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对65岁及以上2型糖尿病老年患者进行每日口服司美格鲁肽治疗的真实世界回顾性研究(SEMA-老年患者研究)

Real-world retrospective study in elderly patients aged 65 years and older with type 2 diabetes mellitus treated with daily oral semaglutide (SEMA-elderly).

作者信息

Fiore Vincenzo, Carbotta Giovanni, Barraco Sonia, Falasca Paolo, Aricò Concetta Nadia, Barucca Alessandra

机构信息

UOSD Diabetologia Endocrinologia, ASL RM5, Rome, Italy.

Unit of Internal Medicine, RM6 Hospital, Rome, Italy.

出版信息

Diabetes Obes Metab. 2025 Apr;27(4):1805-1814. doi: 10.1111/dom.16174. Epub 2025 Jan 10.

Abstract

AIM

This real-world, retrospective cohort study aimed to assess the efficacy, safety and tolerability of oral semaglutide-the first GLP-1 receptor agonist available in oral form-in patients aged 65 years and older with type 2 diabetes mellitus (T2DM).

MATERIALS AND METHODS

The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline (V1) to six months (V3). Secondary endpoints included change in body weight, proportion of patients achieving HbA1c <7%, proportion of patients achieving both an HbA1c reduction of ≥1% and a body weight reduction of ≥5%. Exploratory endpoints were also assessed, including evaluations at three months (V2).

RESULTS

One hundred and one patients (mean age 74.7 ± 6.1 years) started oral semaglutide treatment. Mean HbA1c decreased significantly from V1 to V3 (change: -0.44%, p < 0.001), with reductions already evident at V2. The proportion of patients achieving an HbA1c ≤7% increased from 36.6% at V1 to 61.7% at V3. At V3, 9.6% of patients achieved an HbA1c reduction of ≥1% and a weight loss of ≥5%. Body weight decreased from a baseline mean of 76.8-73.7 kg at V3 (p < 0.001). Body mass index, waist circumference, total cholesterol, low-density lipoprotein cholesterol and systolic blood pressure decreased significantly from V1 to V3, with changes already evident at V2. Eleven patients (10.9%) reported adverse events. Seven patients (6.9%) discontinued treatment.

CONCLUSION

Oral semaglutide effectively improves glycaemic control and weight management in elderly patients with T2DM while improving lipid and cardiovascular parameters and proving to be safe and well tolerated.

摘要

目的

本项真实世界回顾性队列研究旨在评估口服司美格鲁肽(首款口服型胰高血糖素样肽-1受体激动剂)用于65岁及以上2型糖尿病(T2DM)患者的疗效、安全性和耐受性。

材料与方法

主要终点为糖化血红蛋白(HbA1c)从基线(V1)至6个月(V3)的变化。次要终点包括体重变化、HbA1c<7%的患者比例、HbA1c降低≥1%且体重减轻≥5%的患者比例。还评估了探索性终点,包括3个月(V2)时的评估。

结果

101例患者(平均年龄74.7±6.1岁)开始口服司美格鲁肽治疗。HbA1c从V1至V3显著降低(变化:-0.44%,p<0.001),在V2时已明显降低。HbA1c≤7%的患者比例从V1时的36.6%增至V3时的61.7%。在V3时,9.6%的患者HbA1c降低≥1%且体重减轻≥5%。体重从基线平均值76.8 kg降至V3时的73.7 kg(p<0.001)。体重指数、腰围、总胆固醇、低密度脂蛋白胆固醇和收缩压从V1至V3显著降低,在V2时已明显变化。11例患者(10.9%)报告了不良事件。7例患者(6.9%)停止治疗。

结论

口服司美格鲁肽可有效改善老年T2DM患者的血糖控制和体重管理,同时改善血脂和心血管参数,且安全性良好、耐受性佳。

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