- Post-hoc Analyses from the ARISTOTLE
Trial Featured in Late-Breaker and Poster Sessions
- Real-World Data Analyses Include
Database Reviews of U.S. Medicare Patient Population
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc.
(NYSE:PFE) today announced that eight abstracts have been accepted
for presentation at the American College of Cardiology (ACC) 66th
Annual Scientific Session, taking place March 17-19 in Washington,
D.C. In addition to post-hoc analyses from the pivotal Phase 3
ARISTOTLE (Apixaban
for Reduction In STroke
and Other ThromboemboLic Events
in Atrial Fibrillation) trial, the Bristol-Myers Squibb and Pfizer
Alliance will present real-world data analyses that illustrate the
Alliance’s ongoing commitment to understanding the use of direct
oral anticoagulants, including Eliquis™ (apixaban), in routine
clinical practice. This real-world research, part of the global
ACROPOLIS™ (Apixaban ExperienCe Through
Real-WOrld POpuLatIon
Studies) program, aims to complement findings from clinical
trials and contribute to the growing body of knowledge around
anticoagulation.
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In a Late-Breaking Clinical Trials session, the Alliance will
highlight a post-hoc analysis from the ARISTOTLE trial, titled
ARISTOTLE: Digoxin and Mortality in Patients with Atrial
Fibrillation with and without Heart Failure: Does Serum Digoxin
Concentration Matter? Results of the analysis will be presented on
March 19 at 11:00 a.m. Eastern Daylight Time.
“During ACC, the Bristol-Myers Squibb and Pfizer Alliance will
share several analyses that delve deeper into the robust data
generated from the ARISTOTLE study,” said Christoph Koenen, M.D.,
MBA, VP, Development Lead, Eliquis, Bristol-Myers Squibb. “Through
continued analyses and support of the ARISTOTLE trial, we can
examine topics such as outcomes for patients with different
comorbidities and the potential treatment effects of interacting
drugs, which expands our scientific understanding.”
“As physicians evaluate options for reducing stroke risk in
patients with non-valvular atrial fibrillation, they often face
questions about the effectiveness and safety of therapies in
day-to-day practice,” said Rory O’Connor, M.D., Chief Medical
Officer, Pfizer Innovative Health. “Real-world data analyses allow
us to explore the usage of Eliquis and anticoagulants across
various geographies and subgroups of patients. Alongside clinical
data, the real-world data analyses we are presenting during ACC
have the potential to help healthcare providers make more informed
decisions along with their patients.”
Below is a complete list of Bristol-Myers and Pfizer Alliance
presentations during ACC. Abstracts can be accessed through the
ACC.17 Online Program Planner.
Title Presenting Author/Type
Date/Time (EDT)
Location/Session Phase 3 Clinical Trial Post-Hoc
Analyses
ARISTOTLE: Digoxin and Mortality in
Patients with Atrial Fibrillation with and without Heart Failure:
Does Serum Digoxin Concentration Matter?
Session: Late-Breaking Clinical Trials
Lopes et al./
Late-Breaker
Mar. 19, 11:00 AM Late-Breaking
Clinical Trials, ACC.17 Main Tent, Hall D Use of Interacting Drugs
Did Not Modify Treatment Effects of Apixaban Versus Warfarin for
Atrial Fibrillation: Results from the ARISTOTLE Trial
Session: Arrhythmias and Clinical EP:
Anticoagulation Issues
Washam et al./
Poster
Mar. 18,
9:45 AM
Poster Hall, Hall C Aortic Stenosis, but Not Mitral
or Aortic Regurgitation, Associated with Adverse Outcomes with
Atrial Fibrillation: Results from the ARISTOTLE Trial
Session: Arrhythmias and Clinical EP: AF
Miscellaneous and Surgical Issues
Wang et al./
Poster
Mar. 18,
3:45 PM
Poster Hall, Hall C
Real-World Data and Other
Analyses
Effectiveness and Safety of Apixaban,
Dabigatran, and Rivaroxaban Compared to Warfarin among Non-Valvular
Atrial Fibrillation Patients in the US Medicare Population
Session: Atrial Fibrillation,
Anticoagulation and Novel Device Therapies
Amin et al./
Moderated Poster
Mar. 17, 11:15 AM Arrhythmias and
Clinical EP Moderated Poster Theater, Poster Hall, Hall C Real
World Evaluation of Major Bleeding Risk and Costs for All Causes
and Bleeding-related Health Services among Elderly Patients with
Nonvalvular Atrial Fibrillation Treated with Apixaban or Warfarin
Session: Atrial Fibrillation,
Anticoagulation and Novel Device Therapies
Deitelzweig et al./ Moderated Poster
Mar. 17, 10:15 AM Arrhythmias and Clinical EP
Moderated Poster Theater, Poster Hall, Hall C Real-World Comparison
of Major Bleeding and Associated Costs among Oral
Anticoagulant-naïve Non-valvular Atrial Fibrillation Patients
Initiating Apixaban, Dabigatran, Rivaroxaban, or Warfarin in the US
Medicare Population
Session: Arrhythmias and Clinical EP:
Anticoagulation Issues
Amin et al./ Poster Mar. 18,
9:45 AM
Poster Hall, Hall C Bleeding Risk among Japanese
Non-valvular Atrial Fibrillation Patients Initiated on Apixaban,
Dabigatran, Rivaroxaban or Warfarin in the Real World
Session: Arrhythmias and Clinical EP:
Anticoagulation Issues
Wang et al./
Poster
Mar. 18,
9:45 AM
Poster Hall, Hall C What are the Differences in Oral
Anticoagulant Treatment Persistence in Non-Valvular Atrial
Fibrillation in Europe? Real-World Studies in Three European
Countries
Session: Innovative Approaches for
Reducing Risk and Improving Outcomes With Ablation
Fauchier et al./
Poster
Mar. 18,
3:45 PM
Poster Hall, Hall C
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 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
(NVAF); 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 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 ACROPOLIS™
ACROPOLIS™ (Apixaban ExperienCe Through
Real-WOrld POpuLatIon
Studies) is the Eliquis (apixaban) global real-world data
program designed to generate additional evidence from routine
clinical practice settings to further inform healthcare decision
makers, including healthcare providers and payers. The ACROPOLIS
program will include retrospective, outcomes-based analyses from
over 10 databases around the world, including medical records,
medical and pharmacy health insurance claims data, and national
health data systems.
Analyses of real-world data allow for a broader understanding of
patient outcomes associated with Eliquis outside of the clinical
trial setting, as well as insight into other measures of healthcare
delivery, such as hospitalization and costs.
About ARISTOTLE
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.
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 about Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube and Facebook.
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, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.pfizer.com. In
addition, to learn more, please visit us on www.pfizer.com and
follow us on Twitter at @Pfizer and @PfizerNews, LinkedIn, YouTube
and like us on Facebook at Facebook.com/Pfizer.
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. 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,
2016, 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 March 6,
2017. 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, 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, including,
without limitation, the ability to meet anticipated clinical
trial commencement and completion dates as well as the possibility
of unfavorable clinical trial results, including unfavorable new
clinical data and additional analyses of existing clinical data;
decisions by regulatory authorities regarding labeling and other
matters that could affect the availability or commercial potential
of 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, 2016 and in its subsequent reports on Form 10-Q,
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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Bristol-Myers SquibbMedia:Rob Perry,
407-492-4616rob.perry@bms.comorInvestors:Timothy Power,
609-252-7509timothy.power@bms.comorPfizer Inc.Media:Steven
Danehy, 212-733-1538steven.danehy@pfizer.comorInvestors:Ryan
Crowe, 212-733-8160ryan.crowe@pfizer.com
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