Data from New VOYAGER PAD Analyses at ACC.22 Reinforce Benefit of XARELTO® (rivaroxaban) Plus Aspirin in Patients with Peripheral Artery Disease (PAD) and Various Co-Morbid Conditions

An evaluation confirmed good thing about XARELTO^® plus aspirin in decreasing thrombotic hospitalizations for PAD sufferers with and with out power kidney illness (CKD)

A separate evaluation demonstrated PAD sufferers who acquired XARELTO^® plus aspirin along with statin remedy had the bottom danger of the composite of main hostile cardiovascular occasions (MACE) or main hostile limb occasions (MALE) in comparison with all different remedy teams within the examine

RARITAN, N.J., April 1, 2022 /PRNewswire/ — The Janssen Pharmaceutical Firms of Johnson & Johnson right now introduced information from new analyses from the Section 3 VOYAGER PAD medical trial reinforcing the good thing about the XARELTO^® (rivaroxaban) vascular dose (2.5 mg twice each day plus aspirin 100 mg as soon as each day) in decreasing extreme vascular occasions in sufferers with PAD after lower-extremity revascularization (LER), a process that restores blood move to the legs. Information from the 2 analyses display the function that the XARELTO^® vascular dose performs in PAD sufferers with and with out power kidney illness (CKD) and in PAD sufferers with and with no historical past of statin remedy. Outcomes will probably be featured on the American Faculty of Cardiology’s 71^st Annual Scientific Session (ACC.22), hosted in Washington, D.C. and just about from April 2-4, 2022. Janssen is dedicated to investing in research to rework care and deal with the excessive unmet wants of individuals residing with PAD.

Heart problems, also referred to as coronary heart illness, can have an effect on extra than simply the center. One lesser recognized however critical situation is PAD, a typical, power circulatory situation that causes blood vessels to slender, thereby decreasing blood move to the limbs, and most frequently the legs.¹ It’s a illness that usually goes undiagnosed and undertreated.² Within the U.S., PAD impacts an estimated 20 million adults, but solely roughly 8.5 million are recognized.^3,4 Whereas it normally begins asymptomatically, PAD can progress to extreme signs and require revascularization—a surgical process that restores blood move after arteries have been clogged—to keep away from amputation.⁵

“At Janssen, we’re persevering with to spend money on medical analysis to assist evolve the usual of look after folks residing with critical cardiovascular ailments, like PAD, an space of vital unmet want,” mentioned James F. Listing, M.D., Ph.D., International Therapeutic Space Head, Cardiovascular, Metabolism, and Retina, Janssen Analysis & Improvement, LLC. “Our analysis continues to help using the XARELTO^® vascular dose and is a remedy choice physicians ought to think about for sufferers with PAD or coronary artery illness.”

Position of the XARELTO^® vascular dose in decreasing hospitalizations because of thrombotic occasions in PAD sufferers with and with out CKD
Some co-morbid circumstances put sufferers at the next danger of PAD; in truth, sufferers with CKD have the next prevalence of PAD, at 24-32 p.c, with related increased six-month rehospitalization charges in comparison with these with out renal impairment.⁶ Within the VOYAGER PAD trial, the XARELTO^® vascular dose (2.5 mg twice each day plus aspirin 100 mg as soon as each day) considerably diminished hospitalizations because of thrombotic occasions in sufferers who underwent LER, in comparison with sufferers who took aspirin alone (Kaplan-Meier estimate at 3 years: 8.7% vs. 12.1%). The outcomes of a VOYAGER PAD subgroup evaluation of sufferers with and with out CKD, to be introduced as an oral presentation on April 3 (Abstract #906-06), present a constant 4.7 p.c absolute danger discount (ARR) within the subgroup with CKD with XARELTO^® plus aspirin in comparison with aspirin alone (Kaplan-Meier estimate at 3 years: 7.9% vs. 12.6%).

“Sufferers with symptomatic PAD are already at a heightened danger of hospitalization following revascularization,” mentioned Mark Svet, M.D., Inside Medication Resident, College of Colorado Anschutz Faculty of Medication and lead examine writer.^* “Beforehand reported major information from the VOYAGER PAD medical trial established the good thing about XARELTO^® plus aspirin in sufferers with PAD. Our analysis demonstrates the extension of this profit to PAD sufferers with CKD in decreasing charges of readmission following revascularization with out growing bleeding danger in comparison with these with out CKD.”

Impact of the XARELTO^® vascular dose and statin remedy in high-risk sufferers
Excessive ldl cholesterol is one other co-morbid situation that may hurt an individual’s arteries, and raises the chance of PAD.⁷ If excessive ldl cholesterol is not managed, a affected person is extra prone to have PAD and different blood vessel issues.⁷ An extra VOYAGER PAD evaluation to be introduced in a moderated poster presentation on April 2 (Abstract #1024-11) at ACC.22 evaluated PAD sufferers with and with no historical past of statin use, a remedy generally prescribed to decrease levels of cholesterol and cut back the chance of coronary heart assault and stroke.⁸ In keeping with the general VOYAGER PAD medical trial outcomes, the evaluation confirmed that sufferers with PAD post-LER who acquired the XARELTO^® vascular dose (2.5 mg twice each day plus aspirin 100 mg as soon as each day) and statin remedy had a 19 p.c discount within the major endpoint composite of acute limb ischemia (ALI), main amputation for vascular trigger, myocardial infarction, ischemic stroke or cardiovascular demise; a 26 p.c discount of main hostile limb occasions (MALE); and a 32 p.c discount of acute limb harm versus placebo and statin remedy. Total, it was discovered that with or with out statin remedy, the XARELTO^® vascular dose persistently diminished the composite of main hostile cardiovascular occasions (MACE) or MALE after revascularization for PAD.

Each analyses confirmed a numerical however not statistically important improve in thrombolysis in myocardial infarction (TIMI) main bleeding in sufferers handled with XARELTO^® plus aspirin versus aspirin alone, in step with the first outcomes of VOYAGER PAD, no matter CKD at baseline or statin historical past. There was no elevated intracerebral hemorrhage (ICH) or deadly bleeding with XARELTO^® plus aspirin in PAD sufferers with or with out CKD.

In August 2021, the U.S. Food and Drug Administration (FDA) approved an expanded PAD indication for the XARELTO^® vascular dose (2.5 mg twice each day plus aspirin 100 mg as soon as each day) to incorporate sufferers following current LER because of symptomatic PAD. The XARELTO^® vascular dose is the primary and solely authorized remedy for PAD utilizing a twin pathway inhibition (DPI) strategy to focus on each clotting mechanisms, thrombin and platelet activation.

About VOYAGER PAD
The Section 3 VOYAGER PAD study included 6,564 sufferers from 542 websites throughout 34 nations worldwide. Sufferers have been randomized in a 1:1 ratio and acquired both the XARELTO^® vascular dose (2.5 mg twice each day plus aspirin 100 mg as soon as each day) (n=3,286) or aspirin alone (100 mg as soon as each day) (n=3,278). Sufferers have been stratified by revascularization process kind (endovascular vs. surgical) and use of clopidogrel, which was administered on the treating doctor’s discretion. Sufferers have been adopted for a median of 28 months.

The VOYAGER PAD examine met its major efficacy and principal security endpoints, demonstrating the XARELTO^® vascular dose was superior to aspirin alone in decreasing the chance of main hostile limb and cardiovascular occasions by 15 p.c in sufferers with symptomatic PAD after LER. The good thing about including XARELTO^® to aspirin was obvious early, was constant amongst main subgroups and continued to accrue over time. There was no important improve in TIMI^** main bleeding noticed in sufferers handled with the XARELTO^® vascular dose in comparison with aspirin alone (Kaplan-Meier estimate at 3 years 2.65% vs. 1.87%, respectively).

WHAT IS XARELTO^® (rivaroxaban)?

XARELTO^® is a prescription drugs used to:

• cut back the chance of stroke and blood clots in adults who’ve a medical situation known as atrial fibrillation that isn’t attributable to a coronary heart valve drawback. With atrial fibrillation, a part of the center doesn’t beat the way in which it ought to. This will result in the formation of blood clots, which might journey to the mind, inflicting a stroke, or to different components of the physique
• deal with blood clots within the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE)
• cut back the chance of blood clots taking place once more in adults who proceed to be in danger for DVT or PE after receiving remedy for blood clots for at the very least 6 months
• assist forestall a blood clot within the legs and lungs of adults who’ve simply had hip or knee alternative surgical procedure
• assist forestall blood clots in sure adults hospitalized for an acute sickness and after discharge, who’re prone to getting blood clots due to the lack of or decreased capability to maneuver round (mobility) and different dangers for getting blood clots, and who shouldn’t have a excessive danger of bleeding

XARELTO^® is used with low dose aspirin to:

• cut back the chance of significant coronary heart issues, coronary heart assault and stroke in adults with coronary artery illness (a situation the place the blood provide to the center is diminished or blocked)
• cut back the chance of a sudden lower in blood move to the legs, main amputation, critical coronary heart issues or stroke in adults with peripheral artery illness (a situation the place the blood move to the legs is diminished) and contains adults who’ve not too long ago had a process to enhance blood move to the legs

XARELTO^® is utilized in kids to:

• deal with blood clots or cut back the chance of blood clots from taking place once more in kids from start to lower than 18 years, after receiving at the very least 5 days of preliminary remedy with injectable or intravenous medicines used to deal with blood clots.
• assist forestall blood clots in kids 2 years and older with congenital coronary heart illness after the Fontan process.

XARELTO^® was not studied and isn’t beneficial in kids lower than 6 months of age who:

• have been lower than 37 weeks of progress (gestation) at start
• had lower than 10 days of oral feeding, or
• had a physique weight of lower than 5.7 kilos (2.6 kg)

IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO^®?

XARELTO^® might trigger critical negative effects, together with:

• Elevated danger of blood clots when you cease taking XARELTO^®. Individuals with atrial fibrillation (an irregular heartbeat) that isn’t attributable to a coronary heart valve drawback (nonvalvular) are at an elevated danger of forming a blood clot within the coronary heart, which might journey to the mind, inflicting a stroke, or to different components of the physique. XARELTO^® lowers your probability of getting a stroke by serving to to forestall clots from forming. For those who cease taking XARELTO^®, you’ll have elevated danger of forming a clot in your blood.

Don’t cease taking XARELTO^® with out speaking to the physician who prescribes it for you. Stopping XARELTO^® will increase your danger of getting a stroke. If it’s important to cease taking XARELTO^®, your physician might prescribe one other blood thinner drugs to forestall a blood clot from forming.

• Elevated danger of bleeding. XARELTO^® may cause bleeding which will be critical and will result in demise. It’s because XARELTO^® is a blood thinner drugs (anticoagulant) that lowers blood clotting. Throughout remedy with XARELTO^® you might be prone to bruise extra simply, and it could take longer for bleeding to cease. You could be at increased danger of bleeding when you take XARELTO^® and have sure different medical issues.

You will have the next danger of bleeding when you take XARELTO^® and take different medicines that improve your danger of bleeding, together with:

•  
• Aspirin or aspirin-containing merchandise
• Lengthy-term (power) use of non-steroidal anti-inflammatory medication (NSAIDs)
• Warfarin sodium (Coumadin^®, Jantoven^®)
• Any drugs that incorporates heparin
• Clopidogrel (Plavix^®)
• Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
• Different medicines to forestall or deal with blood clots

Inform your physician when you take any of those medicines. Ask your physician or pharmacist in case you are undecided in case your drugs is one listed above.

Name your physician or get medical assist instantly when you or your little one develop any of those indicators or signs of bleeding:

•  
• Sudden bleeding or bleeding that lasts a very long time, comparable to:
• Nosebleeds that occur usually
• Uncommon bleeding from gums
• Menstrual bleeding that’s heavier than regular, or vaginal bleeding
• Bleeding that’s extreme otherwise you can’t management
• Pink, pink, or brown urine
• Brilliant pink or black stools (seems like tar)
• Cough up blood or blood clots
• Vomit blood or your vomit seems like “espresso grounds”
• Complications, feeling dizzy or weak
• Ache, swelling, or new drainage at wound websites
• Spinal or epidural blood clots (hematoma). Individuals who take a blood thinner drugs (anticoagulant) like XARELTO^®, and have drugs injected into their spinal and epidural space, or have a spinal puncture, have a danger of forming a blood clot that may trigger long-term or everlasting lack of the flexibility to maneuver (paralysis). Your danger of creating a spinal or epidural blood clot is increased if:
• A skinny tube known as an epidural catheter is positioned in your again to offer you sure drugs
• You’re taking NSAIDs or a drugs to forestall blood from clotting
• You could have a historical past of inauspicious or repeated epidural or spinal punctures
• You could have a historical past of issues together with your backbone or have had surgical procedure in your backbone

For those who take XARELTO^® and obtain spinal anesthesia or have a spinal puncture, your physician ought to watch you carefully for signs of spinal or epidural blood clots.

Inform your physician instantly when you have:

• again ache
• tingling
• numbness
• muscle weak point (particularly in your legs and ft)
• or lack of management of the bowels or bladder (incontinence)

XARELTO^® isn’t to be used in folks with synthetic coronary heart valves.

XARELTO^® isn’t to be used in folks with antiphospholipid syndrome (APS), particularly with constructive triple antibody testing.

Don’t take XARELTO^® when you or your little one:

• At present have sure kinds of irregular bleeding. Speak to your physician earlier than taking XARELTO^® when you at the moment have uncommon bleeding.
• Are allergic to rivaroxaban or any of the elements of XARELTO^®.

Earlier than taking XARELTO^®, inform your physician about all of your medical circumstances, together with when you or your little one:

• Have ever had bleeding issues
• Have liver or kidney issues
• Have antiphospholipid syndrome (APS)
• Are pregnant or plan to turn out to be pregnant. It’s not recognized if XARELTO^® will hurt your unborn child.
• Inform your physician instantly when you turn out to be pregnant throughout remedy with XARELTO^®. Taking XARELTO^® while you’re pregnant might improve the chance of bleeding in you or in your unborn child.
• Females who’re capable of turn out to be pregnant: Speak together with your physician about being pregnant planning throughout remedy with XARELTO^®. Speak together with your physician about your danger for extreme uterine bleeding in case you are handled with blood thinner medicines, together with XARELTO^®.
• For those who take XARELTO^® throughout being pregnant, inform your physician instantly when you have any indicators or signs of bleeding or blood loss. See “What’s a very powerful info I ought to learn about XARELTO^®?” for indicators and signs of bleeding.
• Are breastfeeding or plan to breastfeed.  XARELTO^® might cross into your breast milk. Speak to your physician about the easiest way to feed your child throughout remedy with XARELTO^®.

Inform your entire docs and dentists that you simply or your little one are taking XARELTO^®. They need to speak to the physician who prescribed XARELTO^® for you earlier than you might have any surgical procedure, medical or dental process.

Inform your physician about all of the medicines you or your little one take, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements. 

A few of your different medicines might have an effect on the way in which XARELTO^® works, inflicting negative effects. Sure medicines might improve your danger of bleeding. See “What’s a very powerful info I ought to learn about XARELTO^®?”

HOW SHOULD I TAKE XARELTO^®?

• Take XARELTO^® precisely as prescribed by your physician.
• Don’t change your dose or cease taking XARELTO^® except your physician tells you to. Your physician might change your dose if wanted.
• Your physician will resolve how lengthy it’s best to take XARELTO^®.
• XARELTO^® might have to be stopped for a number of days earlier than any surgical procedure or medical or dental process. Your physician will let you know when to cease taking XARELTO^® and when to begin taking XARELTO^® once more after your surgical procedure or process.
• If that you must cease taking XARELTO^® for any motive, speak to the physician who prescribed XARELTO^® to you to seek out out when it’s best to cease taking it. Don’t cease taking XARELTO^® with out first speaking to the physician who prescribes it to you.
• When you’ve got issue swallowing XARELTO^® tablets complete, speak to your physician about different methods to take XARELTO^®.
• Don’t run out of XARELTO^®. Refill your prescription of XARELTO^® earlier than you run out. When leaving the hospital following a hip or knee alternative, make sure that you’ll have XARELTO^® obtainable to keep away from lacking any doses.
• For those who take an excessive amount of XARELTO^®, go to the closest hospital emergency room or name your physician instantly.

For those who take XARELTO^® for:

•  
• Atrial Fibrillation that isn’t attributable to a coronary heart valve drawback:
• Take XARELTO^® 1 time a day together with your night meal.
• For those who miss a dose of XARELTO^®, take it as quickly as you keep in mind on the identical day. Take your subsequent dose at your commonly scheduled time. 
• Blood clots within the veins of your legs or lungs:
• Take XARELTO^® 1 or 2 occasions a day as prescribed by your physician.
• For the 10-mg dose, XARELTO^® could also be taken with or with out meals.
• For the 15-mg and 20-mg doses, take XARELTO^® with meals on the similar time every day.
• For those who miss a dose:
• For those who take the 15-mg dose of XARELTO^® 2 occasions a day (a complete of 30 mg of XARELTO^® in 1 day): Take XARELTO^® as quickly as you keep in mind on the identical day. You could take 2 doses on the similar time to make up for the missed dose. Take your subsequent dose at your commonly scheduled time.
• For those who take XARELTO^® 1 time a day: Take XARELTO^® as quickly as you keep in mind on the identical day. Take your subsequent dose at your commonly scheduled time.
• Hip or knee alternative surgical procedure:
• Take XARELTO^® 1 time a day with or with out meals.
• For those who miss a dose of XARELTO^®, take it as quickly as you keep in mind on the identical day. Take your subsequent dose at your commonly scheduled time.
• Blood clots in folks hospitalized for an acute sickness:
• Take XARELTO^® 1 time a day, with or with out meals, while you’re within the hospital and after you might be discharged as prescribed by your physician.
• For those who miss a dose of XARELTO^®, take it as quickly as you keep in mind on the identical day. Take your subsequent dose at your commonly scheduled time.
• Decreasing the chance of significant coronary heart issues, coronary heart assault and stroke in coronary artery illness:
• Take XARELTO^® 2.5 mg 2 occasions a day with or with out meals.
• For those who miss a dose of XARELTO^®, take your subsequent dose at your commonly scheduled time.
• Take aspirin 75 to 100 mg as soon as each day as instructed by your physician.
• Decreasing the chance of a sudden lower in blood move to the legs, main amputation, critical coronary heart issues or stroke in folks with peripheral artery illness, together with those that have not too long ago had a process to enhance blood move to the legs:
• Take XARELTO^® 2.5 mg 2 occasions a day with or with out meals.
• For those who miss a dose of XARELTO^®, take your subsequent dose at your commonly scheduled time.
• Take aspirin 75 to 100 mg as soon as each day as instructed by your physician.

For kids who take XARELTO^®:

•  
• The dose of XARELTO^® is determined by your kid’s physique weight and will probably be calculated by your kid’s physician. Your kid’s physician will let you know if XARELTO^® will be given to your little one with or with out meals.
• The grownup caregiver ought to give the dose.
• In case your little one is taking the pill, the pill must be taken complete and shouldn’t be break up in an try to offer a decrease dose of XARELTO^®.
• In case your little one is taking the oral suspension, use the syringes offered within the authentic carton. The suspension will probably be ready by the pharmacy. See the Directions for Use included within the carton on how one can correctly give a dose of XARELTO^® oral suspension to your little one.
• Don’t swap between the XARELTO^® oral suspension or pill with out first speaking to your physician.
• In case your little one vomits or spits up:
• proper after or inside half-hour of taking the oral suspension, give a brand new full dose.
• greater than half-hour after taking the oral suspension, don’t give the dose once more. Give the subsequent dose on the commonly scheduled time.
• if vomiting or spitting up persists, contact your kid’s physician instantly.
• In case your little one misses a dose:
• In case your little one is taking XARELTO^® 1 time a day, give the dose as quickly as you keep in mind on the identical day. If this isn’t potential, skip this dose and provides the subsequent dose on the commonly scheduled time.
• In case your little one is taking XARELTO^® 2 occasions a day, give the missed morning dose as quickly as you keep in mind. You could give the missed morning dose along with the night dose. Nonetheless, a missed night dose can solely be taken in the identical night.
• In case your little one is taking XARELTO^® 3 occasions a day, skip the missed dose and provides the subsequent dose on the commonly scheduled time.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO^®?

XARELTO^® might trigger critical negative effects:

• See “What’s a very powerful info I ought to learn about XARELTO^®?”

The most typical aspect impact of XARELTO^® in adults was bleeding.

The most typical negative effects of XARELTO^® in kids embody:

• bleeding
• vomiting
• cough
• infected abdomen and intestine

Name your physician for medical recommendation about negative effects. You could report negative effects to the FDA at 1-800-FDA-1088. You may additionally report negative effects to Janssen Prescription drugs, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please learn full Prescribing Information, together with Boxed Warnings, and Medication Guide for XARELTO^®.

Emblems are these of their respective homeowners. Janssen and Bayer collectively are creating rivaroxaban.

Concerning the Janssen Pharmaceutical Firms of Johnson & Johnson
At Janssen, we’re making a future the place illness is a factor of the previous. We are the Pharmaceutical Firms of Johnson & Johnson, working tirelessly to make that future a actuality for sufferers all over the place by preventing illness with science, enhancing entry with ingenuity, and therapeutic hopelessness with coronary heart. We give attention to areas of medication the place we will make the most important distinction: Cardiovascular & Metabolism, Immunology, Infectious Illnesses & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Be taught extra at www.janssen.com. Comply with us at www.twitter.com/JanssenUS and https://twitter.com/JanssenGlobal. Janssen Analysis & Improvement, LLC is a part of the Janssen Pharmaceutical Firms of Johnson & Johnson.

Cautions Regarding Ahead-Trying Statements
This press launch incorporates “forward-looking statements” as outlined within the Non-public Securities Litigation Reform Act of 1995 relating to product growth and the potential advantages and remedy affect of rivaroxaban. The reader is cautioned to not depend on these forward-looking statements. These statements are based mostly on present expectations of future occasions. If underlying assumptions show inaccurate or recognized or unknown dangers or uncertainties materialize, precise outcomes may fluctuate materially from the expectations and projections of Janssen Analysis & Improvement, LLC, any of the opposite Janssen Pharmaceutical Firms and/or Johnson & Johnson. Dangers and uncertainties embody, however usually are not restricted to: challenges and uncertainties inherent in product analysis and growth, together with the uncertainty of medical success and of acquiring regulatory approvals; uncertainty of economic success; manufacturing difficulties and delays; competitors, together with technological advances, new merchandise and patents attained by rivals; challenges to patents; product efficacy or security considerations leading to product remembers or regulatory motion; modifications in conduct and spending patterns of purchasers of well being care services; modifications to relevant legal guidelines and laws, together with world well being care reforms; and tendencies towards well being care price containment. An extra listing and descriptions of those dangers, uncertainties and different elements will be present in Johnson & Johnson’s Annual Report on Type 10-Ok for the fiscal 12 months ended January 2, 2022, together with within the sections captioned “Cautionary Observe Concerning Ahead-Trying Statements” and “Merchandise 1A. Danger Components,” and in Johnson & Johnson’s subsequent Quarterly Studies on Type 10-Q and different filings with the Securities and Change Fee. Copies of those filings can be found on-line at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Not one of the Janssen Pharmaceutical Firms nor Johnson & Johnson undertakes to replace any forward-looking assertion because of new info or future occasions or developments.

REFERENCES 

SOURCE Janssen Pharmaceutical Firms of Johnson & Johnson