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从胰高血糖素样肽-1 受体激动剂切换至 5mg 度拉糖肽:治疗最初 12 周的临床预期。

Switching to Tirzepatide 5 mg From Glucagon-Like Peptide-1 Receptor Agonists: Clinical Expectations in the First 12 Weeks of Treatment.

机构信息

Thomas Jefferson University, Philadelphia, Pennsylvania.

Eli Lilly and Company, Indianapolis, Indiana.

出版信息

Endocr Pract. 2024 Aug;30(8):701-709. doi: 10.1016/j.eprac.2024.05.005. Epub 2024 May 8.

DOI:10.1016/j.eprac.2024.05.005
PMID:38723893
Abstract

OBJECTIVE

This prospective study aimed to describe the clinical course in terms of glycemic outcomes, body weight, and adverse events during the first 12 weeks following a switch from glucagon-like peptide-1 receptor agonists (GLP-1 RAs) directly to tirzepatide 5 mg.

METHODS

Participants were ≥18 years with type 2 diabetes (T2D), glycated hemoglobin (HbA1c) ≥6.5% to ≤9.0%, body mass index ≥25 kg/m and were on a stable treatment dose of GLP-1 RAs (liraglutide every day [1.2, 1.8 mg], semaglutide once-weekly [0.5, 1.0, 2.0 mg], or dulaglutide once-weekly [0.75, 1.5, 3.0, and 4.5 mg]) for ≥3 months at baseline. The primary end point was HbA1c change from baseline at week 12. Secondary end points included change from baseline in fasting serum glucose, body weight, and glucose assessed by continuous glucose monitoring. Safety was also assessed.

RESULTS

Participants were 58.3 years on average, with baseline HbA1c 7.39%, body mass index 35.18 kg/m, T2D duration around 12.4 years, and included 55% females. Semaglutide (55%) and dulaglutide (42%) were the most commonly used GLP-1 RAs at baseline with semaglutide 1.0 mg and dulaglutide 1.5 mg being the most common treatment doses. At week 12, mean HbA1c changed from baseline by -0.43%, fasting serum glucose by -7.83 mg/dL, and body weight by -2.15 kg (all P < .01). Glycemic outcomes and body weight improved in participants in all baseline GLP-1 RA subgroups. Twenty participants (13.2%) developed gastrointestinal events. Three (2%) participants discontinued tirzepatide due to adverse events. There were no severe hypoglycemic events or deaths.

CONCLUSION

In this prospective study, when people with T2D on stable GLP-1 RA treatment were switched directly to tirzepatide 5 mg, they experienced improved glycemic outcomes and additional weight reduction with an acceptable risk of adverse gastrointestinal events over 12 weeks.

摘要

目的

本前瞻性研究旨在描述在直接将胰高血糖素样肽-1 受体激动剂(GLP-1 RA)转换为替西帕肽 5mg 后 12 周内的血糖结果、体重和不良事件的临床过程。

方法

参与者年龄≥18 岁,患有 2 型糖尿病(T2D),糖化血红蛋白(HbA1c)≥6.5%至≤9.0%,体重指数≥25kg/m,并且在基线时接受 GLP-1 RA 的稳定治疗剂量(利拉鲁肽每天[1.2、1.8mg],每周一次的司美格鲁肽[0.5、1.0、2.0mg],或每周一次的度拉糖肽[0.75、1.5、3.0 和 4.5mg])至少 3 个月。主要终点是第 12 周时的 HbA1c 与基线相比的变化。次要终点包括空腹血清葡萄糖、体重和连续血糖监测评估的葡萄糖与基线相比的变化。还评估了安全性。

结果

参与者的平均年龄为 58.3 岁,基线时的 HbA1c 为 7.39%,体重指数为 35.18kg/m,T2D 病程约为 12.4 年,其中 55%为女性。基线时最常用的 GLP-1 RA 是司美格鲁肽(55%)和度拉糖肽(42%),最常见的治疗剂量是司美格鲁肽 1.0mg 和度拉糖肽 1.5mg。第 12 周时,平均 HbA1c 与基线相比下降了 0.43%,空腹血清葡萄糖下降了 7.83mg/dL,体重下降了 2.15kg(均 P<0.01)。所有基线 GLP-1 RA 亚组的血糖和体重均有改善。20 名参与者(13.2%)出现胃肠道事件。3 名参与者(2%)因不良事件停止使用替西帕肽。无严重低血糖事件或死亡。

结论

在这项前瞻性研究中,当接受稳定 GLP-1 RA 治疗的 T2D 患者直接转换为替西帕肽 5mg 时,他们在 12 周内经历了血糖结果的改善和额外的体重减轻,同时胃肠道不良事件的风险可以接受。

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