Lower reporting of venous thromboembolisms events with natural estrogen-based combined oral contraceptives compared to ethinylestradiol-containing pills: A disproportionality analysis of the Eudravigilance database

IF 2.8 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Contraception Pub Date : 2025-02-01 DOI:10.1016/j.contraception.2024.110727

Marie Didembourg , Médéa Locquet , Lucie Raskin , Babel Tsague Tchimchoua , Jean-Michel Dogné , Charlotte Beaudart , Jonathan Douxfils

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引用次数: 0

Abstract

Objectives

Pharmacovigilance data analysis can accelerate the identification of drug-related safety signals or reassure on the safety profile. This study evaluates the venous thromboembolism (VTE) risk of newer combined oral contraceptive (COC) formulations with natural estrogens, such as estradiol (E2) and estetrol (E4), using data from the EudraVigilance database.

Study design

We conducted a disproportionality reporting rate analysis of VTE events associated with various COC formulations by extracting individual case reports from EudraVigilance database up to July 28, 2024. The study compared the proportionality reporting rate between natural estrogen-based COCs (E2 and E4) and conventional synthetic estrogen-based COCs (ethinylestradiol [EE]), with a comparison to EE-levonorgestrel.

Results

The analysis revealed that COCs containing natural estrogens exhibited significantly lower proportionality reporting rates for thrombotic events compared to EE-based COCs. Specifically, E4-drospirenone (E4-DRSP) showed the lowest proportionality reporting rate (0.12), similar to progestin-only pills. EE-DRSP had the highest proportionality reporting rate (2.25), suggesting an increased thrombotic risk.

Conclusions

The study supports the safer thrombotic profile of natural estrogen-based COCs, particularly E2 and E4 formulations, over synthetic estrogen-based COCs containing EE. These findings support the hypothesis that E2- and E4-based pills are safer than EE-based pills, aligning with a shift toward safer contraceptive options in clinical practice.

Implications

Natural estrogens such as E2 and E4 may emerge as safer alternatives to synthetic estrogens like EE, particularly when combined with progestins like DRSP. This multilevel evidence underscores the importance of evidence-based prescribing practices to enhance patient safety and minimize thrombotic risks associated with COC use.

查看原文本刊更多论文

与含炔雌醇的避孕药相比，天然雌激素类药物的静脉血栓栓塞事件报告率较低：Eudravigilance 数据库的比例失调分析。

目标：药物警戒数据分析可加速识别药物相关的安全信号或保证药物的安全性。本研究利用 EudraVigilance 数据库中的数据，评估了含有天然雌激素（如雌二醇（E2）和雌三醇（E4））的新型 COC 制剂的 VTE 风险：我们从 EudraVigilance 数据库中提取了截至 2024 年 7 月 28 日的单个病例报告，对与各种 COC 制剂相关的 VTE 事件进行了比例失调报告率分析。研究比较了天然雌激素类化学合成药物（E2 和 E4）与传统合成雌激素类化学合成药物（EE）之间的比例报告率，并与 EE-左炔诺孕酮（EE-LNG）进行了比较：结果：分析表明，与基于 EE 的 COC 相比，含有天然雌激素的 COC 的血栓事件比例报告率明显较低。具体而言，E4-屈螺酮（E4-DRSP）的比例报告率最低（0.12），与纯孕激素药片相似。EE-屈螺酮（EE-DRSP）的比例报告率最高（2.25），表明血栓风险增加：该研究支持天然雌激素类药物（尤其是 E2 和 E4 配方）比含有 EE 的合成雌激素类药物更安全的血栓形成特征。这些发现支持了基于 E2 和 E4 的药片比基于 EE 的药片更安全的假设，这与临床实践中向更安全的避孕选择转变是一致的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contraception 医学-妇产科学

CiteScore

4.70

自引率

17.20%

发文量

211

审稿时长

69 days

期刊介绍： Contraception has an open access mirror journal Contraception: X, sharing the same aims and scope, editorial team, submission system and rigorous peer review. The journal Contraception wishes to advance reproductive health through the rapid publication of the best and most interesting new scholarship regarding contraception and related fields such as abortion. The journal welcomes manuscripts from investigators working in the laboratory, clinical and social sciences, as well as public health and health professions education.