非奈利酮现可用于治疗与2型糖尿病相关的慢性肾脏病的早期阶段

Finelidone is a non-steroidal selective mineralocorticoid receptor antagonist developed by Bayer. It was approved in China at the end of June 2022. It is used for adult patients with chronic kidney disease related to type 2 diabetes (estimated glomerular filtration rate [eGFR] 25 to <75 mL/min/1.73 m2, accompanied by albuminuria). It can reduce the risk of sustained decline in eGFR and end-stage renal disease.

On February 10, 2023, the European Commission approved the expansion of the labeling in the EU. The indications have been expanded to cover the early stages of chronic kidney disease related to type 2 diabetes, and it is currently suitable for adult patients with chronic kidney disease (associated with albuminuria) related to type 2 diabetes. In preclinical studies, fenelinone has been shown to block the harmful effects of mineralocorticoid receptor overactivation.

Previously, the key phase 3 FIGARO-DKD study results were announced at the 2021 European Society of Cardiology (ESC) Congress and simultaneously published in the New England Journal of Medicine. The FIGARO-DKD study examined the effectiveness and safety of fenelidone compared with placebo in reducing the incidence of cardiovascular events and mortality compared with placebo in approximately 7,400 patients with chronic kidney disease associated with type 2 diabetes. Positive data from the FIGARO-DKD study indicate that fenelinone significantly reduces the risk of cardiovascular events in adults with chronic kidney disease associated with type 2 diabetes compared with placebo.

The American Diabetes Association (ADA) "Guidelines for the Diagnosis and Treatment of Diabetes" included fenelidone for the first time in 2022 and gave it a Level A recommendation. The 2023 version of the ADA Guidelines further enhances its medication status on the basis of continuing the high-level recommendations.

2023 ADA Guidelines: For CKD patients with proteinuria who have an increased risk of cardiovascular events or chronic kidney disease progression, non-steroidal mineralocorticoid receptor antagonists that have been proven effective in clinical trials are recommended to delay the progression of chronic kidney disease and reduce the risk of cardiovascular events. (A)—Section "Chronic Kidney Disease and Risk Management."

2022 ADA Guidelines: For CKD patients who are at increased risk of cardiovascular events or chronic kidney disease progression, or who cannot use SGLT-2i, it is recommended to use nonsteroidal mineralocorticoid receptor antagonists (fenelidone) to delay the progression of chronic kidney disease and reduce the risk of cardiovascular events. (A).

2023 ADA Guidelines: For patients with type 2 diabetes-related chronic kidney disease and proteinuria treated with the maximum tolerated dose of ACEI/ARB, fenelidone can be used in combination to improve cardiovascular outcomes and reduce the risk of chronic kidney disease progression. (A)—Section "Cardiovascular Disease and Risk Management."

New Class A recommendation: 2023 ADA Guidelines: For patients with type 2 diabetes and diabetic nephropathy, consider using SGLT-2i (eGFR ≥ 20 ml/min/1.73m2), GLP-1RA or non-steroidal mineralocorticoid receptor antagonists (eGFR ≥ 25 ml/min/1.73m2) to reduce cardiovascular risk. (A)—Section "Chronic Kidney Disease and Risk Management."

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