Reduction in Albuminuria with Dapagliflozin Exhibits Substantial Interindividual Variability: A Real-World Study Utilizing a Big Data Approach

Jinfang Song^1,2, Yongru Zhuang^1,2, Chenling Wu³, Yi Xu⁴, Ya Chen⁵, Tao Wang⁶, Xiaoxing Yin², Fen Xie¹

¹Department of Pharmacy, Affiliated Hospital of Jiangnan University, Jiangsu, China
²Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy, Xuzhou Medical University, Jiangsu, China
³Department of Data Information, Nanjing Jiangbei New Area biopharmaceutical Public Service Platform Co., Ltd, Jiangsu, China
⁴Phase I Clinical Trial Center, Affiliated Lianyungang Hospital of Xuzhou Medical University, Jiangsu, China
⁵Department of Endocrinology, Affiliated Hospital of Jiangnan University, Jiangsu, China
⁶Department of Pharmacy, Affiliated Hospital of Xuzhou Medical University, Jiangsu, China

DOI : 10.4274/balkanmedj.galenos.2026.2025-12-261

Abstract

Background: Differences in the albuminuria-lowering effect of dapagliflozin and the associated factors require further exploration.

Aims: To evaluate interindividual variability in the albuminuria-lowering effect of dapagliflozin and identify factors associated with the albuminuria response to dapagliflozin.

Study Design: Retrospective observational cohort study.

Methods: This real-world study, utilizing a big data approach, included patients diagnosed with type 2 diabetic kidney disease (T2DKD) who received dapagliflozin treatment for a minimum of 3 months. Using the change in urinary albumin-creatinine ratio (UACR) after 3 months of dapagliflozin treatment as the primary surrogate endpoint, patients with a UACR reduction of > 30% were categorized as responders, whereas the remaining patients were classified as non-responders. Logistic regression analysis was conducted to explore factors affecting the albuminuria response to dapagliflozin, and receiver operating characteristic (ROC) curves were plotted to evaluate the discriminative ability of the associated factors.

Results: Among 10,860 patients with T2DKD, 4,487 (41.32%) were classified as non-responders to dapagliflozin. Logistic regression analysis identified the duration of T2DM (p < 0.001), baseline hemoglobin A1c (HbA1c) (p = 0.002), baseline systolic blood pressure (SBP, p = 0.004), and baseline UACR (p < 0.001) as factors associated with the albuminuria response to dapagliflozin. The areas under the ROC curve for baseline HbA1c, baseline SBP, baseline UACR, duration of T2DM, and the combination of these four factors in assessing the efficacy of dapagliflozin in lowering albuminuria were 0.508, 0.531, 0.563, 0.603, and 0.646, respectively.

Conclusion: Significant interindividual variability was observed in the albuminuria-lowering effect of dapagliflozin in the Chinese population. After adjustment for potential confounders, the duration of T2DM, baseline HbA1c, baseline SBP, and baseline UACR were identified as factors associated with the albuminuria response to dapagliflozin. However, their discriminative ability was limited and inadequate for clinical use according to the ROC analysis.