替扎帕肽对 2 型糖尿病患者的疗效和安全性:不同亚组的 SURPASS-AP-Combo 分析

IF 3.8 3区 医学 Q2 Medicine Diabetes Therapy Pub Date : 2024-05-01 Epub Date: 2024-03-18 DOI:10.1007/s13300-024-01561-2
Yan Bi, Song Lu, Jiani Tang, Liying Du, Linong Ji
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摘要

简介替扎帕肽是一种新型葡萄糖依赖性促胰岛素多肽和胰高血糖素样肽-1受体激动剂。在 SURPASS-AP-Combo 试验中,与格列奈胰岛素相比,每周服用一次的替胰派肽可改善血糖控制和体重减轻,而且亚太地区(主要是中国)的 2 型糖尿病(T2D)患者普遍耐受性良好。这项SURPASS-AP-Combo的事后亚组分析评估了患者基线特征对替哌肽疗效和安全性的潜在影响:方法:根据潜在的影响因素,包括年龄(8.5%)、体重指数(BMI)(2)、体重(结果:在第 40 周,所有替扎帕肽患者的 HbA1c、体重、空腹血清葡萄糖(FSG)和自测血糖的日平均血糖均无明显变化:第 40 周时,在所有亚组中,所有替扎帕肽剂量均可使 HbA1c、体重、FSG 和日平均血糖从基线降低。在所有替扎帕肽剂量中,基线 HbA1c 较高的患者 HbA1c 降低幅度更大,10 毫克替扎帕肽患者体重较高,15 毫克替扎帕肽患者年龄较小。在所有替扎帕肽剂量中,体重较重、基线 HbA1c 较低(5 毫克替扎帕肽)和体重指数(BMI)较高(5 毫克替扎帕肽)的患者体重下降幅度更大:在这项事后分析中,在以中国人为主的 T2D 患者中,在不同亚组中,替扎帕肽与降低血糖和体重相关,这与此前有关替扎帕肽的报道一致:临床试验注册:NCT04093752。
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Efficacy and Safety of Tirzepatide in Patients with Type 2 Diabetes: Analysis of SURPASS-AP-Combo by Different Subgroups.

Introduction: Tirzepatide is a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist. In the SURPASS-AP-Combo trial, once-weekly tirzepatide was associated with improved glycemic control and weight loss versus insulin glargine and was generally well tolerated in an Asia-Pacific, predominately Chinese, population with type 2 diabetes (T2D). This post hoc subgroup analysis of SURPASS-AP-Combo assessed the potential influence of patient baseline characteristics on the efficacy and safety of tirzepatide.

Methods: Changes from baseline to week 40 in HbA1c, body weight, fasting serum glucose (FSG), and daily glucose average from self-measured blood glucose profiles were analyzed by potential influential factors including age (< 65, ≥ 65 years), sex, baseline HbA1c (≤ 8.5, > 8.5%), body mass index (BMI) (< 25, ≥ 25 kg/m2), body weight (< 75, ≥ 75 kg), duration of diabetes (< 10, ≥ 10 years), and concomitant oral antihyperglycemic medications (metformin, metformin plus sulphonylurea). Gastrointestinal adverse events and hypoglycemia were also evaluated.

Results: At week 40, all tirzepatide doses were associated with reduced HbA1c, body weight, FSG, and daily glucose average from baseline in all subgroups. Greater HbA1c reductions were achieved in patients with higher baseline HbA1c across all tirzepatide doses, higher body weight with 10 mg and younger age with 15 mg tirzepatide. Greater reductions in body weight were observed in patients with higher body weight across all tirzepatide doses, lower baseline HbA1c with 5 mg and higher BMI with 5 mg tirzepatide.

Conclusions: In this post hoc analysis, tirzepatide was associated with reduced blood glucose and body weight in a predominantly Chinese population with T2D across different subgroups, consistent with previous reports for tirzepatide.

Clinical trial registration: NCT04093752.

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来源期刊
Diabetes Therapy
Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
6.90
自引率
7.90%
发文量
130
审稿时长
6 weeks
期刊介绍: Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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