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Abstract：
BACKGROUND: There have been several recent advances in the care of patients with chronic kidney disease (CKD), including the use of sodium glucose cotransporter 2 (SGLT2) inhibitors and selective mineralocorticoid receptor antagonists (MRAs). There are very few data reporting the outcomes of these treatments in real-world experience. The aim of this retrospective study is to report the effects of SGLT2 inhibitors, finerenone, and their combination in CKD patients in our community-based setting.
METHODS: Ninety-eight patients with CKD with an estimated glomerular filtration rate (eGFR) between 25 and 90 mL/min per 1.73 m2 and a urine albumin-to-creatinine ratio (UACR) ≥ 30 mg/g were included. Patients were divided into three groups: two monotherapy groups of SGLT2 inhibitors or finerenone and a third combination group of therapy with SGLT2 inhibitors for the first 4 months and SGLT2 inhibitors and finerenone subsequently. The primary outcomes were the timing and percentage of patients achieving a >50% reduction in UACR from baseline.
RESULTS: Group 1 comprised 52 patients on SGLT2i, group 2 had 22 patients on finerenone, and group 3 had 24 patients on combination therapy. The baseline median UACR and mean eGFR were 513 mg/g and 47.9 mL/min per 1.73 m2 in group 1, 548.0 mg/g and 50.5 mL/min per 1.73 m2 in group 2, and 800 mg/g and 60 mL/min per 1.73 m2 in group 3. At baseline, 71 (72.4%) patients were on the angiotensin-converting enzyme inhibitor (ACEi) or the angiotensin receptor blocker (ARB), and 78 (79.5%) patients had type 2 diabetes. After 8 months of follow-up, a >50% decrease in albuminuria was achieved in 96% of patients in group 3, compared to 50% in group 1 and 59% in group 2 (p-values were <0.01 and <0.01, respectively). There was a statistically but not clinically significant change in mean potassium levels in group 2 (+0.4 mmol/L) compared to either group 1 (0.0 mmol/L with p-value: <0.01) or group 3 (-0.01 mmol/L with p-value: <0.01). However, there was no difference in potassium levels when comparing groups 1 and 3. At the end of the follow-up, the average difference in eGFR was -3.4 (8.8), -5.3(10.1), and -7.8 (11.2) mL/min per 1.73 m2 in groups 1, 2, and 3, respectively, without a statistically significant difference between groups.
CONCLUSIONS: In this real-world experience in our community setting, the combination of SGLT2 inhibitors and finerenone in our adult patients with CKD was associated with a very significant and clinically relevant reduction in UACR, without an increased risk of hyperkalemia. Combination therapy of SGLT2 inhibitor and finerenone regarding background use of ACEi/ARB is feasible and should be encouraged for further albuminuria reductions in CKD patients.
METHODS: Ninety-eight patients with CKD with an estimated glomerular filtration rate (eGFR) between 25 and 90 mL/min per 1.73 m2 and a urine albumin-to-creatinine ratio (UACR) ≥ 30 mg/g were included. Patients were divided into three groups: two monotherapy groups of SGLT2 inhibitors or finerenone and a third combination group of therapy with SGLT2 inhibitors for the first 4 months and SGLT2 inhibitors and finerenone subsequently. The primary outcomes were the timing and percentage of patients achieving a >50% reduction in UACR from baseline.
RESULTS: Group 1 comprised 52 patients on SGLT2i, group 2 had 22 patients on finerenone, and group 3 had 24 patients on combination therapy. The baseline median UACR and mean eGFR were 513 mg/g and 47.9 mL/min per 1.73 m2 in group 1, 548.0 mg/g and 50.5 mL/min per 1.73 m2 in group 2, and 800 mg/g and 60 mL/min per 1.73 m2 in group 3. At baseline, 71 (72.4%) patients were on the angiotensin-converting enzyme inhibitor (ACEi) or the angiotensin receptor blocker (ARB), and 78 (79.5%) patients had type 2 diabetes. After 8 months of follow-up, a >50% decrease in albuminuria was achieved in 96% of patients in group 3, compared to 50% in group 1 and 59% in group 2 (p-values were <0.01 and <0.01, respectively). There was a statistically but not clinically significant change in mean potassium levels in group 2 (+0.4 mmol/L) compared to either group 1 (0.0 mmol/L with p-value: <0.01) or group 3 (-0.01 mmol/L with p-value: <0.01). However, there was no difference in potassium levels when comparing groups 1 and 3. At the end of the follow-up, the average difference in eGFR was -3.4 (8.8), -5.3(10.1), and -7.8 (11.2) mL/min per 1.73 m2 in groups 1, 2, and 3, respectively, without a statistically significant difference between groups.
CONCLUSIONS: In this real-world experience in our community setting, the combination of SGLT2 inhibitors and finerenone in our adult patients with CKD was associated with a very significant and clinically relevant reduction in UACR, without an increased risk of hyperkalemia. Combination therapy of SGLT2 inhibitor and finerenone regarding background use of ACEi/ARB is feasible and should be encouraged for further albuminuria reductions in CKD patients.
摘要：
背景：慢性肾脏病（CKD）患者的护理最近取得了一些进展，包括使用钠葡萄糖协同转运蛋白2（SGLT2）抑制剂和选择性盐皮质激素受体拮抗剂（MRAs）。在现实世界的经验中，很少有数据报告这些治疗的结果。这项回顾性研究的目的是报告SGLT2抑制剂的作用，Finerenone,以及它们在我们社区环境中CKD患者中的组合。
方法：纳入98例CKD患者，估计肾小球滤过率（eGFR）为25-90mL/min/1.73m2，尿白蛋白-肌酐比值（UACR）≥30mg/g。将患者分为三组:SGLT2抑制剂或芬酮的两个单一疗法组,以及前4个月的SGLT2抑制剂和随后的SGLT2抑制剂和芬酮的第三组合疗法组。主要结果是UACR从基线降低>50%的患者的时间和百分比。
结果：第1组包括52名SGLT2i患者，第2组有22名患者接受了finetenone，第3组有24例患者接受联合治疗。第1组的基线中位数UACR和平均eGFR分别为513mg/g和47.9mL/min/1.73m2，第2组分别为548.0mg/g和50.5mL/min/1.73m2，第3组分别为800mg/g和60mL/min/1.73m2。在基线,71例(72.4%)患者服用血管紧张素转换酶抑制剂(ACEi)或血管紧张素受体阻滞剂(ARB),78例(79.5%)患者患有2型糖尿病。经过8个月的随访，a在第3组中有96%的患者实现了>50%的白蛋白尿减少,而在第1组中有50%和第2组中有59%(p值分别为<0.01和<0.01).与第1组（0.0mmol/L，p值：<0.01）或第3组（-0.01mmol/L，p值：<0.01）相比，第2组（0.4mmol/L）的平均钾水平有统计学但无临床意义。然而,比较第1组和第3组时，钾水平没有差异。在后续行动结束时，eGFR的平均差异为-3.4(8.8)，-5.3(10.1),在第1、2和3组中，每1.73m2分别为-7.8（11.2）mL/min，组间无统计学差异。
结论：在我们社区环境中的现实世界体验中，在我们的CKD成年患者中，SGLT2抑制剂和finetenone的组合与UACR的非常显着和临床相关的降低有关，不会增加高钾血症的风险。关于ACEi/ARB的背景使用SGLT2抑制剂和finenerone的联合治疗是可行的，应鼓励CKD患者进一步减少蛋白尿。
方法：纳入98例CKD患者，估计肾小球滤过率（eGFR）为25-90mL/min/1.73m2，尿白蛋白-肌酐比值（UACR）≥30mg/g。将患者分为三组:SGLT2抑制剂或芬酮的两个单一疗法组,以及前4个月的SGLT2抑制剂和随后的SGLT2抑制剂和芬酮的第三组合疗法组。主要结果是UACR从基线降低>50%的患者的时间和百分比。
结果：第1组包括52名SGLT2i患者，第2组有22名患者接受了finetenone，第3组有24例患者接受联合治疗。第1组的基线中位数UACR和平均eGFR分别为513mg/g和47.9mL/min/1.73m2，第2组分别为548.0mg/g和50.5mL/min/1.73m2，第3组分别为800mg/g和60mL/min/1.73m2。在基线,71例(72.4%)患者服用血管紧张素转换酶抑制剂(ACEi)或血管紧张素受体阻滞剂(ARB),78例(79.5%)患者患有2型糖尿病。经过8个月的随访，a在第3组中有96%的患者实现了>50%的白蛋白尿减少,而在第1组中有50%和第2组中有59%(p值分别为<0.01和<0.01).与第1组（0.0mmol/L，p值：<0.01）或第3组（-0.01mmol/L，p值：<0.01）相比，第2组（0.4mmol/L）的平均钾水平有统计学但无临床意义。然而,比较第1组和第3组时，钾水平没有差异。在后续行动结束时，eGFR的平均差异为-3.4(8.8)，-5.3(10.1),在第1、2和3组中，每1.73m2分别为-7.8（11.2）mL/min，组间无统计学差异。
结论：在我们社区环境中的现实世界体验中，在我们的CKD成年患者中，SGLT2抑制剂和finetenone的组合与UACR的非常显着和临床相关的降低有关，不会增加高钾血症的风险。关于ACEi/ARB的背景使用SGLT2抑制剂和finenerone的联合治疗是可行的，应鼓励CKD患者进一步减少蛋白尿。
