New indication will help Canadians with coronary artery disease prevent heart attack, stroke or death
Toronto, Ontario (September 18, 2018) – Bayer Inc. has announced that Health Canada has approved XARELTO® (rivaroxaban) film-coated tablet (2.5 mg), in combination with 75 mg – 100 mg acetylsalicylic acid (ASA)* for the prevention of stroke, myocardial infarction and cardiovascular death, and for the prevention of acute limb ischemia and mortality in patients with coronary artery disease (CAD) with or without peripheral artery disease (PAD). The latest indication for Xarelto, in combination with ASA, is based on evidence from COMPASS, the largest study of Xarelto to date, which enrolled 27,395 patients from more than 30 countries, including 50 trial sites in Canada. The COMPASS study was conducted by the Population Health Research Institute (PHRI) based in Hamilton, ON in collaboration with Bayer Inc.
Despite the use of effective secondary preventive strategies, 5 to 10% of patients with cardiovascular disease have recurrent events each year.1, The study called (Cardiovascular OutcoMes for People using Anticoagulation StrategieS) COMPASS, which was led by the Population Health Research Institute of McMaster University and Hamilton Health Sciences, demonstrated how to improve upon ASA to protect against heart attack,stroke or cardiovascular death in patients with CAD, with or without PAD.
The COMPASS study
The COMPASS study demonstrated that Xarelto 2.5 mg twice daily in combination with ASA 100 mg once daily reduced the risk of the composite outcome of stroke, cardiovascular death and heart attack by 24% (relative risk reduction) compared to ASA 100 mg once daily alone.1 Also, Xarelto 2.5 mg twice daily in combination with ASA 100 mg once daily compared with ASA/ 100 mg once daily alone reduced the risk of stroke by 42% (relative risk reduction) and all-cause mortality by 18% (relative risk reduction).1 Bleeding incidence rates were low, and notably, there was no significant increase in fatal or intracranial bleeding.1 The COMPASS findings were also published in The New England Journal of Medicine.1
“The COMPASS results, which support the new indication, have shown that combining ASA with the anti-coagulant Xarelto is far more effective than ASA alone and should change the way clinicians treat these high risk patients. It’s like giving these patients an additional seat belt against future heart attacks and stroke,” said Dr. John Eikelboom, co-principal investigator for COMPASS and Associate Professor, Division of Hematology & Thromboembolism, Department of Medicine, McMaster University, Canada.
About cardiovascular disease
In Canada, approximately 2.4 million people live with cardiovascular disease, which is the second leading cause of death. And according to a recent Leger survey conducted on behalf of Bayer Canada, nearly half of Canadians who have been diagnosed with heart disease and/or have had a heart attack are scared of having another cardiac event and almost 20% did not know that CAD increases the risk of a heart attack. CAD and PAD are caused by atherosclerosis, a chronic, progressive disease which is characterized by a build-up of plaque in the arteries., Patients with these conditions are at risk of developing blood clots which may lead to dangerous infections, loss of limb and loss of life.8,,
About Xarelto® (rivaroxaban)
Rivaroxaban is a non-vitamin K antagonist oral anticoagulant (NOAC), which helps to prevent blood from clotting, and is marketed under the brand name XARELTO®. Xarelto is approved for four indications in Canada:
XARELTO® (rivaroxaban) film-coated tablet (10 mg, 15 mg, 20 mg) is indicated for the:
- prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip replacement (THR) or total knee replacement (TKR) surgery.
- treatment of venous thromboembolic events (deep vein thrombosis [DVT], pulmonary embolism [PE]) and prevention of recurrent DVT and PE.
- prevention of stroke and systemic embolism in patients with atrial fibrillation, in whom anticoagulation is appropriate.
XARELTO® (rivaroxaban) film-coated tablet (2.5 mg), in combination with 75 mg – 100 mg acetylsalicylic acid (ASA), is indicated for the:
- prevention of stroke, myocardial infarction and cardiovascular death, and for the prevention of acute limb ischemia and mortality in patients with coronary artery disease (CAD) with or without peripheral artery disease (PAD)
While licences may differ from country to country, across all indications, Xarelto is approved in more than 130 countries.
Rivaroxaban was discovered by Bayer, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer and in the U.S. by Janssen Pharmaceuticals, Inc. (Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson).
Anticoagulant medicines are potent therapies used to prevent or treat serious illnesses and potentially life-threatening conditions. Before initiating therapy with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.
The full product monograph is available here https://www.bayer.ca/omr/online/xarelto-pm-en.pdf.
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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2017, the Group employed around 99,800 people and had sales of EUR 35.0 billion. Capital expenditures amounted to EUR 2.4 billion, R&D expenses to EUR 4.5 billion. For more information, go to www.bayer.ca.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Juanita Leon Sandy Caetano
Cohn & Wolfe Cohn & Wolfe
(416) 924-5700 ext. 4031 (416) 924-5700 ext. 4046
* Acetylsalicylic acid (ASA) is the active ingredient in ASPIRIN®.
 Eikelboom JW, Connolly SJ, Bosch J et al. Rivaroxaban With and Without Aspirin in Stable Coronary or Peripheral Artery Disease. New England Journal of Medicine 2017; http://www.nejm.org/doi/full/10.1056/NEJMoa1709118#t=article. Accessed May 24, 2018.
 Bhatt DL, Eagle KA, Ohman EM, et al. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA 2010; 304: 1350-7.
 Government of Canada. Heart disease – heart health https://www.canada.ca/en/public-health/services/diseases/heart-disease-heart-health.html Accessed May 23, 2018
 Government of Canada. Heart disease in Canada. https://www.canada.ca/en/public-health/services/publications/diseases-conditions/heart-disease-canada.html Accessed June 2018.
 This poll was conducted by Leger on behalf of Bayer Canada. A total of 500 Canadians aged 50+ who have been diagnosed with heart disease and/or had a heart attack was completed online between May 10th to 21st 2018 using Leger’s online panel, LegerWeb. A probability sample of the same size would yield a margin of error of +/-2.5%, 19 times out of 20.
 Viles-Gonzalez FJ, Fuster V, Badimon JJ. Atherothrombosis: A widespread disease with unpredictable and life-threatening consequences. European Heart Journal 2004;25:1197-1207
 What is Atherosclerosis? U.S. Department of Health & Human Services, National Heart Blood and Lung Institute. https://www.nhlbi.nih.gov/health/health-topics/topics/atherosclerosis. Accessed June 2018
 What Is Peripheral Artery Disease? U.S. Department of Health & Human Services, National Heart Blood and Lung Institute. https://www.nhlbi.nih.gov/health/health-topics/topics/pad. Accessed June 2018
 What Is Coronary Heart Disease? U.S. Department of Health & Human Services, National Heart Blood and Lung Institute. https://www.nhlbi.nih.gov/health/health-topics/topics/cad. Accessed June 2018