A new study showed that kidney disease medication can prevent death from heart failure. Originally the New England Journal of Medicine published this study first.
Clinical trial involving finerenone to treat heart failure
Bayer conducted a clinical trial regarding the drug finerenone to treat heart failure from September 2000 to January 2003. It involved patients age 40 and older in 37 countries. Finerenone is a mineralocorticoid receptor antagonist (MRA), similar to traditional MRAs such as spironolactone and eplerenone. Finerenone showed an 18% improved survival and improvement of heart failure in patients with diabetes and kidney failure. 3,003 patients received a daily dose of finerenone, and 2,998 took a placebo.
Bayer sells the drug finerenone under the brand names Kerendia and Firialta. The FDA originally released the drug for treating heart and kidney problems in patients with chronic kidney disease and diabetes.
Treating borderline heart failure
The study concentrated on patients with borderline heart failure in patients with chronic kidney disease due to type 2 diabetes. Dr. Scott Solomon, professor of medicine at Harvard Medical School said: “We’ve made enormous strides in the field of heart failure in the last 20 to 25 years, but mostly that’s been in the type of heart failure called heart failure with reduced ejection fraction, when the heart doesn’t pump very well,” Solomon said. “But when it comes to heart failure with mildly reduced or preserved ejection fraction, few therapies are available. That’s the reason that we did this trial,” he said. “There’s still a huge unmet need in this population.”
More than 6 million people in the US are suffering from mild heart failure. It is estimated that about half of these patients have a mildly reduced ejection fraction.
FDA approval required for new finerenone indication
The study above showed that finerenone stabilizes patients with borderline heart failure who have mildly reduced or preserved ejection fraction. Dr. Solomon explained that Bayer, the pharmaceutical company behind finerenone, would need to apply to the FDA agency for an expanded indication regarding treatment of heart failure.
Conclusion
A clinical trial showed that the kidney disease medication finerenone can prevent death from heart failure. Bayer sells the drug under the brand names Kerendia and Firialta. Finerenone showed an 18% improved survival and improvement of heart failure in patients with diabetes and kidney failure. In this study the investigators observed about 6000 patients over 2 years and 4 months. In order to have this effect recognized by the FDA, Bayer the drug company involved in the study, would need to apply to the FDA agency for an expanded indication.