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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.
- Source :
-
Journal of the American Heart Association [J Am Heart Assoc] 2018 Mar 10; Vol. 7 (6). Date of Electronic Publication: 2018 Mar 10. - Publication Year :
- 2018
-
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.<br />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).<br />Conclusions: The present pilot study is a cornerstone to develop real-time monitoring for new drugs in our region.<br /> (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)
- Subjects :
- Administration, Oral
Anticoagulants adverse effects
Atrial Fibrillation blood
Atrial Fibrillation diagnosis
Atrial Fibrillation mortality
Cause of Death
Comparative Effectiveness Research
Databases, Factual
Hemorrhage chemically induced
Hemorrhage mortality
Humans
Italy epidemiology
Pilot Projects
Predictive Value of Tests
Product Surveillance, Postmarketing
Recurrence
Risk Assessment
Risk Factors
Stroke blood
Stroke diagnosis
Stroke mortality
Time Factors
Treatment Outcome
Anticoagulants administration & dosage
Atrial Fibrillation drug therapy
Blood Coagulation drug effects
Secondary Prevention methods
Stroke prevention & control
Vitamin K antagonists & inhibitors
Subjects
Details
- Language :
- English
- ISSN :
- 2047-9980
- Volume :
- 7
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Journal of the American Heart Association
- Publication Type :
- Academic Journal
- Accession number :
- 29525786
- Full Text :
- https://doi.org/10.1161/JAHA.117.008034