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ELIQUIS®(apixaban) Approved In Europe For Prevention Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation

“We are confident in ELIQUIS and its differentiated profile and believe it has the potential to transform the standard of care in stroke prevention in nonvalvular atrial fibrillation,” said Ian Read, Chairman and Chief Executive Officer, Pfizer. “With our combined cardiovascular leadership and expertise, we believe that we will successfully introduce this important medicine to patients and physicians in the EU.”

ELIQUIS 5 mg is indicated as a twice-daily oral medication for prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). ELIQUIS does not require International Normalized Ratio (INR) monitoring and there are no known dietary restrictions.

The first-line use of ELIQUIS and other new oral anticoagulants (NOACs) is recommended in The European Society of Cardiology Guidelines for the management of AF where oral anticoagulation is recommended, recognizing the important benefits that ELIQUIS offers in preventing NVAF-related stroke.

CLINICAL TRIAL PROGRAMME

ARISTOTLE

As described in the SmPC, in the ARISTOTLE Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial, ELIQUIS achieved statistically significant superiority in the primary endpoint of prevention of stroke (haemorrhagic or ischaemic) and systemic embolism compared with warfarin. ELIQUIS was superior to warfarin in the primary efficacy endpoint of stroke/systemic embolism, with a 21% relative risk reduction beyond warfarin (1.27% vs. 1.60%, HR=0.79, CI=0.66, 0.95, P=0.0114). ELIQUIS was superior to warfarin for the primary safety endpoint of major bleeding, with a 31 percent relative risk reduction (2.13% vs. 3.09%, HR=0.69, CI=0.60, 0.80, P<0.0001). Intracranial hemorrhage, a subset of major bleeding, occurred with lower incidence with ELIQUIS compared to warfarin (0.33% vs. 0.80%, HR=0.42, CI=0.30, 0.58, P<0.0001). ELIQUIS was superior to warfarin in the key secondary endpoint of all-cause death, with an 11% relative risk reduction (3.52% vs. 3.94%, HR=0.89; CI=0.80, 1.00, P= 0.0465). The use of ELIQUIS did not result in an increase in myocardial infarction in the ARISTOTLE trial. The efficacy results for prespecified subgroups, including CHADS 2 score, age, body weight, gender, renal function, prior stroke or TIA and diabetes were consistent with the primary efficacy results for the overall population studied in the trial.

The overall discontinuation rate due to adverse reactions was 1.8% for ELIQUIS and 2.6% for warfarin in the ARISTOTLE study.

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