PRADAX Approved for for Stroke Prevention in Canadians with Atrial Fibrillation

Published: 2010/10/27
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Synopsis: PRADAX is an alternative for Canadians at high risk of stroke due to atrial fibrillation.

Main Digest

First innovative treatment approved in 20 years for stroke prevention in Canadians with AF - PRADAX is a long awaited alternative for a quarter of a million Canadians at high risk of stroke due to atrial fibrillation (AF).

Boehringer Ingelheim (Canada) Ltd. today announces that Health Canada has granted approval of PRADAX (dabigatran etexilate), an oral anticoagulant for the prevention of stroke and systemic embolism in adults with atrial fibrillation in whom anticoagulation is appropriate. PRADAX is the first innovative drug approved in Canada in more than two decades to reduce the risk of stroke in Canadians with atrial fibrillation.1

PRADAX , at a dose of 150 mg twice daily, was shown to be superior to warfarin, the current standard of care, in reducing a patient's chance of suffering a stroke or systemic embolism (blood clot).3 As with all anticoagulants, bleeding is of concern but PRADAX significantly reduced life threatening, intracranial and total bleeding compared to warfarin.2 PRADAX is expected to offer patients much more freedom as it does not require ongoing blood tests and significantly reduces the costs associated with regular monitoring and doctor's visits. It also has no known food interactions and a low potential for interaction with other drugs.3

"Dabigatran is a significant breakthrough in medicine. We have been waiting for a long time for an alternative to warfarin, our current standard treatment against stroke for patients with atrial fibrillation," says Dr. Stuart Connolly, Director, Division of Cardiology at The Population Health Research Institute, at McMaster University in Hamilton. "It is really great to finally have an alternative new treatment for our patients with atrial fibrillation which is not only safer and more effective than our current blood thinners, but also much easier to use. It is also important that many patients who were unsuitable for standard therapy will now have an effective agent that they can use to prevent stroke. The approval of dabigatran will transform the way we treat and manage atrial fibrillation patients at risk of stroke."

Atrial fibrillation, also known as an irregular heartbeat, affects up to 250,000 Canadians,4 and is a serious yet common heart condition that can lead to severe and debilitating strokes. Canadians with AF are at least five times more at risk of having a stroke and are twice as likely to die from one.4 In Canada, stroke is the leading cause of adult disability and the third leading cause of death5 with up to 15 percent of strokes being caused by AF.4

"Stroke and the resulting disability takes a toll on the patient and family. AF-related strokes tend to be much more severe and prevent survivors from carrying out normal everyday activities," said Dr. Mike Sharma, Deputy Director, Canadian Stroke Network and Director Regional Stroke Program, Ottawa Hospital, Civic Campus. "The costs related to stroke can put a big financial burden on patients' families, as well as the health-care system."

The health care costs for patients in the first six months after a stroke total more than $2.5 billion a year, with direct and indirect costs for each patient averaging $50,000 in the first six months following a stroke.6 People with non-disabling strokes spend up to $24,000 during the first six months and the costs for families can increase to over $100,000 for the most severely affected.7 Examples of stroke-related expenses to families include those associated with caregiving, transportation, and lost income.

President and CEO of Boehringer Ingelheim (Canada) Ltd, Dr. Ted Witek said that the company is pleased with the recent Canadian approval, noting: "The approval of PRADAX in Canada marks a new era for stroke prevention in atrial fibrillation, and for the125-year history of Boehringer Ingelheim as a company. Key to Health Canada's decision was the RE-LY® trial, and we proudly recognize that this global program was coordinated out of McMaster University in Hamilton, Ontario. PRADAX will fulfill an unmet therapeutic need and improve the lives of many Canadian patients with atrial fibrillation."

Coinciding with the Health Canada approval of PRADAX , the Canadian Cardiovascular Society (CCS) has released new guidelines on stroke prevention in atrial fibrillation, which contain guidance on the use of dabigatran etexilate. Based on the strength of the safety and efficacy profile of PRADAX , the guidelines state that dabigatran is preferred over warfarin for overall stroke reduction, particularly the 150mg dose twice-daily.8


PRADAX is a novel, reversible oral direct thrombin inhibitor. It provides its anticoagulant effect by selectively blocking the activity of thrombin, the central enzyme in clot formation.9

The Canadian approval of PRADAX for stroke prevention in atrial fibrillation is based on data from the landmark RE-LY® Trial (Randomized Evaluation of Long term anticoagulant therapy) published last year in the New England Journal of Medicine. The study population included patients with high, moderate, and low risk of stroke. PRADAX was proven to be more effective than warfarin at preventing strokes, with comparable safety2.

Specifically, PRADAX 150 mg twice daily significantly reduced the risk of stroke and systemic embolism by 35 percent versus warfarin (p=0.0001), without increasing the risk of major bleeding, and reducing the risk of intracranial bleeding by 59 percent (p<0.0001).3 The efficacy and safety benefits of PRADAX occurred without any evidence of hepatotoxicity.2

Health Canada has approved the 150mg dose of PRADAX to be taken twice-daily for prevention of stroke and systemic embolism in patients with atrial fibrillation in whom anti-coagulation is appropriate. The 110mg dose has been recommended for use in patients 80 years of age or older and may be considered for patients at higher risk of bleeding.3

About the RE-LY® Trial

The RE-LY® (Randomized Evaluation of Long term anticoagulant therapy) was a global, Phase III, randomized trial of 18,113 patients, enrolled in over 950 centers in 44 countries, including 52 centers in Canada including 1,150 Canadian patients, investigating whether dabigatran etexilate (two blinded doses) was as effective as well-controlled warfarin - INR 2.0 - 3.0 - (open label) for stroke prevention.10

Patients with non-valvular AF and at least one other risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack, or systemic embolism, left ventricular dysfunction, 75 years, 65 with either diabetes mellitus, history of coronary artery disease, or hypertension)10 were enrolled in the study for two years with a minimum follow-up period of one year.10

The RE-LY® trial utilized the established PROBE (prospective, randomized, open-label, blinded endpoint evaluation) clinical trial protocol,10 which has been used in the majority of previous trials of anticoagulation for stroke prevention in patients with AF.10 A PROBE design is more reflective of the differences in the management of warfarin and dabigatran in clinical practice and it is reflective of the standard of care for patients.10

In the RE-LY® trial, all clinical outcomes were adjudicated in a blinded manner to minimize bias in assessment of outcomes for each treatment.10 Gastrointestinal bleeding and dyspepsia occurred more frequently with dabigatran than with warfarin.2

The RE-LY® trial was led by Co-Chairmen Professor Stuart Connolly, co-principal investigator of RE-LY® and Director, Division of Cardiology at The Population Health Research Institute, McMaster University, Hamilton, Canada, and Dr. Salim Yusuf, Professor of Epidemiology and Cardiology, Population Health Research Institute McMaster University, Hamilton, Canada and Dr. Lars Wallentin, Professor of Cardiology and Director of the Uppsala University, Sweden.

About AF

Atrial fibrillation is an irregular heart rhythm known as arrhythmia that can cause the heart to beat very fast. While AF is rare in people under 40, its prevalence increases with age.4

After the age of 55, the incidence of AF doubles with each decade of life.4 Other risk factors include heart disease, high blood pressure and diabetes. After age 60, one-third of all strokes are caused by AF.4

About Boehringer Ingelheim (Canada) Ltd. The Boehringer Ingelheim group is one of the world's 15 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and 41,500 employees.

Founded in 1885, the family-owned company is committed to researching and developing novel products of high therapeutic value for human and veterinary medicine. In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 and the Research and Development Center located in Laval, Quebec, Canada since 1988. Boehringer Ingelheim (Canada) Ltd. is home to more than 700 employees including 160 scientists across the country.

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1 Schwartz, N, Albers, G. Dabigatran challenges warfarin's superiority in stroke prevention in atrial fibrillation. Stroke. 2010;41;1307-1309.

2 Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Eng J Med 2009; 361:1139-1151.

3 PRADAX Product Monograph, October 2010

4 Heart and Stroke Foundation of Canada. 2009 Stroke Report Card. (Accessed July 5, 2010)

5 Canadian Stroke Network. (Accessed July 5, 2010)

6 (Accessed October 19, 2010)

7 Mittmann N, Seung SJ, Sharma M, and the BURST study investigators. Impact of disability status on ischaemic stroke costs. Presented at the 2010 International Stroke Congress, Feb 25 2010, San Antonio, TX. Poster P538; Stroke; 41;4:e390.

8 Carins, John A et al. Prevention of Stroke and Systemic Embolism in Atrial Fibrillation and Flutter. Slides from the CCS Atrial Fibrillation Guidelines Symposium at CCC 2010. Chapter 5, p. 12.

9 Van Ryn J, Hauel, N, Waldmann L. et al. Dabigatran inhibits both clot-bound and fluid-phase thrombin in vitro: comparison to heparin and hirudin. 2008 ATVB Oral Presentations (P570). Arterioscler Thromb Vasc Biol 2008; 28:el36-7.

10 Ezekowitz MD, Connolly S, Parekh A, et al. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulation therapy, warfarin, compared with dabigatran. Am Heart J 2009; 157:805-810.

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