Deepak Bhatt, MD, MPH: Estimating the Potential US Patient Population for Finerenone

In recent years, agents with cardiorenal protective benefits have dominated discussion at cardiology meetings and conferences.

With the revelations of the benefits of SGLT2 inhibitors beyond glucose-lowering and weight loss garnering so much of the spotlight, many in cardiology, and nephrology, have purported the data from finerenone’s phase 3 program and the non-steroidal mineralocorticoid receptor antagonist's subsequent approval have not been met with the acclaim it might had it not been for the explosion of interest and knowledge around SGLT2 inhibitors.

At the American College of Cardiology’s 71st Annual Scientific Sessions, new data from a generalizability study of finerenone using eligibility criteria from the phase 3 program with data from NAHNES is illustrating just how widespread use could be among patients in the US. Presented by Nicholas Chiu, MD, MPH, and written by a team including Chiu, Rahul Aggarwal, MD, George L. Bakris, MD, Bertram Pitt, MD, Deepak L. Bhatt, MD, MPH, results of the study suggest more than 2.2 million patients in the US would be considered eligible for finerenone when using the FIDELIO-DKD and FIGARO-DKD eligibility criteria.

Briefly, the eligibility criteria for FIGARO-DKD included having a UACR of equal to or greater than 30 mg/g but not exceeding 300 mg/g with an eGFR of at or above 25 but not exceeding 90 mL/min/1.73m2 or a UACR of 300 mg/g or more but not exceeding 5000 mg/g with an eGFR at or above 60 mL/min/1.73m2. The eligibility criteria for FIDELIO-DKD included having a UACR at or above 30 but not exceeding 300 mg/g with an eGFR equal to or greater than 25 but not exceeding 60 mL/min/1.73 m² or a UACR of 300 mg/g or more but less than 5000 mg/g with an eGFR at or above 25 but not exceeding 75 mL/min/1.73 m².

Upon analysis, investigators found the FIDELIO-DKD criteria applied to 1,022,705 (95% CI, 830,876-1,214,533) individuals in the US and the FIGARO-DKD criteria applied to 1,980,176 ((5% CI, 1,706,544-2,253,807). In total, 2,232,031 (95% CI, 1,947,816-2,516,246) met inclusion criteria for at least 1 trial. Investigators noted the US population had different albuminuria profiles, with both FIDELIO-DKD and FIGARO-DKD eligible populations displaying lower median UACRs compared to trial participants. Additionally, the corresponding eligible US population based on FIDELIO-DKD criteria had a higher proportion of females (45.1% vs 31.3%) and non-Hispanic Black adults (14.5% vs 4.9%) than the FIDELIO-DKD trial population.

With an interest in learning more about this study and potential clinical use of finerenone, Practical Cardiology caught up with Bhatt at ACC.22.

This study, “Generalizability of FIGARO-DKD and FIDELIO-DKD Trial Criteria to the United States Population Eligible for Finerenone,” was presented at ACC.22.