西班牙 2 型糖尿病患者皮下司美格鲁肽的真实世界研究：前瞻性、多中心临床研究。GLP1 经验队列的结果。
REAL life study of subcutaneous SEMaglutide in patients with type 2 diabetes in SPain: Ambispective, multicenter clinical study. Results in the GLP1-experienced cohort.
机构信息
Hospital Universitario Fundación Jiménez Díaz, Avda. Reyes Católicos, 2, CP 28040 Madrid, Madrid, Spain; Hospital Universitario Infanta Elena, Avda. Reyes Católicos 21, CP 28340 Valdemoro, Madrid, Spain; Instituto de Investigación Sanitaria Fundación Jiménez-Díaz (IIS-FJD), Universidad Autónoma de Madrid (UAM), Hospital Universitario Fundación Jiménez Díaz, Avda. Reyes Católicos, 2, CP 28040 Madrid, Madrid, Spain.
Hospital Universitario Fundación Jiménez Díaz, Avda. Reyes Católicos, 2, CP 28040 Madrid, Madrid, Spain; Hospital Universitario General de Villalba, Carretera de Alpedrete a Moralzarzal M-608 Km 41. CP2 8400 Collado Villalba, Madrid, Spain.
出版信息
J Diabetes Complications. 2024 Dec;38(12):108874. doi: 10.1016/j.jdiacomp.2024.108874. Epub 2024 Sep 17.
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 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 from baseline to 13 months (-0.35 % ± 0.81). Patients who reached the 1.0 mg OW-dose showed a significant reduction in HbA 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.
目的
评估在西班牙真实环境中，将每周一次皮下注射司美格鲁肽转换用于治疗既往接受过其他胰高血糖素样肽-1 受体激动剂（GLP-1RA）的 2 型糖尿病（T2DM）患者的疗效。
方法
西班牙 REAL Life 研究司美格鲁肽治疗 2 型糖尿病患者（REALSEM-SP）在西班牙马德里的 4 个内分泌科进行。纳入接受每周一次（OW）皮下司美格鲁肽治疗且既往接受过其他 GLP-1RA 治疗的 T2DM 成年患者。记录基线时和随访 6±3 个月及 12±3 个月的人口统计学、人体测量学和实验室变量等基线特征。主要结局为随访 12±3 个月时 HbA 的变化，次要结局包括体重、BMI 和其他血糖参数的变化。
结果
共纳入 267 例患者进行分析，平均年龄为 61.6 岁，T2DM 病程平均为 11.3 年。基线时大多数患者有 1 级或 2 级肥胖。从基线到 13 个月，转换为 OW-司美格鲁肽治疗与 HbA 显著降低（-0.35%±0.81%）相关。达到 1.0mg OW 剂量的患者与接受≤0.5mg OW 剂量的患者相比，HbA 显著降低。体重、BMI 和空腹血糖也显著降低。不良事件主要为胃肠道事件，少数情况下导致治疗中断。
结论
在西班牙真实环境中，将每周一次皮下司美格鲁肽转换用于治疗既往接受过其他 GLP-1RA 的 T2DM 患者，与血糖控制和体重管理改善相关。这些发现支持将 OW-司美格鲁肽作为需要额外血糖控制和体重管理的 T2DM 患者的有效选择。
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