TITUSVILLE, N.J., Nov. 17, 2017 /PRNewswire/ -- A new real-world analysis of adults with type 2 diabetes and established
"This is the first real-world study to demonstrate a lower risk of MACE in patients with type 2 diabetes and established CVD who were initiated on SGLT2i therapy," said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen. "These results further reinforce the positive effects of INVOKANA® and SGLT2is in cardiovascular risk reduction."
Study and FindingsThe population-based EASEL study included two cohorts: 12,629 new users of a SGLT2i and 12,629 new users of a non-SGLT2i diabetes medication, both on top of standard-of-care therapy. The two cohorts were matched on propensity scores, with a model including various characteristics such as demographics, duration of diabetes, baseline comorbidities and medication use, diagnoses and procedures, and various health care resource utilization measures. In the SGLT2i cohort, canagliflozin, empagliflozin and dapagliflozin accounted for 58.1 percent, 26.4 percent and 15.5 percent of patients, respectively. The median follow-up for the two cohorts was 1.6 years based on the ITT approach.
The primary outcome was the composite of ACM and HHF. Several other CVD-related events were also assessed as secondary endpoints. The ITT analysis showed that the SGLT2i cohort had statistically significant reductions in the incidence of multiple endpoints compared to the non-SGLT2i cohort, respectively, including:
The incidence rate of below-knee lower extremity amputation (BKA) in the SGLT2i cohort was relatively infrequent — approximately two-fold compared to the non-SGLT2i cohort: 35 vs. 18 events (0.17 vs. 0.09 events per 100 person-years, HR 1.99, CI: 1.12-3.51; P=0.018). It remains unclear whether the BKA risk extends across the SGLT2i class of medications as the study was not powered to make comparisons among individual treatments.
Of the approximately 30 million people living with diabetes in the United States, 90 to 95 percent have type 2 diabetes,1 and are two to four times more likely to die from heart disease than those without diabetes.2
One of the largest public health insurance claims programs in the United States, the Department of Defense Military Health System (MHS) includes active or retired service members and their dependents, with close to 10 million patients actively receiving care. The database integrates all medical, clinical, pharmacy and administrative data for every eligible MHS beneficiary across the United States.
INVOKANA® (canagliflozin) is indicated as an adjunct to diet and exercise to lower blood sugar in adults with type 2 diabetes. It is not indicated to reduce the risk of ACM, HHF or MACE, which includes ACM, non-fatal MI and non-fatal stroke. The landmark CANVAS Program, the largest completed CV outcomes program to date, evaluated the cardiovascular safety and efficacy of canagliflozin relative to placebo in adults with type 2 diabetes who had either established CVD or were at risk for CVD. A supplemental new drug application (sNDA) based on data from the CANVAS Program was filed with the FDA on October 2, 2017.
WHAT IS INVOKANA®?INVOKANA® (canagliflozin) 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® (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®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, including Boxed Warning, and Medication Guide for INVOKANA®.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.
About the Janssen Pharmaceutical CompaniesAt 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.
1 Centers for Disease Control and Prevention. National diabetes statistic report, 2017: estimates of diabetes in the United States. Atlanta, GA: U.S. Department of Health & Human Services, Centers for Disease Control and Prevention, 2017. Available at: https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. Accessed November 16, 2017.2 American Heart Association. Cardiovascular Disease & Diabetes. American Heart Association, 2017. Available at: http://www.heart.org/HEARTORG/Conditions/More/Diabetes/WhyDiabetesMatters/Cardiovascular-Disease-Diabetes_UCM_313865_Article.jsp#.WbawtvnyuUl. Accessed November 16, 2017.
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SOURCE Janssen Pharmaceuticals, Inc.
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