A drug currently used for chronic kidney disease in patients with type 2 diabetes may reduce the risk of worsening heart failure and cardiovascular death in certain people with the disease, according to a new study published Sunday (1) in the New England Journal of Medicine.
The medicine, called finerenone may be an effective therapy in people with heart failure who have slightly reduced or preserved ejection fraction, according to the study.
“People don’t realize this, but if you’re hospitalized for heart failure, your life expectancy can be worse than most cancers, and so we’re desperately looking for therapies that can reduce that risk,” said Scott Solomon, professor of medicine at Harvard Medical School and holder of the Edward D. Frohlich Distinguished Chair at Brigham and Women’s Hospital, who was one of the study’s principal investigators.
“We’ve made tremendous progress in the area of heart failure in the last 20 to 25 years, but most of the time it’s been in the type of heart failure called heart failure with reduced ejection fraction, when the heart doesn’t pump very well,” Solomon says. But when it comes to heart failure with mildly reduced or preserved ejection fraction, few therapies are available.
“That’s why we did this study,” he adds. “There’s still a huge unmet need in this population.”
Ejection fraction refers to the percentage of blood the heart pumps with each beat. When someone has heart failure with slightly reduced or preserved ejection fraction, their heart may be pumping normally, or nearly normally, but they may still have signs or symptoms of heart failure.
More than 6 million people in the United States live with heart failure, and it is estimated that nearly half of all heart failure patients have 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 says.
Heart failure with mildly reduced or preserved ejection fraction can often be treated with drugs called sodium-glucose cotransporter type 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 says.
Finerenone, sold under the brand names Kerendia and Firialta, was approved in 2021 by the U.S. Food and Drug Administration (FDA) to reduce the risk of serious complications in certain adults with chronic kidney disease associated with type 2 diabetes.
For the drug to get FDA approval for use in these people with heart failure, Bayer, the pharmaceutical company responsible for finerenone, would need to ask the agency for an expanded indication.
The new study, funded by Bayer, included more than 6,000 people aged 40 and older in 37 countries who had heart failure and mildly reduced or preserved ejection fraction.
Between September 2020 and January 2023, patients were separated into two groups; 3,003 received a daily dose of finerenone, and 2,998 received 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 participants in the placebo group died from cardiovascular causes during the study, compared with 8.1% in the finerenone group, the data showed.
“The reduction in morbidity and mortality that we observed will translate into years of life free from heart failure events for these patients,” said Solomon, who presented the study results on Sunday at the European Society of Cardiology conference in London.
Finerenone is a type of mineralocorticoid receptor antagonist, or MRA. These medications work by blocking the receptor for the hormone aldosterone. Aldosterone causes the kidneys to retain salt and water, which can increase blood pressure.
When the medication blocks the receptor, the kidneys release excess water and salt from the blood, which can also affect potassium levels, but the medication prevents potassium loss. It is important to keep potassium levels at a certain level, because too much potassium in the blood can damage the heart, and too little can affect certain body functions.
The researchers found that people taking finerenone had a higher risk of hyperkalemia, or excess potassium in the blood. But very few of them — 0.5 percent of patients in the finerenone group and 0.2 percent in the placebo group — were hospitalized for hyperkalemia.
“Any medication that works this way, the mineralocorticoid receptor antagonists, will increase potassium in the blood,” Solomon says. “This is a very well-established and known side effect, but these medications reduce the risk of low potassium, which also puts patients at risk.”
Bayer previously released topline results from this study in early August. In the announcement, Christian Rommel, head of research and development for Bayer’s Pharmaceuticals division, says the company is “looking forward to bringing finerenone to eligible patients as quickly as possible.”
A separate article, published on Sunday (1) in The Lancetreviewed four clinical trials of MRAs in heart failure and found “significant reductions” in heart failure hospitalizations among patients with heart failure.
The meta-analysis showed that steroidal MRAs reduced the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure who had reduced ejection fraction, and nonsteroidal MRAs reduced that 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 therapy for heart failure, cardiologist Michelle Bloom explains that she would consider it as an option for her patients with mildly reduced or preserved ejection fraction.
“I would definitely consider finerenone,” Bloom, a cardiologist specializing in heart failure and director of the Cardio-Oncology Program at NYU Langone Health in New York City, says in an email.
“However, I think the question is what the benefit of finerenone will be over more traditional MRAs like spironolactone and eplerenone. That remains to be answered,” he adds.
Overall, heart failure patients with preserved ejection fraction “have historically been difficult to treat and manage,” says Jayne Morgan, an Atlanta-based cardiologist and vice president of medical affairs at heart health company Hello Heart, in an email.
The new study “certainly provides support for additional therapy with finerenone. However, more data is certainly needed, including independent data not funded by the sponsor,” Morgan says. “In addition, we would like to see more blacks and minorities included to really make the data relevant to all patients.”
In the study, researchers noted that few black patients were included. Still, the study results give “cause for cautious optimism,” Morgan says.
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This content was originally published in Kidney medicine may reduce risk of death in people with heart problems on the CNN Brasil website.
Source: CNN Brasil
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