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U.S. FDA Approves ELIQUIS® (apixaban) To Reduce The Risk Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation

ELIQUIS is the only oral anticoagulant to demonstrate superior risk reductions versus warfarin in three key outcomes—stroke and systemic embolism, major bleeding, and all-cause mortality—for patients with nonvalvular atrial fibrillation.

In ARISTOTLE, ELIQUIS was superior to warfarin in the primary efficacy endpoint of stroke or systemic embolism, with a 21% relative risk reduction beyond warfarin (1.27%/year versus 1.60%/year, HR=0.79, p=0.01). Superiority to warfarin was primarily attributable to a reduction in hemorrhagic stroke and ischemic stroke that converted to hemorrhagic stroke. Purely ischemic strokes occurred with similar rates on both drugs.

ELIQUIS was superior to warfarin for the primary safety endpoint of major bleeding, with a 31% relative risk reduction (2.13%/year versus 3.09%/year, HR=0.69, p<0.0001). Major bleeding was defined as clinically overt bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 g/dL or more; a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least one of the following critical sites: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; or bleeding that was fatal.

The incidence of major gastrointestinal (GI) bleeds was lower with ELIQUIS compared to warfarin (0.83%/year versus 0.93%/year, HR=0.89 [CI=0.70, 1.14]). GI bleed includes upper GI, lower GI, and rectal bleeding. ELIQUIS demonstrated a significant reduction in intracranial hemorrhage versus warfarin with a 59% relative risk reduction (0.33%/year versus 0.82%/year, HR=0.41 [CI=0.30, 0.57]). Intracranial hemorrhage included intracerebral (hemorrhagic stroke), subarachnoid, and subdural bleeds. The incidence of major intraocular bleeding was numerically higher with ELIQUIS compared to warfarin (0.21%/year versus 0.14%/year, HR=1.42 [CI=0.83, 2.45]). Intraocular bleed is within the corpus of the eye (a conjunctival bleed is not an intraocular bleed). ELIQUIS demonstrated a significant reduction in fatal bleeds versus warfarin with a 73% relative risk reduction (0.06%/year versus 0.24%/year, HR=0.27 [CI=0.13, 0.53]). Fatal bleed is an adjudicated death because of bleeding during the treatment period and includes both fatal extracranial bleeds and fatal hemorrhagic stroke. Eliquis demonstrated a significant reduction in clinically relevant non major bleeding (CRNM) versus warfarin (2.08%/year for ELIQUIS compared to 3.00%/year for warfarin [HR= 0.70, P<0.0001]). CRNM was defined as clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to hospital admission, physician-guided medical or surgical treatment, or a change in antithrombotic therapy.

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