2 型糖尿病伴高心血管风险患者肾脏疾病的风险因素：一项探索性分析（DEVOTE 12）。
Risk factors for kidney disorders in patients with type 2 diabetes at high cardiovascular risk: An exploratory analysis (DEVOTE 12).
机构信息
Department of Diabetes and Endocrinology, Life Chatsmed Garden Hospital and Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
School of Medicine, University of North Carolina, Chapel Hill, NC, USA.
出版信息
Diab Vasc Dis Res. 2020 Nov-Dec;17(6):1479164120970933. doi: 10.1177/1479164120970933.
AIM
To investigate risk factors associated with kidney disorders in patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk.
METHODS
In DEVOTE, a cardiovascular outcomes trial, 7637 patients were randomised to insulin degludec (degludec) or insulin glargine 100 units/mL (glargine U100), with standard of care. In these exploratory post hoc analyses, serious adverse event reports were searched using Standardised MedDRA Queries related to chronic kidney disease (CKD) or acute kidney injury (AKI). Baseline predictors of CKD, AKI and change in estimated glomerular filtration rate (eGFR) were identified using stepwise selection and Cox or linear regression.
RESULTS
Over 2 years, eGFR (mL/min/1.73 m) decline was small and similar between treatments (degludec: 2.70; glargine U100: 2.92). Overall, 97 and 208 patients experienced CKD and AKI events, respectively. A history of heart failure was a risk factor for CKD (hazard ratio [HR] 1.97 [95% confidence interval [CI] 1.41; 2.75]) and AKI (HR 2.28 [95% CI 1.64; 3.17]). A history of hepatic impairment was a significant predictor of CKD (HR 3.28 [95% CI 2.12; 5.07]) and change in eGFR (estimate: -8.59 [95% CI -10.20; -7.00]).
CONCLUSION
Our findings indicate that traditional, non-modifiable risk factors for kidney disorders apply to insulin-treated patients with T2D at high CV risk.
TRIAL REGISTRATION
NCT01959529 (ClinicalTrials.gov).
目的
研究高心血管（CV）风险的 2 型糖尿病（T2D）患者发生肾脏疾病的相关风险因素。
方法
在心血管结局试验 DEVOTE 中，7637 例患者被随机分配至胰岛素地特胰岛素（degludec）或甘精胰岛素 100U/ml（glargine U100）治疗，并接受标准治疗。在这些探索性事后分析中，使用与慢性肾脏病（CKD）或急性肾损伤（AKI）相关的标准化 MedDRA 查询，检索严重不良事件报告。使用逐步选择和 Cox 或线性回归，确定 CKD、AKI 和估算肾小球滤过率（eGFR）变化的基线预测因子。
结果
在 2 年期间，两种治疗方法的 eGFR（mL/min/1.73m）下降均较小且相似（degludec：2.70；glargine U100：2.92）。总体而言，97 例和 208 例患者分别发生 CKD 和 AKI 事件。心力衰竭史是 CKD（风险比 [HR] 1.97 [95%置信区间 [CI] 1.41；2.75]）和 AKI（HR 2.28 [95% CI 1.64；3.17]）的危险因素。肝损伤史是 CKD（HR 3.28 [95% CI 2.12；5.07]）和 eGFR 变化（估计值：-8.59 [95% CI -10.20；-7.00]）的显著预测因子。
结论
我们的研究结果表明，传统的、不可改变的肾脏疾病风险因素适用于高心血管风险的胰岛素治疗 T2D 患者。
试验注册
NCT01959529（ClinicalTrials.gov）。
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