Impact of estrogen type on cardiovascular safety of combined oral contraceptives
Impact of estrogen type on cardiovascular safety of combined oral contraceptives
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DOI：
10.1016/j.contraception.2016.06.010
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发表时间：
2016-10-01
期刊：
影响因子：
2.9
通讯作者：
Heinemann, Klaas
中科院分区：
文献类型：
--
作者：
Dinger, Juergen;Thai Do Minh;Heinemann, Klaas
目的：国际主动监测研究“避孕药的安全性：雌激素的作用”（INAS-SCORE）调查了与常规临床环境中建立的COCs相比，使用含有双孕激素和戊酸雌二醇（DNG/EV）的联合口服避孕药（COC）相关的心血管风险。研究设计：跨大西洋、前瞻性、非干预性队列研究，在美国和七个欧洲国家进行，有两个主要暴露组和一个暴露亚组：DNG/EV和其他COC （oCOC）的新使用者，特别是含左炔诺孕酮的COC （LNG）。所有自我报告的感兴趣临床结果（OoI）均通过主治医生和相关源文件进行验证。主要的OoI是严重的心血管事件（SCE），特别是静脉血栓栓塞（vte）事件。实施了全面的后续程序。统计学分析采用Cox回归模型。结果：共有50203名COC新使用者接受了长达5.5年的随访（平均2.1年）。总体而言，这些女性中分别有20.3%和79.7%使用DNG/EV和oCOC（包括11.5%的LNG用户）。随访损失较低，为3.1%。基于47例（VTE）和233例（SCE）事件，初步分析（欧洲数据集）得出DNG/EV与oCOC的调整风险比分别为0.4和0.5。95%置信区间的上界为0.98 （VTE）和0.96 （SCE）。DNG/EV与LNG的相应风险比显示出相似的点估计，但置信区间包括一致性。结论：与oCOC和LNG相比，DNG/EV与心血管风险相似甚至更低。意义声明：与含有左炔诺孕酮或其他孕激素的COC相比，含有DNG和EV的COC与相似甚至更低的心血管风险相关。(C) 2016 Elsevier Inc.版权所有。
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 5.5 years (mean value, 2.1 years). 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. (C) 2016 Elsevier Inc. All rights reserved.