Drospirenone and non-fatal venous thromboembolism: is there a risk difference by dosage of ethinyl-estradiol?
Drospirenone and non-fatal venous thromboembolism: is there a risk difference by dosage of ethinyl-estradiol?
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DOI：
10.1111/jth.12224
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发表时间：
2013-06-01
影响因子：
10.4
通讯作者：
Hartzema, A. G.
中科院分区：
文献类型：
--
作者：
Bird, S. T.;Delaney, J. A. C.;Hartzema, A. G.
背景以前的研究得出结论，屈螺酮会增加非致命性静脉血栓栓塞（VTE）的风险。目前尚不清楚炔雌醇的剂量是否会影响VTE的风险。目的评估屈螺酮的VTE风险，并确定屈螺酮和炔雌醇20 g（DRSP/EE 20）的VTE风险低于屈螺酮和炔雌醇30 g（DRSP/EE 30）。方法我们的队列包括年龄18- 46岁服用含屈螺酮或左炔诺孕酮（LNG）的复方口服避孕药（COCs）的妇女。在2001年至2009年期间的IMS索赔数据库中。使用ICD-9-CM编码和抗凝治疗定义VTE。风险比（HR）从考克斯比例风险模型被用来评估与屈螺酮与左炔诺孕酮相比，VTE的相对风险（RR），调整的倾向得分用于控制基线共病和分层EE剂量和用户类型（新/当前）。ResultsThe研究包括238683屈螺酮和193495左炔诺孕酮用户。在新使用者和当前使用者中，观察到屈螺酮（18.0 VTE/10000女性-年）与左炔诺孕酮（8.9 VTE/10000女性-年）相比，VTE相对风险增加1.90倍（95% CI，1.51-2.39）。在新使用者分析中，DRSP/EE 20的VTE RR是LNG/EE 20的2.35倍（95% CI，1.44-3.82）。在2001年至2006年期间开始使用COC的女性中，DRSP/EE 30的新使用者观察到RR相对于LNG/EE 30增加（2.51，95% CI，1.12-5.64），但2007年至2009年之间未发生（0.76，95% CI，0.42-1.39），这归因于2007年至2009年LNG/EE 30的发生率增加。在直接比较中，DRSP/EE 20与DRSP/EE 30（RR，1.55; 95%CI，0.99-2.41）相比，VTE的风险升高。在DRSP/EE 20中观察到的VTE发生率高于DRSP/EE 30，以及2007年至2009年间左炔诺孕酮的VTE发生率增加是意料之外的。
BackgroundPrevious studies concluded that there was an increased risk of non-fatal venous thromboembolism (VTE) with drospirenone. It is unknown whether the risk is differential by ethinyl-estradiol dosage.ObjectivesTo assess the risk of VTE with drospirenone and to determine whether drospirenone and ethinyl-estradiol 20g (DRSP/EE20) has a lower VTE risk than drospirenone and ethinyl-estradiol 30g (DRSP/EE30).MethodsOur cohort included women aged 18-46years taking drospirenone or levonorgestrel (LNG)-containing combined oral contraceptives (COCs) in the IMS claims database between 2001 and 2009. VTE was defined using ICD-9-CM coding and anticoagulation. The hazard ratio (HR) from Cox proportional hazards models was used to assess the VTE relative risk (RR) with drospirenone compared with levonorgestrel, adjusted by a propensity score used to control for baseline co-morbidity and stratified by EE dosage and user-type (new/current).ResultsThe study included 238683 drospirenone and 193495 levonorgestrel users. Among new and current users, a 1.90-fold (95% CI, 1.51-2.39) increased VTE relative risk was observed for drospirenone (18.0 VTE/10000 women-years) vs. levonorgestrel (8.9 VTE/10000 women-years). In analysis of new users, DRSP/EE20 had a 2.35-fold (95% CI, 1.44-3.82) VTE RR versus LNG/EE20. New users of DRSP/EE30 observed an increased RR versus LNG/EE30 among women starting to use COCs between 2001 and 2006 (2.51, 95% CI, 1.12-5.64) but not between 2007 and 2009 (0.76, 95% CI, 0.42-1.39), attributable to an increased incidence rate with LNG/EE30 from 2007 to 2009. In direct comparison, DRSP/EE20 had an elevated risk of VTE compared with DRSP/EE30 (RR, 1.55; 95% CI, 0.99-2.41).ConclusionsWe observed a modestly elevated risk of VTE with drospirenone, compared with levonorgestrel. The larger VTE incidence rate observed in DRSP/EE20 than in DRSP/EE30 and the increasing VTE incidence rate with levonorgestrel between 2007 and 2009 were unexpected.