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Real-World Study of More than 700,000 People with Type 2 Diabetes (T2D) Shows No Increased Risk of Below-Knee Lower Extremity Amputations with INVOKANA® (canagliflozin) Compared to Other Diabetes Medications | ||
By: PR Newswire Association LLC. - 24 Jun 2018 | Back to overview list |
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TITUSVILLE, N.J. and ORLANDO, Fla., June 24, 2018 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced late-breaking results of a new real-world analysis of more than 700,000 U.S. T2D patients, which found no increased risk of below-knee lower extremity (BKLE) amputation with INVOKANA® (canagliflozin) compared to other sodium glucose cotransporter 2 inhibitors (SGLT2i) or non-SGLT2i anti-hyperglycemic medicines. In addition to the general T2D population, similar results were also seen in a sub-set of patients with T2D and established cardiovascular disease. OBSERVE-4D is the largest, most comprehensive real-world observational study to evaluate the risk of BKLE amputation and hospitalization for heart failure (HHF) across anti-hyperglycemic therapies. Full findings from the late-breaking presentation were highlighted today in the American Diabetes Association's (ADA) 78th Official Press Program in Orlando, Florida and simultaneously published in Diabetes, Obesity and Metabolism. "We initiated OBSERVE-4D to better characterize the real-world use of INVOKANA® and the SGLT2i class, so physicians and their patients could make better informed treatment decisions," said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen Scientific Affairs, LLC. "Prior to this analysis, no real-world study had evaluated head-to-head comparative evidence on amputation and hospitalization for heart failure across individual SGLT2i medicines." Researchers observed no increased risks across the therapy comparisons for BKLE amputations in the general T2D population:
These amputation rates were also consistent in a sub-population with established cardiovascular disease:
"OBSERVE-4D depicts how INVOKANA® and other SGLT2is are being used by people with type 2 diabetes, including in those with established CV disease, in the real world," said John Buse, MD, PhD, Chief of the Division of Endocrinology and Director of the Diabetes Center, University of North Carolina School of Medicine, Chapel Hill, North Carolina. "The overall benefit-risk profile of SGLT2is is positive, and physicians should feel comfortable and confident in prescribing the class to their appropriate patients." In addition to showing no significant imbalance of BKLE amputation, the study also identified a HHF reduction in the general T2D population that was consistent with rates seen in randomized clinical trials and other real-world evidence studies including the SGLT2i class. The HHF result is a positive confirmatory finding and supports the internal validity of the study results:
"The OBSERVE-4D findings are welcome news for patients and the physicians who treat them," said Ralph DeFronzo, MD, professor of medicine and chief of the Division of Diabetes at UT Health. "These data reaffirm the confidence we've always had in the SGLT2i class." SGLT2is, including INVOKANA®, are anti-hyperglycemic therapies prescribed for the treatment of T2D. Evidence was published last year from the CANVAS (CANagliflozin cardioVascular Assessment Study) Program, which was the first program to assess the efficacy, safety, and durability of INVOKANA® in more than 10,000 patients with T2D who had either a prior history of CV disease or at least two CV risk factors. However, an increased risk of BKLE amputation was seen with INVOKANA® in the CANVAS Program and is reflected in its U.S. prescribing information.1,2 About OBSERVE-4D Patients represented a diverse population covered by employer-sponsored plans, Medicare or Medicaid. The two primary outcomes were HHF and BKLE amputation. Patients in the different treatment groups were matched based on demographic and clinical characteristics, including the presence of other diseases and their associated mortality risks. Investigators found similar results for HHF and BKLE amputation in a separate sub-group analysis of 215,633 patients who had established CV disease, representing 30 percent of the entire population from the four databases:
To advance transparency and ensure open access for future research, the study protocol and all results are publicly available at: data.ohdsi.org/AhasHfBkleAmputation. Because of the volume and complexity of the analyses, the researchers created an interactive matrix that allows other scientists to fully explore the data. Real-World Study Limitations OBSERVE-4D investigators also noted that although these results are derived from multiple large datasets reflecting current use in the United States, the number of patients with long-duration exposure (>6 months) and the study's power are limited. Further study will help to fully understand the issue. WHAT IS INVOKANA®? IMPORTANT SAFETY INFORMATION INVOKANA® (canagliflozin) 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®
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, including Boxed Warning, and Medication Guide for INVOKANA®. Janssen Pharmaceuticals, Inc. and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation, including in the United States. Trademarks are those of their respective owners. About the Janssen Pharmaceutical Companies Cautions Concerning Forward-Looking Statement This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the potential benefits and further development of INVOKANA® (canagliflozin). 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 Scientific Affairs, 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 31, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's subsequent Quarterly Reports on Form 10-Q, and other 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. 1 Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377(7):644-657.
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