Supplementary Material for: Change in Urine Albumin-Creatinine Ratio and Occurrence of Hyperkalemia in Patients Initiating Finerenone in the United States: A Cohort Study from the FOUNTAIN platform

Introduction. In 2021, finerenone – a novel, selective non-steroidal mineralocorticoid receptor antagonist – was approved in the US to treat adults with CKD and T2D This study aimed to describe characteristics and short-term outcomes of patients prescribed finerenone since regulatory approval.
Methods. This was a retrospective cohort study using claims and electronic health records data from the OM1 Real-World Data Cloud™. A total of 15,948 US adults with a previous diagnosis of chronic kidney disease (CKD) and type 2 diabetes who initiated
10mg or 20mg finerenone between July 2021 and August 2023 were included. Dosing was evaluated at baseline and over up to 12-months’ follow-up. Change from baseline in urine albumin-to-creatinine ratio (UACR) was evaluated at 4 and 12 months (among 913 and 443 patients, respectively, with available repeat UACR values). Hyperkalemia occurrence was determined at 12 months and over total follow-up.
Results. Median follow-up was 7.2 months. Mean age was 70.3 years; 44.1% were female. At baseline (-365; 0 days) 70% had CKD stage 3; for patients with UACR measurements 80.8% had moderate/severe albuminuria (≥30mg/g). Median UACR was 203mg/g. Co-medication use was: ACE inhibitors/ARBs (51%), SGLT2is (38%), and GLP-1 RAs (26%). 86% of patients initiated 10mg finerenone, and among 2212 patients still under observation at 12 months, 70% were on 10mg. For finerenone initiators with available UACR data, UACR was reduced by 33% at 4 months and 38% at 12 months. Hyperkalemia occurred in 1.2% of the cohort by 12 months (incidence 2.0 per 100 person-years).
Conclusion. Patients who initiated finerenone had a notable reduction in median UACR at 4 months, sustained at 12 months; hyperkalemia occurrence appeared to be low. These initial findings from US clinical practice should be complemented by results from other real-world cohorts of patients started on finerenone.

引言。2021年，非奈利酮（finerenone）——一种新型选择性非甾体盐皮质激素受体拮抗剂——获美国批准用于治疗成人慢性肾脏病（CKD）合并2型糖尿病（T2D）患者。本研究旨在描述自该药物获批上市以来，接受非奈利酮治疗的患者的临床特征及短期转归。

研究方法。本研究为回顾性队列研究，采用OM1真实世界数据云（OM1 Real-World Data Cloud™）中的理赔数据与电子健康档案数据。研究纳入2021年7月至2023年8月期间起始服用10mg或20mg非奈利酮的15948名美国成人患者，这些患者既往均确诊慢性肾脏病（CKD）合并2型糖尿病。在基线及最长12个月的随访期内评估患者的给药方案。分别在随访第4个月和第12个月时评估尿白蛋白/肌酐比值（UACR）较基线的变化（分别有913名和443名患者可获得重复UACR检测数据）。分别在随访12个月时及整个随访周期内评估高钾血症的发生情况。

研究结果。患者的中位随访时间为7.2个月，平均年龄为70.3岁，其中女性占比44.1%。基线期（-365天至0天）内，70%的患者为CKD 3期；在完成UACR检测的患者中，80.8%存在中/重度白蛋白尿（≥30mg/g），中位UACR为203mg/g。患者的合并用药情况为：血管紧张素转换酶抑制剂/血管紧张素Ⅱ受体拮抗剂（ACEI/ARB）占51%、钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）占38%、胰高血糖素样肽-1受体激动剂（GLP-1 RA）占26%。86%的患者起始服用10mg非奈利酮；在随访至12个月时仍在随访队列中的2212名患者中，70%仍维持10mg的给药剂量。在可获得UACR数据的非奈利酮起始治疗患者中，其UACR在随访第4个月时下降33%，第12个月时下降38%。截至随访12个月时，队列中1.2%的患者发生高钾血症，发生率为2.0例/100人年。

结论。起始接受非奈利酮治疗的患者，其中位UACR在随访第4个月时即出现显著下降，且该获益持续至第12个月；高钾血症的发生率较低。这项来自美国临床实践的初步研究结果，还需要其他非奈利酮起始治疗患者的真实世界队列研究结果加以佐证。