Finerenone lowers CV risk in patients with CKD, T2D
Treatment with finerenone led to significantly reduced risk of cardiovascular (CV) events in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), regardless of their CV disease (CVD) history, according to the FIDELIO-DKD* trial presented at AHA 2020.
“Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that inhibits inflammation and fibrosis … [This study showed that] finerenone is an effective investigational treatment option for kidney and CV protection in patients with CKD and T2D,” said lead author Dr Gerasimos Filippatos from the National and Kapodistrian University of Athens, Greece.
This phase III, double-blind, placebo-controlled, multicentre trial involved 5,734 patients with CKD and T2D (average age 66 years, 70.2 percent male), of whom 45.9 percent had a history of CVD at baseline. Participants were randomly assigned to receive either oral finerenone 10 or 20 mg once/day or placebo. The key secondary endpoint of this present study was a composite outcome of CV-related events, such as time to CV death, nonfatal myocardial infarction or stroke, or hospitalization due to heart failure. [AHA 2020, session LBS.07]
At a median follow-up of 2.6 years, a significantly lower incidence of composite CV outcome was observed among patients treated with finerenone compared with placebo (hazard ratio [HR], 0.86, 95 percent confidence interval, 0.75–0.99; p=0.034). The incidence of nonfatal stroke was similar between the two treatment arms (HR, 1.03).
A reduced risk of composite CV events was also observed with finerenone treatment, regardless of whether the patients had a history of CVD or not (HR, 0.85 and 0.86, respectively; p=0.85), compared with the placebo recipients.
Overall, the rates of treatment-emergent adverse events were comparable between the finerenone and the placebo arms, with only 2.3 percent and 0.9 percent of the patients discontinuing the treatment due to hyperkalaemia, respectively, but the increase in serum potassium was manageable, Filippatos noted.
“[As] patients with CKD and T2D are at high risk of CV events, [this study showed that] treatment with finerenone significantly lowered the overall risk of CV events compared with placebo,” Filippatos concluded, who added that “the beneficial effect of finerenone was not altered [even in] … patients with or without a history of CVD.”
“We are pleased to see that finerenone could provide a meaningful treatment option for patients who are battling chronic conditions,” he said.
*FIDELIO-DKD: Efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and diabetic kidney disease