Semaglutide in patients with kidney failure and obesity undergoing dialysis and wishing to be transplanted: A prospective, observational, open-label study

IF 5.4 2区医学 Q1 ENDOCRINOLOGY & METABOLISM Diabetes, Obesity & Metabolism Pub Date : 2024-10-07 DOI:10.1111/dom.15967

Lenka Vanek MD, Amelie Kurnikowski MD, Simon Krenn MD, Sebastian Mussnig MD, Manfred Hecking PhD

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Abstract

Aims

Chronic kidney disease (CKD) and obesity are major global health challenges, eventually leading to kidney replacement therapy (KRT), but body mass index (BMI) thresholds hinder kidney transplantation. Glucagon-like peptide-1 receptor agonists induce weight loss, thereby offering attractive treatment options; however, their safety and efficacy have not been systematically investigated in patients undergoing dialysis.

Materials and Methods

We conducted a prospective 12-week, open-label trial with 13 patients who had a BMI ≥ 30.00 kg/m², were undergoing dialysis (12 haemodialysis and 1 peritoneal dialysis) and had not been listed for transplantation due to their weight. Semaglutide was administered once weekly subcutaneously, and the dose was increased from 0.25 mg to 0.5 mg and then to 1 mg. Study endpoints included change in body weight and BMI (primary – statistically evaluated by repeated measures analysis of variance [ANOVA]), side effects, adverse events, blood parameters and patient-reported outcomes (secondary).

Results

At baseline, the mean age ± standard deviation of patients was 64.0 ± 6.4 years, the mean weight was 113.9 ± 16.6 kg, and the mean BMI was 37.3 ± 3.9 kg/m². At week 12, average weight reduction under semaglutide treatment was 4.6 ± 2.4 kg and ranged from 2.0 to 9.7 kg (p < 0.001 for weight and BMI reduction across the study period). One patient discontinued treatment due to nausea/vomiting, two patients died of unrelated causes and six patients reported side effects. Approximately 9 months after the treatment started, three patients were able to seriously reconsider being listed for transplantation.

Conclusions

Semaglutide treatment resulted in significant reduction in weight and BMI in patients with obesity undergoing dialysis, while maintaining an acceptable side effect profile comparable to that of the non-dialysis population.

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塞马鲁肽在接受透析并希望接受移植的肾衰竭肥胖患者中的应用：一项前瞻性、观察性、开放标签研究。

目的：慢性肾脏病（CKD）和肥胖是全球面临的主要健康挑战，最终导致肾脏替代治疗（KRT），但体重指数（BMI）阈值阻碍了肾脏移植。胰高血糖素样肽-1受体激动剂可诱导体重减轻，从而提供有吸引力的治疗选择；然而，尚未对其在透析患者中的安全性和有效性进行系统研究：我们对 13 名体重指数（BMI）≥ 30.00 kg/m2、正在接受透析（12 名血液透析患者和 1 名腹膜透析患者）且因体重原因未被列入移植名单的患者进行了为期 12 周的前瞻性开放标签试验。塞马鲁肽每周皮下注射一次，剂量从0.25毫克增至0.5毫克，再增至1毫克。研究终点包括体重和体重指数的变化（主要指标--通过重复测量方差分析[ANOVA]进行统计评估）、副作用、不良事件、血液参数和患者报告结果（次要指标）：基线时，患者的平均年龄为（64.0 ± 6.4）岁，平均体重为（113.9 ± 16.6）公斤，平均体重指数为（37.3 ± 3.9）公斤/平方米。在第12周时，接受塞马鲁肽治疗的患者平均体重减轻了4.6±2.4千克，减重幅度在2.0至9.7千克之间（p 结论：塞马鲁肽治疗可使患者体重减轻2.0至9.7千克：塞马鲁肽治疗可显著降低接受透析治疗的肥胖症患者的体重和体重指数，同时保持与非透析人群相当的可接受副作用。

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来源期刊

Diabetes, Obesity & Metabolism 医学-内分泌学与代谢

CiteScore

10.90

自引率

6.90%

发文量

319

审稿时长

3-8 weeks

期刊介绍： Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.