Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near-Real-Time Monitoring Program in Italy.
Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near-Real-Time Monitoring Program in Italy.
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DOI：
10.1161/jaha.117.008034
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发表时间：
2018-03-10
影响因子：
5.4
通讯作者：
Patorno E
中科院分区：
文献类型：
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作者：
Mayer F;Kirchmayer U;Coletta P;Agabiti N;Belleudi V;Cappai G;Di Martino M;Schneeweiss S;Davoli M;Patorno E
真实的实时监测用于对新上市药物进行上市后观察性研究的结束。我们对口服抗凝剂的试验病例实施了一项试点近真实的时间监测计划。具体而言，我们评价了2013 - 2015年期间在意大利拉齐奥地区，直接口服抗凝剂与维生素K拮抗剂相比在非瓣膜性房颤二级预防中的安全性和有效性。使用序贯倾向评分匹配的新用户平行队列设计进行队列研究。采用考克斯模型进行序贯分析。共有10742例患者参与了分析。与维生素K拮抗剂相比，直接口服抗凝剂可降低全因死亡率（0.81; 95%置信区间[CI] 0.66 - 0.99），心血管死亡率（0.71; 95% CI 0.54 - 0.93），心肌梗死（0.67; 95% CI 0.43 - 1.04），缺血性卒中（0.87; 95% CI 0.52 - 1.45），出血性卒中（0.25; 95% CI 0.07 - 0.88），胃肠道出血无显著增加（1.26; 95% CI 0.69 - 2.30）。目前的试点研究是在本区域开展新药真实的实时监测的基石。
Real‐time monitoring is used to the ends of postmarketing observational research on newly marketed drugs. We implemented a pilot near‐real‐time monitoring program on the test case of oral anticoagulants. Specifically, we evaluated the safety and effectiveness of direct oral anticoagulants compared to vitamin K antagonists in nonvalvular atrial fibrillation secondary prevention during 2013‐2015 in the Lazio Region, Italy. A cohort study was conducted using a sequential propensity‐score–matched new user parallel‐cohort design. Sequential analyses were performed using Cox models. Overall, 10 742 patients contributed to the analyses. Compared with vitamin K antagonists, direct oral anticoagulant use was associated with a reduction of all‐cause mortality (0.81; 95% confidence interval [CI] 0.66‐0.99), cardiovascular mortality (0.71; 95% CI 0.54‐0.93), myocardial infarction (0.67; 95% CI 0.43‐1.04), ischemic stroke (0.87; 95% CI 0.52‐1.45), hemorrhagic stroke (0.25; 95% CI 0.07‐0.88), and with a nonsignificant increase of gastrointestinal bleeding (1.26; 95% CI 0.69‐2.30). The present pilot study is a cornerstone to develop real‐time monitoring for new drugs in our region.
影响因子：
2.6
作者：
Avery, Taliser R.;Kulldorff, Martin;Vilk, Yury;Li, Lingling;Cheetham, T. Craig;Dublin, Sascha;Davis, Robert L.;Liu, Liyan;Herrinton, Lisa;Brown, Jeffrey S.
通讯作者：
Brown, Jeffrey S.