Janssen Announces Phase 3b PIONEER AF-PCI Study Data Accepted for Late-Breaking Presentation at AHA Conference

November 7, 2016 8:12 AM EST

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Janssen Pharmaceuticals, Inc. (Janssen) announced that results from the Phase 3b PIONEER AF-PCI study with XARELTO (rivaroxaban) and new INVOKANA (canagliflozin) research will be presented at this year's American Heart Association (AHA) Scientific Sessions in New Orleans, LA, November 12-16, 2016.

PIONEER AF-PCI, which the AHA accepted as a Late-Breaking Clinical Trial presentation, is the first randomized study to evaluate whether a non-vitamin K antagonist oral anticoagulant (NOAC), specifically XARELTO®, can provide an improved safety profile compared to warfarin when given to people with non-valvular atrial fibrillation (NVAF) also receiving antiplatelet therapy after PCI with stenting.

Approximately five to eight percent of people undergoing PCI have atrial fibrillation. For these patients, current guidelines recommend a practice known as "triple therapy", combining dual antiplatelet therapy (DAPT) and warfarin; however, this approach has been associated with an increased risk in bleeding. Until PIONEER AF-PCI, no clinical trials have investigated the safety and efficacy of a NOAC compared to warfarin plus dual antiplatelet therapy among people with NVAF undergoing PCI.

Other notable presentations include new, real-world research evaluating persistence and adherence levels for XARELTO®, and topline results from an analysis of the Premier Healthcare Database evaluating rates of oral anticoagulant use in people with NVAF at hospital discharge.

For INVOKANA®, Janssen will unveil the design and rationale for the CANagliflozin cardioVascular Assessment Study–Renal (CANVAS-R) study, which aims to provide new insights into the effects of INVOKANA® compared to placebo on the benefits of renal disease risk reduction. In addition, a post-hoc analysis of data from four Phase 3 studies will show the efficacy and safety of INVOKANA® in people with type 2 diabetes based on cardiovascular disease history and risk factors.

"Janssen aims to improve the lives of the millions of people with cardiovascular disease and diabetes by bringing patients transformational care and innovative treatment options," said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen. "This important line-up of late-breaking, clinical and real-world research will reveal new insights with the potential to challenge the current standard of care."

Following is a full list of company-sponsored abstracts to be presented at the meeting:

Abstract No.

Title

Date/Time/Location

XARELTO®: Late-Breaking Clinical Trial Session (LBCT)

LBCT.02

An OPen-label, Randomized, Controlled, Multicenter Study ExplorIng TwO TreatmeNt StratEgiEs of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects with Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention PIONEER AF-PCI

Monday, Nov. 14

11:15 – 11:27 a.m. CT

Main Event 1

XARELTO®: Real-World Bleeding Data

M2185 / 2185

Evaluation of the Incidence of Major Bleeding in a Heterogeneous Population of 51,842 Rivaroxaban Users with Non-Valvular Atrial Fibrillation

Poster Session

Monday, Nov. 14

2:00 – 3:15 p.m. CT

Science and Technology Hall / Population Science Section

XARELTO®: Real-World Adherence/Persistence/Satisfaction Data

209

Adherence to QD vs. BID Medications in NVAF Patients is Associated with Reduced Risk of Ischemic Stroke: A Modeling Study using RCT and Claims Data

Oral Session

Monday, Nov. 14

9:30 – 9:40 a.m. CT

Room 348-349

M2076 / 2076

Treatment Persistence with New Oral Anticoagulants for Non-Valvular Atrial Fibrillation: the Quebec Observational Study

Poster Session

Monday, Nov. 14

10:45 a.m. – 12:00 p.m. CT

Science and Technology Hall / Population Science Section

M4086 / 4086

Improved Treatment Satisfaction Independent of Stroke and Bleeding Risk Among Patients Transitioned from a Vitamin K Antagonist to Rivaroxaban: a XANTUS-ACTS Analysis

Poster Session

Monday, Nov. 14

10:45 a.m. – 12:00 p.m. CT

Science and Technology Hall / Clinical Science Section

M2124 / 2124

Persistence with Non-Vitamin K Oral Anticoagulants and Vitamin K Antagonists Treatment: A Nationwide Study of Danish Patients with Non-Valvular Atrial Fibrillation

Poster Session

Monday, Nov. 14

2:00 – 3:15 p.m. CT

Science and Technology Hall / Population Science Section

XARELTO®: Real-World Data Examining Oral Anticoagulant Use/Patient Knowledge

M2074 / 2074

Low Rates of Oral Anticoagulation Use Among Patients Hospitalized with Atrial Fibrillation and at High Risk for Stroke

Poster Session

Monday, Nov. 14

10:45 a.m. – 12:00 p.m. CT

Science and Technology Hall / Population Science Section

M2181 / 2181

Lack of Patient Understanding of Stroke Risk and Treatment Strategies in Those with Newly Diagnosed Atrial Fibrillation: a Concern and an Opportunity

Poster Session

Monday, Nov. 14

2:00 – 3:15 p.m. CT

Science and Technology Hall / Population Science Section

XARELTO®: Real-World Stroke Prevention Data in People with NVAF

194

Outcomes After Ablation and Cardioversion in Patients with Non-Valvular Atrial Fibrillation: Results from the XANTUS Study

Oral Session

Sunday, Nov. 13

6:30 – 6:40 p.m. CT

Room 348-349

M4207 / 4207

Risk of Ischemic Stroke in Newly Diagnosed Heart Failure Patients

Poster Session

Monday, Nov. 14

2:00 – 3:15 p.m. CT

Science and Technology Hall / Clinical Science Section

XARELTO®: Real-World VTE Data

M2083 / 2083

Benefit of Early Discharge Among Patients with Low-Risk Pulmonary Embolism: Focus on Net Clinical Impact

Poster Session

Monday, Nov. 14

10:45 a.m. – 12:00 p.m. CT

Science and Technology Hall / Population Science Section

M2187 / 2187

Effectiveness of Rivaroxaban Among Patients Diagnosed with Pulmonary Embolism

Poster Session

Monday, Nov. 14

2:00 – 3:15 p.m. CT

Science and Technology Hall / Population Science Section

XARELTO®: Phase 3 Sub-Analyses

735

Selective Serotonin Reuptake Inhibitors Increase Bleeding Risk in Anticoagulated Patients with Atrial Fibrillation: an Analysis from the ROCKET AF Trial

Oral Session

Tuesday, Nov. 15

11:10 – 11:15 a.m. CT

Science and Technology Hall / Clinical Science Theater

T5204 / 5204

Rivaroxaban and Improved Modified Rankin Scale Score Among Patients with Acute Coronary Syndrome who Experience Stroke - Insights from the ATLAS ACS-2-TIMI-51 Clinical Trial

Poster Session

Tuesday, Nov. 15

1:30 – 2:45 p.m. CT

Science and Technology Hall / Clinical Science II Section

XARELTO®: Other Data

S2152 / 2152

Machine Learning Methodology Identifies Predictors of a Cardiovascular Composite Measure Among Severe Peripheral Artery Disease Patients

Poster Session

Sunday, Nov. 13

3:45 – 5:00 p.m. CT

Science and Technology Hall / Population Science Section

190

Independent Investigator-Initiated Study:

Comparative Effectiveness and Safety of Reduced Dose Non-vitamin K Antagonist Oral Anticoagulants Versus Warfarin: A Nationwide Cohort Study

Oral Session

Sunday, Nov. 13

5:30 - 5:40 p.m. CT

Room 348-349

T4163 / 4163

Local Expression of Coagulation Factor X (FXa) is Increased in Response to Pressure Overload and Mediates Cardiac Hypertrophy and Fibrosis

Poster Session

Tuesday, Nov. 15

1:30 – 2:45 p.m. CT

Science and Technology Hall / Clinical Science Section

INVOKANA®: Key Data

S2045 / 2045

Efficacy and Safety of Canagliflozin in Patients with Type 2 Diabetes Based on History of Cardiovascular Disease or Cardiovascular Risk Factors

Poster Session

Sunday, Nov. 13

2:00 – 3:15 p.m. CT

Science and Technology Hall / Population Science Section

M2104 / 2104

Rationale, Design and Analysis of the CANagliflozin CardioVascular Assessment Study-Renal (CANVAS-R): a Randomized, Placebo-Controlled Trial

Poster Session

Monday, Nov. 14

10:45 a.m. – 12:00 p.m.

Science and Technology Hall / Population Science Section

WHAT IS XARELTO®?

XARELTO® 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 and pulmonary embolism, and to help reduce the risk of these conditions occurring again.

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®?

  • For people taking XARELTO® for atrial fibrillation:

People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood.

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.

  • XARELTO® can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO® is a blood thinner medicine that reduces blood clotting. While you take XARELTO® you are likely to bruise more easily and it may take longer for bleeding to stop.

You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:

  • Aspirin or aspirin-containing products
  • Non-steroidal anti-inflammatory drugs (NSAIDs)
  • Warfarin sodium (Coumadin®, Jantoven®)
  • Any medicine that contains heparin
  • Clopidogrel (Plavix®)
  • Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
  • Other medicines to prevent or treat blood clots

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:

  • Unexpected bleeding or bleeding that lasts a long time, such as:
    • Nosebleeds that happen often
    • Unusual bleeding from gums
    • Menstrual bleeding that is heavier than normal, or vaginal bleeding
  • Bleeding that is severe or that you cannot control
  • Red, pink, or brown urine
  • Bright red or black stools (looks like tar)
  • Cough up blood or blood clots
  • Vomit blood or your vomit looks like "coffee grounds"
  • Headaches, feeling dizzy or weak
  • Pain, swelling, or new drainage at wound sites

Spinal or epidural blood clots (hematoma): People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:

  • A thin tube called an epidural catheter is placed in your back to give you certain medicine
  • You take NSAIDs or a medicine to prevent blood from clotting
  • You have a history of difficult or repeated epidural or spinal punctures
  • You have a history of problems with your spine or have had surgery on your spine

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 patients with artificial heart valves.

WHO SHOULD NOT TAKE XARELTO®? Do not take XARELTO® if you:

  • Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding.
  • Are allergic to rivaroxaban or any of the ingredients of XARELTO®.

WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®? Before taking XARELTO®, tell your doctor if you:

  • Have ever had bleeding problems
  • Have liver or kidney problems
  • Have any other medical condition
  • Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby. Tell your doctor right away if you become pregnant while taking XARELTO®. If you take XARELTO® during pregnancy, tell your doctor right away if you have bleeding or symptoms of blood loss.
  • Are breastfeeding or plan to breastfeed. It is not known if XARELTO® passes into your breast milk. You and your doctor should decide if you will take XARELTO® or breastfeed.

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 nonprescription 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®?"

Especially tell your doctor if you take:

  • Ketoconazole (Nizoral®)
  • Itraconazole (Onmel™, Sporanox®)
  • Ritonavir (Norvir®)
  • Lopinavir/ritonavir (Kaletra®)
  • Indinavir (Crixivan®)
  • Carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol®-XR, Teril™, Epitol®)
  • Phenytoin (Dilantin-125®, Dilantin®)
  • Phenobarbital (Solfoton™)
  • Rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)
  • St. John's wort (Hypericum perforatum)

Ask your doctor if you are not sure if your medicine is one listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

HOW SHOULD I TAKE XARELTO®?

Take XARELTO® exactly as prescribed by your doctor.

Do not change your dose or stop taking XARELTO® unless your doctor tells you to.

  • Your doctor will tell you how much XARELTO® to take and when to take it.
  • Your doctor may change your dose if needed.

If you take XARELTO® for:

    • Atrial Fibrillation: Take XARELTO® 1 time a day with your evening mealIf you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
    • Blood clots in the veins of your legs or lungs:
      • Take XARELTO® once or twice a day as prescribed by your doctor.
      • Take XARELTO® with food at the same time each day.
      • If you miss a dose of XARELTO®:
        • and take XARELTO® 2 times a day: Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.
        • and take XARELTO® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
    • Hip or knee replacement surgery: Take XARELTO® 1 time a day with or without food. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
  • If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take XARELTO®.
  • Your doctor will decide how long you should take XARELTO®. Do not stop taking XARELTO® without talking to your doctor first.
  • Your doctor may stop XARELTO® for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking XARELTO® again after your surgery or procedure.
  • Do not run out of XARELTO®. Refill your prescription for XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you have XARELTO® available to avoid missing any doses.
  • If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?

Please see "What is the most important information I should know about XARELTO®?"

Tell your doctor if you have any side effect that bothers you or that does not go away.

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.

For more information about XARELTO®, visit www.xarelto.com.

WHAT IS INVOKANA®?

INVOKANA® is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATIONINVOKANA® can cause important side effects, including:

  • Dehydration. INVOKANA® can cause some people to become dehydrated (the loss of too much body water), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure (including diuretics [water pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older
  • Vaginal yeast infection. Women who take INVOKANA® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching
  • Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA® may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or pain in the skin around penis

Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.

Do not take INVOKANA® if you:

  • are allergic to canagliflozin or any of the ingredients in INVOKANA®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
  • have severe kidney problems or are on dialysis

Before you take INVOKANA®, tell your doctor if you have kidney problems; liver problems; history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; are going to have surgery; are eating less due to illness, surgery, or change in diet; pancreas problems; drink alcohol very often (or drink a lot of alcohol in short-term); ever had an allergic reaction to INVOKANA®; or have other medical conditions.

Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKANA® may harm your unborn baby. If you become pregnant while taking INVOKANA®, tell your doctor right away. INVOKANA® may pass into your breast milk and may harm your baby. Do not breastfeed while taking INVOKANA®.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir®, Kaletra® – used to treat HIV infection), or digoxin (Lanoxin®– used to treat heart problems).

Possible Side Effects of INVOKANA®

INVOKANA® may cause serious side effects, including:

  • Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 or type 2 diabetes, during treatment with INVOKANA®. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKANA® even if your blood sugar is less than 250 mg/dL.Stop taking INVOKANA® and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing
  • Kidney problems. Sudden kidney injury has happened to people taking INVOKANA®. Talk to your doctor right away if you: 1) reduce the amount of food or liquid you drink, if you are sick, or cannot eat or 2) you start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long
  • A high amount of potassium in your blood (hyperkalemia)
  • Serious Urinary Tract Infections: may lead to hospitalization and have happened in people taking INVOKANA®. Tell your doctor if you have signs or symptoms of a urinary tract infection such as: burning feeling while urinating, need to urinate often or right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Some people may also have high fever, back pain, nausea, or vomiting
  • Low blood sugar (hypoglycemia). If you take INVOKANA® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA®

Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery.

Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA® and call your doctor right away or go to the nearest hospital emergency room.

Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKANA®. Talk to your doctor about factors that may increase your risk of bone fracture.

The most common side effects of INVOKANA® include: vaginal yeast infections and yeast infections of the penis; changes in urination, including urgent need to urinate more often, in larger amounts, or at night.

Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.

Please see full Product Information and Medication Guide.

Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.

Trademarks are those of their respective owners.

About the Janssen Pharmaceutical Companies At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenUS.



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