The FDA approved finerenone (Kerendia) tablets to lower the risk of cardiovascular death, non-fatal myocardial infarction, kidney function decline, kidney failure, and hospitalization for heart failure in adults with type 2 diabetes (T2D)-related chronic kidney disease (CKD).
The efficacy of finerenone, an investigational nonsteroidal mineralocorticoid receptor antagonist, was assessed in the randomized, multicenter, double-blind, placebo-controlled FIDELIO-DKD trial, the results of which were presented at the ACC.21 virtual meeting and previously reported by BreakingMED.
The FIDELIO-DKD trial randomized 5,674 patients with CKD associated with T2D to either finerenone or placebo—the primary endpoint was a composite of 40% reduction in kidney function, progression to kidney failure, or kidney death.
The results showed that 504 of the 2,833 patients randomized to finerenone had at least one of the events in the composite endpoint compared to 600 of the 2,841 assigned to placebo, the FDA wrote.
“The study also compared the two groups for the number of patients who experienced cardiovascular death, a non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure,” the agency explained. “Results showed that 367 of the 2,833 patients receiving [finerenone] had at least one of the events in the composite endpoint compared to 420 of the 2,841 patients who received a placebo, with the treatment showing a reduction in the risk of cardiovascular death, non-fatal heart attack, and hospitalization for heart failure.”
Side effects associated with treatment with finerenone included hyperkalemia, hypotension, and hyponatremia. The FDA also warned that those with adrenal insufficiency and those being treated with strong CYP3A4 inhibitors should not take finerenone.
Finerenone is manufactured by Bayer Healthcare.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 13
Topic ID: 76,13,730,13,127,192,669,725,918