利拉鲁肽与 2 型糖尿病伴糖尿病肾病患者的肾脏结局。
Exenatide and Renal Outcomes in Patients with Type 2 Diabetes and Diabetic Kidney Disease.
机构信息
Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Department of Endocrinology & Metabolism, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, China.
出版信息
Am J Nephrol. 2020;51(10):806-814. doi: 10.1159/000510255. Epub 2020 Sep 23.
BACKGROUND
Cardiovascular outcomes in clinical trials with type 2 diabetes mellitus (T2DM) patients have shown that glucagon-like peptide-1 receptor agonist can have a beneficial effect on the kidney. This trial aimed to assess the effects of exenatide on renal outcomes in patients with T2DM and diabetic kidney disease (DKD).
METHODS
We performed a randomized parallel study encompassing 4 general hospitals. T2DM patients with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 and macroalbuminuria, defined as 24-h urinary albumin excretion rate (UAER) >0.3 g/24 h were randomized 1:1 to receive exenatide twice daily plus insulin glargine (intervention group) or insulin lispro plus glargine (control group) for 24 weeks. The primary outcome was the UAER percentage change from the baseline after 24 weeks of intervention. The rates of hypoglycemia, adverse events (AEs), and change in eGFR during the follow-up were measured as safety outcomes.
RESULTS
Between March 2016 and April 2019, 92 patients were randomized and took at least 1 dose of the study drug. The mean age of the participants was 56 years. At baseline, the median UAER was 1,512.0 mg/24 h and mean eGFR was 70.4 mL/min/1.73 m2. After 24 weeks of treatment, the UAER percentage change was significantly lower in the intervention group than in the control group (p = 0.0255). Moreover, the body weight declined by 1.3 kg in the intervention group (the difference between the 2 groups was 2.7 kg, p = 0.0001). Compared to the control group, a lower frequency of hypoglycemia and more gastrointestinal AEs were observed in the intervention group.
CONCLUSION
Exenatide plus insulin glargine treatment for 24 weeks resulted in a reduction of albuminuria in T2DM patients with DKD.
背景
在 2 型糖尿病（T2DM）患者的临床试验中，心血管结局表明胰高血糖素样肽-1 受体激动剂对肾脏有益。本试验旨在评估艾塞那肽对 T2DM 合并糖尿病肾病（DKD）患者肾脏结局的影响。
方法
我们进行了一项包括 4 家综合医院的随机平行研究。将估计肾小球滤过率（eGFR）≥30 mL/min/1.73 m2 且有大量白蛋白尿的 T2DM 患者（定义为 24 小时尿白蛋白排泄率（UAER）＞0.3 g/24 h）随机分为 1:1 组，分别接受每日两次艾塞那肽加甘精胰岛素（干预组）或赖脯胰岛素加甘精胰岛素（对照组）治疗 24 周。主要结局为干预 24 周后 UAER 自基线的百分比变化。低血糖发生率、不良事件（AE）和随访期间 eGFR 的变化作为安全性结局进行测量。
结果
2016 年 3 月至 2019 年 4 月，92 例患者被随机分组并至少接受了 1 次研究药物治疗。参与者的平均年龄为 56 岁。基线时，中位 UAER 为 1512.0 mg/24 h，平均 eGFR 为 70.4 mL/min/1.73 m2。治疗 24 周后，干预组 UAER 百分比变化明显低于对照组（p=0.0255）。此外，干预组体重下降 1.3 kg（两组之间的差异为 2.7 kg，p=0.0001）。与对照组相比，干预组低血糖发生率较低，胃肠道 AE 更多。
结论
艾塞那肽加甘精胰岛素治疗 24 周可降低 DKD 的 T2DM 患者的蛋白尿。
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