CoChat
Sign Up
Cited by 160Reproductive Health and ContraceptionVenous Thromboembolism Diagnosis and ManagementPharmacovigilance and Adverse Drug Reactions

Impact of estrogen type on cardiovascular safety of combined oral contraceptives

Dinger, Jürgen, Do Minh, Thai, Heinemann, Klaas·2016·Contraception
DOI 10.1016/j.contraception.2016.06.010
Open this paper in CoChat — free account

Abstract

Objectives The International Active Surveillance study "Safety of Contraceptives: Role of Estrogens" (INAS-SCORE) investigated the cardiovascular risks associated with the use of a combined oral contraceptive (COC) containing dienogest and estradiol valerate (DNG/EV) compared to established COCs in a routine clinical setting.Study design Transatlantic, prospective, noninterventional cohort study conducted in the United States and seven European countries with two main exposure groups and one exposure subgroup: new users of DNG/EV and other COC (oCOC), particularly levonorgestrel-containing COCs (LNG). All self-reported clinical outcomes of interest (OoI) were validated via attending physicians and relevant source documents. Main OoI were serious cardiovascular events (SCE), particularly venous thromboembolic (VTEs) events. Comprehensive follow-up procedures were implemented. Statistical analyses were based on Cox regression models.Results A total of 50,203 new COC users were followed up for up to 5.5years (mean value, 2.1years). Overall 20.3% and 79.7% of these women used DNG/EV and oCOC (including 11.5% LNG users), respectively. A low loss to follow-up of 3.1% was achieved. Based on 47 (VTE) and 233 (SCE) events, the primary analysis (European data set) yielded adjusted hazard ratios for DNG/EV vs. oCOC of 0.4 and 0.5, respectively. The upper bounds of the 95% confidence intervals were 0.98 (VTE) and 0.96 (SCE). The corresponding hazard ratios for DNG/EV vs. LNG showed similar point estimates but the confidence intervals included unity.Conclusion DNG/EV is associated with similar or even lower cardiovascular risk compared to oCOC and LNG.Implication statement A COC containing DNG and EV is associated with similar or even lower cardiovascular risk compared to COCs containing levonorgestrel or other progestogens.

Integrity signals

Registry

Crossref · 10.1016/j.contraception.2016.06.010

Cites

23 of 23 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Related

Authors
Dinger, J., Do Minh, T., & Heinemann, K.
Affiliations
Berlin Center for Epidemiology and Health Research (DE)
Corresponding author
Dinger, Jürgen
Venue
Contraception
Publisher
Elsevier BV
Published
2016-10
Volume
94
Issue
4
Pages
328-339
ISSN
0010-7824 (ISSN-L)
DOI
10.1016/j.contraception.2016.06.010
OpenAlex
W2463663663
Cited by
160
References
23
Citations by year
2026: 11 · 2025: 10 · 2024: 18 · 2023: 17 · 2022: 24 · 2021: 24 · 2020: 15 · 2019: 14 · 2018: 10 · 2017: 10 · 2016: 6
FWCI
13.22
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Contraception (publishedVersion)
  • PubMed (publishedVersion)
Funders
Bayer
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
  • Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords
combined oral contraceptives, cardiovascular safety, dienogest, estradiol valerate, levonorgestrel, venous thromboembolism, progestogens
MeSH terms
Patient Reported Outcome Measures, Adult, Cardiovascular Diseases, Contraceptives, Oral, Combined, Estradiol, Europe, Female, Follow-Up Studies, Humans, Longitudinal Studies, Nandrolone, Prospective Studies, Surveys and Questionnaires, United States, Incidence, Proportional Hazards Models, Levonorgestrel, Venous Thromboembolism, Young Adult

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review