Journal
JOURNAL OF THE AMERICAN HEART ASSOCIATION
Volume 7, Issue 6, Pages -Publisher
WILEY
DOI: 10.1161/JAHA.117.008034
Keywords
anticoagulant; comparative effectiveness; drug therapy; monitoring; pharmacoepidemiology; pilot; real-world; surveillance
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Funding
- Italian Medicine Agency
- grant from the regional Pharmacovigilance
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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, 10742 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.
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