Risk of nonfatal venous thromboembolism with oral contraceptives containing norgestimate or desogestrel compared with oral contraceptives containing levonorgestrel
Risk of nonfatal venous thromboembolism with oral contraceptives containing norgestimate or desogestrel compared with oral contraceptives containing levonorgestrel
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DOI：
10.1016/j.contraception.2006.02.002
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发表时间：
2006-06-01
期刊：
影响因子：
2.9
通讯作者：
Jick, Hershel
中科院分区：
文献类型：
--
作者：
Jick, Susan S.;Kaye, James A.;Jick, Hershel
背景：以前的研究报告称，与使用含有左旋诺孕酮的较老口服避孕药(OCS)相比，使用含有孕激素孕酮和地塞米松的“第三代”口服避孕药(OCS)的患者发生静脉血栓栓塞症(VTE)的风险约为前者的两倍。目的：本研究的目的是通过对比服用诺孕酮或地格列酮的女性患者和服用左旋诺孕酮的女性患者，获得非致命性VTE风险的定量信息。设计、背景和参与者：基于PharMetrics公司的信息，PharMetrics是一家美国公司，该公司收集和记录管理护理计划支付的索赔信息，我们使用嵌套式病例对照研究设计来评估15至39岁的现有OCS使用者中非致命性VTE的相对风险。在2000年1月至2005年3月期间，地格列酮与30毫克EE或左炔诺孕酮与30毫克EE单相和三相制剂一起服用。病例是患有来源不明的有充分记录的VTE的妇女，该VTE是在目前使用研究药物的人中诊断出来的。根据年龄和日历时间，最多四名对照组与每个病例密切匹配，并使用条件Logistic回归计算优势比(OR)，比较三种避孕药使用者患VTE的风险。结果：基于281例新诊断的特发性VTE和1055例对照，我们发现非致死性VTE的调整OR分别为1.1[95%可信区间(CI)，0.8-1.6]和1.7(95%可信区间，1.1-2.4)。每10万妇女年中，Norgstimate、地塞米松和左炔诺孕酮的VTE发生率分别为30.6(95%CI，25.5~36.5)、53.5(95%CI，42.9~66.0)和27.1(95%CI，21.1~34.3)。含去甲肾上腺皮质激素的OCS与含左炔诺孕酮的OCS和含地塞米松的OCS相比，其发生率分别为1.1(95%CI，0.8~1.5)和2.0(95%CI，1.4~2.7)。结论：与含左旋甲基诺孕酮的OCS相比，含地孕激素的OCS使用者发生非致命性VTE的风险显著增加。使用含去甲诺孕酮的OCS的患者发生VTE的风险与使用含有左炔诺孕酮的OCS的患者的风险非常相似。(C)2006 Elsevier Inc.保留所有权利。
Context: Previous studies have reported that users of the "third-generation" oral contraceptives (OCs) containing the progestins gestodene and desogestrel have about twice the risk for venous thromboembolism (VTE) compared to users of older OCs containing levonorgestrel. Estimates of the risk for VTE among users of norgestimate-containing OCs compared to other OCs, however, are lacking.Objective: The purpose of this study is to obtain quantitative information on the risk of nonfatal VTE in women using OCs containing either norgestimate or desogestrel in comparison with women taking OCs containing levonorgestrel.Design, Setting and Participants: Based on information from PharMetrics, a United States-based company that collects and records information on claims paid by managed care plans, we used a nested case-control study design to estimate relative risks of nonfatal VTE among 15- to 39-year-old current users of OCs containing norgestimate with 35 mu g of ethinyl estradiol (EE), desogestrel with 30 mu g of EE or levonorgestrel with 30 mu g of EE, both monophasic and triphasic preparations, during the period January 2000 to March 2005. Cases were women with a well-documented VTE of uncertain origin that was diagnosed in current users of a study drug. Up to four controls were closely matched to each case by age and calendar time, and odds ratios (ORs) were calculated using conditional logistic regression comparing the risk of VTE among users of the three contraceptives. We also estimated and compared the incidence rates for all three OCs.Results: Based on 281 newly diagnosed idiopathic cases of VTE and 1055 controls, we found that the adjusted ORs for nonfatal VTE comparing norgestimate- or desogestrel-containing OC users to users of levonorgestrel-containing OCs were 1.1 [95% confidence interval (CI), 0.8-1.6] and 1.7 (95% CI, 1.1-2.4), respectively. The incidence rates of VTE were 30.6 (95% CI, 25.5-36.5), 53.5 (95% CI, 42.9-66.0) and 27.1 (95% CI, 21.1-34.3) per 100,000 woman-years for users of norgestimate-, desogestrel- and levonorgestrel-containing OCs, respectively. The incidence rate ratios for norgestimate-containing OCs compared to levonorgestrel-containing OCs and desogestrel-containing OCs compared to levonorgestrel-containing OCs were 1.1 (95% CI, 0.8-1.5) and 2.0 (95% CI, 1.4-2.7), respectively.Conclusions: The risk of nonfatal VTE among users of desogestrel-containing OCs is significantly elevated compared to that of levonorgestrel-containing OCs. The risk of VTE in users of norgestimate-containing OCs was closely similar to that of users of levonorgestrel-containing OCs. (c) 2006 Elsevier Inc. All rights reserved.