RARITAN, N.J., Nov. 9, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that 10 data presentations will be shared at the virtual American Heart Association (AHA) Scientific Sessions 2020 from November 13-17. Most notably, four new sub-analyses of XARELTO® (rivaroxaban) from the landmark VOYAGER PAD trial, part of the EXPLORER global cardiovascular research program, will be presented, including two live, featured science oral presentations.
"We're pleased VOYAGER PAD was selected to be front and center once again at a major medical congress, as there's an urgent need for data in the symptomatic PAD population," said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. "We have presented a total of 12 VOYAGER PAD datasets this year and continue to evaluate subgroups of PAD patients within the pivotal trials for rivaroxaban. We look forward to sharing these new analyses with the medical community at AHA."
CLICK TO TWEET: Click to learn more about PAD, including risk factors and causes; signs and symptoms; screening and prevention; health disparities and more at the @JanssenUS Cardiovascular & Metabolism online newsroom. https://ctt.ec/xe305+
On October 26, 2020, Janssen announced that it submitted a supplemental New Drug Application (sNDA) to the FDA to expand the use of XARELTO® in patients with PAD to include reducing the risk of major thrombotic vascular events, such as heart attack and amputation, in symptomatic patients after recent lower-extremity revascularization (LER). XARELTO® is currently approved to reduce the risk of major cardiovascular (CV) events in people with chronic coronary artery disease (CAD) or PAD.
Highlights of the presentations at AHA 2020 include four VOYAGER PAD sub-analyses examining XARELTO® plus aspirin across a diverse range of patient subgroups, including those with critical limb ischemia (CLI). This analysis is of particular importance as patients with CLI are at increased risk of major limb and CV events and many require unplanned revascularization.ii
The following is a list of highlighted abstracts to be presented at AHA 2020:
Abstract No. | Title | Date/Time/Location |
Late-Breaking/Featured Science Presentations | ||
FS.03 | Efficacy and Safety of Rivaroxaban in Patients With PAD Undergoing Lower Extremity Revascularization for Critical Limb Ischemia: Insights from VOYAGER PAD | November 14, 2020 3:42-3:54 p.m. CT*
|
FS.03 | Rivaroxaban Plus Aspirin Versus Aspirin Alone After Endovascular Revascularization for Symptomatic PAD: Insights From VOYAGER PAD | November 14, 2020 3:54-4:06 p.m. CT* |
FS.03 | Efficacy and Safety of Rivaroxaban Monotherapy in Patients With Atrial Fibrillation After Coronary Stenting: Insights From the Afire Trial | November 14, 2020 4:18-4:30 p.m. CT* |
LBS.03 | Rivaroxaban Versus Warfarin in Patients With Bioprosthetic Mitral Valves and Atrial Fibrillation or Flutter: Primary Results From the RIVER Randomized Trial — RIVER Trial | November 14, 2020 12:40-12:50 p.m. CT |
LBS.06 | 3-year Clinical Outcomes in a Nationwide, Randomized, Pragmatic Clinical Trial of Atrial Fibrillation Screening - Mhealth Screening To Prevent Strokes (mSToPS) | November 16, 2020 9:21-9:29 a.m. CT
|
Vascular Protection | ||
291 | Reduction in Venous Thromboembolism With Rivaroxaban Versus Placebo in Peripheral Artery Disease After Lower Extremity Revascularization: Insights from VOYAGER PAD | November 13, 2020 9:00-10:00 a.m. CT* |
293 | Rivaroxaban Reduces Major Cardiovascular and Limb Events in Patients With the High-Risk Triad of Chronic Kidney Disease, Peripheral Artery Disease and Recent Lower Extremity Revascularization: Insights From VOYAGER PAD | November 13, 2020 9:00-10:00 a.m. CT* |
P1714 | Incidence and Costs of Major Atherothrombotic Vascular Events Among Patients with Peripheral Artery Disease After Revascularization | November 13, 2020 9:00-10:00 a.m. CT* |
Stroke Prevention | ||
P1089 | Advanced Age and Preferential Use of Vitamin K Antagonists in Severe Renal Impairment: First Results of the XARENO Registry in Patients with Non-Valvular Atrial Fibrillation and Non-Dialysis Dependent Advanced Chronic Kidney Disease | November 13, 2020 9:00-10:00 a.m. CT* |
P1971 | Oral Anticoagulation Use in High-Risk Atrial Fibrillation Patients is Much Higher than Previously Reported | November 13, 2020 9:00-10:00 a.m. CT* |
*Available on demand for the duration of the Congress
About Peripheral Artery Disease (PAD)
Peripheral artery disease is a narrowing of the peripheral arteries serving the legs, arms and head. The most common symptoms of PAD involving the lower extremities are cramping, pain or tiredness in the leg or hip muscles while walking or climbing stairs.iii It is a serious underlying health condition that impacts an estimated 20 million Americans with only 8.5 million diagnosed.iv,v Often starting as asymptomatic, PAD typically progresses to a more symptomatic, chronic form, with revascularization needed when symptoms become severe or limb-threatening.
WHAT IS XARELTO®?
XARELTO® is a prescription medicine used to:
XARELTO® is used with low dose aspirin to:
It is not known if XARELTO® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?
XARELTO® may cause serious side effects, including:
You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:
Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:
If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).
XARELTO® is not for use in people with artificial heart valves.
XARELTO® is not for use in people with antiphospholipid syndrome (APS), especially with positive triple antibody testing, who have a history of blood clots.
Do not take XARELTO® if you:
Before taking XARELTO®, tell your doctor about all your medical conditions, including if you:
Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some of your other medicines may affect the way XARELTO® works, causing side effects. Certain medicines may increase your risk of bleeding. See "What is the most important information I should know about XARELTO®?"
HOW SHOULD I TAKE XARELTO®?
If you take XARELTO® for:
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
XARELTO® may cause serious side effects:
The most common side effect of XARELTO® was bleeding.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide.
Trademarks are those of their respective owners.
Janssen and Bayer together are developing rivaroxaban. For more information about XARELTO®, visit www.xarelto.com.
About Janssen Cardiovascular & Metabolism
In Cardiovascular & Metabolism (CVM), we take on the most pervasive diseases that burden hundreds of millions of people and healthcare systems around the world. As part of this long-standing commitment and propelled by our successes in treating type 2 diabetes and thrombosis, we advance highly differentiated therapies that prevent and treat life-threatening cardiovascular, metabolic and retinal diseases. Uncovering new therapies that can improve the quality of life for this large segment of the population is an important endeavor – one which Janssen CVM will continue to lead in the years to come. Our mission is global, local and personal. Together, we can reshape the future of cardiovascular, metabolic and retinal disease prevention and treatment. Please visit www.janssen.com/cardiovascular-and-metabolism.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenUS and www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC, is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding XARELTO®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
i Tangelder MJD, Algra A, Lawson JA, Eikelboom BC, et al. Efficacy of oral anticoagulants compared with aspirin after infrainguinal bypass surgery (The Dutch Bypass Oral anticoagulants or Aspirin study): a randomised trial. Lancet. 2000;355(9201):346-351.
ii Dua A, Lee CJ. Epidemiology of peripheral arterial disease and critical limb ischemia. Tech Vasc Interv Radiol. 2016;19(2):91-95.
iii American Heart Association. About Peripheral Artery Disease (PAD). Retrieved November 2, 2020 from https://www.heart.org/en/health-topics/peripheral-artery-disease/about-peripheral-artery-disease-pad.
iv Racial Disparities in Vascular Care. (n.d.). Retrieved October 2, 2020 from https://cardiovascularcoalition.com/our-patients/racial-disparities-in-vascular-care/
v Centers for Disease Control and Prevention. Peripheral Arterial Disease Fact Sheet/Data & Statistics. Retrieved March 20, 2020 from https://www.cdc.gov/heartdisease/pad.htm.
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