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. Open heart surgery can be performed in certain cases of heart attack or heart failure. It is considered in certain cases where angioplasty and stenting are not feasible or have not been successful. For example, if there are multiple blocked arteries or the heart attack has resulted in significant damage to the heart muscle, bypass surgery may be recommended. During bypass surgery, a healthy blood vessel from another part of the body is used to create a new pathway for blood to bypass the blocked arteries, thereby restoring blood flow to the heart.
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.doylestownhealth.org/
