The Use of Semaglutide in Patients With Renal Failure-A Retrospective Cohort Study

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice Pub Date : 2024-10-01 DOI:10.1016/j.eprac.2024.07.008

Jane J. Long MD , Sukhdeep S. Sahi MBBS , Adley I. Lemke PharmD, RPh , Jie Na MS , Oscar A. Garcia Valencia MD , Pooja Budhiraja MBBS , Hani M. Wadei MD , Vineeth Sudhindran MBBS , Roberto Benzo MD , Matthew M. Clark PhD, LP , Meera Shah MB, ChB , David Fipps DO , Pavel Navratil MD , Ahmed A. Abdelrheem MB, ChB , Afsana A. Shaik MBBS , Dustin J. Duffy MS , Niv Pencovich MD, PhD , Pankaj Shah MD , Yogish C. Kudva MBBS , Aleksandra Kukla MD , Tayyab S. Diwan MD

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Abstract

Objective

Semaglutide, a glucagon-like peptide-1 receptor agonist is approved for weight loss and diabetes treatment, but limited literature exists regarding semaglutide use in patients with advanced chronic kidney disease (CKD). Therefore, this project assessed the safety and efficacy of semaglutide among patients with estimated glomerular filtration rate (eGFR) 15-29 mL/min/1.73 m² (CKD stage 4), eGFR<15 mL/min/1.73 m² (CKD stage 5) or on dialysis.

Methods

This is a retrospective electronic medical record based analysis of consecutive patients with advanced CKD (defined as CKD 4 or greater) who were started on semaglutide (injectable or oral). Data was collected between January 2018 and January 2023. Investigators verified CKD diagnosis and manually extracted data. Data were analyzed using Fisher’s exact test, paired t test, linear mixed effects models and Wilcoxon signed rank test.

Results

Seventy-six patients with CKD 4 or greater who initiated semaglutide were included. Most patients had a history of type 2 diabetes mellitus (96.0%), and most were males (53.9%). The mean age was 66.8 y (SD 11.5) with the mean body mass index was 36.2 (SD 7.5). The initial doses were 3 mg orally and 0.25 mg by injection. Maximum prescribed dose was 1 mg (injectable) in 28 (45.2%) patients and 14 mg (orally) in 2 (14.2%) patients. Patients received semaglutide for a median duration of 17.4 (IQR 0.43, 48.8) months. Forty-eight (63.1%) patients reported no adverse effects associated with the therapy. Mean weight decreased from 106.2 (SD 24.2) to 101.3 (SD 27.3) kg (P < .001). Eight patients (16%) with type 2 diabetes mellitus T2DM discontinued insulin after starting semaglutide. Mean hemoglobin A1c (HbA1c) decreased from 8.0% (SD 1.7) to 7.1% (SD 1.3) (P < .001). Adverse effects were the primary reason for semaglutide discontinuation (37.0%), with nausea, vomiting, and abdominal pain being the most common complaints.

Conclusions

Based on this retrospective study semaglutide appears to be tolerated by most individuals with CKD 4 or greater despite associated gastrointestinal side effects similar to those observed in patients with better kidney function and leads to an improvement of glycemic control and insulin discontinuation in patients with T2DM. Modest weight loss (approximately 4.6% of the total body weight) was observed on the prescribed doses. Larger prospective randomized studies are needed to comprehensively assess the risks and benefits of semaglutide in patients with CKD 4 or greater and obesity.

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在肾衰竭患者中使用塞马鲁肽--一项回顾性队列研究

目的胰高血糖素样肽-1 受体激动剂舍马鲁肽被批准用于减肥和糖尿病治疗，但有关舍马鲁肽用于晚期慢性肾病（CKD）患者的文献有限。因此，该项目评估了估计肾小球滤过率（eGFR）为15-29 mL/min/1.73 m2（CKD 4期）、eGFR<15 mL/min/1.73 m2（CKD 5期）或正在透析的患者使用舍马鲁肽的安全性和疗效。方法这是一项基于电子病历的回顾性分析，分析对象为开始使用舍马鲁肽（注射或口服）的连续晚期CKD（定义为CKD 4期或以上）患者。数据收集时间为 2018 年 1 月至 2023 年 1 月。研究人员核实了 CKD 诊断并手动提取了数据。采用费舍尔精确检验、配对 t 检验、线性混合效应模型和 Wilcoxon 符号秩检验对数据进行分析。结果纳入了 76 名开始使用塞马鲁肽的 CKD 4 级或以上患者。大多数患者有 2 型糖尿病病史（96.0%），大多数为男性（53.9%）。平均年龄为 66.8 岁（SD 11.5），平均体重指数为 36.2（SD 7.5）。初始剂量为口服 3 毫克，注射 0.25 毫克。28名患者（45.2%）的最大处方剂量为1毫克（注射），2名患者（14.2%）的最大处方剂量为14毫克（口服）。患者接受塞马鲁肽治疗的中位时间为 17.4 个月（IQR 0.43 - 48.8）。48名（63.1%）患者未报告与治疗相关的不良反应。平均体重从 106.2（标准差 24.2）公斤降至 101.3（标准差 27.3）公斤（P < .001）。8名（16%）2型糖尿病患者（T2DM）在开始使用semaglutide后停用了胰岛素。平均血红蛋白 A1c (HbA1c) 从 8.0% (SD 1.7) 降至 7.1% (SD 1.3) (P < .001)。结论根据这项回顾性研究，大多数 CKD 4 级或以上的患者似乎都能耐受 semaglutide，尽管相关的胃肠道副作用与肾功能较好的患者相似，并能改善 T2DM 患者的血糖控制和停用胰岛素。在处方剂量下观察到适度的体重减轻（约占总重量的 4.6%）。需要进行更大规模的前瞻性随机研究，以全面评估semaglutide对CKD 4级或以上和肥胖症患者的风险和益处。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Endocrine Practice ENDOCRINOLOGY & METABOLISM-

CiteScore

7.60

自引率

2.40%

发文量

546

审稿时长

41 days

期刊介绍： Endocrine Practice (ISSN: 1530-891X), a peer-reviewed journal published twelve times a year, is the official journal of the American Association of Clinical Endocrinologists (AACE). The primary mission of Endocrine Practice is to enhance the health care of patients with endocrine diseases through continuing education of practicing endocrinologists.