If you haven’t yet heard about the drug finerenone, you might before too long. A new report presented at the recent virtual annual meeting of the American Heart Association indicates that finerenone reduced the incidence of cardiovascular (CV) events by 14% in people with chronic kidney disease (CKD) and type 2 diabetes.
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Finerenone, which is manufactured by Bayer AG, a pharmaceutical firm headquartered in Germany, is what’s known as a non-steroidal mineralocorticoid receptor antagonist (MRA). It inhibits the actions of aldosterone and cortisol, which are two hormones produced by the adrenal glands. Aldosterone helps regulate blood pressure and cortisol helps regulate blood sugar levels, blood pressure and metabolism. Sometimes, however, these two hormones can over-activate the body, which raises blood pressure and which can harm the kidneys, the heart and the blood vessels. MRAs help reduce this aldosterone and cortisol-caused over-activation by blocking the harmful effects.
The data presented in the new report came from an ongoing trial called FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease). FIDELIO-DKD, which was instituted to study the efficacy of finerenone, was conducted at more than 1,000 sites in 48 countries and included nearly 6,000 participants. The average age of the subjects was 66 and 70% were men. Preliminary results from the trial, which were released in October, showed positive results about finerenone’s ability to prevent kidney failure. For the new report, the researchers concentrated on cardiovascular outcomes.
Between September 2015 and June 2018, 13,911 patients were screened and 5,674 were randomly selected. Nearly half of them (45.9%) had been diagnosed with cardiovascular disease; about 8% had experienced heart failure. The participants were followed up for some two and a half years, after which the researchers determined that finerenone reduced the risk of the cardiovascular events by 14% compared to a placebo (inactive treatment). According to lead author Gerasimos Filippatos, MD, of Attikon University Hospital in Athens, Greece, “Overall, we found finerenone to be an effective investigational treatment option for cardiovascular protection in patients with chronic kidney disease and type 2 diabetes.”
In some participants an increase in potassium levels in the blood was observed, but according to Christoph Wanner, MD, of the University Hospital in Würzburg, Germany, who was a member of a panel that discussed the new report, that problem is quite manageable. Otherwise, he said, the results of the trial were “robust.” “We see good safety,” he said, adding, “finerenone is both a cardiovascular and kidney protective medication in individuals with type 2 diabetes…. We [have] entered a new era of effective treatments for diabetic kidney disease.”
The online cardiovascular news site TCTMD, which is produced by the Cardiovascular Research Foundation, reported the remarks of Sripal Bangalore, MD, of NYU Langone Health in New York City, who said anything that can lower the high rates of cardiovascular problems in patients with CKD “is definitely clinically relevant and meaningful.” As for the problem of high blood potassium, it can be dealt with: “The key is to make sure that these patients are closely followed… and the potassium levels are closely monitored.” He added that although MRAs are usually not used outside of heart failure because of the lack of data, “Now we have some data in a non-heart failure, diabetic CKD cohort…. So I think this does open up the use [of finerenone] in clinical practice and potentially — in terms of future directions — use of MRAs for non-heart failure indications.”
Want to learn more about protecting your heart? Read “Does Diabetes Hurt Your Heart?” “Fight Off Heart Disease With These Five Heart-Healthy Foods” and “Lower Your Risk of Heart Disease.”