Pharmacy Administration, Kaiser Permanente West Los Angeles Medical Center, Los Angeles, CA.
Department of Nephrology, Kaiser Permanente West Los Angeles Medical Center, Los Angeles, CA.
Perm J. 2021 May;25. doi: 10.7812/TPP/20.242.
The renal benefits of sodium-glucose cotransporter-2 inhibitors (SGLT2) are now well established, and these agents are recommended by the American Diabetes Association and Kidney Disease: Improving Global Outcomes guidelines for patients with type 2 diabetes and chronic kidney disease. However, the safety profile of SGLT2 inhibitors in chronic kidney disease is not as clear. We describe the adverse event rates of SGLT2 inhibitors, primarily empagliflozin, in Kaiser Permanente Southern California members with diabetic kidney disease.
This study was a multicenter retrospective descriptive analysis evaluating Kaiser Permanente Southern California members with type 2 diabetes and chronic kidney disease 1, 2, or 3 who first filled an SGLT2 inhibitor prescription in 2018, with follow-up through 2019. Primary outcomes were event rates of diabetic ketoacidosis, bone fracture, amputation, urinary tract infection, genital mycotic infection, hyperkalemia, and acute kidney injury. Secondary outcomes were mean changes in estimated glomerular filtration rates, serum creatine levels, urine albumin-to-creatinine ratios, and hemoglobin A1c percentages during the follow-up period.
Of 213 patients, 39 experienced at least 1 adverse event, for a total of 50 adverse events. Urinary tract infection had the highest incidence (62.1 events/1000 person-years), followed by genital mycotic infection (58.0 events/1000 person-years). Favorable changes were observed during the follow-up period for urine albumin-to-creatinine ratios and hemoglobin A1c percentages, with mean decreases of 81.8 mg/g and 0.7%, respectively. SGLT2 inhibitors were discontinued in 47.4% of patients, with the top reasons including increase in serum creatinine (8%) and urinary or genital side effects (5.6%).
Although most patients did not experience adverse events, urinary tract infections and genital mycotic infections were more common. Our detection of rates and types of adverse effects replicated most results reported in clinical trials. Discontinuations were largely attributed to reasons other than adverse events.
钠-葡萄糖共转运蛋白 2 抑制剂（SGLT2）的肾脏益处已得到充分证实，美国糖尿病协会和肾脏病：改善全球预后指南建议将其用于 2 型糖尿病和慢性肾脏病患者。然而，SGLT2 抑制剂在慢性肾脏病中的安全性尚不清楚。我们描述了 Kaiser Permanente Southern California 患有糖尿病肾病的成员中 SGLT2 抑制剂（主要是恩格列净）的不良事件发生率。
这项多中心回顾性描述性分析研究评估了 2018 年首次开处 SGLT2 抑制剂处方的 Kaiser Permanente Southern California 患有 2 型糖尿病和慢性肾脏病 1、2 或 3 的成员，随访至 2019 年。主要结局是糖尿病酮症酸中毒、骨折、截肢、尿路感染、生殖器真菌感染、高钾血症和急性肾损伤的发生率。次要结局是在随访期间估算肾小球滤过率、血清肌酐水平、尿白蛋白/肌酐比值和血红蛋白 A1c 百分比的平均变化。
在 213 名患者中，有 39 名至少发生了 1 次不良事件，共发生了 50 次不良事件。尿路感染的发生率最高（62.1 例/1000 人年），其次是生殖器真菌感染（58.0 例/1000 人年）。在随访期间，尿白蛋白/肌酐比值和血红蛋白 A1c 百分比均出现有利变化，分别平均降低 81.8 mg/g 和 0.7%。47.4%的患者停用了 SGLT2 抑制剂，停用的主要原因包括血清肌酐升高（8%）和尿或生殖器副作用（5.6%）。
尽管大多数患者没有发生不良事件，但尿路感染和生殖器真菌感染更为常见。我们检测到的不良事件发生率和类型与临床试验报告的大多数结果相似。停药主要归因于不良事件以外的原因。
