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Apixaban (Eliquis) Superior to Warfarin in Phase III Trial

Subanalysis finds reduced risks of stroke and bleeding (February 21)

Positive results have been reported from a pre-specified subanalysis of the phase III ARISTOTLE trial in relation to patient age.

ARISTOTLE was designed to evaluate the efficacy and safety of apixaban (Eliquis, Bristol-Myers Squibb) compared with warfarin for reducing the risk of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).

The subanalysis found consistent results across age groups for reducing the risk of stroke and systemic embolism and for reducing the risk of all-cause death with fewer bleeding events. Because of the higher risk at an older age (age 75 years and older), the absolute benefit to patients with NVAF was greater with apixaban in the older population. The new data were published in the European Heart Journal.

Apixaban was more effective than warfarin in reducing the risk of stroke and in reducing mortality across age groups, and was associated with less major bleeding, less total bleeding, and less intracranial hemorrhage, regardless of age. The P value for the interaction across age groups was non-significant (P > 0.11 for all) for the major outcomes of stroke and systemic embolism, major bleeding, and death, meaning that the results of this subanalysis were consistent with the overall results of the ARISTOTLE trial.

Source: Bristol Myers-Squibb; February 21, 2014.

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