Higher risk of venous thrombosis associated with drospirenone-containing oral contraceptives: A population-based cohort study

Gronich, N.; Lavi, I.; Rennert, G.

doi:10.1503/cmaj.110463

Cited by 135Venous Thromboembolism Diagnosis and ManagementReproductive Health and ContraceptionBlood Coagulation and Thrombosis Mechanisms

Higher risk of venous thrombosis associated with drospirenone-containing oral contraceptives: A population-based cohort study

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Gronich, N., Lavi, I., Rennert, G.·2011·Canadian Medical Association Journal

DOI 10.1503/cmaj.110463PMC PMC3255137

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Abstract

BACKGROUND: Combined oral contraceptives are a common method of contraception, but they carry a risk of venous and arterial thrombosis. We assessed whether use of drospirenone was associated with an increase in thrombotic risk relative to third-generation combined oral contraceptives. METHODS: Using computerized records of the largest health care provider in Israel, we identified all women aged 12 to 50 years for whom combined oral contraceptives had been dispensed between Jan. 1, 2002, and Dec. 31, 2008. We followed the cohort until 2009. We used Poisson regression models to estimate the crude and adjusted rate ratios for risk factors for venous thrombotic events (specifically deep vein thrombosis and pulmonary embolism) and arterial thromboic events (specifically transient ischemic attack and cerebrovascular accident). We performed multivariable analyses to compare types of contraceptives, with adjustment for the various risk factors. RESULTS: We identified a total of 1017 (0.24%) venous and arterial thrombotic events among 431,223 use episodes during 819 749 woman-years of follow-up (6.33 venous events and 6.10 arterial events per 10,000 woman-years). In a multivariable model, use of drospirenone carried an increased risk of venous thrombotic events, relative to both third-generation combined oral contraceptives (rate ratio [RR] 1.43, 95% confidence interval [CI] 1.15-1.78) and second-generation combined oral contraceptives (RR 1.65, 95% CI 1.02-2.65). There was no increase in the risk of arterial thrombosis with drospirenone. INTERPRETATION: Use of drospirenone-containing oral contraceptives was associated with an increased risk of deep vein thrombosis and pulmonary embolism, but not transient ischemic attack or cerebrovascular attack, relative to second- and third-generation combined oral contraceptives.

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Progestins with lowest possible androgenic action such as cyproterone acetate, chlormalidone, and drospirenone have been associated with increased risk of venous thrombosis.
“Ideally, a progestin with the lowest possible androgenic action such as cyproterone acetate, chlormalidone, and drospirenone should be used. However, they have been associated with increased risk of venous thrombosis [65,66,67].”
From Controversies in the Pathogenesis, Diagnosis and Treatment of PCOS: Focus on Insulin Resistance, Inflammation, and Hyperandrogenism (2022) · cites this paper as [67]
In women with dyslipidaemia, users of combined hormonal contraceptive agents are at increased risk of cerebrovascular accident compared with non-users.
“Similarly, in women with dyslipidaemia,80 results derived from one primary study reported in the systematic review showed that users of combined hormonal contraceptive agents were at an increased risk of myocardial infarction82 and cerebrovascular accident compared with non-users (table 1).83”
From Association between the reproductive health of young women and cardiovascular disease in later life: umbrella review (2020) · cites this paper as [83]

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Authors: Gronich, N., Lavi, I., & Rennert, G.
Affiliations: Technion – Israel Institute of Technology (IL)
Corresponding author: Gronich, N.
ORCID: Gronich, N.
Rennert, G.
Venue: Canadian Medical Association Journal
Publisher: CMA Joule Inc.
Published: 2011-11-07
Volume: 183
Issue: 18
Pages: E1319-E1325
ISSN: 0820-3946 (ISSN-L)
1488-2329
DOI: 10.1503/cmaj.110463
PMC: PMC3255137
OpenAlex: W2171112559
Cited by: 135
References: 41
Citations by year: 2026: 4 · 2025: 4 · 2024: 4 · 2023: 2 · 2022: 4 · 2021: 7 · 2020: 11 · 2019: 10 · 2018: 8 · 2017: 8 · 2016: 11 · 2015: 11 · 2014: 18 · 2013: 19 · 2012: 13
FWCI: 14.18
Type: journal article
Language: en
Open access: gold
doi.org
Locations: Canadian Medical Association Journal (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
Keywords: drospirenone, combined oral contraceptives, venous thrombosis, deep vein thrombosis, pulmonary embolism, arterial thrombosis, transient ischemic attack, stroke, thrombosis risk, second-generation oral contraceptives, third-generation oral contraceptives, women
MeSH terms: Adolescent, Adult, Mineralocorticoid Receptor Antagonists, Androstenes, Child, Contraceptives, Oral, Combined, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Humans, Israel, Middle Aged, Population Surveillance, Prognosis, Incidence, Venous Thrombosis, Progesterone Congeners, Young Adult

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Higher risk of venous thrombosis associated with drospirenone-containing oral contraceptives: A population-based cohort study

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