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.
Keywords
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Article info
Publication history
Published online: February 26, 2007
Accepted:
December 26,
2006
Received in revised form:
December 18,
2006
Received:
November 14,
2006
Identification
Copyright
© 2007 Elsevier Inc. Published by Elsevier Inc. All rights reserved.