FDA批准非奈利酮用于治疗2型糖尿病相关的慢性肾病

Finerenone is a new generation of highly selective non-steroidal mineralocorticoid receptor antagonists researched and developed by Bayer in Germany. It is currently undergoing phase III clinical trials. It is structurally different from early steroid drugs and has greater affinity and selectivity for MR, which can reduce the risk of hyperkalemia and worsening of renal function. Indicated to reduce the risk of persistent eGFR decline, end-stage renal disease, cardiovascular death, non-fatal myocardial infarction and heart failure hospitalization in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

The latest FIDELIO-DKD study is to further evaluate the protective effect of fenelidone on the kidneys on the basis of angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) treatment. The results were published in "N Engl J Med" in 2020.

This randomized, double-blind, placebo-controlled, international multi-center RCT study enrolled 5,734 patients with type 2 diabetes and CKD, with an average follow-up of 2.6 years. Compared with placebo treatment, fenelinone treatment can significantly reduce renal endpoint events (renal failure, eGFR exceeding 40% of baseline, or death due to kidney disease) (17.8% vs 21.1%, P=0.001), and the incidence of cardiac endpoint events is also lower than that of the placebo group (13.0%). vs 14.8%, P=0.03). After 4 months of treatment, the urinary albumin and creatinine in the fenelidone group decreased by 31% compared with the baseline, and persisted. The results confirmed that on the basis of RAS blocker treatment, fenelidone can further reduce the risk of CKD progression and cardiovascular events.

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