TITUSVILLE, N.J., Nov. 7, 2016 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. (Janssen) today 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 / |
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®?
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.
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:
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:
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:
WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®?
Before taking XARELTO®, tell your doctor 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 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:
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.
If you take XARELTO® for:
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 INFORMATION
INVOKANA® can cause important side effects, including:
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:
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:
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.
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, including expectations for research programs and clinical trials. 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 Pharmaceuticals, Inc. or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description 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 January 3, 2016, including in Exhibit 99 thereto, 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 or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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SOURCE Janssen Pharmaceuticals, Inc.