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CORRECTING and REPLACING COMPASS study presented at ESC Congress 2017 – largest rivaroxaban study to date, enrolled 27,395 patients to investigate CAD and PAD

Bayer
Posted on: 28 Aug 17

In the fourth paragraph of release dated 27 August, the quote by Dr Derek Connolly should be replaced with the new text below. Additionally, the document code appearing at the end of the release should be replaced with new code: UKXAR07170353a.

The corrected release reads:

COMPASS STUDY PRESENTED AT ESC CONGRESS 2017 – LARGEST RIVAROXABAN STUDY TO DATE, ENROLLED 27,395 PATIENTS TO INVESTIGATE CAD AND PAD

Bayer’s data shows Xarelto ®(rivaroxaban) significantly lowers the combined risk of stroke, cardiovascular death and heart attack in patients with chronic coronary or peripheral artery disease

  • The highly anticipated COMPASS study, halted early due to highly significant efficacy, reveals clear and consistent clinical benefit
  • Rivaroxaban vascular dose, 2.5 mg twice daily, plus aspirin 100 mg once daily showed a 22% relative risk reduction (absolute risk reduction (ARR): 0.47%) in cardiovascular death compared with aspirin 100 mg once daily alone (current standard of care)
  • Additionally, results showed an unprecedented 42% relative risk reduction (ARR: 0.65%) in stroke

Bayer and its cooperation partner Janssen Research & Development, LLC, today announced results at The European Society of Cardiology (ESC) Congress that are set to change clinical practice in the UK for cardiologists treating patients with coronary artery disease (CAD) and peripheral artery disease (PAD)1.

Highly anticipated Phase III COMPASS study data announced during two hot line presentations at ESC in Barcelona, and simultaneously published in The New England Journal of Medicine, showed Bayer’s Factor Xa inhibitor, rivaroxaban (Xarelto®) vascular dose, (2.5 mg twice daily), plus aspirin 100 mg once daily, reduced the risk of the composite endpoint of stroke, cardiovascular (CV) death and heart attack by 24% (relative risk reduction, ARR: 1.3%) in patients with CAD and PAD1. The study compared this combined approach with aspirin 100 mg once daily alone. Patients included in the study already received guideline recommended therapy for hypertension, high cholesterol and diabetes. A 5 mg twice daily dose of rivaroxaban was also investigated but did not reach statistical significance.

Rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily:

  • Was superior to aspirin 100 mg once daily alone for the prevention of the composite endpoint of stroke, CV death and MI (primary efficacy outcome)1
  • Significantly reduced the risk of stroke by 42% (relative risk reduction, ARR: 0.65%), and CV death by 22% (relative risk reduction, ARR: 0.47%)1
  • Demonstrated a 20% improvement (relative risk reduction, ARR: 1.14%) in net clinical benefit (defined as the reduction in stroke, CV death, and heart attack balanced against the most serious bleeding events) providing clinicians with the first evidence that rivaroxaban not only has a more favourable risk-benefit profile than current best practice, but also offers protective benefits in patients with the high risk conditions of CAD and PAD1
  • Reduced the risk of heart attack by 14% (relative risk reduction, ARR: 0.31%) however this result was not statistically significant1

Overall bleeding incidence rates were low, and while there was an increase in major bleeding, notably there was no significant increase in fatal or intracranial bleeding. Importantly, in the PAD patient population, the combination of major adverse limb events plus all major amputations of a vascular cause were reduced significantly.

Dr Derek Connolly, Consultant Interventional Cardiologist at Birmingham City Hospital and COMPASS trial investigator commented: “The results of the COMPASS trial exceeded all expectations, demonstrating efficacy in reducing serious cardiovascular events that was so compelling we offered the treatment to study participants in an open-label extension trial. This study further builds on rivaroxaban’s role in a wide range of complex conditions including atrial fibrillation. This was the biggest study of rivaroxaban to date, and when licensed for these conditions, it will provide cardiologists with a new option for treating CAD and PAD.”

Dr Luis Felipe Graterol, UK Medical Director, Bayer, said: “The results from COMPASS have important implications for daily clinical practice, demonstrating the broader protective benefits of Xarelto across multiple indications. Bayer has a robust heritage in addressing unmet needs in cardiovascular health, and a strong pipeline of new indications that we hope will make a real difference for patients now and in the future. While Xarelto is already widely used by cardiologists across a spectrum of cardiovascular indications, Bayer is committed to investigating its wider benefits across new indications, as well as building on and refining current evidence to guide prescribing decisions.”

The COMPASS study is the largest clinical study of rivaroxaban to date. The study was stopped approximately one year ahead of schedule due to highly significant efficacy and Bayer, Janssen and the Population Health Research Institute (PHRI) are working towards offering rivaroxaban to study participants in an open-label extension trial. Rivaroxaban is the only non-vitamin K antagonist oral anticoagulant (NOAC) investigated in secondary prevention for cardiovascular disease.

The results, along with Bayer’s ongoing research into AF and concomitant conditions, have significant implications for how UK cardiologists will respond to high-risk patients now and in the future. Rivaroxaban’s extensive clinical development programme makes it the most studied novel OAC in the world. Since it was first approved in the orthopaedic setting in 2008, 23 million patients worldwide have received it in daily clinical practice2.

Reporting of side effects:

This medicine is subject to additional monitoring ▼. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See www.mhra.gov.uk/yellowcard for how to report side effects.

About CAD and PAD

Coronary artery disease (CAD) is the most common cause of cardiovascular disease and is estimated to occur in up to 20-30% of patients with AF3. It is responsible for approximately 7.3 million deaths worldwide every year4, with up to half of all middle-aged men and women at risk of developing CAD during their lifetime5. The number of patients with AF and CAD that will have to undergo coronary revascularisation has doubled in the last decade6.

Peripheral artery disease (PAD), while often undiagnosed, affects over 27 million people in Europe and North America and is an important risk marker of cardiovascular disease7.

About COMPASS 1

The Phase III randomised controlled COMPASS study is the largest clinical study of rivaroxaban to date with 27,395 patients. COMPASS was conducted in collaboration with the PHRI in more than 600 research sites across more than 30 countries worldwide8.

The COMPASS study evaluated the use of rivaroxaban for the prevention of major adverse cardiac events (MACE) including CV death, myocardial infarction (MI) and stroke in patients with coronary artery disease, peripheral artery disease or both.

Patients received a run-in of aspirin 100 mg once daily for 30 days, and were then randomised in a 1:1:1 ratio to receive (with or without pantoprazole):

  • Rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily
  • Rivaroxaban 5 mg twice daily
  • Aspirin 100 mg once daily

Patients who were being treated with a proton pump inhibitor (PPI) prior to enrollment continued with their existing medication. Patients without a continued need for PPI treatment were randomised to pantoprazole or its placebo.

Efficacy Outcomes 1

For the primary efficacy outcome, rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily was superior to aspirin 100 mg once daily alone for the prevention of the composite endpoint of stroke, CV death and MI (hazard ratio [HR] 0.76; 95% confidence interval [CI] 0.66-0.86; P<0.001). Rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily reduced the risk of stroke by 42% (HR 0.58; 95% CI 0.44-0.76; P<0.001, CV death by 22% (HR 0.78; 95% CI 0.64-0.96; P=0.02) and heart attack by 14% (HR 0.86; 95% CI 0.70-1.05; P=0.14). Rivaroxaban 5 mg twice daily also reduced the composite outcome of stroke, CV death and MI but these results were not statistically significant.

Rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily compared with aspirin 100 mg once daily alone improved the net clinical benefit defined as the composite of stroke, CV death, MI, fatal bleeding or symptomatic bleeding in a critical organ (HR 0.80; 95% CI 0.70-0.91; P<0.001). Rivaroxaban 5 mg twice daily compared with aspirin 100 mg once daily did not improve the net clinical benefit.

Safety Outcomes 1

The main safety outcome was a modification of the International Society on Thrombosis and Haemostasis (ISTH) criteria for major bleeding, and included fatal bleeding, symptomatic bleeding in a critical organ, bleeding into a surgical site requiring reoperation, and bleeding leading to hospitalisation (including presentation to an acute care facility without overnight stay). Unlike the ISTH criteria, all bleeding leading to presentation to an acute care facility or hospitalisation was considered as major.

Rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily compared with aspirin 100 mg once daily alone increased the risk of major bleeding (HR 1.70, 95% CI 1.40-2.05, P<0.001). Most of the major bleeding was into the gastrointestinal tract, with no significant increase in fatal bleeds, intracranial bleeds or symptomatic bleeds into a critical organ.

Although there was also a significant increase in major bleeding as defined using the non-modified ISTH scale, incidence rates using this definition were approximately one-third lower when compared to those obtained when using modified ISTH criteria.

About Xarelto ® (Rivaroxaban)

The extensive clinical development programme for rivaroxaban evaluating/ investigating the protection of different patient populations at risk of venous and arterial thromboembolism (VAT) makes it the most studied novel OAC in the world. To date, Xarelto® has been approved for use in more than 125 countries, across all indications, and in the UK specifically to date across the following indications9:

  • The prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors
  • The treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults
  • The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery
  • The prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine

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. (a Johnson & Johnson Company). Anticoagulant medicines are potent therapies used to prevent and treat blood clots the consequences of which may be serious, or to 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.

Responsible use of Xarelto is a very high priority for Bayer, and the company has developed a ‘Prescriber’s Guide’ for physicians and a ‘Xarelto Patient Card’ for patients to support best practice.

Bayer: Science For A Better Life

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 2015, the Group employed around 117,000 people and had sales of EUR 46.3 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.3 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.co.uk

Forward Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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.

1 Eikelboom, J.W., Connolly, S.J., Bosch, J., et al. Rivaroxaban With and Without Aspirin in Stable Coronary or Peripheral Artery Disease. New England Journal of Medicine 2017

2 Data on file, Bayer UK

3 Capodanno, D., et al. Management of Antiplatelet and Anticoagulation Therapy in Patients with Atrial Fibrillation in the Setting of Acute Coronary Syndromes or Percutaneous Coronary Interventions. Circulation: Cardiovascular Interventions. 2014; 7:113-24

4 Zaromitidou, M., et al. Atherosclerosis and coronary artery disease: from basics to genetics. 2016. UK: Elsevier.

5 Lloyd-Jones, D., et al. Lifetime risk of developing coronary artery heart disease. Lancet. 1999; 353(9147): 89-92

6 Bhatnagar, P., et al. The epidemiology of cardiovascular disease in the UK 2014. Heart. 2015;101(15): 1182-9

7 Belch, J., et al. Critical issues in peripheral arterial disease detection and management: a call to action. Arch Intern Med. 2003; 163(8): 884-92

8 Cappato, R., et al. COMPASS PAD study design. Exploring unmet needs in venous and arterial thromboembolism with rivaroxaban. Thromb Haemost. 2016; 116(2): 2-12

9 eMC. 2017. Xarelto SPC. Available at: https://www.medicines.org.uk/emc/medicine/25586 [Last accessed: August 2017]

UKXAR07170353a

Date of Preparation: August 2017

View source version on businesswire.com: http://www.businesswire.com/news/home/20170827005029/en/

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Last updated on: 28/08/2017

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