One-in-Four Canadians Over 40 Will Suffer From Atrial Fibrillation in Their
Health Canada Approves Eliquis™, a New Oral Anticoagulant, for the
Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation
|Increased risk of stroke is one of the most serious medical concerns|
|for people with atrial fibrillation. The condition increases a |
|person's risk of stroke up to five times.(2) |
MONTREAL, Dec. 6, 2012 /CNW/ - Health Canada has approved the oral
anticoagulant Eliquis™ (apixaban) for the prevention of stroke and systemic
embolism in patients with atrial fibrillation (AF).(3) The announcement was
made today by Bristol-Myers Squibb Canada Co. and Pfizer Canada Inc., who
collaborated on the development of the new treatment.
This approval provides a new treatment option for Canadian patients with AF
who typically require life-long anticoagulation therapy (blood thinners) to
lessen their increased risk of a life-threatening or disabling stroke.(3)
Due to Canada's aging population, AF is a growing problem. AF affects more
than 350,000 people in Canada and increases the risk of stroke up to five
times.(2) It is the most common cardiac arrhythmia (irregular heart rhythm)
that starts in the upper parts (atria) of the heart.(4) Unfortunately,
one-in-four Canadians over 40 years of age will suffer from AF in their life
time.(1 )What's more, the death rate of AF-related strokes is twice as high as
from strokes unrelated to AF.(5)
"AF places people at an increased risk of stroke.(4 )Yet despite available
treatment options, many patients remain inadequately managed or
untreated,"(6,7) says Dr. Paul Dorian, Department Division Director,
Cardiology, University of Toronto, and Staff Cardiac Electrophysiologist, St.
Michael's Hospital. "New oral anticoagulants (NOACs) are now the first
recommended options for most patients for stroke prevention in Canada, and by
making new therapies like Eliquis available, the goal is to reduce the burden
of this disease."
Health Canada's approval of Eliquis is based on data from global studies
(ARISTOTLE and AVERROES), which evaluated almost 24,000 patients in what is
the largest clinical trial program conducted to date in patients with AF, in
which Canada was a significant participant.(8,9) The studies compared Eliquis
with warfarin and acetylsalicylic acid (ASA), respectively, and looked at
efficacy relating to stroke and systemic embolism and safety relating to major
bleeding as the primary endpoints, and all-cause death as a secondary
"Stroke is a leading cause of death and disability in Canada.(10) It is a
devastating condition, causing great stress for patients and their families
and costing our healthcare system more than $2.5 billion annually,"(10 )says
Janet McTaggart, Executive Director, Stroke Survivors Association. "Finding
plausible solutions to reduce the number of strokes, which is on the rise in
Canada, will be of great benefit to those affected, their families, and our
"As a person living with atrial fibrillation, fatigue and shortness of breath
are symptoms that I have experienced. I know that my conditionputs me at
greater risk for other medical problems, one being stroke," says Anna Loughlin
who was diagnosed with AF approximately four years ago.
As a class, NOACs have been officially recognized by the Canadian
Cardiovascular Society (CCS) clinical practice guidelines for stroke
prevention in AF as a preferable option to warfarin,(11) previously considered
the standard of care.
Eliquis is also approved in Canada for the prevention of venous thromboembolic
events (VTE) in adult patients who have already undergone elective knee or hip
The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial
Fibrillation (ARISTOTLE) trial compared apixaban with warfarin for the
prevention of stroke or systemic embolism in patients with AF and at least one
additional risk factor for stroke. The primary objective of ARISTOTLE was to
determine whether apixaban is non-inferior to warfarin at reducing the stroke
and systemic embolism, and if so, then determine if apixaban is superior to
warfarin for the prevention of stroke and systemic embolism, major bleeding
and for all-cause death.(12) To read more about this study, visit:
About AVERROES(9 )
The AVERROES (Apixaban, Versus Acetylsalicylic Acid [ASA] to Prevent Stroke in
Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K
Antagonist Treatment) study, led out of McMaster University in Hamilton,
Ontario was designed to determine the efficacy and safety of apixaban, at a
dose of 5 mg twice-daily, as compared with ASA, at a dose of 81 to 324 mg
daily, for the treatment of patients with AF for whom vitamin K antagonist
(VKA, such as warfarin) was considered unsuitable. The primary objective of
the study was to determine whether apixaban 5 mg twice-daily (2.5 mg
twice-daily in selected patients) was superior to ASA (81 to 324 mg QD) in the
prevention of stroke or systemic embolism. Assessments of superiority of
apixaban versus ASA were also pre-specified for major vascular events
(composite outcome of stroke, systemic embolism, myocardial infarction or
vascular death) and all-cause death.(3)
Many patients with AF at moderate or high risk for stroke are not treated with
a VKA.(13) Presently, the only alternative to a VKA with a labeled indication
for AF is antiplatelet therapy with ASA.(13) The AVERROES study tested the
hypothesis that apixaban is superior to ASA for the prevention of stroke or
systemic embolism in patients with AF at moderate or high risk for stroke.(13)
To read more about this study, visit:
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide
collaboration to develop and commercialize Eliquis, an investigational oral
anticoagulant discovered by Bristol-Myers Squibb. This global alliance
combines Bristol-Myers Squibb's longstanding strengths in cardiovascular drug
development and commercialization with Pfizer's global scale and expertise in
About Bristol-Myers Squibb Canada Co.
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of
Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission
is to discover, develop and deliver innovative medicines that help patients
prevail over serious diseases. Bristol-Myers Squibb Canada is a leading
provider of medicines to fight cancer, cardiovascular and metabolic disorders,
infectious diseases (including HIV/AIDS), nervous system diseases and serious
mental illness. Bristol-Myers Squibb Canada's operations are headquartered in
About Pfizer in Canada
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., one of the
world's leading biopharmaceutical companies. Every day, Pfizer Canada
employees work to advance wellness, prevention, treatments and cures that
challenge the most feared diseases of our time. We apply science and our
global resources to improve the health and well-being of Canadians at every
stage of life. Our commitment is reflected in everything Pfizer does, from our
disease awareness initiatives to our community partnerships, to our belief
that it takes more than medication to be truly healthy. To learn more about
Pfizer's More than Medication philosophy and programs, visit
morethanmedication.ca. To learn more about Pfizer Canada, visit www.pfizer.ca.
(1) Lloyd-Jones DM, et al. Lifetime risk for development of atrial
fibrillation: the Framingham Heart Study. Circulation 2004;110:1042-6.
(2) Heart and Stroke Foundation. Statistics.
m. Accessed October 2012.
(3) Eliquis™ Product Monograph. BMS/Pfizer Canada Alliance. December 2012.
(4) HealthLinkBC. Atrial Fibrillation Overview.
http://www.healthlinkbc.ca/kb/content/special/hw160870.html. Accessed October
(5) Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D.
Impact of atrial fibrillation on the risk of death: the Framingham Heart
Study.Circulation. 1998 Sep 8;98(10):946-52.
(6) Woolfenden, A.R., Alberts, G.W. Long-term stroke prevention in atrial
fibrillation. BC Medical Journal (BCMJ). April 2002. Vol. 44, No. 3: pages
(7) Bell A. How does the use of atrial fibrillation patient tools for stroke &
bleeding risk assessment (CHADS2/CHADSVASC/HAS-BLED) in Canada impact
prescribing habits? Assesment of Canadian physician use of objective risk
assessment and stroke prophylaxis in patients with atrial fibrillation.
Canadian Cardiovascular Congress. Toronto, October 27 to 31, 2012.
(8) Granger, C.B., et al. Apixaban versus Warfarin in Patients with Atrial
Fibrillation. New England Journal of Medicine. 2011: pgs 981-992.
(9) Connolly, S.J., et al. Apixaban in Patients with Atrial Fibrillation. New
England Journal of Medicine. 2011: pgs 1-12.
(10) Canadian Stroke Network. Top 10 facts and figures on stroke.
www.lifeafterstroke.ca/stroke/. Accessed October 2012.
(11) Skanes AC, Healey JS, Cairns JA, et al.; Canadian Cardiovascular Society
Atrial Fibrillation Guidelines Committee. Focused 2012 update of the Canadian
Cardiovascular Society atrial fibrillation guidelines: recommendations for
stroke prevention and rate/rhythm control. Can J Cardiol. 2012
(12) Lopes et al. Apixaban for reduction in stroke and other ThromboemboLic
events in atrial fibrillation (ARISTOTLE) trial: design and rationale. Am
Heart J. 2010 Mar;159(3):331-9.
(13) Eikelboom et al. Rationale and design of AVERROES: apixaban versus
acetylsalicylic acid to prevent stroke in atrial fibrillation patients who
have failed or are unsuitable for vitamin K antagonist treatment. Am Heart J.
Jacqueline Zonneville NATIONAL Public Relations 416-848-1398
Christina Antoniou Pfizer Canada 1-866-9PFIZER (734937)
Monica Flores Bristol-Myers Squibb Canada 514-333-3845 email@example.com
SOURCE: Pfizer Canada Inc.
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