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New Heart Failure Medications 2022- FDA-Approved for Patients with Heart Failure with Reduced Ejection Fraction

In today's day and age, modern medicine is making so much progress with research and development. There are a lot of treatments available for heart failure but still a need to find better medications because of the increasing number of patients with heart failure. This article will give information about the new heart failure medications in 2022 approved by the FDA. Read ahead till the end to learn more about the new medicine in detail.

By Shreya Sanas

Updated on 27th, Oct'22

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Overview

Heart failure occurs when your heart becomes weak or stiff and struggles to pump blood and oxygen to the rest of your body. Heart failure can result from a heart attack, excessive blood pressure, coronary artery disease, genetic cardiac abnormalities, heart valve disease and other risk factors.

 

It is a common disease affecting at least 60 million people worldwide, and the number is growing yearly. Although various treatments are available for the condition, the mortality rates are high and advanced medications are needed to help the patients.

 

As one of the world's top causes of disability and mortality, with devastating consequences for healthcare systems and the global economy, it is critical to develop and provide solutions to fill the current gaps in heart failure therapy. Millions of lives are at stake if this disease's treatment landscape is improved.

 

The U.S. Food and Drug Administration (FDA) ensures that safe and effective medications are available to improve patients' health. They understand that there is a need for a new treatment for heart failure. They approved a new medication for heart failure on 24th February 2022, called . It is sold under the brand name Jardiance. 

 

What is the New Medication for Heart Failure? 

 

Jardiance was first introduced in 2014 by the FDA to treat type 2 Diabetes. 

Jardiance has also been licensed to lower the risk of cardiovascular death in individuals with type 2 diabetes and pre-existing cardiovascular disease and those with heart failure and a poor ejection fraction.

 

Jardiance is the first and only heart failure medication to show a statistically significant risk reduction in cardiovascular mortality and heart failure hospitalization, independent of ejection fraction.

 

The FDA clearance is a big step forward for the nearly 3 million individuals in the United States who have heart failure with maintained ejection fraction, which has been identified as "the single highest unmet need in cardiovascular medicine."

 

The studies have shown that a randomized, multinational, double-blind trial comparing 2,997 people who received Jardiance, 10m mg once a day, to 2,991 participants who got the placebo assessed the safety and efficacy as an addition to standard of care medication.

 

Would you like to know how the study was conducted? Here it is..

 

The patients were randomly assigned to either empagliflozin 10 mg (n = 2,997) or a corresponding placebo (n = 2,991). 

 

Diabetes status, geographic region, estimated glomerular filtration rate (eGFR) and left ventricular ejection fraction (LVEF; 50%/50%) were all used to stratify the trial. All of the patients were getting proper heart failure therapy.

 

Principal Findings of New Treatment for Heart Failure

 

The major outcome, cardiovascular (CV) mortality or HF hospitalization, was 13.8% vs. 17.1% for empagliflozin vs. placebo (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.69-0.90, p 0.001).

CV death: 7.3% vs. 8.2% (HR 0.91, 95% CI 0.76-1.09)

Hospitalization for heart failure: 8.6% vs. 11.8% (HR 0.71, 95% CI 0.60-0.83)

The benefit for the primary outcome was comparable in persons with and without type 2 diabetes. The advantage appeared to be considerably diminished in individuals with an EF of 60%.

 

 "We were participating in the study, and it was amazing to see the findings," says Dr. Sangrigoli, a phase III clinical trial investigator for EMPEROR-Preserved®. “Before this, we had no treatment for those with heart failure who had normal (preserved) cardiac function, which accounted for 50% of our heart failure patients.”

 

Findings from the trial: Advantages of the New Medications of Heart Failure 2022

 

"Empagliflozin has demonstrated a statistically significant and clinically relevant effect in patients with heart failure throughout the spectrum of ejection fraction in phase III studies," stated Javed Butler, M.D., chairman of the Department of Medicine at the University of Mississippi.”

 

 

Who can't take this new medication for Heart failure?

  • Jardiance is not recommended for persons who have type 1 diabetes. It may increase their chances of developing diabetic ketoacidosis (increased ketones in the blood or urine).
  • Jardiance is not recommended for people with type 2 diabetes who have the significant renal disease because it may not function.
  • You could get severe Urinary Tract Infections due to Jardiance. If you see any UTIs, such as a burning sensation while urinating, frequent urination, pain in the stomach or pelvis area, fever, or chills, you should talk to your doctor about it. 
  • If you combine Jardiance with another medication that might cause low blood sugar, such as sulfonylurea or insulin, your chance of developing low blood sugar increases.

Not all the side effects of Jardiance are seen in everyone. You should inform your doctor about your medical history before taking Jardiance so that they can make a firm decision about it. 

 

 

The complexity of heart failure needs that medical professionals think and act holistically, with a patient-centered approach. They should work together to achieve the shared aim of knowing the subtleties of the heart failure patient experience to progress early identification, intervention, and access to novel treatment options that will improve patients' outcomes.

 

 

 

References:

https://www.fda.gov

https://www.doylestownhealth.org/ 

https://www.astrazeneca.com/

https://www.boehringer-ingelheim.us/

https://investor.lilly.com/  

https://www.acc.org

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Frequently Asked Questions
Question and Answers (109)
How long can you go without blood pressure medication

Asked anonymously on 5th August, 2022 at 2:54 pm

There can be many possibilities for the problem.. better to follow doctors advice... to avoid unwanted complications.
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Dr. Arun Kumar

Sir mujay stone tha jo nikal gaya tha, abhi mujay phir right side me dard hota he or kabhi kabhi left side chest me bahout pain hota he

Asked anonymously on 21st November, 2021 at 9:14 pm

You need NCCT KUB to see if any stones in urinary tract. 

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Dr. Neeta Verma

What treatment would you suggest to person with LVEP 10% still the person is walking and talking normally

Asked by Bhagyashree on 12th January, 2020 at 5:49 am

As per my understanding, the patient is having LVEF 10% and is walking and talking normally (leading a normal active healthy life). To me it seems to one of the rare case where a person having LVEF 10% and leading active healthy life. You should consult a cardiologist and get the ECHO repeated either there may a mistake in the previous report or if it's a miracle then it should be studied further. Get in touch with experts from Best Cardiologists in Mumbai, or page of any other city. Hope our answer helps you.

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Dr. Babita Goel

My father is suffering from sever triple blockage in arteries, admitted to hospital but as he is a obese person they refuse to do cabg he weighed 92 kg now,they have put one stent but 2 arteries are left with 100 % blockage, is there any problem in future ,can he do regular activities ,he is an advocate . please beg you answer this .Is there any issues found that 2 blocked arteries ???

Asked by Anupama A on 4th January, 2020 at 8:34 pm

As per my understanding, the patient seems to have triple vessel disease and the doctor has put one stent, but two other arteries having 100% blockage are left untreated. The ideal treatment for triple vessel disease is CABG, but there may be some more underlying factors due to which the cardiologist may have advise against CABG. You can always take a second opinion from other cardiologists, who on evaluating the patient and the reports will guide and clear all your doubts. Consult some of the Best Cardiologists in Mumbai, or any other city. Hope our answer helps you.

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Dr. Babita Goel

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