REAL life study of subcutaneous SEMaglutide in patients with type 2 diabetes in SPain: Ambispective, multicenter clinical study. Results in the GLP1-experienced cohort

IF 2.9 3区医学 Q3 ENDOCRINOLOGY & METABOLISM Journal of diabetes and its complications Pub Date : 2024-09-17 DOI:10.1016/j.jdiacomp.2024.108874

Jersy Jair Cárdenas-Salas , Roberto Miguel Sierra Poyatos , Bogdana Luiza Luca , Begoña Sánchez Lechuga , Naiara Modroño Móstoles , Teresa Montoya Álvarez , María de la Paz Gómez Montes , Jorge Gabriel Ruiz Sánchez , Diego Meneses González , Raquel Sánchez-Lopez , Carlos Casado Cases , Víctor Pérez de Arenaza Pozo , Clotilde Vázquez Martínez

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Abstract

Objective

To evaluate the efficacy of switching to once-weekly subcutaneous semaglutide in patients with type 2 diabetes mellitus (T2DM) who were previously treated with other glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in a real-world setting in Spain.

Methods

The REAL Life study of SEMaglutide in Patients with Type 2 diabetes in Spain (REALSEM-SP) was conducted in four endocrinology departments in Madrid, Spain. Adult patients with T2DM who were prescribed once-weekly (OW) subcutaneous semaglutide and had been previously treated with other GLP-1 RAs were included. Baseline characteristics, including demographic, anthropometric, and laboratory variables, were recorded at baseline and at 6 ± 3 and 12 ± 3 months of follow-up. The primary outcome was the change in HbA_1c at 12 ± 3 months of follow-up, with secondary outcomes including changes in weight, BMI, and other glycemic parameters.

Results

A total of 267 patients were included in the analysis, with a mean age of 61.6 years and a mean T2DM duration of 11.3 years. The majority of patients had grade 1 or 2 obesity at baseline. Switching to OW-semaglutide was associated with a significant reduction in HbA_1c from baseline to 13 months (−0.35 % ± 0.81). Patients who reached the 1.0 mg OW-dose showed a significant reduction in HbA_1c compared to those on the ≤0.5 mg OW-dose. Significant reductions in weight, BMI, and fasting plasma glucose were also observed. Adverse events were mostly gastrointestinal and led to treatment withdrawal in few cases.

Conclusion

Switching to OW-subcutaneous semaglutide in patients with T2DM previously treated with other GLP-1 RAs was associated to improvements in glycemic control and weight management in a real-world setting in Spain. These findings support the use of OW-semaglutide as an effective option for patients with T2DM who require additional glycemic control and weight management.

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SPain的2型糖尿病患者皮下注射SEMaglutide的真实生活研究：前瞻性多中心临床研究。有 GLP1 经验人群的研究结果。

目的在西班牙的实际环境中，评估之前接受过其他胰高血糖素样肽-1受体激动剂（GLP-1 RA）治疗的2型糖尿病（T2DM）患者改用每周一次的皮下注射塞马鲁肽的疗效：西班牙 2 型糖尿病患者 SEMaglutide 真实生活研究（REALSEM-SP）在西班牙马德里的四个内分泌科进行。研究对象包括开具了每周一次（OW）皮下注射塞马鲁肽处方并曾接受过其他 GLP-1 RAs 治疗的成年 T2DM 患者。在基线、6±3 个月和 12±3 个月的随访中记录了基线特征，包括人口统计学、人体测量和实验室变量。主要结果是随访 12±3 个月时 HbA1c 的变化，次要结果包括体重、体重指数和其他血糖参数的变化：共有 267 名患者参与分析，平均年龄为 61.6 岁，T2DM 平均病程为 11.3 年。大多数患者基线肥胖程度为 1 级或 2 级。从基线到13个月期间，改用OW-西马鲁肽可显著降低HbA1c（-0.35 % ± 0.81）。与OW剂量≤0.5毫克的患者相比，OW剂量达到1.0毫克的患者HbA1c明显降低。体重、体重指数和空腹血浆葡萄糖也有显著降低。不良反应主要是胃肠道反应，导致停药的病例很少：结论：在西班牙的真实世界中，曾接受过其他 GLP-1 RAs 治疗的 T2DM 患者改用 OW 皮下注射塞马鲁肽可改善血糖控制和体重管理。这些研究结果表明，对于需要额外血糖控制和体重管理的 T2DM 患者来说，使用 OW-塞马鲁肽是一种有效的选择。

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

Journal of diabetes and its complications 医学-内分泌学与代谢

CiteScore

5.90

自引率

3.30%

发文量

153

审稿时长

16 days

期刊介绍： Journal of Diabetes and Its Complications (JDC) is a journal for health care practitioners and researchers, that publishes original research about the pathogenesis, diagnosis and management of diabetes mellitus and its complications. JDC also publishes articles on physiological and molecular aspects of glucose homeostasis. The primary purpose of JDC is to act as a source of information usable by diabetes practitioners and researchers to increase their knowledge about mechanisms of diabetes and complications development, and promote better management of people with diabetes who are at risk for those complications. Manuscripts submitted to JDC can report any aspect of basic, translational or clinical research as well as epidemiology. Topics can range broadly from early prediabetes to late-stage complicated diabetes. Topics relevant to basic/translational reports include pancreatic islet dysfunction and insulin resistance, altered adipose tissue function in diabetes, altered neuronal control of glucose homeostasis and mechanisms of drug action. Topics relevant to diabetic complications include diabetic retinopathy, neuropathy and nephropathy; peripheral vascular disease and coronary heart disease; gastrointestinal disorders, renal failure and impotence; and hypertension and hyperlipidemia.