- Twenty-two abstracts to be
presented, including new analyses from ARISTOTLE and real-world
data analyses evaluating the risk of major bleeding,
bleeding-related hospital readmissions, hospitalization rates and
healthcare costs among patients with nonvalulvar atrial
fibrillation (NVAF) receiving novel oral anticoagulant
(NOACs)
- Results from the AEGEAN (Assessment
of an Educational and Guidance Programme for Eliquis Adherence in
Nonvalvular Atrial Fibrillation) study will also be presented as a
late-breaking trial
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 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
PresentingAuthor/Type
Date/Time(BST)
Location/Session Randomized Trials
Assessment of an Educational and Guidance
Programme for Eliquis Adherence in Nonvalvular Atrial Fibrillation
(AEGEAN)Session: Atrial Fibrillation / Pacing
Gilles Montalescot / Hot Line Oral
Aug. 3017:16-17:28
London – Main Auditorium Steven Lip /
Discussant Review
Aug. 3017:28-17:35
London – Main Auditorium Panel Discussion
Aug. 3017:28-17:38
London – Main Auditorium
Real-World Data
Analyses
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 WarfarinSession: Anticoagulation and atrial
fibrillation III
Gregory Lip, et al / Poster
Aug. 3014:00-15:30
Poster Area – Poster Area
Major Bleeding, Hospitalization Rates and
Healthcare Costs among Non-Valvular Atrial Fibrillation Patients
Naïve to Oral Anticoagulation and Newly Treated with Novel Oral
AnticoagulantsSession: Impact of the environment on anticoagulation
in non-valvular atrial fibrillation
Steven Deitelzweig, et al /
Oral, Rapid Fire
Aug. 3014:09-14:18
Holland Park – The Hub
Real-World Comparison of Bleeding Risks
among Non-Valvular Atrial Fibrillation Patients on Apixaban,
Dabigatran, Rivaroxaban: Cohorts Comprising New Initiators and/or
Switchers from WarfarinSession: Impact of the environment on
anticoagulation in non-valvular atrial fibrillation
Gregory Lip, et al / Oral, Rapid Fire
Aug. 3014:45-14:54
Holland Park – The Hub
Lower Risk of Myocardial Infarction in
Atrial Fibrillation Patients Treated with Vitamin K Antagonist than
in Combination with Acetylsalicylic Acid (ASA) or ASA AloneSession:
Oral anticoagulants still in the focus
Christina Jiyoung Lee, et al /
Moderated Poster
Aug. 3111:20-11:37
Tunis – Village 7
Patient Profile in Non-Valvular Atrial
Fibrillation (NVAF) and Stroke: Findings from a Real-World Setting
in SpainSession: Atrial fibrillation III
Cinira Lefevre, et al / Poster
Sept. 18:30-12:30
Poster Area – Poster Area
Real-World Comparison of Major Bleeding
Risk among Non-Valvular Atrial Fibrillation Patients Newly
Initiated on Apixaban, Dabigatran, Rivaroxaban or WarfarinSession:
Anticoagulation and atrial fibrillation III
Gregory Lip, et al / Poster
Sept. 114:00-18:00
Poster Area – Poster Area
Real-World Bleeding Risk among
Non-Valvular Atrial Fibrillation (NVAF) Patients Prescribed
Apixaban, Dabigatran, Rivaroxaban and Warfarin: Analysis of
Electronic Health RecordsSession: Anticoagulation and atrial
fibrillation III
Lin, et al / Poster
Sept. 114:00-18:00
Poster Area – Poster Area
Patient Profile of Oral Anticoagulation
(OAC) Use in People with Nonvalvular Atrial Fibrillation (NVAF):
Findings from REACT-AF 2 Study in UK Primary Care DataSession:
Anticoagulation and atrial fibrillation I
Andrew Maguire, et al / Poster
Sept. 114:00-18:00
Poster Area – Poster Area
Management of Anticoagulation in Patients
with Non-Valvular Atrial Fibrillation in General Practice in UK:
Evolution and Characteristics of Patients Not Treated with
Antithrombotic TherapySession: Anticoagulation and atrial
fibrillation II
Essra Ridha, et al /
Poster
Sept. 114:00-18:00
Poster Area – Poster Area
Management of Anticoagulation in Patients
with Nonvalvular Atrial Fibrillation in General Practice in UK:
Evolution and Characteristics of Patients Treated with Antiplatelet
Therapy AloneSession: Anticoagulation and atrial fibrillation
III
Essra Ridha, et al /
Poster
Sept. 114:00-18:00
Poster Area – Poster Area
Clinical and Demographic Characteristics
According to Dosage among Nonvalvular Atrial Fibrillation Patients
Newly Initiated on Novel Oral AnticoagulantsSession:
Anticoagulation and atrial fibrillation I
Cristina Masseria, et al / Poster
Sept. 114:00-18:00
Poster Area – Poster Area
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
Steven Deitelzweig, et al / Poster
Sept. 114:00-18:00
Poster Area – Poster Area
Phase 3 Clinical Trial
Subanaylses
Less Non-Major Bleeding with Apixaban
versus Warfarin among Patients with Atrial Fibrillation: Insights
from the ARISTOTLE TrialSession: Impact of the environment on
anticoagulation in non-valvular atrial fibrillation
Maria Cecilia Bahit, et al / Oral, Rapid Fire
Aug. 3014:27-14:36
Holland Park – The Hub
Efficacy and Safety of Apixaban Compared
with Warfarin in Relation to Renal Function over Time in Patients
with Atrial Fibrillation: Insights from the ARISTOTLE TrialSession:
Impact of the environment on anticoagulation in non-valvular atrial
fibrillation
Ziad , et al / Oral, Rapid Fire
Aug. 3014:36-14:45
Holland Park – The Hub
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 FibrillationSession: Anticoagulation in non-valvular
atrial fibrillation
John Alexander, et al / Oral
Aug. 3014:37-14:54
Madrid – Village 4
External Validation of the Biomarker-Based
ABC-Stroke Risk Score for Atrial FibrillationSession: Predicting
the future: the accuracy of risk scores
Ziad Hijazi, et al /
Moderated Poster
Aug, 3116:50-17:07
San Marino – Village 2
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
TrialSession: Flash news on antithrombotics
Emil Hagstrom, et al / Oral, Rapid Fire
Sept. 19:33-9:42
Agora – Poster Area
Digoxin Use is Associated with Higher
Mortality among Patients with Atrial Fibrillation with and without
Heart Failure: Insights from the ARISTOTLE TrialSession: New
insights in arrhythmias: mechanisms and treatment
Roberto Rordorf, et al / Poster
Sept. 114:00-18:00
Poster Area – Poster Area
Indirect Treatment
Comparisons and Economic Value Analyses
Potential Clinical Benefits and Cost
Savings Associated with Inclusion of Apixaban in the Formulary for
Treatment of Patients with Venous ThromboembolismSession:
Thrombosis and coagulation
Melissa Hamilton, et al / Poster
Aug. 308:30-12:30
Poster Area– Poster Area
A Simulated Head-to-Head Comparison of
Stroke and Major Bleeding with Apixaban versus Rivaroxaban in
High-Risk NVAF PatientsSession: Atrial fibrillation and
anticoagulation
Jack Ishack, et al /
Poster
Aug. 3114:00-18:00
Poster Area – Poster Area
Comparative Cost-Effectiveness of Oral
Anticoagulants for Stroke Prevention in Non-Valvular Atrial
Fibrillation Patients in the UKSession: Antithrombotic prophylaxis
in atrial fibrillation
Tereza Lanitis, et al / Moderated Poster
Sept. 110:51-11:00
Moderated Poster Station – Poster Area
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
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE
RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
(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. (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:
- use of indwelling epidural catheters
- concomitant use of other drugs that affect hemostasis, such
as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet
inhibitors, other anticoagulants
- a history of traumatic or repeated epidural or spinal
punctures
- a history of spinal deformity or spinal surgery
- optimal timing between the administration of ELIQUIS and
neuraxial procedures is not known
Monitor patients frequently for signs and symptoms of
neurological impairment. If neurological compromise is noted,
urgent treatment is necessary. Consider the benefits and
risks before neuraxial intervention in patients anticoagulated or
to be anticoagulated.
CONTRAINDICATIONS
- Active pathological bleeding
- Severe hypersensitivity reaction to
ELIQUIS (e.g., anaphylactic reactions)
WARNINGS AND PRECAUTIONS
- 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.
- 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 antiplatelet agents, other anticoagulants, heparin,
thrombolytic agents, SSRIs, SNRIs, and NSAIDs.
- 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.
- 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.
- 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.
- 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.
- 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
- The most common and most serious
adverse reactions reported with ELIQUIS were related to
bleeding.
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER
INTERVENTIONS
- 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
- 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.
- 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.
- 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
- 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) 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 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 and available
at www.sec.gov and www.pfizer.com.
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version on businesswire.com: http://www.businesswire.com/news/home/20150824005495/en/
Bristol-Myers SquibbMedia:Kirby Hosea,
609-419-5071kirby.hosea@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorBill Szablewski,
609-252-5894william.szablewski@bms.comorPfizer Inc.Media:Steven
Danehy, 212-733-1538steven.danehy@pfizer.comorInvestors:Ryan Crowe,
212-733-8160ryan.crowe@pfizer.com
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