Transcript
Welcome to DataPulse from ERA 2025. This activity, titled “Albuminuria Change and Finerenone's Effect on Cardiovascular Outcomes” is provided by Medcon International.
Dr. McCausland:
Hello, and greetings from ERA 2025 in Vienna. My name is Finnian McCausland, and I'm delighted to present a summary of the data that we presented here at ERA in 2025. And our project was entitled Changes in Albuminuria and the Effect of Finerenone on Cardiovascular Outcomes. And this is insights from the FINEARTS-Heart Failure trial.
So just by way of background, albuminuria accounted for a modest proportion of the reduction in cardiovascular outcomes among patients in an analysis of the FIDELITY cohort. And this was a pooled cohort of 2 studies that evaluated patients with type 2 diabetes, albuminuria, and chronic kidney disease. And so therefore we asked, would albuminuria potentially mediate some of the treatment benefits that were seen with the FINEARTS-Heart Failure trial for finerenone versus placebo?
Again, just to give you a brief summary, FINEARTS-Heart Failure enrolled patients with heart failure with preserved ejection fraction, enrolled over 6,000 patients, and were randomized to finerenone versus placebo in a 1:1 fashion, and they found a significant reduction in the primary composite cardiovascular outcome for finerenone versus placebo.
Albuminuria was measured at baseline and during follow-up in FINEARTS-Heart Failure, and so we have a very robust data set to analyze changes in albuminuria and how they could potentially mediate the treatment effects that we saw with finerenone. So to do this, we analyzed the change in albuminuria as measured by the urine albumin-to-creatinine ratio between baseline and 3 months among participants of FINEARTS-Heart Failure.
And what we found was at baseline, the albuminuria was around 18 mg/g, so this is a relatively low overall risk for progression of kidney disease among these patients. But we found that at 3 months, finerenone resulted in a significant reduction of around 26% in the UACR compared with placebo.
And when we performed our mediation analysis, we found this albuminuria reduction also accounted for about 34% of the treatment effects of finerenone versus placebo. This was really intriguing, as this number is very, very similar to that that was found in the FIDELITY mediation analysis, which is around 37% of the treatment effect that was mediated.
And this really kind of highlights a couple of things. First, the importance of albuminuria as a prognostic factor in terms of patients with heart failure and preserved ejection fraction. Second, the fact that we saw similar levels of the proportion of treatment effect mediated, even among patients with relatively low levels of albuminuria, is extremely interesting and provocative.
Of course, there are other mediators that must be at play and this will be the focus of further analysis. But in summary, I think, again, this really highlights the importance of albuminuria and albuminuria reduction as potential mediators along the pathway for adverse cardiovascular outcomes among patients with heart failure and preserved ejection fraction.
So again, thank you for listening. This is a summary of our results from ERA in Vienna 2025. We hope to see you soon.
Thank you for listening to this DataPulse from ERA 2025. This activity is provided by Medcon International Thank you for listening.
