medwireNews: A prespecified analysis of the FIDELIO-DKD trial shows that finerenone reduces the risk for cardiovascular disease (CVD) events in people with type 2 diabetes and chronic kidney disease (CKD), irrespective of whether they have pre-existing heart disease.
Gerasimos Filippatos (Attikon University Hospital, Athens, Greece) and co-researchers note, however, that the pre-existence of CVD was established using medical records rather than clinical examination, so a proportion of participants without known CVD may have had subclinical disease.
At baseline, 46.0% of the 2833 study participants treated with finerenone and 45.8% of the 2841 given placebo had CVD. During the median follow-up of 2.6 years, the composite CV outcome (CV death, myocardial infarction, stroke, or hospitalization for heart failure) occurred in 17.7% and 20.2% of the finerenone and placebo group, respectively, giving incidence rates of 7.18 and 8.50 per 100 person–years and a nonsignificant hazard ratio of 0.85.
There was a similar pattern, albeit with lower overall rates, among participants without a history of CVD. The composite outcome rates were 8.9% and 10.2% for those given finerenone and placebo, respectively, equating to incidence rates of 3.43 and 3.92 per 100 person–years and a nonsignificant hazard ratio of 0.86. The CVD risk reduction with finerenone was statistically significant in the study population overall, as previously reported.
The results were consistent for multiple participant subgroups, including those with and without a history of heart failure, the researchers note in Circulation.
They add that the benefits were gained “on top of a background of optimized renin–angiotensin system inhibitor therapy with well-controlled blood pressure and blood glucose levels.”
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