The Cardiovascular Department, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan.
College of Medicine, Chang Gung University, Taoyuan, Taiwan.
Diabetes Obes Metab. 2021 Sep;23(9):2077-2089. doi: 10.1111/dom.14446. Epub 2021 Jun 13.
To investigate the impact of initial decline in estimated glomerular filtration rate (eGFR) in patients with type 2 diabetes (T2D) following sodium-glucose co-transporter-2 inhibitor (SGLT2i) treatment.
We used medical data from a multicentre healthcare provider in Taiwan and recruited 11 769 patients with T2D with baseline/follow-up eGFR data available after 1 to 3 months of SGLT2i treatment from 1 June 2016 to 31 December 2018. Patients were followed up from the drug index date until the occurrence of adverse clinical events, SGLT2i discontinuation or the end of the study period, whichever took place first.
Overall, SGLT2i treatment was associated with an initial eGFR decline of 3.5% ± 14.0% after a median treatment period of 10 weeks. A total of 37.1% (n = 4371) of patients experienced no eGFR decline, and 30.5% (n = 3593), 20.2% (n = 2376), 8.5% (n = 999) and 3.7% (n = 430) of patients experienced an eGFR decline of 0%-10%, 10%-20%, 20%-30% and more than 30%, respectively. The mean eGFR over time became stable after 6 months in all eGFR decline categories, even in the group with a pronounced eGFR decline of more than 30%. Compared with no eGFR decline, an initial eGFR decline of 0%-10%, 10%-20% or 20%-30% was not associated with a higher risk of atrial fibrillation (AF), major adverse cardiovascular events (MACE, including ischaemic stroke, systemic embolism and acute myocardial infarction)/heart failure (HF) and composite renal outcome (doubling of the serum creatinine level/end-stage kidney disease), whereas an eGFR decline of more than 30% was associated with a higher risk of new-onset AF (adjusted hazard ratio [aHR] = 2.20, 95% confidence interval [CI] = 1.40-3.47), MACE/HF (aHR = 2.09, 95% CI = 1.04-4.17) and composite renal outcome (aHR = 1.82, 95% CI = 1.18-2.83). The multivariate analysis indicated that the use of a diuretic or insulin, presence of stroke, older age, female sex, a higher HbA1c level, and a lower body mass index of less than 25 kg/m were independent factors associated with an eGFR decline of more than 30% following SGLT2i initiation.
A pronounced eGFR decline of more than 30% following SGLT2i treatment was associated with adverse cardiovascular or renal events among patients with T2D.
研究钠-葡萄糖共转运蛋白 2 抑制剂（SGLT2i）治疗后 2 型糖尿病（T2D）患者肾小球滤过率（eGFR）初始下降对患者的影响。
我们使用了来自台湾一家多中心医疗服务提供者的医疗数据，招募了 11769 例基线/随访时 eGFR 数据可用的 T2D 患者，这些患者在 2016 年 6 月 1 日至 2018 年 12 月 31 日期间接受 SGLT2i 治疗后 1-3 个月。患者从药物起始日期开始随访，直至发生不良临床事件、停止使用 SGLT2i 或研究结束，以先发生者为准。
总体而言，中位治疗期为 10 周后，SGLT2i 治疗与 eGFR 初始下降 3.5%±14.0%相关。共有 37.1%（n=4371）的患者 eGFR 无下降，30.5%（n=3593）、20.2%（n=2376）、8.5%（n=999）和 3.7%（n=430）的患者 eGFR 分别下降 0%-10%、10%-20%、20%-30%和大于 30%。在所有 eGFR 下降类别中，eGFR 在 6 个月后均趋于稳定，即使在 eGFR 下降大于 30%的组中也是如此。与 eGFR 无下降相比，eGFR 初始下降 0%-10%、10%-20%或 20%-30%与心房颤动（AF）、主要不良心血管事件（MACE，包括缺血性卒中、全身性栓塞和急性心肌梗死/心力衰竭（HF））和复合肾脏结局（血清肌酐水平升高两倍/终末期肾病）风险增加无关，而 eGFR 下降大于 30%与新发 AF（校正后危险比[aHR] 2.20，95%置信区间 [CI] 1.40-3.47）、MACE/HF（aHR 2.09，95%CI 1.04-4.17）和复合肾脏结局（aHR 1.82，95%CI 1.18-2.83）风险增加相关。多变量分析表明，使用利尿剂或胰岛素、有卒中史、年龄较大、女性、较高的糖化血红蛋白（HbA1c）水平以及较低的身体质量指数（BMI）小于 25kg/m2是与 SGLT2i 起始后 eGFR 下降大于 30%相关的独立因素。
在 T2D 患者中，SGLT2i 治疗后 eGFR 明显下降大于 30%与不良心血管或肾脏事件相关。
