在现实世界中使用西马鲁肽促进肥胖血液透析患者体重减轻:一项多中心横断面描述性研究。

IF 1.6 Q3 UROLOGY & NEPHROLOGY
Canadian Journal of Kidney Health and Disease Pub Date : 2025-03-17 eCollection Date: 2025-01-01 DOI:10.1177/20543581251324588
Jodianne Couture, Pascale Robert, Marie-France Beauchesne, Gabriel Dallaire, Annie Lizotte, Jo-Annie Lafrenière, Julie Beauregard, Janique Doucet
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引用次数: 0

摘要

背景:肥胖可能是影响肾移植资格的一个问题。西马鲁肽是治疗肥胖的一个有趣的选择,但关于其在透析患者中的疗效和安全性的数据很少。目的:本研究的共同主要终点是描述使用西马鲁肽的参与者与未使用西马鲁肽的对照组相比,在治疗开始和治疗后3、6和12个月的体重(%)和体重指数(BMI)的变化。次要终点包括使用剂量的描述和报告的不良事件。设计:多中心横断面描述性研究。地点:加拿大魁北克省和新不伦瑞克省的七个血液透析中心。患者:接受血液透析治疗且BMI至少为30 kg/m2的成人纳入研究。测量方法:以透析结束时的目标体重(kg)定义体重。体重指数由体重定义,kg/m2。方法:作为主要目标,我们收集了体重记录,并计算BMI为30 kg/m2或更高的参与者在第0、3、6和12个月的BMI。从问卷调查、社区药店和记录中收集了西马鲁肽的剂量和任何不良事件的提及情况。结果:2023年6月共1286例患者接受血液透析治疗。其中,396人(31%)的BMI为30 kg/m2或更高。251名参与者参与了这项研究,其中41名(16%)接受了西马鲁肽治疗。与对照组相比,西马鲁肽治疗组从基线到3、6和12个月体重变化百分比的估计治疗差异为-2.26%,95%可信区间(CI), -3.68至-0.84,P = 0.002;-0.94%, 95% CI, -2.17 ~ 0.29, P = 0.135;和-0.64%;95% CI, -2.04 ~ 0.76, P = 0.370。3、6和12个月时BMI的估计治疗差异为-0.87 kg/m2, 95% CI, -1.38 ~ -0.36, P < .001;-0.35 kg/m2, 95% CI, -0.79 ~ 0.09, P = 0.119;和-0.23 kg/m2, 95% CI分别为-0.72 ~ 0.27,P = .371。3个月时,两组体重和BMI变化的估计治疗差异有统计学意义。对所有持续治疗12个月的西马鲁肽组患者(N = 15)进行敏感性分析。该组与对照组体重变化百分比的估计治疗差异为-3.04%,95% CI, -5.18 ~ -0.89, P = 0.006;-1.97%, 95% CI, -3.79 ~ -0.14, P = 0.035;和-2.83%,95% CI, -4.66至-1.00,P = 0.003分别在3、6和12个月。西马鲁肽组第0 ~ 12个月的平均体重变化为-3.88±7.90 kg,对照组为-0.52±5.53 kg (P = 0.015)。通过敏感性分析,持续治疗12个月的受试者在第0个月至第12个月的体重变化为-6.83±6.90 kg。西马鲁肽的处方剂量为1mg(49%)。不良事件的发生导致5名参与者(12%)减少剂量,13名参与者(32%)停止治疗。局限性:本研究存在非随机设计、随访时间短、样本量小、治疗依从性和不良反应数据不完整等局限性。患者特征的差异、用于减肥的有限的西马鲁肽剂量以及随着时间的推移而减少的样本量进一步降低了结论的强度,需要对组比较进行谨慎的解释。结论:这项研究表明,西马鲁肽促进血液透析成人肥胖患者的体重减轻,但停药是常见的,并且有常见的不良事件报道。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Real-World Use of Semaglutide to Promote Weight Loss in Obese Adults With Hemodialysis: A Multicenter Cross-Sectional Descriptive Study.

Background: Obesity can be an issue for renal transplant eligibility. Semaglutide constitutes an interesting choice for obesity treatment, but little data exist regarding its efficacy and security among dialysis patients.

Objectives: The co-primary endpoints of this study were to describe the change in body weight (%) and in body mass index (BMI) from the beginning and after 3, 6, and 12 months of treatment for participants who used semaglutide compared with a control group of non-users. Secondary endpoints included description of dosages used and reported adverse events.

Design: Multicenter cross-sectional descriptive study.

Setting: Seven hemodialysis centers in Quebec and New Brunswick, Canada.

Patients: Adults receiving hemodialysis treatment with BMI of at least 30 kg/m2 were included.

Measurements: Weight as defined by the target body weight (kg) at the end of dialysis. Body mass index is defined by weight, kg/m2.

Methods: As a primary objective, we collected in records the body weights and calculated BMI at months 0, 3, 6, and 12 for participants with BMI of 30 kg/m2 or greater. The dosages of semaglutide and the mention of any adverse events were also collected from questionnaire to participants, to community drug stores, and from records.

Results: A total of 1286 patients received hemodialysis treatments in June 2023. Of these, 396 (31%) had a BMI of 30 kg/m2 or greater. Two hundred fifty-one participants were included in the study and 41 (16%) received semaglutide. The estimated treatment differences for the percentage change in body weight from baseline to 3, 6, and 12 months for semaglutide compared with the control group were -2.26%, 95% confidence interval (CI), -3.68 to -0.84, P = .002; -0.94%, 95% CI, -2.17 to 0.29, P = 0.135; and -0.64%; 95% CI, -2.04 to 0.76, P = .370, respectively. The estimated treatment differences at 3, 6, and 12 months for BMI were -0.87 kg/m2, 95% CI, -1.38 to -0.36, P < .001; -0.35 kg/m2, 95% CI, -0.79 to 0.09, P = .119; and -0.23 kg/m2, 95% CI, -0.72 to 0.27, P = .371, respectively. The estimated treatment difference in body weight and BMI change between the 2 groups was statistically significant at 3 months. A sensitivity analysis was carried out with all the participants of the semaglutide group who continued the treatment for 12 months (N = 15). The estimated treatment differences for the percentage change in body weight between this group and the control group were -3.04%, 95% CI, -5.18 to -0.89, P = .006; -1.97%, 95% CI, -3.79 to -0.14, P = .035; and -2.83%, 95% CI, -4.66 to -1.00, P = .003 at 3, 6, and 12 months, respectively. The average body weight change between months 0 and 12 was -3.88 ± 7.90 kg in the semaglutide group compared with -0.52 ± 5.53 kg in the control group (P = .015). With the sensitivity analysis, the body weight change between Months 0 and 12 was -6.83 ± 6.90 kg for the participants who continued their treatment for 12 months. The dosage of 1 mg of semaglutide was the most prescribed (49%). The occurrence of adverse events led to dose reduction in 5 participants (12%) and to treatment discontinuation in 13 participants (32%).

Limitations: This study has several limitations, including its non-randomized design, short follow-up period, small sample size, and incomplete data on treatment compliance and adverse effects. Differences in patient characteristics, limited semaglutide doses for weight loss, and declining sample sizes over time further reduce the strength of conclusions, necessitating cautious interpretation of group comparisons.

Conclusions: This study suggests that semaglutide promotes weight loss in hemodialyzed adults with obesity, but discontinuation of treatment was frequent and common adverse events were reported.

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来源期刊
CiteScore
3.00
自引率
5.90%
发文量
84
审稿时长
12 weeks
期刊介绍: Canadian Journal of Kidney Health and Disease, the official journal of the Canadian Society of Nephrology, is an open access, peer-reviewed online journal that encourages high quality submissions focused on clinical, translational and health services delivery research in the field of chronic kidney disease, dialysis, kidney transplantation and organ donation. Our mandate is to promote and advocate for kidney health as it impacts national and international communities. Basic science, translational studies and clinical studies will be peer reviewed and processed by an Editorial Board comprised of geographically diverse Canadian and international nephrologists, internists and allied health professionals; this Editorial Board is mandated to ensure highest quality publications.
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