- Eliquis® (apixaban)
use was associated with lower rates of stroke or systemic embolism
and major bleeding than matched patients receiving rivaroxaban or
dabigatran
- This oral presentation is one of
nine Bristol-Myers Squibb-Pfizer Alliance abstracts being presented
at the American College of Cardiology's 67th Annual Scientific
Session & Expo
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE:
PFE) will present findings today from a real-world data (RWD)
analysis titled, Comparison of Effectiveness, Safety, and the Net
Clinical Outcome between Different Direct Oral Anticoagulants in
162,707 Non-Valvular Atrial Fibrillation Patients Treated in US
Clinical Practice. This is the largest RWD analysis reporting
outcomes among different direct oral anticoagulants (DOACs),
including Eliquis® (apixaban), rivaroxaban and dabigatran, to date.
In this analysis, apixaban use was associated with significantly
lower rates of both stroke/systemic embolism (S/SE) (hazard ratio
[HR]:0.83, 95% confidence interval [CI]: 0.73 to 0.94, p=0.004) and
major bleeding (MB) (HR:0.54, 95% CI: 0.50 to 0.58, p=<0.001)
when compared to rivaroxaban; and significantly lower rates of both
S/SE (HR:0.69, 95% CI: 0.56 to 0.84, p=<0.001) and MB (HR:0.77,
95% CI: 0.68 to 0.88, p=<0.001) when compared to dabigatran.
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This retrospective observational analysis utilizing
pre-specified endpoints included three 1:1 propensity score
individually matched DOAC cohorts: apixaban vs. rivaroxaban
(n=125,238), apixaban vs. dabigatran (n=54,192), and dabigatran vs.
rivaroxaban (n=55,076). The analysis also revealed that in the
dabigatran vs. rivaroxaban cohort, dabigatran was associated with a
significantly lower rate of MB (HR:0.67, 95% CI: 0.60 to 0.74,
p=<0.001) and a non-significantly higher rate of S/SE (HR:1.18,
95% CI: 0.98 to 1.43, p=0.080). It is important to note that, at
this time, there are no head-to-head clinical trials comparing
DOACs. Anticoagulants, including Eliquis, increase the risk of
bleeding and can cause serious, potentially fatal, bleeding. Please
see important safety information below for Eliquis, including BOXED
WARNINGS.
“Most observational, real-world data analyses of direct oral
anticoagulants have used single data sources; in this analysis, we
pooled CMS Medicare data and four U.S. Managed Care claims
databases, including both commercial and Medicare Advantage lives,
covering in total more than 180 million beneficiaries annually1,2 –
more than half of the U.S. population,” said Steven Deitelzweig,
M.D., System Department Chair of Hospital Medicine, Ochsner Medical
Center, New Orleans, and one of the analysis’ primary
investigators. “Being able to see patient claims from different
data sets with good representation across the country may help
decision making in clinical practice.”
Study Details: This was a retrospective observational
cohort analysis of non-valvular atrial fibrillation (NVAF) patients
utilizing pre-specified endpoints and analyzed using
propensity-score matching (PSM). It includes NVAF patients
(n=162,707) from ARISTOPHANES (Anticoagulants for
Reduction In STroke: Observational
Pooled analysis on Health outcomes ANd
Experience of patientS), an ongoing real-world data
analysis initiative that now includes anonymized patient records
from more than 300,000 patients. The analysis presented at ACC
includes patients who initiated apixaban, rivaroxaban or
dabigatran, from Jan. 1, 2013, to Sept. 30, 2015, pooled from 5
large databases, including CMS fee-for-service Medicare data,
Truven MarketScan® Commercial Claims and Encounter and Medicare
Supplemental and Coordination of Benefits Database, the IMS
PharMetrics Plus™ Database, the Optum Clinformatics™ Data Mart, and
the Humana Research Database. After 1:1 DOAC-DOAC PSM in each
database, the resulting patient records were pooled. Patients were
followed for a mean of six months. Cox models were used to evaluate
the rates of S/SE and of MB across DOACs within one year of therapy
initiation. Patients with NVAF were included regardless of the dose
of DOACs used.
Limitations of Real-World Data Analyses and of
ARISTOPHANES: Real-world data have the potential to supplement
randomized controlled trial data by providing additional
information about how a medicine performs in routine medical
practice. Real-world data analyses have several limitations. For
example, the source and type of data used may limit the
generalizability of the results and of the endpoints. Observational
real-world studies can only evaluate association and not causality.
Due to these limitations, real-world data analyses cannot be used
as stand-alone evidence to validate the efficacy and/or safety of a
treatment. It is important to note that, at this time, there are
no head-to-head clinical trials comparing direct oral
anticoagulants.
In this analysis, although PSM was used to control for multiple
confounders, there is still potential for residual bias. Claims for
a filled prescription do not indicate that the medication was
consumed or taken as prescribed. Also, medications filled over the
counter or provided as samples are not captured in the claims
data.
BMS-Pfizer Alliance Real-Word Data (RWD) Program:
ARISTOPHANES is part of the Bristol-Myers Squibb-Pfizer Alliance
global RWD analysis program, ACROPOLIS™ (Apixaban
ExperienCe Through Real-WOrld
POpuLatIon Studies), designed to
generate additional evidence from routine clinical practice
settings to further inform healthcare decision makers, including
healthcare providers and payers. The ACROPOLIS program includes
retrospective, outcomes-based analyses from over 16 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 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 multiple 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
- Combined P-gp and Strong CYP3A4
Inhibitors: Inhibitors of P- glycoprotein (P-gp) and cytochrome
P450 (CYP3A4) 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 combined P-gp and strong CYP3A4
inhibitors (e.g., ketoconazole, itraconazole, or ritonavir). In
patients already taking 2.5 mg twice daily, avoid coadministration
of ELIQUIS with combined P-gp and strong CYP3A4
inhibitors.ClarithromycinAlthough clarithromycin is a combined P-gp
and strong CYP3A4 inhibitor,pharmacokinetic data suggest that no
dose adjustment is necessary with concomitant administration with
Eliquis.
- Combined P-gp and Strong CYP3A4
Inducers: Avoid concomitant use of ELIQUIS with combined P-gp
and strong CYP3A4 inducers (e.g., rifampin, carbamazepine,
phenytoin, St. John’s wort) because such drugs will decrease
exposure to apixaban.
- 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
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 the research, development and commercialization of
pharmaceutical products. 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,
2017, 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 11,
2018. 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, 2017 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 U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
1 Li, X et al. Effectiveness and safety of apixaban versus
warfarin in non-valvular atrial fibrillation patients in
“real-world” clinical practice. Thrombosis and Haemostasis. 2017;
6, 1,007-1,216. https://doi.org/10.1160/TH17-01-0068.
2 Amin, A et al. Risk of stroke/systemic embolism, major
bleeding and associated costs in non-valvular atrial fibrillation
patients who initiated apixaban, dabigatran, or rivaroxaban
compared with warfarin in the United States Medicare population.
Current Medical Research and Opinion. DOI:
10.1080/03007995.2017.1345729
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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: Neha
Wadhwa, 212-733-2835neha.wadhwa@pfizer.comorInvestors: Ryan
Crowe, 212-733-8160ryan.crowe@pfizer.com
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