使用替扎帕肽持续减轻体重后的血糖控制时间:SURPASS 临床试验计划的事后分析。

IF 5.4 2区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Brandon K. Bergman PharmD, Julio Rosenstock MD, W. Timothy Garvey MD, Rachel L. Batterham MBBS, Yanyun Chen PhD, Minzhi Liu PhD, Palash Sharma PhD, Chrisanthi A. Karanikas MS, Vivian T. Thieu PhD
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引用次数: 0

摘要

目的:这项参与者水平的探索性分析评估了来自exceed项目的2型糖尿病(T2D)患者接受替西帕肽治疗后血糖控制和/或体重持续下降的持续时间。材料和方法:来自transcend 1-5的参与者(N = 6246)被随机分配到每周一次的替西帕肽(5、10或15 mg)或比较剂(安慰剂每周一次,西马鲁肽每周一次1 mg,去葡萄糖糖胰岛素或甘精胰岛素)。结论:在这项事后分析中,与安慰剂和活性比较物相比,替西肽治疗T2D患者的血糖控制持续时间更长,体重下降更持久。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Time spent in glycaemic control with sustained body weight reduction with tirzepatide: A post hoc analysis of the SURPASS clinical trial programme

Time spent in glycaemic control with sustained body weight reduction with tirzepatide: A post hoc analysis of the SURPASS clinical trial programme

Aims

This participant-level exploratory analysis assessed the continuous time spent in glycaemic control and/or with sustained weight reductions with tirzepatide treatment in participants with type 2 diabetes (T2D) from the SURPASS programme.

Materials and Methods

Participants (N = 6246) from SURPASS 1–5 were randomized to once weekly tirzepatide (5, 10 or 15 mg) or comparator (once weekly placebo, once weekly semaglutide 1 mg, insulin degludec or insulin glargine). Continuous time spent with HbA1c < 7.0% (53 mmol/mol), ≤6.5% (48 mmol/mol) and ≥5% body weight reduction and combined HbA1c ≤ 6.5% (48 mmol/mol) with a ≥5% body weight reduction were assessed through 40 weeks (SURPASS-1, -2, and -5) or 52 weeks (SURPASS-3 and -4). The non-parametric Wilcoxon rank sum test was used to compare the median duration of continuous time spent in control, and logistic regression was used to analyse the proportion of participants achieving glycaemic control and body weight reduction at any time points or at the end of the primary study period.

Results

Median time spent with HbA1c < 7.0% (53 mmol/mol) was 80% (tirzepatide) versus 70% (semaglutide) and 0% (placebo) of the treatment duration in 40-week studies, and 77%–85% (tirzepatide) versus 62% (insulin degludec) and 23% (insulin glargine) of the treatment duration in 52-week studies (p < 0.001). Time spent with HbA1c < 7.0% (53 mmol/mol) was generally similar across all tirzepatide doses in each study. Dose-dependent increases in time spent with ≥5% body weight reduction were observed with tirzepatide (median time spent: 20%–77% with tirzepatide versus 25% with semaglutide 1 mg) (p < 0.001). Tirzepatide-treated participants experienced longer time spent with HbA1c ≤ 6.5% (48 mmol/mol) and ≥5% body weight reduction versus semaglutide (median: 35%–60% vs. 7%) (p < 0.001).

Conclusions

In this post hoc analysis, people with T2D experienced substantially longer continuous time in glycaemic control and more sustained body weight reductions with tirzepatide versus placebo and active comparators.

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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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