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
Jürgen C. Dinger, Lothar Heinemann, Dörthe Kühl-Habich
Center for Epidemiology and Health Research (ZEG), 10115 Berlin, Germany. dinger@zeg-berlin.de
Berlin Center for Epidemiology and Health ResearchROR
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 AND MATERIALS: 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.
PMID 17434015 17434015 DOI 10.1016/j.contraception.2006.12.019 10.1016/j.contraception.2006.12.019
Cite this article
Dinger, J. C., Heinemann, L. A. J., & Kühl-Habich, D. (2007). 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. *Contraception*, *75*(5), 344-354. https://doi.org/10.1016/j.contraception.2006.12.019
Dinger JC, Heinemann LAJ, Kühl-Habich D. 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. Contraception. 2007;75(5):344-354. doi:10.1016/j.contraception.2006.12.019
Dinger, J. C., et al. "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." *Contraception*, vol. 75, no. 5, 2007, pp. 344-354.
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