The FINE-HEART program aimed to evaluate the safety and efficacy of finerenone, a non-steroidal mineralocorticoid receptor antagonist (MRA), in key patient populations with type 2 diabetes, chronic kidney disease, and heart failure. By pooling data from three major Phase III trials—FINEARTS-HF, FIDELIO-DKD, and FIGARO-DKD—this comprehensive analysis sought to provide a clearer understanding of finerenone’s effects on cardiovascular mortality, renal outcomes, and hospitalizations for heart failure. The study also focused on subgroups based on diabetes control, offering valuable insights into its potential role in patients with coexisting conditions.
In this interview, we spoke with Dr. Pardeep Jhund (University of Glasgow, Glasgow, UK), the study’s presenter at EASD 24, to explore the rationale for pooling the trial data, the methodology of the FINE-HEART analysis, and the key findings on finerenone’s impact across the glycaemic spectrum. Additionally, we discuss its safety profile as well as the potential clinical implications the study’s findings have on managing patients with diabetes and related complications.
Associated abstract:
Vaduganathan M et al. FINE-HEART: an integrated pooled analysis of finerenone across 3 phase III trials of heart failure and chronic kidney disease and type 2 diabetes. Abstract LBA06. EASD 2024.
Questions:
- What was the rationale for pooling the analysis of finerenone across three Phase III trials in patients with type 2 diabetes, chronic kidney disease and heart failure? (0.07)
- How was the FINE-HEART pooled analysis conducted, and what did it reveal about finerenone’s efficacy and safety in the key subgroups? (1:00)
- What are the potential clinical implications of these findings? (3:44)
Disclosures: Prof. Pardeep Jhund discloses serving as a consultant for AstraZeneca, Boehringer Ingelheim and Novartis; receiving grant/research support from Analog Devices Inc, AstraZeneca and Roche Diagnostics; serving on the advisory boards for AstraZeneca and Novartis; and participating in the Speaker’s Bureau for Intas Pharmaceuticals, Pro Adwise Communications and Sun Pharma. Other financial or material support includes being a Director at GCTP Ltd.
This content has been developed independently by Touch Medical Media for touchENDOCRINOLOGY. It is not affiliated with the European Association for the Study of Diabetes (EASD). Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. No endorsement of unapproved products or unapproved uses is either made or implied by mention of these products or uses by Touch Medical Media or any sponsor. Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media.
Transcript:
Hello. I’m Pardeep Jhund. I’m Professor of Cardiology and Epidemiology at the University of Glasgow in Scotland, UK
Q: What was the rationale for pooling the analysis of finerenone across three Phase III trials in patients with type 2 diabetes, chronic kidney disease and heart failure?
and Epidemiology at the University of Glasgow in Scotland, UK.
We performed a pooled analysis of finerenone against placebo in all of the large randomised trials that currently being conducted in, using finerenone because we really wanted to determine what the benefit of finerenone was across the entire spectrum of cardiovascular, kidney and metabolic patients because we know that many of these patients have one or more of those conditions, and the conditions often travel with each other. So if a patient has one, they often have one of the other ones. And we really wanted to give a broader context to the benefit of finerenone in this growing patient population.
Q: How was the FINE-HEART pooled analysis conducted, and what did it reveal about finerenone’s efficacy and safety in the key subgroups?
We conducted the FINE-HEART study by combining three large randomized trials that have been used to examine the effectiveness of finerenone. They were the FINEARTS-HF trial, which was conducted in patients with heart failure with mildly reduced to preserved ejection fraction, heart failure, and then the FIDELIO- and FIGARO-DKD trials, which were conducted in patients with type 2 diabetes and varying degrees of, chronic kidney disease.
Now that analysis was previously published, and we had examined the outcome of cardiovascular death as our primary outcome and then a whole range of other outcomes including kidney composite end points, heart failure hospitalizations, all cause mortality.
Now in this analysis, what we did was we only looked at the patients who had type 2 diabetes so that we could look at the effectiveness of finerenone across the spectrum of diabetes and diabetes control. And we did that by splitting patients up according to their baseline glycated haemoglobin A1C (HbA1c). And what we found was that it didn’t matter what your baseline HbA1C was. The treatment effectiveness of finerenone was the same regardless of what your starting point was. It didn’t matter if you’re that high HbA1C or a low HbA1C. You derive benefit, and finerenone reduced the risk of the kidney composite outcome, heart failure hospitalizations, major adverse cardiovascular events, so cardiovascular death, non-fatal MI, stroke, and heart failure, and all cause death, in these patients.
And then we also looked to see what happened when you added finerenone to other diabetes therapies. So it didn’t matter what diabetes therapies you were taking, how many you were taking, and in particular, whether you were taking an SGLT2 inhibitor or a GLP-1 receptor agonist at baseline, you had benefit from taking finerenone as opposed to placebo in terms of all of these outcomes.
And then finally, we looked at safety. And the safety profile of finerenone was, as you might expect, with a mineralocorticoid receptor antagonist (MRA), there was some more hyperkalemia in the MRA group, the finerenone group, than there was in the placebo group. However, interestingly, hypokalemia was halved by being on finerenone, which I think is an important finding for our patients and for clinicians.
Q: What are the potential clinical implications of these findings?
What we have shown in our analysis of the FINE-HEART trials is that finerenone can be used in a broad range of patients with cardiovascular, kidney and metabolic complications. And in this analysis in particular, in all patients with type 2 diabetes, regardless of what their baseline HbA1C is, regardless of what diabetes therapies they’re taking, and especially on top of SGLT2 inhibitors and GLP-1 receptor agonists. So there’s a broad range of patients who are going to benefit out there from being on finerenone.
Interviewer/Editor: Gina Furnival
Cite: Jhund P. Benefits of finerenone for patients with type 2 diabetes, cardiovascular, kidney and metabolic complications. touchENDOCRINOLOGY. September 16, 2024.
