According to research presented by Dr. George Bakris of the University of Chicago, treatment with finerenone resulted in a lower risk of the progression of chronic kidney disease (CKD) and cardiovascular events.
If chronic kidney disease (CKD) gets worse, wastes can build to high levels in the blood. It can cause lifelong complications such as high blood pressure, weak bones, anemia, nerve damage, and malnutrition. Also, CKD increases the risk of having heart and blood vessel disease. These issues can mature slowly over a long period. Therefore, early detection and treatment are vital components to prevent this from getting worse. It can often lead to kidney failure, requiring dialysis or a kidney transplant to maintain life when it begins to progress.
Type 2 diabetes is the number one cause of chronic kidney disease worldwide. International guidelines for CKD and type 2 diabetes patients recommend controlling hypertension and hypoglycemia and using angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and sodium-glucose cotransporter two inhibitors. However, with this current treatment, the progression of patients with CKD persists, so alternate therapies are needed in conjunction with current recommended therapies. These points led to the construction of this trial, referred to as the FIDELIO-DKD trial. The name comes from the full title, the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease trial.
This trial sought to determine that finerenone slows progression and reduces morbidity and mortality in CKD and type 2 diabetes patients. Dr. Bakris and his colleagues submitted this research to the New England Journal of Medicine to examine and summarize the benefits of finerenone in this patient population. Finerenone is a nonsteroidal selective mineralocorticoid receptor antagonist. It has been shown to reduce the albumin-creatinine ratio while having a more negligible effect on potassium levels than spironolactone. In this trial, the authors, sponsored by Bayer, used a randomized, double-blind, placebo-controlled, multicenter clinical approach. 13,911 patients were screened, 5734 patients were randomized, and 5674 were included in the statistical analysis. Eligible patients included adult patients defined as being older than 17 years old. Patients also had type 2 diabetes and CKD while being treated with an ACE inhibitor or ARB at the maximum dose. CKD was classified under two different criteria. The first one included consistent moderately elevated albuminuria to creatinine ratio of 30-299, an eGFR rate of 25 to less than 60 ml per minute, and a history of diabetic retinopathy. The second criteria included severely elevated albumin to creatinine ratio 300-5000, eGFR of 25 to less than 75ml per minute. The eligible patients were then assigned randomly to receive oral finerenone or placebo. The primary outcome was based on a time-to-event analysis of kidney failure. The secondary outcome was also assessed on a time-to-event analysis of nonfatal heart attack, nonfatal stroke, or hospitalization for heart failure.
This study showed that patients with CKD and type 2 diabetes who received finerenone had a lower risk of primary outcome event defined as kidney failure, with 17.8% verse 21.1%. In addition, patients in this group also had a lower risk of secondary outcomes, defined as cardiovascular events with 13.0% verse 14.8%. These benefits were observed in 12 months for the primary outcome and one month for the secondary outcomes. However, the risk of a primary outcome was more negligible in a previous study examining canagliflozin in the CREDENCE trial. These differences can be attributed to the inclusion and exclusion criteria used when choosing patients.
In conclusion, there are established treatments for CKD and type 2 diabetes patients. However, the progression of CKD and type 2 diabetes continues. As stated by Dr. George Bakris, initiating the medication finerenone could contribute to the potent anti-inflammatory and antifibrotic effects that may slow CKD progression. Limitations of this study include most patients having advanced CKD and only 4.7% of the patients identified as being Black. These factors may limit the generalizability of the findings.
- Type 2 diabetes is the number one cause of chronic kidney disease worldwide.
- Early detection and treatment are vital components to prevent this from getting worse.
- Finerenone is a nonsteroidal selective mineralocorticoid receptor antagonist that has been shown to reduce the albumin-creatinine ratio and reduce progression to kidney failure.
Bakris, George. “Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes.” New England Journal of Medicine, 23 Oct. 2020, pp. 2219–2229., link
“Chronic Kidney Disease Symptoms and Causes.” National Kidney Foundation, link
“Heart Failure.” National Heart Lung and Blood Institute, U.S. Department of Health and Human Services, link
Kmeone Kingdom, MPH, PharmD Candidate, South College School of Pharmacy