Efficacy and safety in tirzepatide-treated Korean adults with type 2 diabetes-A post hoc analysis of SURPASS-AP-combo and SURPASS-3.

IF 5.7 2区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Byung Wan Lee, Chang Beom Lee, Soo Lim, Sin Gon Kim, Nan Hee Kim, Jong Chul Won, Woo Je Lee, Min Ju Kang, Ju Young Yuh, Li Ying Du, Hyojin Lim, Kyu Jeung Ahn
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Abstract

Aims: This post hoc analysis assessed the efficacy and safety data in tirzepatide-treated Korean patients with type 2 diabetes (T2D).

Materials and methods: Data specifically from Korean patients treated with tirzepatide 5, 10, or 15 mg in the multicentre, randomised, open-label, parallel-group, phase 3 trials SURPASS-AP-Combo and SURPASS-3 were extracted and analysed. Efficacy (change from baseline in glycated haemoglobin [HbA1c] and body weight, and proportions of participants achieving HbA1c and body weight targets) and safety endpoints were evaluated at week 40 (SURPASS-AP Combo) and week 52 (SURPASS-3).

Results: In the SURPASS-AP-Combo and SURPASS-3, 79 of 687 and 27 of 1079 tirzepatide recipients, respectively, were Korean. In Korean participants in SURPASS-AP-Combo across all tirzepatide doses, least squares mean (LSM) HbA1c was reduced from baseline by 2.75% to 3.25% and HbA1c targets of <7.0% and ≤6.5% were achieved by 84.6% to 100% at week 40; LSM body weight reductions of -6.8% to -10.9% from baseline were achieved. The composite endpoint of HbA1c ≤6.5% without body weight gain or clinically significant documented symptomatic or severe hypoglycaemia was achieved by 69.2% to 85.2% of tirzepatide recipients. Findings were similar in Korean participants of SURPASS-3. The safety profile of tirzepatide in Korean participants was generally consistent with that in the overall SURPASS-AP-Combo and SURPASS-3 populations.

Conclusions: Consistent with the overall results of the SURPASS-AP-Combo and SURPASS-3 trials, this post hoc subgroup analysis found clinically meaningful reductions in HbA1c and body weight after treatment periods of 40 to 52 weeks in Koreans with T2D treated with tirzepatide.

替西肽治疗韩国成人2型糖尿病的疗效和安全性——对SURPASS-AP-combo和SURPASS-3的事后分析
目的:本事后分析评估了替西肽治疗的韩国2型糖尿病(T2D)患者的疗效和安全性数据。材料和方法:提取并分析多中心、随机、开放标签、平行组、3期试验SURPASS-AP-Combo和SURPASS-3中接受替西帕肽5、10或15mg治疗的韩国患者的数据。在第40周(SURPASS-AP Combo)和第52周(SURPASS-3)评估疗效(糖化血红蛋白[HbA1c]和体重从基线的变化,以及达到HbA1c和体重目标的参与者比例)和安全性终点。结果:在SURPASS-AP-Combo和SURPASS-3中,687名替西肽受体中有79名韩国人,1079名替西肽受体中有27名韩国人。在接受所有替西肽剂量的SURPASS-AP-Combo治疗的韩国参与者中,最小二乘平均值(LSM) HbA1c从基线降低了2.75%至3.25%,HbA1c目标的结论:与SURPASS-AP-Combo和SURPASS-3试验的总体结果一致,该后特设亚组分析发现,接受替西肽治疗40至52周后,韩国T2D患者的HbA1c和体重有临床意义的降低。
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来源期刊
Diabetes, Obesity & Metabolism
Diabetes, Obesity & Metabolism 医学-内分泌学与代谢
CiteScore
10.90
自引率
6.90%
发文量
319
审稿时长
3-8 weeks
期刊介绍: Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.
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