Dabigatran, warfarin comparable for stroke prevention in real-world patients with AF

For prevention of ischemic stroke, dabigatran and warfarin were associated with similar outcomes in real-world patients with nonvalvular atrial fibrillation, but dabigatran was associated with increased risk for gastrointestinal bleeding in elderly adults, according to new data published in Circulation: Cardiovascular Quality and Outcomes.

Researchers conducted a systematic review and analysis of seven retrospective cohort studies published from 2012 to 2015 covering 348,750 patients to assess the safety and efficacy of dabigatran (Pradaxa, Boehringer Ingelheim) compared with warfarin for stroke prevention in patients with nonvalvular AF. The mean follow-up of all studies was 2.2 years.

Results showed that dabigatran was not superior to warfarin for stroke prevention (pooled HR for 150-mg dose = 0.92; 95% CI, 0.84-1.01; pooled HR for 110-mg dose = 0.92; 95% CI, 0.72-1.18). Both doses were associated with lower risk for intracranial bleeding compared with warfarin (pooled HR for 150-mg dose = 0.44; 95% CI, 0.34-0.59; pooled HR for 110-mg dose = 0.49; 95% CI, 0.34-0.72). However, the risk for GI bleeding was higher with the 150-mg dose compared with warfarin (pooled HR = 1.23; 95% CI, 1.01-1.5); the same trend was not observed with the 110-mg dose (pooled HR = 0.91; 95% CI, 0.55-1.51).

“Stratified by study age distribution, there was no evidence for an increased risk of gastrointestinal bleeding with dabigatran in studies of younger populations, but there was an increased risk of [approximately] 50% for dabigatran 150 mg vs. warfarin in studies of older populations,” Robert J. Romanelli, PhD, MPH, of the Palo Alto Medical Foundation Research Institute, and colleagues wrote. – by Tracey Romero

Disclosure: The researchers report no relevant financial disclosures.

Source: www.healio.com