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从真实世界的利用数据看肥胖和 2 型糖尿病患者中司美格鲁肽的使用:美国全民健康研究计划的分析。

Semaglutide use in people with obesity and type 2 diabetes from real-world utilization data: An analysis of the All of US Program.

机构信息

Lister Hill National Center for Biomedical Communications, National Library of Medicine, National Institutes of Health, Bethesda, Maryland, USA.

出版信息

Diabetes Obes Metab. 2024 Nov;26(11):4989-4995. doi: 10.1111/dom.15911. Epub 2024 Sep 9.

Abstract

AIM

To analyse data from the All of Us Research Program to evaluate the real-world application and long-term effectiveness of semaglutide in treating type 2 diabetes and obesity patients in a large population.

MATERIALS AND METHODS

We identified patients prescribed semaglutide and analysed differences in route of administration and the time on semaglutide. For individuals diagnosed with obesity, we measured changes in body mass index (BMI) and weight from baseline, while measured changes in HbA1c for those patients with type 2 diabetes. We also examined the occurrence of newly diagnosed common adverse events from taking semaglutide.

RESULTS

For 3739 semaglutide patients, those on injectable semaglutide (3364 patients) averaged 301.54 days on the medication, with 20.36% having no end date, while those on oral semaglutide (435 patients) averaged 172.48 days, with 24.60% having no end date. We found average decreases of 1.54 kg/m in BMI, 4.65 kg in weight and 0.75% in HbA1c for semaglutide users. The decreases were larger in participants taking injectable formulation, probably because of higher starting values. Over time, improvements in these outcomes diminished, but the values remained significantly lower than baseline levels. Approximately only 1.0% of patients reported newly diagnosed common adverse events.

CONCLUSIONS

Consistent with clinical trial findings, this real-world data analysis showed that semaglutide was well tolerated and that, for a large population, it effectively reduced BMI, body weight and HbA1c, albeit to smaller magnitudes than observed in clinical trials. These findings provide valuable insights into real-world experience and the long-term effectiveness of semaglutide.

摘要

目的

分析“所有人研究计划”的数据,评估在大人群中使用司美格鲁肽治疗 2 型糖尿病和肥胖患者的真实世界应用和长期疗效。

材料和方法

我们确定了处方司美格鲁肽的患者,并分析了给药途径和司美格鲁肽使用时间的差异。对于诊断为肥胖的患者,我们测量了从基线开始的体重指数(BMI)和体重的变化,而对于 2 型糖尿病患者,则测量了 HbA1c 的变化。我们还检查了服用司美格鲁肽后新诊断的常见不良事件的发生情况。

结果

在 3739 名司美格鲁肽患者中,接受注射用司美格鲁肽(3364 名患者)的患者平均用药 301.54 天,20.36%的患者没有截止日期,而接受口服司美格鲁肽(435 名患者)的患者平均用药 172.48 天,24.60%的患者没有截止日期。我们发现司美格鲁肽使用者的 BMI 平均下降 1.54kg/m,体重下降 4.65kg,HbA1c 下降 0.75%。使用注射制剂的参与者降幅较大,可能是因为起始值较高。随着时间的推移,这些结果的改善程度有所减弱,但仍明显低于基线水平。大约只有 1.0%的患者报告新诊断的常见不良事件。

结论

与临床试验结果一致,这项真实世界数据分析表明,司美格鲁肽具有良好的耐受性,对于大人群而言,它能有效降低 BMI、体重和 HbA1c,尽管降幅小于临床试验观察到的结果。这些发现为司美格鲁肽的真实世界经验和长期疗效提供了有价值的见解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa44/11462475/9b98eb24a8ac/nihms-2018147-f0001.jpg

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