The latest data of "fenerone" announced! What is the efficacy and safety in obese patients?

Translator: Dong Bingzi Affiliated Hospital of Qingdao University

Introduction: From September 19 to 23, 2022, the 2022 European Association for the Study of Diabetes Annual Conference, a major international conference in the field of endocrinology, was held
in Stockholm, Sweden in the form of "online + offline".
At the meeting, scholars shared a research report
entitled "Cardiorenal Outcomes and Safety Outcomes of Finerenone in Patients with Obesity, Chronic Kidney Disease (CKD) and Type 2 Diabetes".

Previous studies: Phenirenal ketone confers cardiac and renal benefits in type 2 diabetes

Finerenone is a selective nonsteroidal mineralocorticoid receptor antagonist (MRA), and the FIDELITY study (pooled analysis of the FIDELIO-DKD and FIGARO-DKD studies) showed that fenelidone reduced the risk
of cardiovascular (CV) and renal outcomes in patients with type 2 diabetes and chronic kidney disease (CKD).
Previous studies have shown that patients with abdominal obesity respond better
to MRA treatment than those without visceral obesity.
This study explored the efficacy and safety
of phenirectone in obese patients.

Recent data: Phenelidone shows similar cardiorenal benefits in obese patients

Patients with type 2 diabetes mellitus and CKD (urine albumin-to-creatinine ratio [UACR] ≥30-≤5000 mg/g and estimated glomerular filtration rate [eGFR] ≥25 ml/min/1.
73 m2), receiving renin-angiotensin system suppression therapy, were randomized 1:1 to phenirenal renerone-treated group or placebo
.
This study assessed the effects
of composite cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalisation for heart failure) and composite renal endpoints (renal failure, sustained decrease in eGFR from baseline≥57%, or death from renal causes) in people with or without obesity.
Abdominal obesity is defined as a significant increase in waist-to-hip ratio (WHR) of ≥0.
85 in women and 0.
9
in men ≥.
The analysis results show:

1.
WHR was significantly increased
in 12,124 (93%) patients at baseline.
Among patients with a significant increase in WHR, 56% had a BMI ≥ 30 kg/m2
.
Higher rates of cardiovascular events were observed in patients with a significant increase in WHR (13.
8 percent in the WHR increase group [1671/12124]; There was no significant increase in WHR in 10.
1% [85/844]
).

2.
The effect of phenirefone on cardiovascular composite outcomes did not change
due to WHR levels.
The effect of fenerone on renal composite outcomes was also consistent regardless of WHR level (WHR significant increase group: HR 0.
76, 95% CI 0.
65 to 0.
87; WHR no significant increase group: HR 0.
88, 95% CI 0.
54 to 1.
43; p-interaction 0.
53).

3.
Overall, adverse events seen in treatment were comparable between fenerone and placebo and between WHR subgroups
.
The incidence of hyperkalemia due to phenirenal therapy was 1.
7% and 0.
5% and 1.
1% and 1.
2%
in patients with a significant increase in WHR and a non-significant increase compared with placebo.

Summary of this article

In the FIDELITY study, the efficacy and safety profile of fenerone in patients with CKD, T2D and obesity were broadly consistent
with those of the general population.
In June 2022, fenerone, a new generation of nonsteroidal selective mineralocorticoid receptor antagonists, was approved in China to improve the risk of cardiovascular and renal events in chronic kidney disease related to type 2 diabetes, and is a new option
to improve cardiovascular and renal outcomes in patients with type 2 diabetes.

Translator's introduction

Dong Bingzi

Doctor of Medicine, Postdoctoral Fellow, Deputy Chief Physician, Department of Endocrinology, Affiliated Hospital of
Qingdao University.
Graduated from Tokushima University (Japanese Ministry of Education, Culture, Sports, Culture, Sports, Scholarship International Student), engaged in clinical and basic research on bone metabolism
.
In recent years, he has published 13 SCI papers as the first/corresponding author, published research results in JBMR, Int J Biol Sci, etc.
, participated in the editing of 3 monographs, 2 main translators, presided over 1 National Natural Science Foundation of China, 2 provincial and ministerial projects, and participated in 2 provincial and ministerial awards
.
He is currently a youth committee member of the Endocrinology Branch of the Chinese Geriatrics Association, a member of the Osteoporosis and Bone Mineral Diseases Specialist Branch of Shandong Medical Association, a member of the Osteoporosis and Bone Mineral Diseases Branch of Shandong Medical Association, and a member and secretary
of the Osteoporosis and Bone Mineral Diseases Specialty Branch of Qingdao Medical Association.