Sunagawa Kae, Hirai Keiji, Sunagawa Sumito, Kamiya Norifumi, Komesu Isao, Sunagawa Yusako, Sunagawa Hiroshi, Nakachi Ken, Hirai Aizan, Ookawara Susumu, Morishita Yoshiyuki
Sunagawa Medical Clinic, Okinawa, Japan.
Division of Endocrinology, Diabetes and Metabolism, Hematology, and Rheumatology, University of the Ryukyus, Okinawa, Japan.
Diabetes Metab Syndr Obes. 2024 Oct 14;17:3767-3781. doi: 10.2147/DMSO.S471535. eCollection 2024.
The aim of this study was to investigate the additional effects of empagliflozin on liraglutide in patients with advanced-stage type 2 diabetic kidney disease.
Forty-one patients were randomly assigned (1:1) to treatment with liraglutide alone during the first 6 months and subsequent treatment with liraglutide plus empagliflozin during the next 6 months (liraglutide plus empagliflozin group) (n = 20) or treatment with liraglutide alone for 12 months (liraglutide group) (n = 21). Liraglutide was administered subcutaneously once daily at a starting dose of 0.3 mg/day and up-titrated weekly by 0.3 mg to a maximum dose of 0.9 mg/day. Empagliflozin was administered orally at a dose of 10 mg once daily. The primary outcome was the change in renal function (estimated glomerular filtration rate) during the latter 6 months. Secondary outcomes were changes in body weight, systolic blood pressure, hemoglobin, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride, uric acid, blood glucose, hemoglobin A1c, and urine protein creatinine ratio during the latter 6 months.
Empagliflozin significantly increased the hemoglobin concentration (from 12.9 ± 1.9 to 13.7 ± 1.9 g/dL; p<0.05) and decreased body weight (from 66.1 ± 12.9 to 64.5 ± 12.6 kg; p<0.05). No significant differences were observed between the groups for estimated glomerular filtration rate, systolic blood pressure, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride, uric acid, blood glucose, hemoglobin A1c, and urine protein creatinine ratio.
Empagliflozin increased hemoglobin concentration and decreased body weight in patients with advanced-stage type 2 diabetic kidney disease who received liraglutide. However, empagliflozin did not provide short-term benefits with regard to renal function decline, urinary protein excretion, or glycemic control in these patients.
本研究旨在探讨恩格列净对晚期2型糖尿病肾病患者使用利拉鲁肽时的附加作用。
41例患者被随机（1:1）分配，20例在最初6个月单独使用利拉鲁肽治疗，随后6个月使用利拉鲁肽加恩格列净治疗（利拉鲁肽加恩格列净组），21例单独使用利拉鲁肽治疗12个月（利拉鲁肽组）。利拉鲁肽起始剂量为0.3mg/天，皮下注射，每日1次，每周递增0.3mg，最大剂量为0.9mg/天。恩格列净口服，剂量为10mg，每日1次。主要结局是后6个月肾功能（估计肾小球滤过率）的变化。次要结局是后6个月体重、收缩压、血红蛋白、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、甘油三酯、尿酸、血糖、糖化血红蛋白和尿蛋白肌酐比值的变化。
恩格列净显著提高了血红蛋白浓度（从12.9±1.9g/dL增至13.7±1.9g/dL；p<0.05），并降低了体重（从66.1±12.9kg降至64.5±12.6kg；p<0.05）。两组在估计肾小球滤过率、收缩压、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、甘油三酯、尿酸、血糖、糖化血红蛋白和尿蛋白肌酐比值方面未观察到显著差异。
在接受利拉鲁肽治疗的晚期2型糖尿病肾病患者中，恩格列净提高了血红蛋白浓度并降低了体重。然而，恩格列净在这些患者的肾功能下降、尿蛋白排泄或血糖控制方面未提供短期益处。
