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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

Dinger JC et al., 2007

Contraception, 75(5), 344-354

DOI 10.1016/j.contraception.2006.12.019 PMID 17434015 Source

Abstract

Objectives

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.

Topics

Contraception/Comparison > Side Effects > Hormonal ContraceptionContraception/Comparison > Effectiveness > Typical Use
drospirenone oral contraceptive safety, birth control pill cardiovascular risks, venous thromboembolism oral contraceptives, drospirenone versus levonorgestrel safety, oral contraceptive blood clot risk, hormonal contraception adverse events, contraceptive pill thromboembolism rates, oral contraceptive surveillance study, drospirenone arterial thromboembolism, birth control pill mortality risk

Cite this article

Dinger, J., Heinemann, L., & 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

Keywords

Adult, Androstenes, Arrhythmias, Cardiac, Contraceptives, Oral, Combined, Female, Humans, Mineralocorticoid Receptor Antagonists, Mortality, Thromboembolism

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