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No significant differences noted among new oral anticoagulants for stroke prevention in AF
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Results from an indirect comparison study using data from RE-LY, ROCKET-AF and ARISTOTLE indicated that apixaban, both doses of dabigatran etexilate or rivaroxaban were comparable in terms of safety and efficacy.
Researchers found a 26% lower risk for stroke and systemic embolism with dabigatran 150 mg twice daily (Pradaxa, Boehringer Ingelheim) and significantly lower risks for hemorrhagic stroke and nondisabling stroke compared with rivaroxaban (Xarelto, Janssen). For prevention of stroke and systemic embolism, data demonstrated no significant differences between apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) vs. dabigatran 150 mg twice daily and dabigatran 110 mg twice daily or rivaroxaban, as well as between rivaroxaban and dabigatran 110 mg twice daily. Similarly, no differences were noted for ischemic stroke.
With apixaban, major bleeding was 26% lower than with dabigatran 150 mg twice daily and 34% lower than with rivaroxaban, but it was not significantly different with dabigatran 110 mg twice daily. Additionally, major or clinically relevant bleeding was 34% lower with apixaban vs. rivaroxaban. Dabigatran 110 mg twice daily was also associated with 23% less major bleeding and 54% less intracranial bleeding compared with rivaroxaban.
Safety endpoints were also similar for apixaban and dabigatran 110 mg twice daily, and MI events were not significantly different between both doses of dabigatran and apixaban.
“Dabigatran 150 mg [twice daily] was superior to rivaroxaban for some efficacy endpoints, whereas major bleeding was significantly lower with dabigatran 110 mg [twice daily] or apixaban,” the researchers wrote. “Only a head-to-head direct comparison of the different new [oral anticoagulants] would fully answer the question of efficacy/safety differences between the new drugs for stroke prevention in [atrial fibrillation].”
Disclosure: Dr. Lip has served as a consultant for Astellas, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daiichi-Sankyo, Merck, Sanofi and Portola; and has been on the speakers’ bureau for Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb/Pfizer and Sanofi-Aventis. Drs. Larsen and Rasmussen have served as speakers for Bristol-Myers Squibb/Pfizer and Boehringer-Ingelheim. Dr. Skjøth reported no relevant financial disclosures.
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