[August 24, 2015] |
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Bristol-Myers Squibb and Pfizer to Present New Data on Eliquis (apixaban) at the ESC Congress 2015
Bristol-Myers
Squibb Company (NYSE:BMY) and Pfizer
Inc. (NYSE:PFE) announced today that 22 abstracts (late-breaking,
rapid-fire, oral and poster presentations) will be presented at the ESC (News - Alert)
Congress 2015, to be held August 29 to September 2 in London, United
Kingdom. The new data reinforce the Alliance's commitment to the ongoing
evaluation of Eliquis in both the nonvalvular atrial fibrillation
(NVAF) and venous thromboembolism (VTE) patient populations. In
addition, data from the AEGEAN (Assessment of an Educational and
Guidance Programme for Eliquis Adherence in Nonvalvular Atrial
Fibrillation) study evaluating adherence among NVAF patients further
extends the Alliance's commitment to patient care.
"The Bristol-Myers Squibb and Pfizer Alliance is pleased to share 22
abstracts, which include important Eliquis data from both
clinical trials and real-world analyses, at one of the world's largest
and most influential cardiovascular meetings," said Douglas Manion,
M.D., head of specialty development, Bristol-Myers Squibb.
"Clinical trial data are important in evaluating a medication's efficacy
and safety under well-controlled circumstances, and their findings can
be supplemented by real-world data on the use of a product for approved
indications in routine clinical practice," said Rory O'Connor, M.D.,
senior vice president and head of Global Medical Affairs, Global
Innovative Pharma Business, Pfizer Inc.
The complete list of Bristol-Myers Squibb and Pfizer Alliance
presentations is included below. Abstracts can be accessed on the ESC
Congress 2015 website.
Title
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Presenting Author/Type
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Date/Time (BST)
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Location/Session
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Randomized Trials
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Assessment of an Educational and Guidance Programme for Eliquis
Adherence in Nonvalvular Atrial Fibrillation (AEGEAN)
Session:
Atrial Fibrillation / Pacing
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Gilles Montalescot / Hot Line Oral
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Aug. 30 17:16-17:28
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London - Main Auditorium
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Steven Lip /
Discussant Review
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Aug. 30 17:28-17:35
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London - Main Auditorium
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Panel Discussion
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Aug. 30 17:28-17:38
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London - Main Auditorium
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Real-World Data Analyses
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Real-World Comparison of Major Bleeding Risks among Non-Valvular
Atrial Fibrillation Patients on Apixaban, Dabigatran, Rivaroxaban:
Cohorts Comprising New Initiators and/or Switchers from Warfarin
Session:
Anticoagulation and atrial fibrillation III
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Gregory Lip, et al / Poster
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Aug. 30 14:00-15:30
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Poster Area - Poster Area
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Major Bleeding, Hospitalization Rates and Healthcare Costs among
Non-Valvular Atrial Fibrillation Patients Naïve to Oral
Anticoagulation and Newly Treated with Novel Oral Anticoagulants
Session:
Impact of the environment on anticoagulation in non-valvular
atrial fibrillation
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Steven Deitelzweig, et al /
Oral, Rapid Fire
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Aug. 30 14:09-14:18
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Holland Park - The Hub
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Real-World Comparison of Bleeding Risks among Non-Valvular Atrial
Fibrillation Patients on Apixaban, Dabigatran, Rivaroxaban:
Cohorts Comprising New Initiators and/or Switchers from Warfarin
Session:
Impact of the environment on anticoagulation in non-valvular
atrial fibrillation
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Gregory Lip, et al / Oral, Rapid Fire
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Aug. 30 14:45-14:54
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Holland Park - The Hub
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Lower Risk of Myocardial Infarction in Atrial Fibrillation
Patients Treated with Vitamin K Antagonist than in Combination
with Acetylsalicylic Acid (ASA) or ASA Alone
Session:
Oral anticoagulants still in the focus
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Christina Jiyoung Lee, et al /
Moderated Poster
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Aug. 31 11:20-11:37
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Tunis - Village 7
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Patient Profile in Non-Valvular Atrial Fibrillation (NVAF) and
Stroke: Findings from a Real-World Setting in Spain
Session:
Atrial fibrillation III
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Cinira Lefevre, et al / Poster
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Sept. 1 8:30-12:30
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Poster Area - Poster Area
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Real-World Comparison of Major Bleeding Risk among Non-Valvular
Atrial Fibrillation Patients Newly Initiated on Apixaban,
Dabigatran, Rivaroxaban or Warfarin
Session:
Anticoagulation and atrial fibrillation III
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Gregory Lip, et al / Poster
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Sept. 1 14:00-18:00
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Poster Area - Poster Area
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Real-World Bleeding Risk among Non-Valvular Atrial Fibrillation
(NVAF) Patients Prescribed Apixaban, Dabigatran, Rivaroxaban and
Warfarin: Analysis of Electronic Health Records
Session:
Anticoagulation and atrial fibrillation III
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Lin, et al / Poster
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Sept. 1 14:00-18:00
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Poster Area - Poster Area
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Patient Profile of Oral Anticoagulation (OAC) Use in People with
Nonvalvular Atrial Fibrillation (NVAF): Findings from REACT-AF 2
Study in UK Primary Care Data
Session:
Anticoagulation and atrial fibrillation I
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Andrew Maguire, et al / Poster
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Sept. 1 14:00-18:00
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Poster Area - Poster Area
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Management of Anticoagulation in Patients with Non-Valvular Atrial
Fibrillation in General Practice in UK: Evolution and
Characteristics of Patients Not Treated with Antithrombotic Therapy
Session:
Anticoagulation and atrial fibrillation II
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Essra Ridha, et al /
Poster
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Sept. 1 14:00-18:00
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Poster Area - Poster Area
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Management of Anticoagulation in Patients with Nonvalvular Atrial
Fibrillation in General Practice in UK: Evolution and
Characteristics of Patients Treated with Antiplatelet Therapy Alone
Session:
Anticoagulation and atrial fibrillation III
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Essra Ridha, et al /
Poster
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Sept. 1 14:00-18:00
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Poster Area - Poster Area
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Clinical and Demographic Characteristics According to Dosage among
Nonvalvular Atrial Fibrillation Patients Newly Initiated on Novel
Oral Anticoagulants
Session: Anticoagulation and
atrial fibrillation I
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Cristina Masseria, et al / Poster
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Sept. 1 14:00-18:00
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Poster Area - Poster Area
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Early Assessment of Bleeding-Related Hospital Readmissions among
Non-Valvular Atrial Fibrillation Patients Treated with the New
Oral Anticoagulants Using an Electronic Medical Record Database in
the U.S.
Session: Anticoagulation and atrial
fibrillation III
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Steven Deitelzweig, et al / Poster
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Sept. 1 14:00-18:00
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Poster Area - Poster Area
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Phase 3 Clinical Trial Subanaylses
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Less Non-Major Bleeding with Apixaban versus Warfarin among
Patients with Atrial Fibrillation: Insights from the ARISTOTLE
Trial
Session: Impact of the environment on
anticoagulation in non-valvular atrial fibrillation
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Maria Cecilia Bahit, et al / Oral, Rapid Fire
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Aug. 30 14:27-14:36
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Holland Park - The Hub
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Efficacy and Safety of Apixaban Compared with Warfarin in Relation
to Renal Function over Time in Patients with Atrial Fibrillation:
Insights from the ARISTOTLE Trial
Session: Impact of
the environment on anticoagulation in non-valvular atrial
fibrillation
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Ziad , et al / Oral, Rapid Fire
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Aug. 30 14:36-14:45
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Holland Park - The Hub
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Stroke and Bleeding Outcomes with Apixaban versus Warfarin in
Patients with High Creatinine, Low Body Weight or High Age
Receiving Standard Dose Apixaban for Stroke Prevention in Atrial
Fibrillation
Session: Anticoagulation in
non-valvular atrial fibrillation
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John Alexander, et al / Oral
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Aug. 30 14:37-14:54
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Madrid - Village 4
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External Validation of the Biomarker-Based ABC-Stroke Risk Score
for Atrial Fibrillation
Session: Predicting the
future: the accuracy of risk scores
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Ziad Hijazi, et al /
Moderated Poster
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Aug, 31 16:50-17:07
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San Marino - Village 2
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Management and Clinical Consequences of Major Bleeding in
High-Risk Patients Following an Acute Coronary Syndrome. Is
Aspirin the Problem? Insights from the APPRAISE-2 Trial
Session:
Flash news on antithrombotics
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Emil Hagstrom, et al / Oral, Rapid Fire
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Sept. 1 9:33-9:42
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Agora - Poster Area
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Digoxin Use is Associated with Higher Mortality among Patients
with Atrial Fibrillation with and without Heart Failure: Insights
from the ARISTOTLE Trial
Session: New insights in
arrhythmias: mechanisms and treatment
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Roberto Rordorf, et al / Poster
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Sept. 1 14:00-18:00
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Poster Area - Poster Area
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Indirect Treatment Comparisons and Economic Value Analyses
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Potential Clinical Benefits and Cost Savings Associated with
Inclusion of Apixaban in the Formulary for Treatment of Patients
with Venous Thromboembolism
Session: Thrombosis and
coagulation
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Melissa Hamilton, et al / Poster
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Aug. 30 8:30-12:30
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Poster Area- Poster Area
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A Simulated Head-to-Head Comparison of Stroke and Major Bleeding
with Apixaban versus Rivaroxaban in High-Risk NVAF Patients
Session:
Atrial fibrillation and anticoagulation
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Jack Ishack, et al /
Poster
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Aug. 31 14:00-18:00
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Poster Area - Poster Area
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Comparative Cost-Effectiveness of Oral Anticoagulants for Stroke
Prevention in Non-Valvular Atrial Fibrillation Patients in the UK
Session:
Antithrombotic prophylaxis in atrial fibrillation
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Tereza Lanitis, et al / Moderated Poster
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Sept. 1 10:51-11:00
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Moderated Poster Station - Poster Area
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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 for multiple indications in the U.S. based on efficacy and
safety data, including results from seven Phase 3 clinical trials. Eliquis
is a prescription medicine indicated to reduce the risk of stroke and
systemic embolism in patients with nonvalvular atrial fibrillation; for
the prophylaxis of deep vein thrombosis (DVT), which may lead to
pulmonary embolism (PE), in patients who have undergone hip or knee
replacement surgery; for the treatment of DVT and PE; and to reduce the
risk of recurrent DVT and PE following initial therapy.
ELIQUIS Indications and Important Safety
Information
Indications
ELIQUIS is indicated to reduce the risk of stroke and systemic embolism
in patients with nonvalvular atrial fibrillation.
ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT),
which may lead to pulmonary embolism (PE), in patients who have
undergone hip or knee replacement surgery.
ELIQUIS is indicated for the treatment of DVT and PE, and to reduce the
risk of recurrent DVT and PE following initial therapy.
ELIQUIS Important Safety Information
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WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE
RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
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(A) Premature discontinuation of any oral anticoagulant,
including ELIQUIS, increases the risk of thrombotic events. If
anticoagulation with ELIQUIS is discontinued for a reason other than
pathological bleeding or completion of a course of therapy, consider
coverage with another anticoagulant.
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(B) Epidural or spinal hematomas may occur in patients treated
with ELIQUIS who are receiving neuraxial anesthesia or undergoing
spinal puncture. These hematomas may result in long-term or
permanent paralysis. Consider these risks when scheduling patients
for spinal procedures. Factors that can increase the risk of
developing epidural or spinal hematomas in these patients include:
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use of indwelling epidural catheters
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concomitant use of other drugs that affect hemostasis, such
as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet
inhibitors, other anticoagulants
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a history of traumatic or repeated epidural or spinal
punctures
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a history of spinal deformity or spinal surgery
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optimal timing between the administration of ELIQUIS and
neuraxial procedures is not known
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Monitor patients frequently for signs and symptoms of
neurological impairment. If neurological compromise is noted, urgent
treatment is necessary.
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Consider the benefits and risks before neuraxial intervention in
patients anticoagulated or to be anticoagulated.
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CONTRAINDICATIONS
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Active pathological bleeding
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Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic
reactions)
WARNINGS AND PRECAUTIONS
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Increased Risk of Thrombotic Events after Premature
Discontinuation: Premature discontinuation of any oral
anticoagulant, including 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 atrial fibrillation
patients. If ELIQUIS is discontinued for a reason other than
pathological bleeding or completion of a course of therapy, consider
coverage with another anticoagulant.
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Bleeding Risk: ELIQUIS increases the risk of bleeding and can
cause serious, potentially fatal, bleeding.
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Concomitant use of drugs affecting hemostasis increases the risk
of bleeding, including aspirin and other antiplatelet agents,
other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs,
and NSAIDs.
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Advise patients of signs and symptoms of blood loss and to report
them immediately or go to an emergency room. Discontinue ELIQUIS
in patients with active pathological hemorrhage.
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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.
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Spinal/Epidural Anesthesia or Puncture: Patients treated with
ELIQUIS undergoing spinal/epidural anesthesia or puncture may develop
an epidural or spinal hematoma which can result in long-term or
permanent paralysis.
The risk of these events may be
increased by the postoperative use of indwelling epidural catheters or
the concomitant use of medicinal products affecting hemostasis.
Indwelling epidural or intrathecal catheters should not be removed
earlier than 24 hours after the last administration of ELIQUIS. The
next dose of ELIQUIS should not be administered earlier than 5 hours
after the removal of the catheter. The risk may also be increased by
traumatic or repeated epidural or spinal puncture. If traumatic
puncture occurs, delay the administration of ELIQUIS for 48 hours.
Monitor
patients frequently and if neurological compromise is noted, urgent
diagnosis and treatment is necessary. Physicians should consider the
potential benefit versus the risk of neuraxial intervention in ELIQUIS
patients.
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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.
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Acute PE in Hemodynamically Unstable Patients or Patients who
Require Thrombolysis or Pulmonary Embolectomy: Initiation of
ELIQUIS is not recommended as an alternative to unfractionated heparin
for the initial treatment of patients with PE who present with
hemodynamic instability or who may receive thrombolysis or pulmonary
embolectomy.
ADVERSE REACTIONS
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The most common and most serious adverse reactions reported with
ELIQUIS were related to bleeding.
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS
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ELIQUIS should be discontinued at least 48 hours prior to elective
surgery or invasive procedures with a moderate or high risk of
unacceptable or clinically significant bleeding. ELIQUIS should be
discontinued at least 24 hours prior to elective surgery or invasive
procedures with a low risk of bleeding or where the bleeding would be
noncritical in location and easily controlled. Bridging
anticoagulation during the 24 to 48 hours after stopping ELIQUIS and
prior to the intervention is not generally required. ELIQUIS should be
restarted after the surgical or other procedures as soon as adequate
hemostasis has been established.
DRUG INTERACTIONS
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Strong Dual Inhibitors of CYP3A4 and P-gp: Inhibitors of
cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) increase
exposure to apixaban and increase the risk of bleeding. For patients
receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose
of ELIQUIS by 50% when ELIQUIS is coadministered with drugs that are
strong dual inhibitors of CYP3A4 and P-gp (e.g., ketoconazole,
itraconazole, ritonavir, or clarithromycin). In patients already
taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with
strong dual inhibitors of CYP3A4 and P-gp.
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Strong Dual Inducers of CYP3A4 and P-gp: Avoid concomitant use
of ELIQUIS with strong dual inducers of CYP3A4 and P-gp (e.g.,
rifampin, carbamazepine, phenytoin, St. John's wort) because such
drugs will decrease exposure to apixaban and increase the risk of
stroke and other thromboembolic events.
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Anticoagulants and Antiplatelet Agents: Coadministration of
antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic
NSAID use increases the risk of bleeding. APPRAISE-2, a
placebo-controlled clinical trial of apixaban in high-risk post-acute
coronary syndrome patients treated with aspirin or the combination of
aspirin and clopidogrel, was terminated early due to a higher rate of
bleeding with apixaban compared to placebo.
PREGNANCY CATEGORY B
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There are no adequate and well-controlled studies of ELIQUIS in
pregnant women. Treatment is likely to increase the risk of hemorrhage
during pregnancy and delivery. ELIQUIS should be used during pregnancy
only if the potential benefit outweighs the potential risk to the
mother and fetus.
Please see full Prescribing Information, including BOXED WARNINGS and
Medication Guide, available at www.bms.com.
About ARISTOTLE and APPRAISE-2
ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic
Events in Atrial Fibrillation) was designed to evaluate the efficacy and
safety of Eliquis versus warfarin for the prevention of stroke or
systemic embolism. In ARISTOTLE, 18,201 patients were randomized (9,120
patients to Eliquis and 9,081 to warfarin). ARISTOTLE was an
active-controlled, randomized, double-blind, multi-national trial in
patients with nonvalvular atrial fibrillation or atrial flutter, and at
least one additional risk factor for stroke. Patients were randomized to
treatment with Eliquis 5 mg orally twice daily (or 2.5 mg twice
daily in selected patients, representing 4.7 percent of all patients) or
warfarin (target INR range 2.0-3.0), and followed for a median of 1.8
years.
APPRAISE-2 (Apixaban for Prevention of Acute Ischemic Events - 2)
evaluated Eliquis in patients at risk of ischemic events. It was
designed to randomize approximately 10,800 patients with a recent acute
coronary syndrome (ACS (News - Alert)) to Eliquis 5 mg twice daily or placebo,
in addition to mono or dual antiplatelet therapy. The study was stopped
early based on the recommendation of an independent Data Monitoring
Committee (DMC). There was clear evidence of a clinically important
increase in bleeding among patients randomized to Eliquis. This
increase in bleeding was not offset by clinically meaningful reductions
in ischemic events.
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide
collaboration to develop and commercialize apixaban, an oral
anticoagulant discovered by Bristol-Myers Squibb. This global alliance
combines Bristol-Myers Squibb's long-standing strengths in
cardiovascular drug development and commercialization with Pfizer's
global scale and expertise in this field.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to discover, develop and deliver innovative medicines that help
patients prevail over serious diseases. For more information, please
visit www.bms.com
or follow us on Twitter (News - Alert) at http://twitter.com/bmsnews.
About Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world's
premier innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
more than 150 years, Pfizer has worked to make a difference for all who
rely on us. To learn more, please visit us at www.pfizer.com.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding product development. Such forward-looking
statements are based on current expectations and involve inherent risks
and uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking
statement can be guaranteed. Among other risks, there can be
no guarantee that Eliquis will receive approval for these additional
indications or, if approved, that these additional indications will lead
to increased commercial success. Forward-looking statements in this
press release should be evaluated together with the many uncertainties
that affect Bristol-Myers Squibb's business, particularly those
identified in the cautionary factors discussion in Bristol-Myers
Squibb's Annual Report on Form 10-K for the year ended December 31,
2014, in our Quarterly Reports on Form 10-Q and our Current Reports on
Form 8-K. Bristol-Myers Squibb undertakes no obligation to
publicly update any forward-looking statement, whether as a result of
new information, future events or otherwise.
PFIZER DISCLOSURE NOTICE
The information contained in this release is as of August 24, 2015.
Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future
events or developments.
This release contains forward-looking information about Eliquis
(apixaban), including its potential benefits, and clinical trial data
that involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied by
such statements. Risks and uncertainties include, among other things,the
uncertainties inherent in research and development; the ability to
successfully commercialize Eliquis; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer's Annual Report on Form 10-K for the fiscal year ended December
31, 2014 and in its subsequent reports on Form 10, including in the
sections thereof captioned "Risk Factors" and "Forward-Looking
Information and Factors That May Affect Future Results", as well as in
its subsequent reports on Form 8-K, all of which are filed with the SEC (News - Alert)
and available at www.sec.gov and www.pfizer.com.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150824005495/en/
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