Velocity Clinical Research, Los Angeles, CA 90057, USA.
Division of Endocrinology, University of Miami Miller School of Medicine, Miami, FL 33136, USA.
J Clin Endocrinol Metab. 2024 Jan 18;109(2):557-568. doi: 10.1210/clinem/dgad495.
Efficacy and safety of tirzepatide, a once-weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, have been studied in patients with type 2 diabetes in the global phase 3 SURPASS program.
This work aimed to assess the efficacy and safety of tirzepatide in Hispanic/Latino and non-Hispanic/Latino patients in SURPASS-1 to -4 clinical trials.
A total of 5679 patients were included, 2895 of self-reported Hispanic/Latino ethnicity, in this exploratory analysis of SURPASS-1 to -4 trial data. Interventions included tirzepatide 5, 10, or 15 mg, placebo, or active comparator (semaglutide 1 mg, insulin degludec, and insulin glargine). Change in glycated hemoglobin A1c (HbA1c) and body weight from baseline to week 40 (SURPASS-1 and -2) and to week 52 (SURPASS-3 and -4), and other efficacy and safety outcomes were evaluated within Hispanic/Latino and non-Hispanic/Latino subgroups.
Among Hispanic/Latino and non-Hispanic/Latino patients treated with tirzepatide, respectively, HbA1c decreased significantly from baseline, ranging from 1.9% to 2.7% and 1.7% to 2.5%, and body weight decreased significantly from baseline, ranging from 5.3 kg to 12.4 and 6.5 kg to 17.1 kg (both P < .05) vs comparators across all trials. Subgroup trends were consistent with the overall trial populations. Treatment-emergent adverse events were reported in similar proportions across the subgroups and were primarily gastrointestinal disorders. The incidence of hypoglycemia was low.
Tirzepatide significatively reduced HbA1c and body weight in Hispanic/Latino and non-Hispanic/Latino patients. Tirzepatide was generally well tolerated in both subgroups. Efficacy and safety trends were comparable between subgroups and within the overall trial populations.
在全球 3 期 SURPASS 项目中，研究了每周一次的葡萄糖依赖性胰岛素促分泌多肽和胰高血糖素样肽-1 受体激动剂替西帕肽在 2 型糖尿病患者中的疗效和安全性。
本研究旨在评估替西帕肽在 SURPASS-1 至 -4 临床试验中西班牙裔/拉丁裔和非西班牙裔/拉丁裔患者中的疗效和安全性。
本探索性分析纳入了 SURPASS-1 至 -4 试验数据中的 5679 例患者，其中 2895 例自我报告为西班牙裔/拉丁裔。干预措施包括替西帕肽 5、10 或 15mg、安慰剂或阳性对照物（司美格鲁肽 1mg、德谷胰岛素和甘精胰岛素）。从基线到第 40 周（SURPASS-1 和 -2）和第 52 周（SURPASS-3 和 -4）的糖化血红蛋白 A1c（HbA1c）和体重变化，以及其他疗效和安全性结局，在西班牙裔/拉丁裔和非西班牙裔/拉丁裔亚组中进行了评估。
在接受替西帕肽治疗的西班牙裔/拉丁裔和非西班牙裔/拉丁裔患者中，分别从基线起 HbA1c 显著降低，范围为 1.9%至 2.7%和 1.7%至 2.5%，体重显著降低，范围为 5.3kg 至 12.4kg 和 6.5kg 至 17.1kg（均 P<.05），而在所有试验中，与对照物相比。亚组趋势与总体试验人群一致。在各个亚组中，报告的治疗相关不良事件比例相似，主要为胃肠道疾病。低血糖的发生率较低。
替西帕肽显著降低了西班牙裔/拉丁裔和非西班牙裔/拉丁裔患者的 HbA1c 和体重。替西帕肽在这两个亚组中通常具有良好的耐受性。疗效和安全性趋势在亚组之间和总体试验人群中是可比的。
