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Use of real-world evidence data to evaluate the comparative effectiveness of second-line type 2 diabetes medications on chronic kidney disease
medRxiv - Endocrinology Pub Date : 2021-06-18 , DOI: 10.1101/2021.06.15.21258963
Yu Deng , Farhad Ghamsari , Alice Lu , Jingzhi Yu , Lihui Zhao , Abel N Kho

Chronic kidney disease (CKD) is a common complication of type 2 diabetes mellitus (T2DM). Approximately one-third of patients with T2DM also have CKD. In clinical trial studies, several anti-diabetic medications (ADM) show evidence of preventing the progression of CKD. Biguanides (e.g., metformin) are widely accepted as the first line medication. However, the comparativeness effectiveness of second line ADMs on CKD outcomes in T2DM is unclear. In addition, results from clinical trials may not generalize into routine clinical practice. In this study, we aimed to investigate the association of second line ADMs with incident CKD and CKD hospitalization in T2DM patients using real-world data from electronic health records. Our study found that treatment with sodium-glucose cotransporter 2 (SGLT-2) inhibitors was significantly associated with a lower risk of CKD incidence in both primary analysis (hazard ratio, 0.43; 95% CI, [0.22;0.87]; p-value,0.02) (SU) as a second-line ADM. Treatment with a dipeptidyl peptidase 4 (DPP-4) inhibitor was significantly associated with lower CKD incidence (hazard ratio, 0.7; 95% CI, [0.53;0.96]; p-value, 0.03) and lower CKD hospitalization events (hazard ratio, 0.6; 95% CI, [0.37; 0.96]; p-value, 0.04) in the primary analysis. However, both associations were not significant in the sensitivity analysis. We did not observe significant association between use of GLP-1, TZD, insulin and CKD incidence or hospitalization compared to use of SU as the second-line ADM.

中文翻译:

使用真实世界的证据数据评估二线 2 型糖尿病药物治疗慢性肾病的比较有效性

慢性肾病 (CKD) 是 2 型糖尿病 (T2DM) 的常见并发症。大约三分之一的 T2DM 患者也患有 CKD。在临床试验研究中,几种抗糖尿病药物 (ADM) 显示出预防 CKD 进展的证据。双胍类(如二甲双胍)被广泛接受为一线药物。然而,二线 ADM 对 T2DM 中 CKD 结果的比较有效性尚不清楚。此外,临床试验的结果可能无法推广到常规临床实践中。在本研究中,我们旨在使用来自电子健康记录的真实世界数据调查二线 ADM 与 T2DM 患者 CKD 事件和 CKD 住院之间的关联。我们的研究发现,用钠-葡萄糖协同转运蛋白 2 (在作为二线 ADM 的主要分析中,SGLT-2) 抑制剂与较低的 CKD 发病风险显着相关(风险比,0.43;95% CI,[0.22;0.87];p 值,0.02)(SU) . 使用二肽基肽酶 4 (DPP-4) 抑制剂治疗与较低的 CKD 发生率(风险比,0.7;95% CI,[0.53;0.96];p 值,0.03)和较低的 CKD 住院事件(风险比, 0.6;95% CI,[0.37;0.96];p 值,0.04)在主要分析中。然而,这两种关联在敏感性分析中都不显着。与使用 SU 作为二线 ADM 相比,我们没有观察到使用 GLP-1、TZD、胰岛素和 CKD 发生率或住院之间的显着关联。
更新日期:2021-06-25
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