Aziz Sohail, Harun Sabariah Noor, Sheikh Ghadzi Siti Maisharah
School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia.
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, MAHSA University, Jenjarom, Malaysia.
J Diabetes. 2025 Jun;17(6):e70104. doi: 10.1111/1753-0407.70104.
Estimated glomerular filtration rate (eGFR) is a key clinical marker for assessing kidney complications in type 2 diabetes mellitus (T2DM). This study aimed to develop and validate a disease progression model of eGFR in Malaysian T2DM patients, with and without diabetic nephropathy (DN).
Retrospective data from 251 patients (3241 observations) were analyzed using NONMEM software. Baseline eGFR was assessed without covariates, and both linear and non-linear models were tested. Model selection was based on the likelihood ratio test (5% significance level), objective function value (OFV), visual predictive check (VPC), relative standard error, and scientific plausibility. External validation was performed using data from 109 patients.
A linear model best described disease progression, with a baseline eGFR of 84.6 mL/min/1.73 m and a decline rate of -0.0041 mL/min/1.73 m/year. Cardiovascular disease (CVD) reduced eGFR by 1.05 mL/min/1.73 m/year, while fasting blood sugar (FBS) above 7.4 mmol/L correlated with an additional decline of 0.043 mL/min/1.73 m/year. Angiotensin receptor blockers (ARBs) improved eGFR by 0.4 mL/min/1.73 m/year, whereas statins and metformin contributed improvements of 0.34 and 0.32 mL/min/1.73 m/year, respectively. External validation confirmed model consistency with observed data.
Glycaemic control and CVD significantly impact eGFR decline. ARBs, statins, and metformin help preserve kidney function. Effective glycaemic management is crucial in slowing kidney deterioration, especially in T2DM patients at risk for DN.
估计肾小球滤过率（eGFR）是评估2型糖尿病（T2DM）肾脏并发症的关键临床指标。本研究旨在建立并验证马来西亚T2DM患者（伴或不伴糖尿病肾病（DN））的eGFR疾病进展模型。
使用NONMEM软件分析了251例患者（3241次观察）的回顾性数据。在不考虑协变量的情况下评估基线eGFR，并对线性和非线性模型进行了测试。模型选择基于似然比检验（5%显著性水平）、目标函数值（OFV）、视觉预测检查（VPC）、相对标准误差和科学合理性。使用109例患者的数据进行外部验证。
线性模型最能描述疾病进展，基线eGFR为84.6 mL/min/1.73 m²，下降率为-0.0041 mL/min/1.73 m²/年。心血管疾病（CVD）使eGFR每年降低1.05 mL/min/1.73 m²，而空腹血糖（FBS）高于7.4 mmol/L与eGFR每年额外下降0.043 mL/min/1.73 m²相关。血管紧张素受体阻滞剂（ARB）使eGFR提高0.4 mL/min/1.73 m²/年，而他汀类药物和二甲双胍分别使eGFR提高0.34和0.32 mL/min/1.73 m²/年。外部验证证实模型与观察数据一致。
血糖控制和CVD对eGFR下降有显著影响。ARB、他汀类药物和二甲双胍有助于保护肾功能。有效的血糖管理对于减缓肾脏恶化至关重要，尤其是在有DN风险的T2DM患者中。
