G. D Hospital & Diabetes Institute, Kolkata, West Bengal, India.
Jawaharlal Nehru Medical College & Hospital, Kalyani, West Bengal, India.
Diabetes Metab Syndr. 2022 Oct;16(10):102638. doi: 10.1016/j.dsx.2022.102638. Epub 2022 Oct 4.
BACKGROUND & AIMS: Finerenone is a novel non-steroidal mineralocorticoid antagonist (MRA) recently approved for the treatment of chronic kidney disease (CKD) in people with type 2 diabetes (T2D). We aim to conduct a systematic review of finerenone to know the efficacy and safety of finerenone in CKD with or without T2D.
A systematic search in the electronic database of PubMed and Google Scholar was made from inception until September 09, 2022, using several MeSH keywords related to finerenone. Ongoing trials were additionally searched from ClinicalTrials.Gov.
Five phase 2 and three phase 3, randomized, double-blind, placebo- or active-controlled studies of finerenone have been published to date and several other randomized and real-world studies of finerenone are currently undergoing.
In short-term studies in patients with CKD and reduced ejection heart failure, with or without T2D, finerenone 20 mg appears to have a better renal outcome compared with spironolactone and a better mortality outcome compared with eplerenone, with significantly lesser hyperkalemia compared to both spironolactone and finerenone. In long-term studies in patients with CKD and T2D, finerenone 10/20 mg significantly reduces the progression of renal disease and reduced CV endpoints (especially heart failure hospitalization) compared to placebo. Finerenone has no effect on HbA1c, body weight, and sexual side effects including gynecomastia, and has only a modest effect on blood pressure. However, hyperkalemia leading to drug withdrawal was significantly higher with finerenone compared to placebo. Safety data in real-world settings is a pressing priority.
非奈利酮是一种新型非甾体类盐皮质激素受体拮抗剂(MRA),最近被批准用于治疗 2 型糖尿病(T2D)患者的慢性肾脏病(CKD)。我们旨在对非奈利酮进行系统评价,以了解非奈利酮在伴或不伴 T2D 的 CKD 中的疗效和安全性。
从开始到 2022 年 9 月 9 日,我们在电子数据库 PubMed 和 Google Scholar 中进行了系统搜索,使用了与非奈利酮相关的几个 MeSH 关键词。此外,还从 ClinicalTrials.gov 中搜索了正在进行的试验。
迄今为止,已经发表了五项非奈利酮的 2 期和三项 3 期、随机、双盲、安慰剂或阳性对照研究,还有几项非奈利酮的随机和真实世界研究正在进行中。
在伴有或不伴有 T2D 的 CKD 和射血分数降低性心力衰竭患者的短期研究中,与螺内酯相比,非奈利酮 20mg 似乎具有更好的肾脏结局,与依普利酮相比具有更好的死亡率结局,与螺内酯和非奈利酮相比,血钾升高的发生率明显较低。在伴有 T2D 的 CKD 患者的长期研究中,与安慰剂相比,非奈利酮 10/20mg 显著降低了肾脏疾病的进展和减少了心血管终点事件(尤其是心力衰竭住院)。非奈利酮对 HbA1c、体重和包括男性乳房发育在内的性副作用没有影响,对血压的影响也较小。然而,与安慰剂相比,非奈利酮导致药物停药的血钾升高发生率显著更高。真实世界环境中的安全性数据是当务之急。