Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near‐Real‐Time Monitoring Program in Italy
BackgroundReal‐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...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2018-03-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.117.008034 |
| _version_ | 1818775914665738240 |
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| author | Flavia Mayer Ursula Kirchmayer Paola Coletta Nera Agabiti Valeria Belleudi Giovanna Cappai Mirko Di Martino Sebastian Schneeweiss Marina Davoli Elisabetta Patorno |
| author_facet | Flavia Mayer Ursula Kirchmayer Paola Coletta Nera Agabiti Valeria Belleudi Giovanna Cappai Mirko Di Martino Sebastian Schneeweiss Marina Davoli Elisabetta Patorno |
| author_sort | Flavia Mayer |
| collection | DOAJ |
| description | BackgroundReal‐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 ResultsA 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). ConclusionsThe present pilot study is a cornerstone to develop real‐time monitoring for new drugs in our region. |
| first_indexed | 2024-12-18T11:04:37Z |
| format | Article |
| id | doaj.art-263cb65ddced48e59cb882ac4938d88c |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-12-18T11:04:37Z |
| publishDate | 2018-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-263cb65ddced48e59cb882ac4938d88c2022-12-21T21:10:08ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802018-03-017610.1161/JAHA.117.008034Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near‐Real‐Time Monitoring Program in ItalyFlavia Mayer0Ursula Kirchmayer1Paola Coletta2Nera Agabiti3Valeria Belleudi4Giovanna Cappai5Mirko Di Martino6Sebastian Schneeweiss7Marina Davoli8Elisabetta Patorno9Department of Epidemiology, Local Health Authority Roma 1 Lazio Regional Health Service, Rome, ItalyDepartment of Epidemiology, Local Health Authority Roma 1 Lazio Regional Health Service, Rome, ItalyCentre for Oral Anticoagulant Therapy, Santo Spirito Hospital, Rome, ItalyDepartment of Epidemiology, Local Health Authority Roma 1 Lazio Regional Health Service, Rome, ItalyDepartment of Epidemiology, Local Health Authority Roma 1 Lazio Regional Health Service, Rome, ItalyDepartment of Epidemiology, Local Health Authority Roma 1 Lazio Regional Health Service, Rome, ItalyDepartment of Epidemiology, Local Health Authority Roma 1 Lazio Regional Health Service, Rome, ItalyDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MADepartment of Epidemiology, Local Health Authority Roma 1 Lazio Regional Health Service, Rome, ItalyDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MABackgroundReal‐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 ResultsA 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). ConclusionsThe present pilot study is a cornerstone to develop real‐time monitoring for new drugs in our region.https://www.ahajournals.org/doi/10.1161/JAHA.117.008034anticoagulantcomparative effectivenessdrug therapymonitoringpharmacoepidemiologypilot |
| spellingShingle | Flavia Mayer Ursula Kirchmayer Paola Coletta Nera Agabiti Valeria Belleudi Giovanna Cappai Mirko Di Martino Sebastian Schneeweiss Marina Davoli Elisabetta Patorno 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 anticoagulant comparative effectiveness drug therapy monitoring pharmacoepidemiology pilot |
| title | Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near‐Real‐Time Monitoring Program in Italy |
| title_full | Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near‐Real‐Time Monitoring Program in Italy |
| title_fullStr | Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near‐Real‐Time Monitoring Program in Italy |
| title_full_unstemmed | Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near‐Real‐Time Monitoring Program in Italy |
| title_short | Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near‐Real‐Time Monitoring Program in Italy |
| title_sort | safety and effectiveness of direct oral anticoagulants versus vitamin k antagonists pilot implementation of a near real time monitoring program in italy |
| topic | anticoagulant comparative effectiveness drug therapy monitoring pharmacoepidemiology pilot |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.117.008034 |
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