Kidney disease medication found to reduce risk of cardiovascular death in certain heart failure patients in new study

By Jacqueline Howard, CNN

(CNN) — A medication that is currently used for chronic kidney disease in patients with type 2 diabetes has been found to reduce the risk of worsening heart failure and cardiovascular death in certain people with heart failure, according to a new study.

The medication, finerenone, could be an effective therapy in people with heart failure who have mildly reduced or preserved ejection fraction, suggests the study, published Sunday in the New England Journal of Medicine.

“People don’t realize this, but if you’re hospitalized for heart failure, you have a life expectancy that can be worse than most cancers, and so we have been desperately looking for therapies that can lower that risk,” said Dr. Scott Solomon, professor of medicine at Harvard Medical School and the Edward D. Frohlich Distinguished Chair at Brigham and Women’s Hospital, who was a trial principal investigator in the study.

“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.”

Ejection fraction refers to the percentage of blood the heart pumps out with each beat. When someone has heart failure with mildly reduced or preserved ejection fraction, their heart could be pumping normally, or somewhat normally, but still be showing signs or symptoms of heart failure. More than 6 million people in the United States are living with heart failure, and it’s estimated that nearly half of all patients with heart failure have a mildly reduced or preserved ejection fraction.

The new study “highlights the importance of this type of heart failure, which is only growing as our population ages,” Solomon said.

Heart failure with mildly reduced or preserved ejection fraction often can be managed with medications called sodium-glucose co-transporter 2 or SGLT2 inhibitors, which help lower blood sugar. But the new study suggests that finerenone “could potentially be a second pillar of therapy in patients with heart failure with mildly reduced or preserved ejection fraction,” Solomon said.

Finerenone, sold under the brand names Kerendia and Firialta, was approved in 2021 by the US Food and Drug Administration to reduce the risk of serious complications in certain adults with chronic kidney disease associated with type 2 diabetes.

In order for the drug to get FDA approval for use in these people with heart failure, Bayer, the pharmaceutical company behind finerenone, would need to apply to the agency for an expanded indication.

The new study, funded by Bayer, included more than 6,000 people 40 and older in 37 countries who had heart failure and mildly reduced or preserved ejection fraction.

Between September 2020 and January 2023, the patients were separated into two groups; 3,003 were provided a daily dose of finerenone, and 2,998 were given a placebo.

The international team of researchers found that there were 1,024 heart failure events among people in the placebo group, compared with 842 events in the finerenone group.

Additionally, 8.7% of the participants in the placebo group died from cardiovascular causes during the course of the study, compared with 8.1% of the finerenone group, the data showed.

“The reduction in morbidity and mortality that we see will translate to years of life free of heart failure events in these patients,” said Solomon, who presented the study findings Sunday at the European Society of Cardiology conference in London.

Finerenone is a type of mineralocorticoid receptor antagonist, or MRA. These drugs work by blocking the receptor for the hormone aldosterone. Aldosterone makes the kidneys hold on to salt and water, which can raise your blood pressure. When the drug blocks the receptor, the kidneys release excess water and salt from the blood, which can also affect potassium levels, but the drug prevents the loss of potassium. It’s important to keep potassium at certain levels because too much in the blood can damage the heart, and low levels can affect certain functions in the body.

The researchers found that people taking finerenone showed a higher risk of hyperkalemia, or having too much potassium in the blood. But very few of them – 0.5% of patients in the finerenone group and 0.2% in the placebo group – were hospitalized for hyperkalemia.

“Any drug that works in this way, the mineralocorticoid receptor antagonists, will raise potassium in the blood,” Solomon said. “This is a very well-established and known side effect, but these drugs reduce the risk of low potassium, which also places patients at risk.”

Bayer previously released top line results from this study in early August. In that announcement, Dr. Christian Rommel, head of research and development at Bayer’s Pharmaceuticals Division, said the company is “eager to bring finerenone to eligible patients as soon as possible.”

A separate paper, published Sunday in The Lancet, reviewed four clinical trials on MRAs in heart failure and found “significant reductions” in heart failure hospitalizations among heart failure patients.

The meta-analysis showed that steroidal MRAs reduced the risk of cardiovascular death or heart failure hospitalization in patients with heart failure who had reduced ejection fraction, and nonsteroidal MRAs reduced this risk in people with heart failure who had mildly reduced or preserved ejection fraction. Finerenone, a nonsteroidal MRA, was among the drugs in the trials.

If the FDA expands the use of finerenone as a heart failure therapy, cardiologist Dr. Michelle Bloom said, she would think about it as an option for her patients with mildly reduced or preserved ejection fraction.

“I would certainly consider using finerenone,” Bloom, heart failure cardiologist and system director of the Cardio-Oncology Program at NYU Langone Health in New York, said in an email.

“However, I think the question is what the benefit of finerenone will be over the more traditional MRAs such as spironolactone and eplerenone. This remains to be answered,” she said.

Overall, heart failure patients with preserved ejection fraction “have historically been difficult to treat and manage,” Dr. Jayne Morgan, an Atlanta-based cardiologist and vice president for medical affairs at the heart health company Hello Heart, said in an email.

The new study “certainly provides support for additive therapy with finerenone. However certainly more data is needed, including independent data not financed by the sponsor,” Morgan said. “Further, we’d like to see more Blacks and minorities enrolled to truly make the data relevant to all sufferers.”

In the study, the researchers noted that few Black patients were enrolled.

Still, the study findings give “reason for cautious optimism,” Morgan said.

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