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Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near-Real-Time Monitoring Program in Italy.


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.

SUBMITTER: Mayer F 

PROVIDER: S-EPMC5907561 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near-Real-Time Monitoring Program in Italy.

Mayer Flavia F   Kirchmayer Ursula U   Coletta Paola P   Agabiti Nera N   Belleudi Valeria V   Cappai Giovanna G   Di Martino Mirko M   Schneeweiss Sebastian S   Davoli Marina M   Patorno Elisabetta E  

Journal of the American Heart Association 20180310 6


<h4>Background</h4>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.<h4>Methods and results</h4>A cohort study was conducted  ...[more]

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