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Drospirenone-containing combined oral contraceptives and the risk of arterial thrombosis: a population-based nested case-control study.

Authors: Larivée N ,Suissa S ,Eberg M, Joseph L, Eisenberg MJ, Abenhaim HA, Filion KB.
Publication date: 20170130
Journal: BJOG. 2016 Oct 5. doi: 10.1111/1471-0528.14358. [Epub ahead of print]
DOI: 10.1111/1471-0528.14358.

OBJECTIVE:

To compare the rate of arterial thromboembolism (ATE) of drospirenone-containing COCs to that of levonorgestrel-containing COCs.

DESIGN:

Population-based cohort study.

SETTING:

United Kingdom’s Clinical Practice Research Datalink (CPRD), which contains clinical records for >11 million patients.

POPULATION:

Women aged 16-45 years prescribed a drospirenone- or levonorgestrel-containing COC between May 2002 and June 2012.

METHODS:

We conducted nested case-control analyses using risk set sampling to randomly select up to 10 controls for each ATE case, matched on age, cohort entry year, CPRD registration year, COC user type (first-time ever, new, switcher, or prevalent users), duration of COC use, duration of progestin-only or implantable contraceptive use, pre-cohort entry duration of drospirenone and levonorgestrel use, and duration of follow up.

MAIN OUTCOME MEASURES:

We used conditional logistic regression to estimate hazard ratios and 95% confidence intervals (CIs), adjusted for high￾dimensional propensity scores.

RESULTS:

Our cohort included 339 743 women followed over a mean 4.4 years, during which 228 ATE cases occurred: 37 myocardial infarctions, 170 strokes, and 21 other ATEs; overall rate: 1.5 events per 10 000 person-years (PYs). After adjusting for potential confounders, the hazard ratio for ATE with current use of drospirenone-containing COCs versus current use of levonorgestrel￾containing COCs was 0.89 (95% CI 0.35, 2.28), corresponding to a rate difference of -0.16 events per 10 000 PYs. CONCLUSIONS: The overall rate of ATE in this population is low regardless of which COC was taken. We found little evidence of a difference in the rate of ATE with drospirenone- versus levonorgestrel-containing COCs.

TWEETABLE ABSTRACT:

Little evidence was found of a greater incidence of arterial thrombosis with drospirenone versus levonorgestrel contraceptives

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