The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results of a new subgroup analysis from the landmark phase 3 CREDENCE study, showing INVOKANA® (canagliflozin) significantly reduced the risk of major cardiovascular (CV) events and kidney failure in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD)
SAN FRANCISCO, June 11, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results of a new subgroup analysis from the landmark phase 3 CREDENCE study, showing INVOKANA® (canagliflozin) significantly reduced the risk of major cardiovascular (CV) events and kidney failure in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). These positive results were observed in patients taking INVOKANA®, including those with CV risk factors but no history of CV disease (primary prevention group) and patients with history of CV disease, defined as a history of coronary, cerebrovascular or peripheral vascular disease (secondary prevention group). Results were presented today at the American Diabetes Association’s 79th Scientific Sessions. “The CREDENCE study demonstrates canagliflozin’s ability to manage some of the most common yet serious complications from T2D, including CV and kidney diseases,” said study investigator Kenneth W. Mahaffey, M.D., Professor and Vice Chair of Clinical Research, Department of Medicine, Stanford University School of Medicine, and Director, Stanford Center for Clinical Research (SCCR), Stanford, Calif.1 “We’re particularly excited about this new analysis because it’s the first time a type 2 diabetes medicine has shown a cardiovascular benefit in patients who did not have preexisting CV disease. This is an important, clinically meaningful finding as it uncovers the potential of canagliflozin to offer a protective effect in this patient population.” Published in The New England Journal of Medicine this past April, the Phase 3 CREDENCE study evaluated CV and renal outcomes in patients with T2D and CKD taking either INVOKANA® or placebo, in addition to standard of care. Results from the CREDENCE study were also recently added to the American Diabetes Association’s Standards of Medical Care in Diabetes, which gives healthcare professionals the latest evidence-based recommendations to treat people with type 2 diabetes and chronic kidney disease. For the new subgroup analysis being presented at ADA, CREDENCE researchers specifically examined CV and renal outcomes in the primary prevention group (n=2,181; 49.6%) and secondary prevention group (n=2,220; 50.4%). Compared to secondary prevention participants, primary prevention participants were younger (61.4 vs. 64.6 years) and more often female (36.6% vs. 31.3%), but with similar T2D duration (15.2 vs. 16.4 years). Click to Tweet: New #CREDENCE analysis shows significant reduction in #CV events and kidney failure in patients with T2D and chronic #kidneydisease #ADA2019 https://ctt.ec/rye7a+ “About one in three people with type 2 diabetes have chronic kidney disease, which puts them at increased risk of kidney failure and negative cardiovascular outcomes,i like cardiovascular death, heart attack, stroke, and heart failure,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “With the results from our CREDENCE study, INVOKANA® is now poised to become the first therapy in nearly two decades for treating chronic kidney disease in people with type 2 diabetes, providing both kidney and cardiovascular protection.” CV Outcomes
Renal and Safety Outcomes
In addition, CREDENCE found the incidence rates of adverse events and serious adverse events were numerically lower for patients treated with INVOKANA® as compared to placebo. For the subgroup analysis, safety outcomes were similar in both primary and secondary prevention groups. Of note, there was no difference in fracture risk or incidence of amputations in the primary and secondary prevention groups. About CREDENCE In March 2019, Janssen submitted a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for INVOKANA® to reduce the risk of end-stage kidney disease, the doubling of serum creatinine, and renal or CV death for adults with CKD and T2D, based on data from the CREDENCE study. The application was given a Priority Review, which FDA assigns to medicines that may offer significant improvements in the treatment, diagnosis or prevention of a serious condition. If this new indication is approved, INVOKANA® would be the first T2D medication to treat CKD, one of the most common and potentially life-threatening comorbidities associated with T2D.i The FDA most recently approved an indication for INVOKANA® in October 2018 to reduce the risk of major adverse CV events, including heart attack, stroke or death due to a CV cause in adults with T2D who have established CV disease. INVOKANA® is also indicated to lower blood sugar in adults with T2D. INVOKANA® is contraindicated for patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), ESKD, or those on dialysis. In addition, INVOKANA® is not recommended when eGFR is persistently less than 45 mL/min/1.73 m2. Please see the Important Safety Information below and the full Prescribing Information for additional details. WHAT IS INVOKANA®?
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 a history of amputation; heart disease or are at risk for heart disease; blocked or narrowed blood vessels (usually in leg); damage to the nerves (neuropathy) of your leg; diabetic foot ulcers or sores; 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 click here for full Product Information, including Boxed Warning, and Medication Guide for INVOKANA®. Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation. Trademarks are those of their respective owners. About Janssen Cardiovascular & Metabolism About the Janssen Pharmaceutical Companies of Johnson & Johnson Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC, is one 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 Janssen research in type 2 diabetes. 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 30, 2018, 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. Media contacts: Jessica Castles Smith Investor contacts: Lesley Fishman 1 Dr. Kenneth Mahaffey worked directly with Janssen R&D and was compensated for his work on the CREDENCE study. i Bailey RA, Wang Y, Zhu V, Rupnow MF. Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging. BMC Research Notes. 2014;7:415. doi:10.1186/1756-0500-7-415.
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