Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 μg of ethinyl estradiol
Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 μg of ethinyl estradiol
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DOI：
10.1016/j.contraception.2006.01.001
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发表时间：
2006-03-01
期刊：
影响因子：
2.9
通讯作者：
Jick, H
中科院分区：
文献类型：
--
作者：
Jick, SS;Kaye, JA;Jick, H
比赛：人们担心，一种含有炔雌醇（EE）和诺孕曲明的新型透皮避孕贴剂与以前上市的口服避孕药（OC）相比，会增加静脉血栓栓塞（VTE）的风险。目的：与使用OC的女性相比，获得了使用避孕贴片的女性发生非致死性VTE风险的定量信息，炔诺肟（单相或三相）和35 μ g EE（诺孕酯-35），一种已经上市十多年的OC。设计、设置和参与者：基于Pharmacy信息的嵌套病例对照设计，一家总部位于美国的公司，收集和组织有关管理式医疗计划支付的索赔信息。这项研究的对象是所有15至44岁的妇女，她们在2002年4月1日之后开始使用避孕贴或诺孕酯-35。病例为目前使用这两种研究药物之一且在无可识别临床风险因素（特发性VTE）的情况下记录了VTE诊断的女性。最多四个对照组匹配到每个病例的年龄和日历time.Main结果测量：比值比（OR）比较两种避孕药的新用户的非致命性静脉血栓栓塞的风险和非致命性静脉血栓栓塞的发病率为新用户的每个研究contractions.Results：我们确定了68个新诊断的，特发性静脉血栓栓塞病例的研究人群。在病例对照分析中，避孕贴剂与诺孕酯-35相比的OR为0.9（95% CI 0.5-1.6）。静脉血栓栓塞的总发病率为52.8/100，000女性年（95% CI 35.8-74.9），诺孕酯使用者中为41.8/100，000妇女-年-35（95% CI 29.4-57.6），目前使用避孕贴剂与诺孕酯-35的年龄校正VTE发病率比（IRR）为1.1（95%CI 0.7-1.8）。结论：避孕贴片的非致死性静脉血栓栓塞的风险与含35 μ g炔雌醇和诺孕酯的口服避孕药的风险相似。2006年爱思唯尔公司All rights reserved.
Contest: There is concern that a new transdermal contraceptive patch containing ethinyl estradiol (EE) and the progestin norelgestromin increases the risk for venous thromboembolism (VTE) compared to previously marketed oral contraceptives (OCs).Objective: Quantitative information was obtained on the risk of nonfatal VTE in women using the contraceptive patch in comparison to women using OCs, norgestimate (either monophasic or triphasic) and 35 mu g EE (norgestimate-35), an OC that has been marketed for over a decade.Design, Setting and Participants: Nested case-control design based on information from PharMetrics, a US-based company that collects and organizes information on claims paid by managed care plans. The study was nested among all women aged 15 to 44, who started either the contraceptive patch or norgestimate-35 after April 1, 2002. Cases were women with current use of one of these two study drugs and a documented diagnosis of VTE in the absence of identifiable clinical risk factors (idiopathic VTE). Up to four controls were matched to each case by age and calendar time.Main Outcome Measures: Odds ratios (ORs) comparing the risk of nonfatal VTE in new users of the two contraceptives and incidence rates of nonfatal VTE for new users of each of the study contraceptives.Results: We identified 68 newly diagnosed, idiopathic cases of VTE in the study population. In the case-control analysis, the OR comparing the contraceptive patch to norgestimate-35 was 0.9 (95% CI 0.5-1.6). The overall incidence rate for VTE was 52.8 per 100,000 women-years (95% CI 35.8-74.9) among users of the contraceptive patch and 41.8 per 100,000 women-years among users of norgestimate-35 (95% Cl 29.4-57.6), and the age-adjusted VTE incidence rate ratio (IRR) for current use of the contraceptive patch vs. norgestimate-35 was 1.1 (95% CI 0.7-1.8).Conclusions: The risk of nonfatal VTE for the contraceptive patch is similar to the risk for OCs containing 35 mu g ethinylestradiol and norgestimate. 2006 Elsevier Inc. All rights reserved.