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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Author
Mayer, Flavia
Kirchmayer, Ursula
Coletta, Paola
Agabiti, Nera
Belleudi, Valeria
Cappai, Giovanna
Di Martino, Mirko
Davoli, Marina
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https://doi.org/10.1161/JAHA.117.008034Metadata
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Mayer, Flavia, Ursula Kirchmayer, Paola Coletta, Nera Agabiti, Valeria Belleudi, Giovanna Cappai, Mirko Di Martino, Sebastian Schneeweiss, Marina Davoli, and Elisabetta Patorno. 2018. “Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near‐Real‐Time Monitoring Program in Italy.” Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease 7 (6): e008034. doi:10.1161/JAHA.117.008034. http://dx.doi.org/10.1161/JAHA.117.008034.Abstract
Background: 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. Methods and Results: 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). Conclusions: The present pilot study is a cornerstone to develop real‐time monitoring for new drugs in our region.Other Sources
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5907561/pdf/Terms of Use
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