Re-evaluating Safety and Effectiveness of Dabigatran Versus Warfarin in a Nationwide Data Environment: A Prevalent New-User Design Study
Journal
Drugs - Real World Outcomes
Journal Volume
6
Journal Issue
3
Pages
93-104
Date Issued
2019
Author(s)
Abstract
Introduction: The new user cohort design is widely used to assess the effects of a new drug, such as dabigatran, but inherently excludes some users due to prior use of the comparator drug, for example warfarin. The prevalent new-user design offers a solution that includes all eligible users of the new drug. Objective: To evaluate the safety and effectiveness of dabigatran versus warfarin in non-valvular atrial fibrillation (NVAF) patients with prevalent new-user design. Methods: Taiwan National Health Insurance and mortality data from 2011 through 2015 were utilized. From an incident NVAF cohort, we identified dabigatran initiators as either incident or prevalent (switchers from warfarin) new users. Time- and prescription-based exposure sets were formed for dabigatran initiators to account for prior warfarin prescriptions. A comparable warfarin user was matched on the time-conditional propensity score to the dabigatran initiator in each set. The matched patients were followed for clinical outcomes, with Cox proportional hazards model used to estimate hazard ratios (HRs). Results: There were 10,811 dabigatran initiators, including 22% prevalent new users (switchers), who formed the exposure sets and were matched 1:1 to warfarin users. Dabigatran use was associated with lower risks of intracranial hemorrhage (HR 0.51; 95% confidence interval [CI] 0.39, 0.66) and gastrointestinal bleeding (HR 0.81; 95% CI 0.70, 0.92), compared with warfarin use. These effects were similar between the incident and prevalent new users. Conclusion: Using a design that includes both incident and prevalent new users of dabigatran, the use of dabigatran is associated with lower major bleeding risk than warfarin use among patients with incident NVAF. ? 2019, The Author(s).
SDGs
Other Subjects
apixaban; dabigatran; edoxaban; rivaroxaban; warfarin; aged; all cause mortality; ambulatory care; Article; atrial fibrillation; brain hemorrhage; brain ischemia; cerebrovascular accident; CHA2DS2-VASc score; clinical evaluation; clinical outcome; cohort analysis; comorbidity; congestive heart failure; coronary artery bypass surgery; drug efficacy; drug exposure; drug safety; drug use; extracorporeal circulation; female; follow up; gastrointestinal hemorrhage; health care personnel; heart transplantation; heart valve commissurotomy; heart valve replacement; hemiplegia; hospital admission; human; ICD-9-CM; incidence; major clinical study; male; medical history; mitral valve stenosis; mortality; percutaneous coronary intervention; pharmacology; predictive value; prescription; prevalence; priority journal; propensity score; reimbursement; Taiwan; valvular heart disease; venous thromboembolism
Publisher
Springer International Publishing
Type
journal article