Abstract
Objectives
The “Long-term Active Surveillance Study for Oral Contraceptives” investigated the
risks of long-term use of a 21-day regimen of drospirenone and ethinylestradiol (DRSP)
compared to established oral contraceptives (OCs) in a routine clinical setting.
Study design
Prospective, controlled, non-interventional cohort study conducted in seven European
countries with three main exposure groups: new users of DRSP, levonorgestrel-containing
OCs (LNG), and OCs containing other progestogens (Other OCs). All self-reported clinical
outcomes of interest (OoI) were validated via attending physicians and relevant source
documents. Main OoI were serious clinical outcomes, in particular cardiovascular events.
Comprehensive follow-up procedures were implemented. Statistical analyses were based
on Cox regression models.
Results
A total of 1,113 study centers enrolled 59,510 women. Overall 28%, 26% and 45% of
these women used DRSP, LNG and Other OCs, respectively. Study participants were followed
for up to ten years (mean value, 5.4 years), which generated 318,784 woman-years (WY) of observation. Low loss to follow-up
and drop-out rates of 2.9% and 16.8% were achieved. DRSP, LNG, and Other OCs showed
similar incidence rates of venous thromboembolism. Corresponding hazard ratios (HRs)
were close to unity. For arterial thromboembolic events (ATE) and initiation of antihypertensive
treatment statistically significant lower risks were found for DRSP compared to LNG
and Other OCs.
Conclusion
DRSP use was associated with similar general health risks and a low risk of ATE compared
to OCs containing other progestogens.
Implication statement
The 21-day regimen of drospirenone-containing combined oral contraceptives is associated
with similar risk of VTE compared to other combined oral contraceptives as well as
potentially with a lower risk of ATE.
Keywords
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Article info
Publication history
Published online: January 26, 2016
Accepted:
January 23,
2016
Received in revised form:
January 20,
2016
Received:
February 4,
2015
Footnotes
☆Funding: Unconditional grant from Bayer AG, Germany.
☆Conflict of Interest: The study was funded by a manufacturer of hormonal contraceptives. The study was supervised by an independent Safety Monitoring and Advisory Council with full authority over the study (including study protocol, protocol amendments, data analysis, and stopping the study). The funder had no access to the source data and did not participate in designing the study or analyzing the data.
☆Registration Number at the clinical trials registry of the US National Library of Medicine: NCT00676065 (Please note: This is not a clinical trial.)
Identification
Copyright
© 2016 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
