May 28, 2018 PR-M05-18-NI-101
TITUSVILLE, N.J., May 24, 2018 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new real-world data that showed frail patients with non-valvular atrial fibrillation (NVAF) experienced significantly fewer strokes and systemic emboli when treated with XARELTO® (rivaroxaban) over a two-year period compared to those taking warfarin. Specifically, long-term XARELTO® use reduced the risk of stroke and systemic embolism by 32 percent and ischemic stroke alone by 31 percent compared to warfarin, with no significant increase in major bleeding. Results from the study, which also assessed the efficacy and safety of apixaban and dabigatran each versus warfarin, were recently published in the Journal of the American Heart Association.
Affecting nearly six million Americans, NVAF increases a person's risk of stroke by five times and accounts for 15 to 20 percent of all strokes.i,ii Frailty is a common clinical syndrome mainly seen in older adults that makes it harder for them to recover from stressful cardiovascular events and vulnerable for poorer health outcomes. People with NVAF are four times more likely to be classified as frail than people without NVAF,iii and research has shown frail people with NVAF are less likely to receive anticoagulation than non-frail people.iv,v,vi
"There is not widespread consensus on the best way to manage frail patients with NVAF in clinical practice, which is why some patients are not treated at all and remain at high risk of having a stroke," said Craig Coleman, PharmD, Professor of Pharmacy Practice, University of Connecticut. "These results show long-term rivaroxaban use reduced stroke and systemic embolism in a vulnerable patient group, without increasing the risk of major bleeding. They also give physicians important insights into a well-tolerated, effective approach to treat their frail patients with NVAF."
In the study, researchers used U.S. Truven MarketScan claims data and identified frail patients with NVAF taking XARELTO®, apixaban, or dabigatran. Each treatment group was matched separately with warfarin users in a 1:1 ratio and followed for up to two years or until an event, insurance disenrollment or end of follow-up occurred. The primary efficacy outcome was stroke (ischemic or hemorrhagic) or systemic embolism. Major bleeding was the primary safety outcome.
Researchers made the following two-year observations:
"This study adds to the growing body of evidence supporting the positive efficacy and safety profile of XARELTO® across a broad spectrum of patients with NVAF, which now includes the frail population," said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen Pharmaceuticals, Inc. Real-world data like this study are critical to informing and helping physicians best treat their patients' cardiovascular diseases."
About the Frailty Study
A total of 19,077 patients were identified using claims data from U.S. MarketScan databases from November 2011 to December 2016. These patients were new users of anticoagulant therapy with XARELTO®, apixaban, dabigatran, or warfarin, who had not been previously treated with an anticoagulant. They also had at least 12 months of continuous insurance coverage, and were considered frail. Frailty was determined using the Johns Hopkins Claims-based Frailty Indicator scoring algorithm, which weighs 21 criteria identifiable in claims data, including demographics, comorbidities, and physical and cognitive dysfunction.
Each eligible XARELTO®, apixaban, and dabigatran user was propensity score matched to a warfarin user in a 1:1 ratio, which helped minimize the presence of baseline differences between cohorts. A total of 10,754 patients were included in the retrospective study, with 2,635 taking XARELTO®, 1,392 apixaban, 1,350 dabigatran, and 5,377 warfarin. This study was supported by Bayer AG, Berlin, Germany.
Real-world data have the potential to supplement randomized controlled trial data by providing additional information about how a medicine performs in routine medical practice; however, they have limitations and cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment.
Additionally, it is possible some of the analyses within this specific study may not have been sufficiently powered based on smaller sample sizes.
About Real-World XARELTO® Research
XARELTO® is the most-studied oral Factor Xa inhibitor in the world today. More than 200,000 people have been evaluated in published real-world research since the approval of XARELTO® across all approved indications in the U.S. Post-marketing studies and registries continue to confirm the safety and efficacy of XARELTO® in routine clinical use across a broad spectrum of patients. There have been no head-to-head randomized trials directly comparing non-vitamin K antagonist oral anticoagulants.
One recent study, REVISIT-US, found XARELTO® is providing an appropriate balance of benefit and risk with respect to ischemic stroke and found a significant reduction in intracranial hemorrhage in routine clinical practice. These are two of the most serious types of events physicians work the hardest with their patients to avoid, given their potential for irreversible harm.
WHAT IS XARELTO®?
XARELTO® (rivaroxaban) is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.
XARELTO® is also a prescription medicine used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months.
XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about XARELTO® (rivaroxaban)?
Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO®increases your risk of having a stroke.
If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.
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).
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. 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®?
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 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.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements," as defined in the Private Securities Litigation Reform Act of 1995, regarding product development and the presentation of new data and analyses regarding XARELTO®(rivaroxaban). 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 any of the 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 31, 2017, including in the sections captioned "Item 1A. Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements," 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. Neither 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 Colilla S et al. Estimates of Current and Future Incidence and Prevalence of Atrial Fibrillation in the U.S. Adult Population. Am J Cardiol 2013;112(8):1142-1147.
ii American Heart Association (2014, April 16). Prevention Strategies for Atrial Fibrillation. Retrieved from: http://www.heart.org/HEARTORG/Conditions/Arrhythmia/AboutArrhythmia/Prevention-Strategies-for-Atrial-Fibrillation-AFib-or-AF_UCM_423784_Article.jsp#.VvRBcuIrKUk
iii Coleman CI, Bunz TJ, Eriksson D, Meinecke AK and Sood NA. Effectiveness and safety of rivaroxaban vs warfarin in people with non-valvular atrial fibrillation and diabetes: an administrative claims database analysis. 2018 April; doi: 10.1111/dme.13648https://onlinelibrary.wiley.com/doi/epdf/10.1111/dme.13648.
iv Perera V, Bajorek BV, Matthews S, Hilmer SN. The impact of frailty on the utilisation of antithrombotic therapy in older patients with atrial fibrillation. Age Ageing 2009;38:156–162.
v Induruwa I, Evans NR, Aziz A, Reddy S, Khadjooi K, Romero-Ortuno R. Clinical frailty is independently associated with non-prescription of anticoagulants in older patients with atrial fibrillation. Geriatr Gerontol Int 2017;17:2178–2183.
vi Lefebvre MC, St-Onge M, Glazer-Cavanagh M, Bell L, Kha Nguyen JN, Viet-Quoc Nguyen P, Tannenbaum C. The effect of bleeding risk and frailty status on anticoagulation patterns in octogenarians with atrial fibrillation: the FRAIL-AF study. Can J Cardiol 2016;32:169–176.
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