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Bristol-Myers Squibb And Pfizer To Present New Data On Eliquis® (apixaban) At The ESC Congress 2014

Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) announced today that they will present 14 abstracts (oral and poster presentations) at the ESC Congress 2014, organized by the European Society of Cardiology, to be held August 30 to September 4 in Barcelona, Spain. The new clinical trial data and GHEOR analyses assessing cost effectiveness and real-world use reinforce the alliance’s commitment to the ongoing analysis of Eliquis in both the NVAF and VTE patient populations.

The complete list of Bristol-Myers Squibb/Pfizer alliance presentations is included below. Abstracts can be accessed on the ESC Congress 2014 website.

Title Presenting Author/Type Date/Time (CEST) Location/Session
ARISTOTLE Biomarker Analyses
Galectin-3 is associated with worse clinical outcome in patients with atrial fibrillation: A substudy from the ARISTOTLE trial

 

Session: Posters Sessions

Asberg, S./

Poster

31 Aug

14:00 - 18:00

Poster area - Central Village
A new biomarker based risk score for predicting major bleeding in atrial fibrillation - the ABC (age, biomarkers, current disease) risk score

 

Session: Prediction and Prevention of Atrial fibrillation (AF)

Hijazi, Z./

Moderated Poster

31 Aug

15:38 - 15:47

Moderated

poster corner- Central Village

The efficacy of apixaban compared to warfarin in patients with atrial fibrillation with high coagulation activity despite anticoagulant treatment

 

Session: Atrial Fibrillation: How to improve prognosis?

Christersson, C./

Abstract Session

2 Sep

08:45 - 09:00

Tbilisi - Village 7
Interleukin-6 and C-reactive protein and risk for cardiovascular events and death in anticoagulated patients with atrial fibrillation

 

Session: Posters Sessions

Aulin, J./

Poster

2 Sep

14:00 - 18:00

Poster area - Central Village
AMPLIFY and AMPLIFY-EXT
Apixaban for the treatment of venous thromboembolism in cancer patients: data from the AMPLIFY trial

 

Session: Posters Sessions

Agnelli, G./

Poster

2 Sep

08:30 - 12:30

Poster area - Central Village
Analysis of the bleeding and thromboembolic risk with concomitant use of antiplatelet treatment in the AMPLIFY trial

 

Session: Refining antithrombotic therapy in coronary artery disease

Cohen, A./

Moderated Poster

31 Aug

10:00 - 10:08

Moderated poster corner - Central Village
Predictors of hospitalization during extended treatment of venous thromboembolism in the AMPLIFY-EXT trial

 

Session: Acute Pulmonary Embolism

Cohen, A/

Oral

30 Aug

11:18 - 11:36

Cairo Village
Indirect Treatment Comparisons and Economic Value Analyses
Efficacy and safety of apixaban versus edoxaban for stroke prevention in NVAF patients: an indirect treatment analysis

 

Session: Novel Oral Anticoagulants: Trials, Costs and Real Life Use

Lip GYH/

Oral

2 Sep

11:00 - 11:15

Vilinius Village
Potential impact of apixaban on formulary budget and clinical outcomes in non-valvular atrial fibrillation patients

 

Session: Novel Oral Anticoagulants: Trials, Costs and Real Life Use

Kachroo, S./

Oral

2 Sep

11:30 - 11:45

Vilinius Village
Cost-effectiveness of apixaban compared to edoxaban for stroke prevention in non-valvular atrial fibrillation

 

Session: Posters Sessions

Lip GYH/

Poster

2 Sep

14:00 - 18:00

Central Village
Comparison of apixaban, dabigatran and rivaroxaban in the acute treatment and prevention of venous thromboembolism: systematic review and network meta-analysis

 

Session: Venous Thromboembolism: What’s New

Cohen, A./

Oral

2 Sep

17:15 - 17:30

Tbilisi Village
Cost-effectiveness of apixaban compared to other anticoagulants for the acute (6-month) treatment of venous thromboembolism

 

Session: Venous Thromboembolism: What’s New

Lanitis, T./

Oral

2 Sep

16:45 - 17:00

Tbilisi Village
Real World Data Analyses
Real world discontinuation among early users of apixaban, dabigatran, rivaroxaban or warfarin among atrial fibrillation patients newly initiated on anticoagulation therapy: tell of first 200 days

 

Session: Novel Oral Anticoagulants: Trials, Costs and Real Life Use

Phatak, H./

Oral

2 Sep

12:15 - 12:30

Vilinius Village
Warfarin discontinuation in patients with unprovoked venous thromboembolism: a large U.S. insurance database analysis

 

Session: Posters Sessions

Liu JXC/

Poster

2 Sep

8:30 to 12:00

Central Village

About Eliquis

Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis decreases thrombin generation and blood clot formation. Eliquis is approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in the United States, European Union, Japan and a number of other countries around the world. Eliquis is approved for the prophylaxis of deep vein thrombosis (DVT) which can lead to PE (pulmonary embolism) in adult patients who have undergone elective hip or knee replacement surgery in the United States, European Union and a number of other countries around the world. Eliquis is not approved for this indication in Japan.

IMPORTANT SAFETY INFORMATION

WARNINGS: (A) DISCONTINUING ELIQUIS IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE, (B) SPINAL/EPIDURAL HEMATOMA

(A) Discontinuing ELIQUIS places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with ELIQUIS must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered .

(B) When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins, heparinoids, or Factor Xa inhibitors for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.

The risk of these events may be increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet aggregation inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.

Monitor patients for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary. Consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

CONTRAINDICATIONS

  • Active pathological bleeding
  • Severe hypersensitivity reaction to ELIQUIS (apixaban) (e.g., anaphylactic reactions)

WARNINGS AND PRECAUTIONS

  • Increased Risk of Stroke with Discontinuation of ELIQUIS in Patients with Nonvalvular Atrial Fibrillation: Discontinuing ELIQUIS in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If ELIQUIS must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.
  • Bleeding Risk: ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal bleeding. Concomitant use of drugs affecting hemostasis increases the risk of bleeding including aspirin and other anti-platelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs. Patients should be made aware of signs or symptoms of blood loss and instructed to immediately report to an emergency room. Discontinue ELIQUIS in patients with active pathological hemorrhage.
  • There is no established way to reverse the anticoagulant effect of apixaban, which can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). A specific antidote for ELIQUIS is not available. Hemodialysis does not appear to have a substantial impact on apixaban exposure. Protamine sulfate and vitamin K would not be expected to affect the anticoagulant activity of apixaban. There is no experience with antifibrinolytic agents (tranexamic acid, aminocaproic acid) in individuals receiving apixaban. There is neither scientific rationale for reversal nor experience with systemic hemostatics (desmopressin and aprotinin) in individuals receiving apixaban. Use of procoagulant reversal agents such as prothrombin complex concentrate, activated prothrombin complex concentrate, or recombinant factor VIIa may be considered but has not been evaluated in clinical studies. Activated charcoal reduces absorption of apixaban thereby lowering apixaban plasma concentrations.
  • Prosthetic Heart Valves: The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart valves and is not recommended in these patients.

ADVERSE REACTIONS

The most common and most serious adverse reactions reported with ELIQUIS (apixaban) were related to bleeding.

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