College of Medicine, Taipei Medical University, Taipei, Taiwan.
Department of Internal Medicine, National Taiwan University Hospital, 7 Chung-Shan South Road, Taipei, 100, Taiwan.
Cardiovasc Diabetol. 2024 Sep 3;23(1):327. doi: 10.1186/s12933-024-02424-7.
Sodium-glucose cotransporter 2 inhibitors (SGLT-2is) have demonstrated associations with lowering cardiovascular outcomes in patients with type 2 diabetes mellitus (T2DM). However, the impact of SGLT-2is on individuals at dialysis commencement remains unclear. The aim of this real-world study is to study the association between SGLT-2is and outcomes in patients with T2DM at dialysis commencement.
This is a retrospective cohort study of electronic health records (EHRs) of patients with T2DM from TriNetX Research Network database between January 1, 2012, and January 1, 2024. New-users using intention to treatment design was employed and propensity score matching was utilized to select the cohort. Clinical outcomes included major adverse cardiac events (MACE) and all-cause mortality. Safety outcomes using ICD-10 codes, ketoacidosis, urinary tract infection (UTI) or genital infection, dehydration, bone fracture, below-knee amputation, hypoglycemia, and achieving dialysis-free status at 90 days and 90-day readmission.
Of 49,762 patients with T2DM who initiated dialysis for evaluation, a mere 1.57% of patients utilized SGLT-2is within 3 months after dialysis. 771 SGLT-2i users (age 63.3 ± 12.3 years, male 65.1%) were matched with 771 non-users (age 63.1 ± 12.9 years, male 65.8%). After a median follow-up of 2.0 (IQR 0.3-3.9) years, SGLT-2i users were associated with a lower risk of MACE (adjusted Hazard Ratio [aHR] = 0.52, p value < 0.001), all-cause mortality (aHR = 0.49, p < 0.001). SGLT-2i users were more likely to become dialysis-free 90 days after the index date (aHR = 0.49, p < 0.001). No significant differences were observed in the incidence of ketoacidosis, UTI or genital infection, hypoglycemia, dehydration, bone fractures, below-knee amputations, or 90-day readmissions.
Our findings indicated a lower incidence of all-cause mortality and MACE after long-term follow-up, along with a higher likelihood of achieving dialysis-free status at 90 days in SGLT-2i users. Importantly, they underscored the potential cardiovascular protection and safety of SGLT-2is use in T2DM patients at the onset of dialysis.
钠-葡萄糖共转运蛋白 2 抑制剂(SGLT-2is)已被证明与 2 型糖尿病(T2DM)患者降低心血管结局有关。然而,SGLT-2is 对开始透析的个体的影响尚不清楚。本真实世界研究旨在研究 SGLT-2is 在开始透析时的 T2DM 患者中的结局的相关性。
这是一项来自 TriNetX 研究网络数据库的电子健康记录(EHR)的回顾性队列研究,时间为 2012 年 1 月 1 日至 2024 年 1 月 1 日。采用意向治疗设计新使用者,并使用倾向评分匹配选择队列。临床结局包括主要不良心脏事件(MACE)和全因死亡率。使用 ICD-10 代码、酮症酸中毒、尿路感染(UTI)或生殖器感染、脱水、骨折、膝下截肢、低血糖和在 90 天和 90 天内实现无透析状态的安全性结局。
在 49762 名因评估而开始透析的 T2DM 患者中,只有 1.57%的患者在透析后 3 个月内使用了 SGLT-2is。771 名 SGLT-2i 使用者(年龄 63.3±12.3 岁,男性 65.1%)与 771 名非使用者(年龄 63.1±12.9 岁,男性 65.8%)匹配。在中位随访 2.0(IQR 0.3-3.9)年后,SGLT-2i 使用者发生 MACE 的风险较低(调整后的危险比[aHR] = 0.52,p 值 < 0.001),全因死亡率(aHR = 0.49,p < 0.001)。SGLT-2i 使用者在索引日期后 90 天更有可能实现无透析状态(aHR = 0.49,p < 0.001)。酮症酸中毒、UTI 或生殖器感染、低血糖、脱水、骨折、膝下截肢或 90 天再入院的发生率无显著差异。
我们的研究结果表明,在长期随访后,SGLT-2i 使用者的全因死亡率和 MACE 发生率较低,且在 90 天内达到无透析状态的可能性更高。重要的是,这些发现强调了 SGLT-2is 在开始透析的 T2DM 患者中的潜在心血管保护作用和安全性。