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 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, 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.
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: 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.
SOURCE: Pfizer Canada Inc.
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