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Contraception. 2016 Oct;94(4):328-39. doi: 10.1016/j.contraception.2016.06.010. Epub 2016 Jun 22.

Impact of estrogen type on cardiovascular safety of combined oral contraceptives.

Author information

1
Pharmacoepidemiology, Berlin, Germany. Electronic address: pharmacoepidemiology@t-online.de.
2
ZEG-Berlin Center for Epidemiology and Health Research, Berlin, Germany.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01009684.

KEYWORDS:

ATE; Combined oral contraceptives; Dienogest; Estradiol valerate; Routine clinical practice; VTE

[Indexed for MEDLINE]

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