Sglt2 Inhibitors: The Fourth Pillar
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:
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.
Jardiance Is The Only Sglt2i Approved To Treat Patients With Hf Across The Lvef Spectrum1
- §Clinically proven=meeting the primary endpoint in clinical trials.
- *JARDIANCE 10 mg is indicated in adults for the treatment of symptomatic chronic heart failure.1
- Adult patients with chronic heart failure and reduced ejection fraction .
- Adult patients with chronic heart failure and preserved ejection fraction .2,3
- The ESC Guidelines include ‘pharmacological treatments indicated in patients with NYHA class II-IV HF with reduced ejection fraction .’ ACEi=angiotensin-converting enzyme inhibitor
- ARB=angiotensin II receptor blocker ARNI=angiotensin receptor neprilysin inhibitor CV=cardiovascular eGFR=estimated glomerular filtration rate ESC=European Society of Cardiology HF=heart failure HFA=Heart Failure Association HFpEF=heart failure with preserved ejection fraction HFrEF=heart failure with reduced ejection fraction HHF=hospitalisation for heart failure LVEF=left ventricular ejection fraction MRA=mineralocorticoid receptor antagonist NYHA=New York Heart Association RRR=relative risk reduction SGLT2i=sodium-glucose cotransporter 2 inhibitor.
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.
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Clinical Trials On Jardiance
Jardiances safety and efficacy for patients with heart failure and HFrEF were investigated in EMPERORReduced, an international, randomised, double-blind, Phase III clinical trial.
In the clinical study, 3,730 patients with or without T2D having chronic heart failure with 40% or less LVEF were enrolled and randomised to receive Jardiance 10mg or placebo . These were then followed for 16 months.
The studys composite primary endpoint was the time to the first event of cardiovascular death or hospitalisation for heart failure . The secondary endpoint was the occurrence of first and recurrent HHF.
Jardiance significantly reduced the risk of cardiovascular death or hospitalisation for heart failure by 25% compared to placebo. It was also found to be superior in reducing the occurrence of first and recurrent HHF by 30% compared to placebo.
The drugs safety profile for the condition was consistent with its established safety profile. The most common adverse effects reported during the clinical study were urinary tract infections and female genital mycotic infections.
Ingredients Of Jardiance And Farxiga
Jardiance contains the active drug empagliflozin. Farxiga contains the active drug dapagliflozin.
These drugs belong to the same class of medications: sodium-glucose co-transporter 2 inhibitors. They work by making your kidneys remove more sugar from your blood and eliminate it from your body in your urine.
In addition, one of the ways they help heart disease is by lowering your blood pressure.
Jardiance and Farxiga are FDA-approved for some of the same uses, as well as different ones.
- Uses for both Jardiance and Farxiga:
- To help control blood sugar levels in adults with type 2 diabetes. The drugs are approved for use in combination with diet and exercise.
- To reduce the risk of hospitalization and death from heart failure. For this use, Farxiga is prescribed for adults who have heart failure, but who dont have type 2 diabetes.
Note: Neither Jardiance nor Farxiga is approved for treating type 1 diabetes.
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Before Taking This Medicine
You should not use Jardiance if you are allergic to empagliflozin, or if you have:
severe kidney disease .
To make sure Jardiance is safe for you, tell your doctor if you have ever had:
liver or kidney disease
a bladder infection or urination problems
a genital infection
problems with your pancreas, including surgery
alcoholism, or if you currently drink large amounts of alcohol
if you are on a low salt diet or
if you are 65 or older.
Follow your doctor’s instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.
You should not use Jardiance during the second or third trimester of pregnancy.
Do not breastfeed while you are taking Jardiance.
Jardiance is not approved for use by anyone younger than 18 years old.
Switching Between Jardiance And Farxiga
You might be interested in switching from Jardiance to Farxiga or vice versa. For instance, if one of the drugs doesnt work well enough to control your blood sugar, you may consider switching. You might also wonder about switching if you have side effects that bother you from either of these drugs.
Switching between these drugs is possible, but your doctor may advise against it. This is because the drugs work in the same way and have very similar side effects. Therefore, you might not gain anything by switching.
If youre concerned about whether your treatment is working or about side effects, talk with your doctor. They can let you know whether switching to Jardiance or Farxiga is a good option for you. Or they may recommend changing to a different type of diabetes drug instead.
Note: Never change your medications without your doctors approval and guidance.
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Us Fda Approves Jardiance To Treat Adults With Heart Failure Regardless Of Left Ventricular Ejection Fraction
– Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction
– FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. with heart failure with preserved ejection fraction, which has been classified as “the single largest unmet need in cardiovascular medicine”,
– Heart failure represents a significant, growing disease burden in the U.S., with more than 8 million cases expected by 2030
RIDGEFIELD, Conn. and /PRNewswire/ — The U.S. Food and Drug Administration has approved Jardiance® 10 mg to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, Boehringer Ingelheim Eli Lilly and Company announced today.
Jardiance is not for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. It is not for use to improve glycemic control in adults with type 2 diabetes with an eGFR below 30 mL/min/1.73 m2 as it is likely to be ineffective in this setting based upon its mechanism of action.
Jardiance can be initiated in adults with heart failure with an eGFR as low as 20 mL/min/1.73 m2.
A key secondary endpoint analysis from EMPEROR-Preserved showed that Jardiance reduced the relative risk of first and recurrent hospitalizations for heart failure by 27% .
What is JARDIANCE?
Fda Approves Jardiance Empagliflozin For Wider Range Of Patients With Heart Failure
Eli Lilly and Boehringer Ingelheims blockbuster diabetes drug Jardiance has been granted approval by the US Food and Drug Administration for a wider range of heart failure patients.
The approval builds upon previously secured indications, including the use of Jardiance to reduce the risk of cardiovascular death plus hospitalisation for heart failure with reduced left ventricular ejection fraction , which the FDA greenlighted in 2021.
With the expanded indication, Jardiance is the only drug to be cleared to improve outcomes in all heart failure patients, no matter their ejection fraction status.
The FDA initially approved the drug in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Jardiance is also authorised to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
According to the FDA, heart disease impacts more than 650,000 people in the US each year. Despite advancements in treatment in multiple drug classes, mortality remains a significant issue and treatment options for a broader range of patients are needed.
The FDAs decision to expand the indications for Jardiance was based on results from the international, randomised, double-blind EMPEROR-Preserved phase III trial, which evaluated the safety and efficacy of Jardiance 10mg compared to placebo and standard of care therapy.
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How Should I Take Jardiance
Take Jardiance exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
You may take Jardiance with or without food.
Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. Empagliflozin can cause life-threatening ketoacidosis . Even if your blood sugar is normal, contact your doctor if a urine test shows that you have high ketones in the urine.
Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.
Low blood sugar can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.
You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Jardiance.
Your treatment may also include diet, exercise, weight control, and special medical care.
Store at room temperature away from moisture and heat.
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 .
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Jardiance Approved For Heart Failure With Reduced Ejection Fraction
The Food and Drug Administration has approved Jardiance® to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction .
The approval was based on data from the phase 3 EMPEROR-Reduced trial , which evaluated the efficacy and safety of empagliflozin as adjunct to standard of care therapy in 3730 adults with chronic heart failure New York Heart Association functional class II-IV) with reduced ejection fraction . Patients were randomly assigned 1:1 to receive either empagliflozin 10mg once daily or placebo.
The primary endpoint was the time to first event of either cardiovascular death or hospitalization for heart failure . A key secondary endpoint was the occurrence of HHF .
Results showed that empagliflozin significantly reduced the risk for CV death or HHF by 25% compared with placebo this was mostly driven through a reduction in HHF. Empagliflozin reduced the risk of first and recurrent HHF by 30% compared with placebo .
Warnings Of Jardiance And Farxiga
Jardiance and Farxiga work in the same way in your body, and the same warnings apply to both of them. Some of these warnings are mentioned below. Before you start using Jardiance or Farxiga, be sure to talk with your doctor to see if these warnings apply to you.
Warnings for Jardiance and Farxiga include:
- Kidney disease. Both of these drugs can cause kidney damage. If you already have problems with your kidneys, these drugs could make it worse. Talk with your doctor about whether these drugs are safe for you. If you have severe kidney disease, you shouldnt take Jardiance or Farxiga.
- Dehydration and low blood pressure. Both of these drugs make you lose more fluid than usual. This can lead to dehydration and low blood pressure. If youre older than 65 years, have kidney problems, or are taking diuretic drugs, youre more likely to have this problem. Talk with your doctor about whether these drugs are right for you.
- History of genital yeast infections. Both of these drugs can cause genital yeast infections, such as thrush. If youve had ongoing or recurrent genital yeast infections in the past, you may have a higher risk for these infections when using one of these drugs. Talk with your doctor about whether these drugs are right for you.
- High cholesterol. Both of these drugs can increase your cholesterol level. If you already have high cholesterol, your doctor may want to monitor your cholesterol level while you take one of these drugs.
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Fda Grants Jardiance Breakthrough Therapy Designation For Heart Failure With Preserved Ejection Fraction
– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction
RIDGEFIELD, Conn. Food and Drug Administration granted Breakthrough Therapy designation for Jardiance® as an investigational treatment for adults with heart failure with preserved ejection fraction , Boehringer Ingelheim Eli Lilly and Company announced today.
The decision is based on results from the landmark EMPEROR-Preserved phase III trial, in which Jardiance demonstrated a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction compared with placebo. The benefit was independent of ejection fraction or diabetes status. Results from EMPEROR-Preserved were presented at the European Society of Cardiology Congress 2021 on The New England Journal of Medicine .
HFpEF accounts for approximately half of the more than 6 million heart failure cases in the U.S. No currently approved treatments have been clinically proven to significantly improve outcomes specifically for people with HFpEF.
What is JARDIANCE?
JARDIANCE is a prescription medicine used to:
JARDIANCE is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis .
IMPORTANT SAFETY INFORMATION