"- My name is Gerasimos Filippatos, I'm Professor of Cardiology at the University of Athens, Greece.
Rationale for a Pooled Analysis of FIGARO-DKD and FIDELIO-DKD
As you know, in FIDELIO, we investigated cardiovascular, kidney endpoints in patients with more advanced chronic kidney disease and diabetes. And in FIGARO, we investigated in patients with lesser severe chronic kidney disease and diabetes in a broader population. I think it is clinically useful to see in a large number of patients with several degrees of chronic kidney disease, diabetes. What is the effect of finerenone versus placebo in patients growth with chronic kidney disease and diabetes? This is rationale behind this pooled analysis of FIDELIO and FIGARO, the FIDELITY analysis.
Study Design and Main Outcomes
Like in FIGARO and FIDELIO, patients with chronic kidney disease with a broad spectrum of estimated glomerular filtration rate and uACR have been randomised in the trial, a very broad spectrum, and these patients were on optimal therapy with ACE inhibitors or ARBs. Patients with heart failure, with reduced ejection fraction have been excluded for the trial because have an indication 1A for an MRA.
What These Findings Add to Current Research on Finerenone
Despite the fact that most of the colleagues who see this know already the main, the primary results of FIDELITY, let me just repeat it that we've seen in FIDELITY an improvement in cardiovascular and kidney outcomes in these patients with chronic kidney disease and diabetes. We know that in this group of patients, there is an increased risk of mortality and cardiovascular mortality is the main reason for deaths in these patients. So we thought that it would be interesting and important to investigate the causes of death in the population of FIDELITY. And we confirm in this large number of patients, more than 13,000, that cardiovascular mortality was the main cause of mortality, the other important causes of mortality were cancer and infection, but the numbers of deaths in these two groups were similar between finerenone and placebo, and we had a very low number of the renal deaths in the whole population. What we found is that in treatment analysis, there was an 18% decrease in all-cause cardiovascular mortality in patients who were on finerenone compared to placebo and there was a 25% decrease in sudden cardiac death. As you remember in the primary analysis of FIDELITY we have seen a decrease in the number of deaths in cardiovascular and total mortality and we thought that it's worth seeing, to analyse more investigate more the details of this and the cause of this mortality.
I think that it's clear now and because we are in a cardiology congress, that a broad spectrum of patients with chronic kidney disease and diabetes should receive finerenone. Until now, in chronic kidney disease patients with diabetes, we had only ACE or ARBs. Recently, SGLT2 inhibition has been added and now we have finerenone. So I think that in the majority of patients with chronic kidney disease and diabetes, we go like we are going in heart failure with more than one therapies. And I think that this is good for the patients with chronic disease and diabetes.
Knowledge Gaps and How These Can Be Overcome
I think that what we don't know is what is the effect of combination of the above mentioned therapies, but in finerenone, in the FIDELIO, FIGARO and the FIDELITY analysis, we have a subgroup of patients with SGLT2 inhibitors and GLP-1 arrays and we've seen despite the small number, we've seen at least similar results from the combination of these therapies. So I think the way to go as I said before is to combine therapies for better protection of these patients with chronic kidney disease and diabetes.”