Bertram Pitt, M.D.- Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes
Link to Abstract- https://www.nejm.org/doi/full/10.1056/NEJMoa2110956?query=cardiology
Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, has been shown to improve cardiorenal outcomes in patients with stage 3 or 4 chronic kidney disease (CKD) and significant albuminuria, as well as type 2 diabetes. Finerenone's usage in patients with type 2 diabetes and other forms of CKD is unknown.
In this double-blind trial, patients with CKD and type 2 diabetes were randomly randomized to either finerenone or a placebo. Patients with a urinary albumin-to-creatinine ratio of 30 to less than 300 and an estimated glomerular filtration rate (eGFR) of 25 to 90 ml per minute per 1.73 m2 of body surface area (stage 2 to 4 CKD) or a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of at least 60 ml per minute per 1.73 m2 of body surface area (stage 2 to (stage 1 or 2 CKD). Patients were given renin–angiotensin system blockers that had been adjusted to the maximal dose on the manufacturer's label that did not cause unacceptable side effects before randomization. The primary outcome was a composite of mortality from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure, as measured by a time-to-event analysis. The first secondary outcome was a composite of kidney failure, a prolonged drop in eGFR of at least 40% from baseline, or death due to renal causes. Adverse occurrences reported by investigators were used to assess safety.
RESULTS A total of 7437 patients were randomly assigned to one of two groups. During a median follow-up of 3.4 years, a primary outcome event occurred in 458 of 3686 patients (12.4%) in the finerenone group and 519 of 3666 patients (14.2%) in the placebo group (hazard ratio, 0.87; 95 percent confidence interval [CI], 0.76 to 0.98; P=0.03), with the benefit driven primarily by a lower incidence of hospitalization for hepatitis C. (hazard ratio, 0.71; 95 percent CI, 0.56 to 0.90). 350 patients (9.5%) in the finerenone group and 395 (10.8%) in the placebo group experienced the secondary composite result (hazard ratio, 0.87; 95 percent CI, 0.76 to 1.01). There was no significant difference in the overall frequency of adverse events across groups. Finerenone (1.2 percent) had a greater rate of hyperkalemia-related trial regimen discontinuation than placebo (0.8 percent) (0.4 percent ).
Finerenone medication improved cardiovascular outcomes in patients with type 2 diabetes and stage 2 to 4 CKD with moderately elevated albuminuria or stage 1 or 2 CKD with severely elevated albuminuria when compared to placebo. (Funded by Bayer; NCT02545049 on ClinicalTrials.gov for FIGARO-DKD.) (This link will open in a new tab.)