Finerenone reduced the composite of cardiovascular death, nonfatal MI, nonfatal stroke, or heart failure hospitalization by 13% (HR 0.87) compared to placebo in type 2 diabetes and CKD.
RCT (n=7,437)
Double-blind
1:1
Yes
Does finerenone reduce the composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure in patients with type 2 diabetes and chronic kidney disease?
In patients with type 2 diabetes and mild-to-moderate chronic kidney disease, the addition of finerenone to maximum tolerated RAS blockade significantly reduced cardiovascular events, primarily driven by a reduction in heart failure hospitalizations.
Hazard Ratio: 0.87 (95% CI 0.76–0.98)
Absolute Event Rate: 12.4% vs 14.2%
Absolute Risk Reduction: 2.1%
Number Needed to Treat: 47
p-value: p=0.03
BACKGROUND: Finerenone, a selective nonsteroidal mineralocorticoid receptor antagonist, has favorable effects on cardiorenal outcomes in patients with predominantly stage 3 or 4 chronic kidney disease (CKD) with severely elevated albuminuria and type 2 diabetes. The use of finerenone in patients with type 2 diabetes and a wider range of CKD is unclear. METHODS: (stage 1 or 2 CKD). Patients were treated with renin-angiotensin system blockade that had been adjusted before randomization to the maximum dose on the manufacturer's label that did not cause unacceptable side effects. The primary outcome, assessed in a time-to-event analysis, was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. The first secondary outcome was a composite of kidney failure, a sustained decrease from baseline of at least 40% in the eGFR, or death from renal causes. Safety was assessed as investigator-reported adverse events. RESULTS: A total of 7437 patients underwent randomization. Among the patients included in the analysis, 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 in 519 of 3666 (14.2%) in the placebo group (hazard ratio, 0.87; 95% confidence interval CI, 0.76 to 0.98; P = 0.03), with the benefit driven primarily by a lower incidence of hospitalization for heart failure (hazard ratio, 0.71; 95% CI, 0.56 to 0.90). The secondary composite outcome occurred in 350 patients (9.5%) in the finerenone group and in 395 (10.8%) in the placebo group (hazard ratio, 0.87; 95% CI, 0.76 to 1.01). The overall frequency of adverse events did not differ substantially between groups. The incidence of hyperkalemia-related discontinuation of the trial regimen was higher with finerenone (1.2%) than with placebo (0.4%). CONCLUSIONS: Among 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, finerenone therapy improved cardiovascular outcomes as compared with placebo. (Funded by Bayer; FIGARO-DKD ClinicalTrials.gov number, NCT02545049.).
A Sat, study conducted a rct in Chronic kidney disease and type 2 diabetes (n=7,437). Finerenone vs. Placebo was evaluated on Composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure (HR 0.87, 95% CI 0.76-0.98, p=0.03). Finerenone reduced the composite of cardiovascular death, nonfatal MI, nonfatal stroke, or heart failure hospitalization by 13% (HR 0.87) compared to placebo in type 2 diabetes and CKD.
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