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
{"title":"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","authors":"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","doi":"10.1111/dom.70111","DOIUrl":null,"url":null,"abstract":"<p><strong>Aims: </strong>This post hoc analysis assessed the efficacy and safety data in tirzepatide-treated Korean patients with type 2 diabetes (T2D).</p><p><strong>Materials and methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7000,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety in tirzepatide-treated Korean adults with type 2 diabetes-A post hoc analysis of SURPASS-AP-combo and SURPASS-3.\",\"authors\":\"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\",\"doi\":\"10.1111/dom.70111\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aims: </strong>This post hoc analysis assessed the efficacy and safety data in tirzepatide-treated Korean patients with type 2 diabetes (T2D).</p><p><strong>Materials and methods: </strong>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).</p><p><strong>Results: </strong>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. 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Efficacy and safety in tirzepatide-treated Korean adults with type 2 diabetes-A post hoc analysis of SURPASS-AP-combo and SURPASS-3.
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.
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.