Tirzepatide Improved Health-Related Quality of Life Compared with Insulin Lispro in Basal Insulin-Treated Adults with Type 2 Diabetes and Inadequate Glycaemic Control: A Randomised Controlled Phase 3b Trial (SURPASS-6).

IF 3.8 3区 医学 Q2 Medicine Diabetes Therapy Pub Date : 2024-09-01 Epub Date: 2024-07-15 DOI:10.1007/s13300-024-01620-8
Kristina Secnik Boye, Jiat Ling Poon, Laura Fernández Landó, Hélène Sapin, Ruth Huh, Mianbo Wang, Suzanne Williamson, Hiren Patel
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Abstract

Introduction: Patients with type 2 diabetes (T2D) who require intensification of basal insulin therapy need treatment options that can improve their health-related quality of life (HRQoL) and translate into better outcomes. These analyses compared patient-reported outcomes (PROs) in patients with T2D receiving tirzepatide or insulin lispro.

Methods: The randomised, open-label, multinational, phase 3b SURPASS-6 trial (NCT04537923) was conducted at 135 medical research centres and hospitals in 15 countries and compared two recommended treatment intensification strategies in people with T2D and inadequate glycaemic control on basal insulin: addition of once-weekly tirzepatide versus addition of prandial insulin lispro. Randomisation was stratified by country, baseline glycated haemoglobin level and metformin use. PROs were measured using the Short Form-36 Health Survey version 2 (SF-36v2) acute form (secondary outcome), EQ-5D-5L, Ability to Perform Physical Activities of Daily Living (APPADL) questionnaire and Impact of Weight on Self-Perceptions (IW-SP) questionnaire (tertiary/exploratory outcomes). PROs were compared for the tirzepatide-pooled dose group (5, 10 and 15 mg) and each tirzepatide dose group versus insulin lispro at 52 weeks using the modified intention-to-treat efficacy analysis set.

Results: Between 19 October 2020 and 01 November 2022, 2267 people were assessed and 1428 participants with T2D were randomised. At 52 weeks, participants in the tirzepatide-pooled group had statistically significant improved scores across all SF-36v2 domains and both component summary scores compared with insulin lispro-treated participants (p < 0.05), with the largest differences observed in the general health, vitality and mental health domains. Statistically significant improved APPADL and IW-SP total scores, as well as EQ visual analogue scale and EQ-5D-5L index scores (after adjustment for baseline scores), were observed in tirzepatide-pooled participants compared with insulin lispro-treated participants.

Conclusions: In adult patients with T2D and inadequate glycaemic control with basal insulin, tirzepatide treatment was associated with greater improvements in HRQoL than prandial insulin therapy in addition to clinically significant improvements in glycaemic and body weight-related parameters.

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与利舒胰岛素相比,替扎帕肽可改善基础胰岛素治疗且血糖控制不佳的 2 型糖尿病成人的健康相关生活质量:随机对照 3b 期试验 (SURPASS-6)。
导言:需要加强基础胰岛素治疗的2型糖尿病(T2D)患者需要能够改善其健康相关生活质量(HRQoL)并带来更好疗效的治疗方案。这些分析比较了接受替扎帕肽或赖脯胰岛素治疗的 T2D 患者的患者报告结果(PROs):随机、开放标签、多国、3b 期 SURPASS-6 试验(NCT04537923)在 15 个国家的 135 个医学研究中心和医院进行,比较了两种针对基础胰岛素血糖控制不佳的 T2D 患者的推荐强化治疗策略:添加每周一次的替哌肽和添加餐前利斯普胰岛素。随机分组按国家、基线糖化血红蛋白水平和二甲双胍使用情况进行。采用简表-36健康调查2版(SF-36v2)急性表(二级结果)、EQ-5D-5L、日常生活体力活动能力(APPADL)问卷和体重对自我认知的影响(IW-SP)问卷(三级/探索性结果)测量PROs。采用修改后的意向治疗疗效分析集,比较了52周时替扎帕肽联合剂量组(5、10和15毫克)和各替扎帕肽剂量组与利舒普胰岛素的PROs:2020年10月19日至2022年11月1日期间,共对2267人进行了评估,1428名T2D患者被随机分配。52周时,与利舒伐他汀胰岛素治疗组相比,替扎帕肽联合治疗组患者在所有SF-36v2领域的得分以及两个部分的总分均有统计学意义上的显著改善(P 结论:替扎帕肽联合治疗组患者在所有SF-36v2领域的得分以及两个部分的总分均有统计学意义上的显著改善(P对于基础胰岛素血糖控制不佳的 T2D 成年患者,与餐前胰岛素治疗相比,替扎帕肽治疗不仅能显著改善血糖和体重相关参数,还能改善患者的 HRQoL。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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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.
期刊最新文献
Treatment Patterns and Glycaemic Control Between 2015 and 2019 in Tianjin, China: A Real-World Study of Adults with Type 2 Diabetes. Safety and Effectiveness of Concomitant iGlarLixi and SGLT-2i Use in People with T2D During Ramadan Fasting: A SoliRam Study Sub-analysis. The Effects of Imeglimin on Muscle Strength in Patients with Type 2 Diabetes: A Prospective Cohort Study. Correction to: Comparative Efficacy and Safety of Tirzepatide in Asians and Non-Asians with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. An SMS-Guided Basal Insulin Titration in People with Type 2 Diabetes New on Insulin.
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