (DRSP)-containing oral contraceptives (OCs) and other OCs.


METHODS
The European Active Surveillance study (EURAS) was a multinational, prospective, noninterventional cohort study of new users of DRSP, levonorgestrel (LNG) and other progestin-containing OCs. Semiannual follow-up was based on mailed questionnaires, with additional follow-up procedures when needed.


RESULTS
Overall, 58,674 women were followed for 142,475 women-years of observation. Loss to follow-up was 2.4%. Serious adverse and fatal events were rare, and rate ratios were close to unity (1.0). Cox regression analysis of cardiovascular outcomes yielded hazard ratios for DRSP-containing vs. LNG-containing and other OCs of 1.0 and 0.8 (upper 95% confidence limits, 1.8 and 1.3) for venous, and 0.3 and 0.3 (upper 95% confidence limits, 1.2 and 1.5) for arterial thromboembolism, respectively.


CONCLUSIONS
Risks of adverse cardiovascular and other serious events in users of a DRSP-containing OC are similar to those associated with the use of other OCs.
Dinger
Jürgen C
JC
Center for Epidemiology and Health Research (ZEG), 10115 Berlin, Germany. dinger@zeg-berlin.de
Heinemann
Lothar A J
LA
Kühl-Habich
Dörthe
D
D000328:Adult; D000736:Androstenes / Q000009:adverse effects*; D001145:Arrhythmias, Cardiac / Q000209:etiology; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects*; D005260:Female; D006801:Humans; D000451:Mineralocorticoid Receptor Antagonists / Q000009:adverse effects*; D009026:Mortality; D013923:Thromboembolism / Q000209:etiology
D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D000451:Mineralocorticoid Receptor Antagonists; C035144:drospirenone