One-in-Four Canadians Over 40 Will Suffer From Atrial Fibrillation in Their Life Time(1)

One-in-Four Canadians Over 40 Will Suffer From Atrial Fibrillation in Their 
Life Time(1) 
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 
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 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 
replacement surgery.(3) 
About ARISTOTLE(8)
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. 
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: 
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, Quebec. 
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. 
References
______________________________ 
(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.ht
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 
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: pages 
135-140.
(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.   
Jacqueline Zonneville NATIONAL Public Relations 416-848-1398 
jzonneville@national.ca 
Christina Antoniou Pfizer Canada 1-866-9PFIZER (734937) 
christina.antoniou@pfizer.com 
Monica Flores Bristol-Myers Squibb Canada 514-333-3845 monica.flores@bms.com   
SOURCE: Pfizer Canada Inc. 
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CO: Bristol-Myers Squibb Canada
ST: Quebec
NI: MTC HEA HEA ECOSURV  
-0- Dec/06/2012 15:40 GMT