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在SURPASS临床试验项目中接受替尔泊肽治疗的2型糖尿病患者的患者报告结局

Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme.

作者信息

Boye Kristina S, Thieu Vivian Thuyanh, Sapin Hélène, Lee Clare J, Landó Laura Fernández, Brown Katelyn, Bray Ross, Wiese Russell J, Patel Hiren, Rodríguez Ángel, Yu Maria

机构信息

Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.

出版信息

Diabetes Ther. 2023 Nov;14(11):1833-1852. doi: 10.1007/s13300-023-01451-z. Epub 2023 Aug 1.

Abstract

INTRODUCTION

Tirzepatide, a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 receptor agonist, is approved for glycaemic control for people with type 2 diabetes (T2D). The SURPASS-1 to -5 clinical trials assessed the efficacy of once weekly tirzepatide (5, 10 and 15 mg) versus placebo or active comparators (semaglutide 1 mg, insulin degludec and insulin glargine) in T2D. We evaluated patient-reported outcomes (PROs) that measured overall quality of life (QoL), treatment satisfaction and weight-related attributes across the five SURPASS studies.

METHODS

PRO instruments utilised at baseline and primary timepoint (40 weeks for SURPASS-1, -2 and -5; 52 weeks for SURPASS-3 and -4) or early termination visit were EQ-5D-5L (SURPASS-1 to -5); Impact of Weight on Self-Perceptions (SURPASS-1 to -5); Ability to Perform Physical Activities of Daily Living (SURPASS-1 to -5); Diabetes Treatment Satisfaction Questionnaire (SURPASS-2 to -5); and Impact of Weight on Quality of Life-Lite Clinical Trials Version (SURPASS-2 only).

RESULTS

Across all five studies at week 40/52, tirzepatide improved patients' QoL measured by general health and weight-related PROs over the comparator. Generally, higher doses of tirzepatide resulted in greater increases in PRO scores.

CONCLUSION

Overall, tirzepatide produced significant health and weight-related QoL improvements versus comparators in the five SURPASS studies.

CLINICAL TRIAL REGISTRATION

SURPASS-1: NCT03954834; SURPASS-2: NCT03987919; SURPASS-3: NCT03882970; SURPASS-4: NCT03730662; SURPASS-5: NCT04039503.

摘要

简介

替尔泊肽是一种新型的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,已被批准用于控制2型糖尿病(T2D)患者的血糖。SURPASS-1至-5临床试验评估了每周一次替尔泊肽(5、10和15毫克)与安慰剂或活性对照药(司美格鲁肽1毫克、德谷胰岛素和甘精胰岛素)治疗T2D的疗效。我们在五项SURPASS研究中评估了患者报告的结局(PRO),这些结局衡量了总体生活质量(QoL)、治疗满意度和与体重相关的属性。

方法

在基线和主要时间点(SURPASS-1、-2和-5为40周;SURPASS-3和-4为52周)或提前终止访视时使用的PRO工具包括EQ-5D-5L(SURPASS-1至-5);体重对自我认知的影响(SURPASS-1至-5);进行日常生活体育活动的能力(SURPASS-1至-5);糖尿病治疗满意度问卷(SURPASS-2至-5);以及体重对生活质量的影响-简易临床试验版(仅SURPASS-2)。

结果

在第40/52周的所有五项研究中,与对照药相比,替尔泊肽通过总体健康和与体重相关的PRO改善了患者的QoL。一般来说,替尔泊肽剂量越高,PRO评分增加越大。

结论

总体而言,在五项SURPASS研究中,与对照药相比,替尔泊肽在健康和与体重相关的QoL方面有显著改善。

临床试验注册

SURPASS-1:NCT03954834;SURPASS-2:NCT03987919;SURPASS-3:NCT03882970;SURPASS-4:NCT03730662;SURPASS-5:NCT04039503。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a31/10570242/412e917df27a/13300_2023_1451_Fig1_HTML.jpg

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