This pooled analysis compared the risk of venous thromboembolism (VTE) associated with combined oral contraceptives (COCs) containing estradiol (E2) valerate-dienogest with those containing ethinyl E2-levonorgestrel. Data were retrieved from two large, prospective, observational cohort studies. Propensity score subclassification was applied to balance baseline parameters between the COC user cohorts. Crude and adjusted hazard ratios (HRs) were calculated based on the extended Cox model. The pooled data set included 11,616 E2 valerate-dienogest users and 18,681 ethinyl E2-levonorgestrel users, contributing 17,932 and 29,140 women-years of observation, respectively. A significantly decreased VTE risk in E2 valerate-dienogest COCs compared with ethinyl E2-levonorgestrel COCs was observed (propensity score-stratified HR 0.46, 95% CI, 0.22-0.98). This pooled analysis expands data from a previous postauthorization safety study and provides valuable real-world safety information on the relative safety of current COCs.

中文翻译：

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戊酸雌二醇-地诺孕素与乙炔雌二醇-左炔诺孕酮联合口服避孕药相比的静脉血栓栓塞风险。

该汇总分析比较了含有雌二醇 (E2) 戊酸-地诺孕素的复方口服避孕药 (COC) 与含有乙炔 E2-左炔诺孕酮的复方口服避孕药 (COC) 相关的静脉血栓栓塞 (VTE) 风险。数据取自两项大型前瞻性观察队列研究。应用倾向评分子分类来平衡 COC 用户群体之间的基线参数。粗略和调整后的危险比 (HR) 是根据扩展 Cox 模型计算的。汇总数据集包括 11,616 名 E2 戊酸-地诺孕素使用者和 18,681 名乙炔 E2-左炔诺孕酮使用者，分别贡献了 17,932 和 29,140 女性观察年。与乙炔 E2-左炔诺孕酮 COC 相比，E2 戊酸-地诺孕素 COC 的 VTE 风险显着降低（倾向评分分层 HR 0.46，95% CI，0.22-0.98）。这项汇总分析扩展了之前授权后安全研究的数据，并提供了有关当前 COC 相对安全性的有价值的现实世界安全信息。