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
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
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 endpoint.8,9
"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 healthcare system."
"As a person living with atrial fibrillation, fatigue and shortness of
breath are symptoms that I have experienced. I know that my
condition puts 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 replacement surgery.3
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: http://www.nejm.org/doi/full/10.1056/NEJMoa1107039.
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: http://www.nejm.org/doi/full/10.1056/NEJMoa1007432.
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 this field.
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 Montreal,
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. http://www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3483991/k.34A8/Statistics.htm. 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 2012.
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:
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 Mar;28(2):125-36.
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. 2010 Mar;159(3):348-353.
SOURCE: Pfizer Canada Inc.
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