Denny Olivia, Albanese Nicole P, Meaney Calvin J, Siwarski Nicole E, Monte Scott V
General Physician Primary Care, Buffalo, NY, USA.
Buffalo Medical Group, Buffalo, NY, USA.
J Pharm Technol. 2024 Dec 19:87551225241302731. doi: 10.1177/87551225241302731.
Expansion of sodium-glucose cotransporter-2 inhibitor (SGLT2i) use in chronic kidney disease (CKD) prompted a pragmatic study of their safety and effectiveness in patients with type 2 diabetes mellitus (T2DM) and late-stage CKD. The primary clinical endpoint was change in HbA. Secondary clinical endpoints included change in body weight and blood pressure. Safety endpoints included kidney function indices, mycotic or urinary tract infection, acute kidney injury, dehydration, and ketoacidosis. Adult patients with T2DM and late-stage CKD prescribed an SGLT2i between June 1, 2018 and June 1, 2023 were included in this retrospective cohort study. Late-stage CKD was defined as CKD stage G3b, G4, or G5, including requiring dialysis or kidney transplantation. Endpoints were compared between patients who continued an SGLT2i versus those who discontinued. Fifty-nine patients were included. Short-term follow-up over 4.2 ± 1.7 months revealed no difference in HbA between groups. Extended follow-up in a truncated sample over 10.4 ± 2.6 months showed modest, yet significantly lower HbA with continuation (median: -0.3 vs 0.1%; = 0.04). Weight loss was greater when treatment continued (median: -1.8 vs 0.2 kg; = 0.01), whereas blood pressure did not differ. No differences in safety endpoints were observed. Kidney function mildly, but significantly worsened with continuation (median estimated glomerular filtration rate [eGFR]: -2.7 vs 0 mL/min/1.73 m; = 0.03). Patients with T2DM and late-stage CKD had similar glucose control and safety profiles irrespective of SGLT2i continuation or discontinuation. This may favor clinical decision-making toward benefits of SGLT2i reduction in weight, cardiovascular events, CKD progression, and hospitalizations over potential safety concerns in these patients.
钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）在慢性肾脏病（CKD）中的应用范围不断扩大，促使人们对其在2型糖尿病（T2DM）和晚期CKD患者中的安全性和有效性进行了一项实用性研究。主要临床终点是糖化血红蛋白（HbA）的变化。次要临床终点包括体重和血压的变化。安全性终点包括肾功能指标、真菌或尿路感染、急性肾损伤、脱水和酮症酸中毒。本回顾性队列研究纳入了2018年6月1日至2023年6月1日期间开具SGLT2i处方的T2DM和晚期CKD成年患者。晚期CKD定义为CKD G3b、G4或G5期，包括需要透析或肾移植。比较了继续使用SGLT2i的患者与停药患者的终点指标。共纳入59例患者。4.2±1.7个月的短期随访显示，两组间HbA无差异。在一个截短样本中进行的10.4±2.6个月的延长随访显示，继续用药组的HbA略有下降，但显著低于停药组（中位数：-0.3%对0.1%；P=0.04）。继续治疗时体重减轻更明显（中位数：-1.8 kg对0.2 kg；P=0.01），而血压无差异。未观察到安全性终点有差异。继续用药时肾功能轻度但显著恶化（估计肾小球滤过率[eGFR]中位数：-2.7对0 mL/min/1.73 m²；P=0.03）。无论是否继续使用SGLT2i，T2DM和晚期CKD患者的血糖控制和安全性特征相似。这可能有利于临床决策，支持SGLT2i在减轻体重、心血管事件、CKD进展和住院方面的益处，而不是关注这些患者潜在的安全性问题。
