Nineteen abstracts to be presented,
including new post-hoc sub-analyses from the ARISTOTLE Phase 3
trial and multiple retrospective real-world data analyses from
ACROPOLIS
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE:
PFE) announced today that 19 abstracts (late-breaking, rapid-fire,
oral and poster presentations) will be presented at ESC Congress
2016, to be held August 27–31 in Rome, Italy. These new data from
post-hoc analyses from ARISTOTLE (Apixaban for
Reduction In STroke and Other
ThromboemboLic Events in Atrial Fibrillation)
and retrospective real-world data analyses continue to underscore
the Alliance’s commitment to the evaluation of Eliquis for patients
with nonvalvular atrial fibrillation (NVAF) and venous
thromboembolism (VTE). Of note, several of the real-world data
analyses are part of ACROPOLIS™ (Apixaban ExperienCe
Through Real-WOrld POpuLatIon
Studies), a global real-world data research program designed
to further evaluate the effectiveness and safety of apixaban in
routine clinical practice.
“The Bristol-Myers Squibb and Pfizer Alliance is pleased to
share 19 abstracts, which include new real-world analyses, as well
as new sub-analyses from the pivotal Phase 3 ARISTOTLE trial,” said
Rory O’Connor, M.D., Chief Medical Officer, Internal Medicine,
Pfizer Innovative Health. “We look forward to the opportunity to
contribute to the scientific discussion and continued research
during ESC Congress 2016.”
“As patient and provider needs continue to evolve, it’s
essential that we deepen our understanding of how medicines are
working in real-world situations,” said Jack Lawrence, M.D., Vice
President, Cardiovascular Specialty Development, Bristol-Myers
Squibb. “This year at ESC Congress 2016, we’ll be discussing new
NVAF and VTE data that complement our robust body of clinical trial
data.”
The complete list of Bristol-Myers Squibb and Pfizer Alliance
presentations is included below. Abstracts can be accessed on the
ESC Congress 2016 website.
Title Presenting Author/Type Date/Time
(BST) Location/Session Phase 3 Clinical Trial
Sub-Analyses
Patients with Atrial Fibrillation and
History of Falls Are at High Risk for Bleeding but Have Less
Bleeding with Apixaban than Warfarin: Results from the ARISTOTLE
Trial
Session: New Trends in Antithrombotic
Therapy for Atrial Fibrillation
Rao et al. /Oral, Rapid Fire
Aug. 28,11:10
Agora 1 – Poster Area
Efficacy and Safety of Apixaban versus
Warfarin in Patients with Atrial Fibrillation and Active Cancer:
Insights from the ARISTOTLE Trial
Session: New Trends in Antithrombotic
Therapy for Atrial Fibrillation
Melloni et al. /Oral, Rapid Fire
Aug. 28,11:20
Agora 1 – Poster Area
Patients with Atrial Fibrillation Treated
with Apixaban Are Less Likely to Discontinue Study Drug When
Compared with Warfarin: Insights from the ARISTOTLE Trial
Session: Poster Session 3: Anticoagulation
in Atrial Fibrillation III
Xavier et al. /Poster
Aug. 28,14:00
Poster Area
Real-World Data and Other Analyses
Contemporary Results from EHR Study of
Real-World Bleeding Risk among Elderly and Overall Non-Valvular
Atrial Fibrillation Patients Prescribed Apixaban, Dabigatran,
Rivaroxaban and Warfarin
Session: New Trends in Antithrombotic
Therapy for Atrial Fibrillation
Horblyuk et al. /Oral, Rapid Fire
Aug. 28,12:00
Agora 1 – Poster Area
Real-World Comparisons of Major Bleeding
Risk and Major Bleeding-Related Hospitalization Costs among Elderly
Non-Valvular Atrial Fibrillation Patients Newly Initiated on
Apixaban or Warfarin
Session: Poster Session 3: Anticoagulation
in Atrial Fibrillation
Lip et al. /
Poster
Aug. 28,14:00
Poster Area
Is Major Bleeding Risk for Oral
Anticoagulants Similar Between Non-Valvular Atrial Fibrillation
Patients Newly Initiated on Warfarin and Propensity-Score Matched
NOAC Initiators? A Real World Study
Session: Poster Session 3: Anticoagulation
in Atrial Fibrillation
Lip et al. /Poster
Aug. 28,14:00
Poster Area
Major Bleeding Risk in Patients 75 Years
of Age or Older with Non-Valvular Atrial Fibrillation Initiating
Oral Anticoagulants: A ‘Real-World’ Comparison of Warfarin,
Apixaban, Dabigatran, or Rivaroxaban
Session: Poster Session 3: Anticoagulation
in Atrial Fibrillation II
Lip et al. /
Poster
Aug. 28,14:00
Poster Area
Is There a Difference in Treatment
Persistence Across Oral Anticoagulants? Results of a UK Cohort
Study Evaluating Oral Anticoagulation Therapy in an Atrial
Fibrillation Population
Session: Poster Session 3: Anticoagulation
in Atrial Fibrillation
Stynes et al. /Poster
Aug. 28,14:00
Poster Area
Real-World Comparison of Major Bleeding
and Associated Costs among Treatment-Naïve Non-Valvular Atrial
Fibrillation Patients Initiating Apixaban or Warfarin
Session: Poster Session 3: Anticoagulation
in Atrial Fibrillation II
Trocio et al. /Poster
Aug. 28,14:00
Poster Area
Aspirin, not without Bleeding Risk in the
Real World: Results of a UK Cohort Study Evaluating the Use of
Antiplatelet Therapy for Stroke Prevention in Atrial Fibrillation
(AF)
Session: Poster Session 3: Anticoagulation
in Atrial Fibrillation III
Ridha et al. / Poster
Aug. 28,14:00
Poster Area
Is Aspirin Monotherapy Effective for
Stroke Prevention in the Real World? A UK Cohort Study Evaluating
the Incidence of Stroke in the Absence of Anticoagulation in Atrial
Fibrillation (AF)
Session: Poster Session 3: Anticoagulation
in Atrial Fibrillation II
Ridha et al. /
Poster
Aug. 28,14:00
Poster Area Differences in the Characteristics of Patients with
Non-Valvular Atrial Fibrillation Who Are Newly Prescribed Apixaban,
Rivaroxaban, Dabigatran and VKA in General Practice in the UK
Session: Poster Session 3: Anticoagulation
in Atrial Fibrillation
Stynes et al. /Poster
Aug. 28,14:00
Poster Area
Risk of Bleeding with Non-Vitamin K
Antagonists and Phenprocoumon in Routine Care Patients with
Non-Valvular Atrial Fibrillation
Session: Poster Session 3: Anticoagulation
in Atrial Fibrillation III
Hohnloser et al. /Poster
Aug. 28,14:00
Poster Area
Are Your Atrial Fibrillation (AF) Patients
Protected from Ischaemic Stroke? Clinical Characteristics of AF
Patients Eligible for Stroke Prevention but Remaining Untreated in
UK Clinical Practice
Session: Poster Session 3: Anticoagulation
in Atrial Fibrillation II
Ridha et al. /Poster
Aug. 28,14:00
Poster Area
Bleeding Risk for Non-Valvular AF Patients
Prescribed Warfarin, or Standard Doses of Apixaban 5mg BID,
Dabigatran 150mg BID or Rivaroxaban 20mg QD in Real-World Practice:
Findings from EHR
Session: Are You Still Afraid about
Bleeding Risk of Antithrombotic Therapy in Atrial Fibrillation?
Lip et al. /Oral, Advances in Science
Aug. 28,14:18
Minsk – Village 4
Demographic and Clinical Characteristics
Associated with Initiation of Individual Oral Anticoagulants among
Patients with Newly Diagnosed Venous Thromboembolism
Session: Poster Session 4: Thrombosis and
Coagulation
Li et al. /Poster
Aug. 29,08:30
Poster Area
A Nationwide Register Study to Compare
Bleeding Rates in Patients with Non-Valvular Atrial Fibrillation
Prescribed Oral Anticoagulants
Session: Registries Atrial
Fibrillation
Halvorsen et al. /Late-Breaker
Aug. 29,08:45
Raphael – The Hub
Costs of Major Adverse Outcomes in
Patients with Incident Venous Thromboembolism in Clinical Practice
in the United Kingdom
Session: Advances in Pulmonary
Embolism
Cohen et al. /Poster
Aug. 29,16:03
Moderated Poster Station – Poster Area
Potential Impact of Apixaban on Hospital
Resource Use in Patients with Venous Thromboembolism
Session: Antithrombotics in Daily Clinical
Practice
Li et al. /Oral, Rapid Fire
Aug 30,17:24
Galileo – The Hub
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 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 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, Pfizer has worked to make a difference for
all who rely on us. For more information, please visit us
at www.pfizer.com. In addition, to learn more, follow us on
Twitter at @Pfizer
and @Pfizer_News, 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,
2015, 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 23,
2016. 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; 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, 2015 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160823005490/en/
Bristol-Myers SquibbMedia: Rob Perry, 407-492-4616,
rob.perry@bms.comInvestors: Bill Szablewski, 609-252-5894,
william.szablewski@bms.comorPfizer Inc.Media: Steven Danehy,
212-733-1538, steven.danehy@pfizer.comInvestors: Ryan Crowe,
212-733-8160, ryan.crowe@pfizer.com
Pfizer (NYSE:PFE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From Apr 2023 to Apr 2024