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Jardiance For Heart Failure Without Diabetes

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What Should You Tell Your Doctor Before Starting Jardiance

Heart Failure Spotlight: Jardiance® (empagliflozin) tablets: The Impact of EMPA-REG OUTCOME

You should not take this medication if you have a hypersensitivity to empagliflozin or any of the inactive ingredients in Jardiance or if you are on dialysis.

You should take Jardiance with caution if you have certain medical conditions, including:

  • Heart disease or low blood pressure
  • Kidney problems or decreased kidney function
  • History of urinary tract infections
  • Scheduled surgery
  • Change in diet or amount of food you are eating
  • Problems with your pancreas or pancreatic surgery
  • Are a chronic alcohol drinker or you binge drink
  • Dizziness or lightheadedness

Jardiance can sometimes cause serious side effects such as:

  • Serious allergic reactions including life-threatening anaphylaxis
  • Low blood sugar , especially if taken with a sulfonylurea
  • Kidney problems
  • Volume depletion, especially in patients with reduced kidney function, elderly patients, or patients on loop diuretics

Speak with your healthcare professional about the possible drug interactions with any other prescription drugs, over-the-counter products, vitamins, and supplements you are taking. These are not all of the possible side effects of Jardiance. You should always seek medical advice for any questions or concerns relating to your medical condition or treatment. You can report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The Future Of Sglt2 Inhibitors For Heart Failure

Several clinical trials are in design or launching to determine whether SGLT2 inhibitors offer other potential cardiac benefits, such as improving the heart muscle function. Additional trials include measuring the effects on broader populations with kidney disease and assessing SGLT2 inhibitor effects after a heart attack in patients who do not have diabetes.

Future research will help cardiologists determine which patients might benefit most from SGLT2 inhibitors and at what point in the disease process.

Over the course of my career, Ive witnessed the development of numerous classes of diabetes drugs that have now been proven to have cardiovascular safety, such as the thiazolidinediones, various forms of long-acting insulin, and dipeptidyl peptidase 4 inhibitors, as well as two classes with proven cardiovascular benefits the SGLT2 inhibitors and the glucagon-like peptide 1 receptor agonists.

Since regulatory agencies in the U.S. and Europe began requiring cardiovascular safety assessment in 2008, I have had the privilege of being involved in the clinical trials assessment of most of the diabetes drugs developed in that time.

To visit with a specialist about heart failure treatment options, call orrequest an appointment online.

Growing Use Of Diabetes Drugs For Other Conditions

This latest study fits a trend of diabetes drugs being tested as treatments for other health conditions, often with promising results. Another drug in the SGLT2 inhibitor family, Farxiga was approved last year as a treatment for HFrEF in the United States, so it was logical to try out Jardiance for the same condition.

Our observations suggest that SGLT2 inhibitors could become a new therapeutic strategy for the treatment of HFrEF patients independently of their diabetic status, the researchers wrote. It remains to be determined, they note, whether Jardiance could benefit people with heart failure who dont have reduced ejection fraction.

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Jardiance Improves Outcomes In Heart Failure Without Diabetes

One reason diabetes is so devastating, in the big picture, is because of how closely its tied to heart disease. People with both type 1 and type 2 diabetes have a higher risk of certain forms of cardiovascular disease, and people with type 2 are at an especially high risk of heart disease related to higher blood pressure, elevated or abnormal cholesterol and triglyceride levels, and obesity. For this reason, screening for cardiovascular disease risk factors is a regular and important part of diabetes care.

To get cutting-edge diabetes news, strategies for blood glucose management, nutrition tips, healthy recipes, and more delivered straight to your inbox, !

Cardiovascular risks and benefits are also an important consideration for any diabetes drug both when the U.S. Food and Drug Administration is considering whether to approve a new drug, and when you and your doctor are deciding whether a drug is right for you. Some diabetes drugs are tied to cardiovascular benefits in addition to their effect on blood glucose levels. Metformin considered the first-line drug for type 2 diabetes is probably the most prominent example, with possible benefits in people with heart failure as well as a potentially protective effect against dementia in people with diabetes.

Empagliflozin Versus Dapagliflozin In Hf Treatment

Jardiance 25

Both dapagliflozin and empagliflozin are listed in the ESC Guidelines for Diagnosis and Treatment of Acute and Chronic Heart Failure. In Table 3, we compared the most relevant studies on the use of these two drugs for heart failure. The primary endpoints in each of these studies are death from cardiovascular causes or worsening of heart failure treated as urgent hospitalization or an event requiring intravenous therapy. The report of the DELIVER study, which is investigating the effect of dapagliflozin on HFmrEF and HFpEF and is complementary to the DAPA-HF study, is not yet available. DELIVER is also equivalent in some ways to the EMPEROR-Preserved study involving empagliflozin. The DAPA-HF, EMPEROR-Reduced and EMPEROR-Preserved studies showed significant effects of both dapagliflozin and empagliflozin in reducing mortality and the number of hospitalizations compared to the placebo group. The effects were consistent across prespecified subgroups, including the presence or absence of diabetes at baseline. To date, empagliflozin remains the only SGLT2 inhibitor whose efficacy extends over a wide range of LVEF, as proven in the EMPEROR-Preserved study therefore, it has advantages over dapagliflozin.

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What Is The Difference Between Jardiance And Invokana

Jardiance and Invokana are both used along with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Jardiance is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus or heart failure. Both medications are classified as SGLT 2 inhibitors that are taken by mouth once a day. They both commonly cause side effects such as vaginal yeast infection, genital yeast infection in men, and increased cholesterol levels. While they have not been compared directly, both medications have been shown to be effective in lowering HbA1c levels, fasting and postprandial glucose levels, weight, and systolic blood pressure.

Is Jardiance Generic Available

Jardiance is an oral diabetes medication manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. that was approved by the United States Food and Drug Administration in 2014. It is classified as a sodium-glucose co-transporter 2 inhibitor. SGLT-2 inhibitors are sometimes referred to as flozins or gliflozins because of the common ending in the generic names of this class.

Currently, there is currently no generic version of Jardiance available. It is not known when the first generic version of Jardiance will become available but based on the patents and regulatory protections it appears that the earliest date for generic entry will be Feb. 24, 2025. Learn more about the earliest potential release date for generic Jardiance and options to save money on this medication.

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Animal Study Supports Mechanism For Glucose

byNicole Lou, Staff Writer, MedPage Today April 15, 2019

The SGLT2 inhibitor empagliflozin shifted myocardial metabolism from glucose to other more energy-efficient metabolites in a pig model, researchers said, suggesting a mechanism for its cardiac benefits beyond glucose lowering.

Among non-diabetic pigs with an induced MI, those that were randomized to empagliflozin had better myocardial energy production and lower uptake of glucose. Consumption of more ketone bodies, free fatty acids, and branched-chain amino acids was demonstrated by greater uptake of these three metabolites compared with control animals at 2 months.

With greater utilization of the non-glucose fuel, empagliflozin increased myocardial ATP production and improved myocardial work efficiency, as Juan Badimon, PhD, of Mount Sinai School of Medicine in New York City, and colleagues reported in the April 23 issue of the Journal of the American College of Cardiology.

In turn, the improved myocardial energetics resulted in enhanced left ventricular systolic function and an easing of adverse LV remodeling at the anatomical, metabolic, and neurohormonal levels, the investigators found. “Therefore, it seems reasonable to conclude that the benefits of empagliflozin are, at least in part, mediated via a mechanism independent of its glucose-lowering activity.”

Control and experimental groups shared a similar extent of initial induced ischemic myocardial injury.

Disclosures

Benefits In Heart Function Quality Of Life

Jardiance (empagliflozin)- Heart failure

In the study, published in the Journal of the American College of Cardiology, Jardiance was found to improve the function of the hearts left ventricle its main pumping chamber in people with heart failure with reduced ejection fraction . This type of heart failure means that a persons ejection fraction a measure of how much blood the left ventricle pumps out with each heartbeat is less than 40%.

The study had 84 participants, all of whom had with HFrEF but didnt have diabetes. They were randomly assigned to take either 10 milligrams of Jardiance, or a placebo , once daily for six months. Researchers were interested not only in potential improvements in heart function, but also in how the treatment might affect participants reported quality of life.

After six months, there were several notable differences between the Jardiance group and the placebo group. Jardiance was associated with a reduction in volume in the left ventricle indicating better function both during heartbeats and between heartbeats . Compared with placebo, Jardiance was also associated with a reduction in the mass of the left ventricle, down by 17.8 grams versus 4.1 grams. The actual measure of ejection fraction how much blood the heart pumps out went up too, by 6% compared with just 0.1% in the placebo group.

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What Drug Is Comparable To Jardiance

There are a number of medications available to manage a diagnosis of type 2 diabetes mellitus if Jardiance is not the right medication for you. These medications should be used along with a diet and exercise program developed by your doctor or diabetes care team.

Some alternative oral medications that your doctor may prescribe include:

  • Invokana , an oral tablet taken once a day
  • Farxiga , an oral tablet taken once a day
  • Steglatro , an oral tablet taken once a day
  • Glucophage , an oral tablet taken up to 3 times a day
  • Tradjenta , an oral tablet taken once a day

Mount Sinai Clinical Trial Results Could Help Lead To Fda Approval

Empagliflozin, a recently developed diabetes drug, can effectively treat and reverse heart failure in both diabetic and non-diabetic patients, according to researchers at the Icahn School of Medicine at Mount Sinai.

Their clinical trial showed that this medication can improve the hearts size, shape, and function, leading to better exercise capacity and quality of life, which will reduce hospitalizations for heart failure patients. The results were presented on Friday, November 13, at the American Heart Association Scientific Sessions 2020 and simultaneously published in the Journal of the American College of Cardiology.

Our clinical trials promising results show this diabetes drug can ameliorate lives of heart failure patients with reduced ejection fraction, enhance their exercise capacity, and improve their quality of life with little to no side effects. We expect this work will help lead to U.S. Food and Drug Administration approval of empagliflozin for this patient population in the coming months, said first author Carlos Santos-Gallego, MD, postdoctoral fellow at the Icahn School of Medicine at Mount Sinai.

Importantly, the researchers noted that the drug did not appear to cause hypoglycemia, or low blood sugar, in non-diabetic patients.

About the Mount Sinai Health System

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Empagliflozin Is The First Approved Sglt2 Inhibitor In The Us For Reducing Hard Outcomes In Hf Patients With Preserved Ef

The US Food and Drug Administration today announced that empagliflozin is now approved for the treatment of patients with heart failure with preserved ejection , making it the first sodium-glucose cotransporter 2 inhibitor to be cleared for these patientsa group for whom few treatments have proved effective.

The expanded indication is based on results of the EMPEROR-Preserved randomized trial, which was led by Stefan Anker, MD, PhD , and published last year in the New England Journal of Medicine. Specifically, empagliflozin is approved for reducing the risk of cardiovascular death and hospitalization for HF in patients with HFpEF.

Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology at the FDAs Center for Drug Evaluation and Research, noted that the approval gives physicians another tool for treating patients with few other options. While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure, he said in a statement.

Dapagliflozin , another SGLT2 inhibitor, was approved last year by the FDA for the treatment of HFrEF patients, and both empagliflozin and dapagliflozin are approved in Europe for the treatment of HFrEF. Dapagliflozin is not approved for the treatment of patients with HFpEF.

Sglt2 Inhibitors: The Fourth Pillar

Jardiance: New Oral Medication for Type 2 Diabetes Lives Up to the Hype ...

The exact reasons why this newest class of drugs treats HFrEF is still being researched. One of the leading theories is that this change is mediated through fixing sodium-related problems in the kidneys, restoring normal kidney physiology. Several hypotheses have been developed about how SGLT2 inhibitors may work to reduce heart failure risk:

  • Reduce inflammation: Diabetes and atherosclerosis, as well as heart failure, cause inflammation and vice versa, and SGLT2 inhibitors are thought to decrease inflammation, independent of their effects on blood sugar.
  • Restore normal feedback within the kidney: The kidney filters glucose into the urine through a cluster of capillaries at the beginning of the kidney tubule . Then glucose is taken back into the bloodstream by SGLT2. Drugs that block SGLT2 also block glucose and sodium re-uptake, which results in the kidney sensing normal sodium and chloride levels in the urine. That reflects appropriate blood pressure and intravascular volume signaling the kidneys to reduce blood flow and normalize blood pressure within the glomerulus.
  • Reduce sympathetic nervous system activity: This reduces the heart rate and blood pressure because we are essentially turning off the adrenaline nervous system response.
  • SGLT2 drugs are expensive. However, robust clinical evidence has resulted in many insurance companies covering at least one of the members of the drug class as a preferred therapy.

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    Limitations Of Empagliflozin Use In Patients With Hf

    The clinical value of empagliflozin in cardiological patients should be assessed considering not only the potential benefits, but also the adverse effects and risks of using SGLT-2 inhibitors . The use of empagliflozin is not recommended and should not be implemented if Glomerular Filrtation Rate is less than 20 mL/min/1.73 m2 . GFR-related criterion may often determine limitations in using empagliflozin in patients with HF, as they often suffer from comorbid renal disease . Besides, empagliflozin is not used in patients with HF codominant to type 1 diabetes or in those with diabetic ketoacidosis . Other contraindications include women in their second and third trimesters of pregnancy and those with a severe hypersensitivity reaction to empagliflozin .

    Jardiance Approved For Heart Failure Independent Of Lvef

    The Food and Drug Administration has approved Jardiance® to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with HF. Previously, the treatment was only approved to reduce the risk of CV death and hospitalization for HF in patients with HF and reduced ejection fraction.

    The approval was based on data from the randomized, double-blind, phase 3 EMPEROR-Preserved trial , which compared the efficacy and safety of empagliflozin, a sodium-glucose co-transporter 2 inhibitor, to placebo in 5988 adults with HF with preserved ejection fraction, with and without diabetes. The study population included patients with left ventricular ejection fraction < 50% , LVEF 50 to < 60% and LVEF 60% .

    Patients were randomly assigned 1:1 to receive either empagliflozin 10mg once daily or placebo , in addition to standard of care for up to 38 months. The primary endpoint of the study was the time to first event of either CV death or hospitalization for HF.

    Results showed that the primary outcome event occurred in 13.8% of empagliflozin-treated patients vs 17.1% of those who received placebo, corresponding to a 21% relative risk reduction . The reduction was mostly attributed to a lower risk of hospitalization for HF .

    Treatment with empagliflozin was also associated with significantly lower risk of first and recurrent hospitalizations for HF compared with placebo .

    Reference

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    Jardiance Reduced The Combined Relative Risk Of Cardiovascular Death And Hospitalization For Heart Failure By 25% In Adults With And Without Diabetes Who Had Heart Failure With Reduced Ejection Fraction

    RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 29, 2020 /PRNewswire/ — Full results from the EMPEROR-Reduced phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, showed that Jardiance® was associated with a significant 25% relative risk reduction in the primary endpoint of time to cardiovascular death or hospitalization due to heart failure. The trial evaluated the effect of adding Jardiance versus placebo to standard of care. The results will be presented today at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, and published in The New England Journal of Medicine, Boehringer Ingelheim and Eli Lilly and Company announced.

    The findings from the primary endpoint were consistent in subgroups with and without type 2 diabetes. Key secondary endpoint analyses from the trial demonstrated that Jardiance reduced the relative risk of first and recurrent hospitalization for heart failure by 30%. Additionally, the rate of decline in eGFR, a measure of kidney function decline, was slower with Jardiance than with placebo.

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