Format

Send to

Choose Destination
J Am Heart Assoc. 2018 Mar 10;7(6). pii: e008034. doi: 10.1161/JAHA.117.008034.

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

Author information

1
Department of Epidemiology, Local Health Authority Roma 1 Lazio Regional Health Service, Rome, Italy.
2
Department of Epidemiology, Local Health Authority Roma 1 Lazio Regional Health Service, Rome, Italy u.kirchmayer@deplazio.it.
3
Centre for Oral Anticoagulant Therapy, Santo Spirito Hospital, Rome, Italy.
4
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.

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.

KEYWORDS:

anticoagulant; comparative effectiveness; drug therapy; monitoring; pharmacoepidemiology; pilot; real‐world; surveillance

PMID:
29525786
PMCID:
PMC5907561
DOI:
10.1161/JAHA.117.008034
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Atypon Icon for PubMed Central
Loading ...
Support Center