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ESC HF 25: FIVE-STAR: Impact of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD
Published: 20 May 2025
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ESC HF 25 - FIVE-STAR primary outcome is neutral, though finerenone was shown to significantly reduce UACR rates with a 29% greater reduction compared to placebo.
We are joined by Dr Atsushi Tanaka (Saga University, Saga, JP) to discuss the findings from FIVE-STAR, a randomized trial investigating the effects of finerenone on vascular stiffness and cardiorenal biomarkers in patients with type 2 diabetes. The phase 4 trial enrolled 100 patients, and the primary outcome measure was change in cardio-ankle vascular index (CAVI) at 24 weeks after initiation of protocol treatment when compared to baseline.
The primary outcome was neutral, with individual changes in CAVI from baseline to week 24 resulting in a P value of 0.760. In the subgroup analysis, the finerenone group favoured the primary endpoint in younger patients, those with lower HbA1c and those with a higher LVEF at baseline. In terms of secondary outcomes, finerenone was found to significantly reduce UACR rates, with a 29% greater reduction when compared to placebo.
Interview Questions:
1. What was the key rationale behind conducting the FIVE-STAR trial?
2. What was the study design and patient population?
3. What were the key findings?
4. How do these findings help us understand the broader cardiorenal protective effects observed in the phase III studies?
5. How do you foresee these mechanistic insights influencing future trial designs or clinical use of MRAs in T2D and CKD?
Recorded on-site at ESC HF in Belgrade, 2025.
Editors: Yazmin Sadik, Jordan Rance
Videographers: Tom Green and Mike Knight
Support: This is an independent interview produced by Radcliffe CVRM.
I am Atsushi Tanaka from Saga University, Japan. Today I will introduce the primary result of the FIVE-STAR trial.
What was the key rationale behind conducting the FIVE-STAR trial?
Finerenone therapy reduces the risk of cardiovascular and renal events in previous large-scale clinical trials. However, limited data are currently available regarding the mechanisms underlying the clinical benefits of finerenone therapy.
What was the study design and patient population?
The FIVE-STAR trial included the clinically stable patients with type 2 diabetes and CKD having albuminuria. The eligible patients were equally randomised to placebo and finerenone therapy in this study.
In this FIVE-STAR trial we investigated the effect of finerenone therapy on arterial stiffness assessed by CAVI and other cardiornal biomarkers in this patient population.
What were the key findings?
In this FIVE-STAR trial finerenone therapy led to the neutral effect on the CAVI, but finerenone therapy reduced durably and significantly UACR and systolic blood pressure and also reduced eGFR, but finerenone therapy caused no evidence of hyperkalemia and hypokalemia in this patient population.
How do these findings help us understand the broader cardiorenal protective effects observed in the phase III studies?
The finerenone therapy did not cause any effect on cardiovascular stiffness though but finerenone therapy reduced UACR and systolic blood pressure.
These findings would be very helpful in the clinical settings for patients with type 2 diabetes and CKD patients.
How do you foresee these mechanistic insights influencing future trial designs or clinical use of MRAs in T2D and CKD?
In this FIVE-STAR trial, as an exploratory endpoint, several [illegible] biomarkers responded to the finerenone therapy, but this was exploratory in nature and limited using only two panels tested. So our findings will need to be validated in the future study to help us understand, better understand the hemodynamic and non-hemodynamic pathways of finerenone therapy in this patient population.
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