Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc.
(NYSE:PFE) today announced results of a pre-specified secondary
analysis of the Eliquis Phase 3 AMPLIFY-EXT trial (Apixaban
after the initial Management of PuLmonary
embolIsm and deep vein thrombosis with First-line
therapY-EXTended Treatment). The analysis evaluated
clinical and demographic predictors of all-cause hospitalization in
patients with VTE, which includes deep vein thrombosis (DVT) and
pulmonary embolism (PE). Results from this analysis demonstrated
that during the 12-month extended treatment of VTE, Eliquis
significantly reduced the risk of hospitalization versus placebo.
This effect was independent of other variables including renal
function, the only other significant predictor of hospitalization
in the AMPLIFY-EXT population. These data were presented during an
oral session today in Barcelona, Spain, at the ESC Congress
2014.
“The results of this AMPLIFY-EXT secondary analysis showed that
Eliquis significantly reduced the risk of hospitalization,
irrespective of other variables,” said Dr. Alexander T. Cohen,
study investigator and consultant physician, Department of
Hematology, Guy’s and St. Thomas’ Hospitals, King’s College,
London. “The findings from this secondary analysis provide
additional support for extended anticoagulation with Eliquis in VTE
patients.”
AMPLIFY-EXT was a randomized, double-blind, placebo-controlled
extended treatment superiority study with 12 months of treatment
plus one month follow-up in patients with VTE who completed six to
12 months of anticoagulation therapy. The secondary analysis
presented today showed that, compared with placebo, Eliquis 2.5 mg
(p=0.032) and 5 mg (p=0.004) were both associated with significant
reduction in all-cause hospitalization. Of the 2,486 patients
included in the AMPLIFY-EXT trial, 138 patients were hospitalized
at least once, including 62 (7.48%) in the placebo group (n=829),
42 (5.00%) in the Eliquis 2.5 mg group (n=840), and 34 (4.18%) in
the Eliquis 5 mg group (n=813). Of the first hospitalizations in
the placebo group, a total of 32 (51.6%) were attributed to VTE
recurrence versus six (17.7%) in the Eliquis 5 mg group and 11
(26.2%) in the Eliquis 2.5 mg group.
The following factors were clinically significant and
independent predictors of all-cause hospitalization during the
trial:
- Eliquis 2.5 mg versus placebo (HR=0.65,
95% CI=0.43-0.96)
- Eliquis 5 mg versus placebo (HR=0.54,
95% CI=0.36-0.83)
- Severe or moderate renal impairment
versus normal renal function (HR=2.26, 95% CI=1.30-3.92).
Sex, age, baseline body weight and type of VTE did not
significantly predict hospitalization.
A total of 14 Bristol-Myers Squibb/Pfizer alliance-sponsored
abstracts, including the AMPLIFY-EXT pre-specified secondary
analysis described above, were accepted for presentation at the ESC
Congress 2014.
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 to reduce the risk of stroke and systemic embolism in
patients with nonvalvular atrial fibrillation in the United States,
European Union, Japan and a number of other countries around the
world. Eliquis is approved for prevention of VTE in adult patients
who have undergone elective hip or knee replacement surgery in the
United States, European Union and a number of other countries
around the world. Eliquis is not approved for this indication in
Japan. Eliquis is approved for the treatment of DVT and PE, and
prevention of recurrent DVT and PE following initial therapy in the
United States and European Union.
ELIQUIS 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.
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 anti-platelet 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 CYP3A4 and P-gp increase exposure to
apixaban and increase the risk of bleeding. For patients receiving
ELIQUIS doses greater than 2.5 mg twice daily, the dose of ELIQUIS
should be decreased by 50% when it is coadministered with drugs
that are strong dual inhibitors of CYP3A4 and P-gp (e.g.,
ketoconazole, itraconazole, ritonavir, or clarithromycin). For
patients receiving ELIQUIS at a dose of 2.5 mg twice daily, avoid
coadministration 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 DVT and PE
VTE encompasses two serious conditions: DVT, a blood clot in a
deep vein, usually in the lower leg, thigh, or pelvis, which
partially or totally blocks the flow of blood; and PE, a blood clot
that blocks one or more vessels in the lungs. Approximately one
million patients in the EU are diagnosed every year with VTE. In
the U.S., the number of adults with VTE is projected to more than
double from 950,000 in 2006 to 1.82 million in 2050. Once a VTE has
occurred, approximately 33% of patients may experience a recurrence
within 10 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, please visit http://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 SquibbMedia:Danielle Halstrom,
609-252-3403danielle.halstrom@bms.comorInvestors:Ranya
Dajani, 609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.comorPfizer Inc.Media:Jennifer
Kokell, 212-733-2596jennifer.kokell@pfizer.comorAndrew Widger, +44
1737 330 909andrew.widger@pfizer.comorInvestors:Ryan Crowe,
212-733-8160ryan.crowe@pfizer.com
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