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FDA review confirms benefits, risks of Pradaxa
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An ongoing FDA review of dabigatran and warfarin in Medicare beneficiaries concluded that patients taking dabigatran had a lower risk for ischemic stroke, intracranial hemorrhage and death, similar risk for MI and a higher risk for gastrointestinal bleeding compared with patients taking warfarin.
Except for MI, the findings are consistent with clinical trial results that resulted in the approval of dabigatran (Pradaxa, Boehringer Ingelheim), according to a safety announcement from the agency. In the RE-LY study, patients randomly assigned dabigatran had a higher risk for MI than patients randomly assigned warfarin. The drugs are approved to reduce the risk for stroke and systemic embolic events in patients with nonvalvular atrial fibrillation.
“As a result of our latest findings, we still consider Pradaxa to have a favorable benefit-to-risk profile and have made no changes to the current label or recommendations for use,” the agency stated in the announcement. “Patients should not stop taking Pradaxa (or warfarin) without first talking with their health care professionals. Health care professionals who prescribe Pradaxa should continue to follow the dosing recommendations in the drug label.”
As part of its ongoing review, the FDA performed an observational cohort study of more than 134,000 Medicare beneficiaries who were new users of dabigatran or warfarin and had received a diagnosis of AF in the previous 6 months prior to starting therapy.
Compared with those prescribed warfarin, patients prescribed dabigatran had a lower risk for ischemic stroke (11.3 per 1,000 person-years vs. 13.9 per 1,000 person years; adjusted HR=0.8; 95% CI, 0.67-0.96), intracranial hemorrhage (3.3 per 1,000 person-years vs. 9.6 per 1,000 person years; adjusted HR=0.34; 95% CI, 0.26-0.46) and death (32.6 per 1,000 person-years vs. 37.8 per 1,000 person years; adjusted HR=0.86; 95% CI, 0.77-0.96), according to the report.
Compared with those prescribed warfarin, patients prescribed dabigatran had a higher risk for major GI bleeding (34.2 per 1,000 person-years vs. 26.5 per 1,000 person years; adjusted HR=1.28; 95% CI, 1.14-1.44) and no difference in risk for MI (15.7 per 1,000 person-years vs. 16.9 per 1,000 person years; adjusted HR=0.92; 95% CI, 0.78-1.08).
The agency stated that it plans to publish its findings, and that health care professionals and patients should report any adverse events related to dabigatran or warfarin to the FDA MedWatch program.