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A Prospective Single-Blind Randomized Trial of Ramipril, Eplerenone and Their Combination in Type 2 Diabetic Nephropathy
Cardiorenal Medicine ( IF 2.4 ) Pub Date : 2020-09-30 , DOI: 10.1159/000508670
Mostafa El Mokadem 1 , Yasser Abd El Hady 2 , Ashraf Aziz 3
Affiliation  

Introduction: Angiotensin-converting enzyme inhibitors (ACEI) combined with mineralocorticoid receptor antagonists were found to have a beneficial effect on patients with chronic kidney disease. Objective: The aim of our clinical trial was to compare the antialbuminuric effect of ramipril monotherapy, eplerenone monotherapy and eplerenone/ramipril combination therapy in patients with stage 1 hypertension and type 2 diabetes mellitus. Methods: In a single-blind, randomized clinical trial, 75 hypertensive patients (stage 1 hypertension) with type 2 diabetes mellitus and microalbuminuria were randomized in a 1:1:1 ratio to 1 of 3 groups: ramipril 10 mg monotherapy (25 patients), eplerenone 50 mg monotherapy (25 patients) and combination therapy of eplerenone/ramipril 50/10 mg (25 patients) through a randomized clinical trial. Blood pressure, urinary albumin/creatinine ratio (UACR), serum creatinine, estimated glomerular filtration rate (eGFR) and serum K level were measured before randomization and after 24 weeks. Results: Ramipril and eplerenone monotherapy showed a significant lowering of UACR compared with baseline levels (p ≤ 0.0001). The eplerenone/ramipril combination group showed a more significant reduction of UACR compared with the ramipril and eplerenone monotherapy groups (p = 0.0001). There was a more significant lowering of systolic blood pressure in the combination group (p #x3c; 0.0001). A nonsignificant change of serum potassium level, serum creatinine and eGFR was found among the 3 groups. Conclusion: Addition of eplerenone to ACEI shows an added antialbuminuric effect without significant change of the serum K level compared with eplerenone or ACEI.
Cardiorenal Med


中文翻译:

雷米普利、依普利酮及其联合治疗 2 型糖尿病肾病的前瞻性单盲随机试验

介绍:血管紧张素转换酶抑制剂(ACEI)联合盐皮质激素受体拮抗剂被发现对慢性肾病患者具有有益作用。目的:我们的临床试验的目的是比较雷米普利单药治疗、依普利酮单药治疗和依普利酮/雷米普利联合治疗对 1 期高血压和 2 型糖尿病患者的抗白蛋白尿作用。方法:在一项单盲、随机临床试验中,75 名患有 2 型糖尿病和微量白蛋白尿的高血压患者(1 期高血压)以 1:1:1 的比例随机分配到 3 组中的 1 组:雷米普利 10 毫克单药治疗(25 名患者),通过一项随机临床试验,依普利酮 50 mg 单药治疗(25 名患者)和依普利酮/雷米普利 50/10 mg 联合治疗(25 名患者)。在随机分组前和 24 周后测量血压、尿白蛋白/肌酐比值 (UACR)、血清肌酐、估计肾小球滤过率 (eGFR) 和血清 K 水平。结果:与基线水平相比,雷米普利和依普利酮单药治疗显示 UACR 显着降低(p≤ 0.0001)。与雷米普利和依普利酮单药治疗组相比,依普利酮/雷米普利联合治疗组的 UACR 降低更显着​​(p = 0.0001)。联合组的收缩压降低更为显着(p #x3c;0.0001)。3组血清钾水平、血清肌酐和eGFR变化不显着。结论:与依普利酮或 ACEI 相比,在 ACEI 中加入依普利酮显示出增加的抗白蛋白尿作用,而血清 K 水平没有显着变化。
心肾医学
更新日期:2020-09-30
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