Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics.

IF 3.8 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2024-11-12 DOI:10.1007/s13300-024-01660-0

Christophe De Block, Jennifer Peleshok, John P H Wilding, Anita Y M Kwan, Neda Rasouli, Juan M Maldonado, Carol Wysham, Minzhi Liu, Grazia Aleppo, Brian D Benneyworth

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引用次数: 0

Abstract

Introduction: Newer incretin-based therapies for type 2 diabetes (T2D) have the potential to substantially reduce glycated hemoglobin (HbA1c) and weight with a low associated risk of hypoglycemia. This study aimed to assess the percentage of participants randomized to tirzepatide or comparator who achieved the composite endpoint of HbA1c ≤ 6.5% and weight reduction ≥ 10% without hypoglycemia across prespecified baseline characteristics: T2D duration (≤ 5, > 5-10, or > 10 years), sex, HbA1c (≤ 8.5% or > 8.5%), age (< 65 or ≥ 65 years), and body mass index (< 30, 30 to < 35, or ≥ 35 kg/m²).

Methods: This post hoc analysis of SURPASS-1 through -5 evaluated adult study participants with T2D treated with tirzepatide 5, 10, or 15 mg versus placebo or active comparator. Missing HbA1c and weight values were imputed from mixed models for repeated measures. Logistic regression was used to compare tirzepatide versus comparators for the percentage of participants reaching the composite endpoint.

Results: Across subgroups, the composite endpoint was achieved by a median of approximately 30%, 45%, and 54% of participants who received tirzepatide 5, 10, and 15 mg, respectively; this was consistent across baseline subgroups, except that a greater percentage of women than men achieved the composite endpoint. The most common treatment-emergent adverse events were gastrointestinal in nature.

Conclusions: In this post hoc analysis, tirzepatide achieved the composite outcome of glycemic control and weight loss with no hypoglycemia, irrespective of baseline characteristics. This may help clinicians as they select suitable treatment in diverse populations.

Trial registration: ClinicalTrials.gov: NCT03954834, NCT03987919, NCT03882970. NCT03730662, and NCT04039503.

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SURPASS-1 至 -5 的事后分析：替泽帕肽对成人 2 型糖尿病患者的疗效和安全性与基线特征无关。

导言：基于增量素的2型糖尿病（T2D）新疗法有望大幅降低糖化血红蛋白（HbA1c）和体重，同时低血糖风险较低。本研究旨在评估在预设的基线特征下，随机接受替扎帕肽或比较药治疗的参与者中达到 HbA1c≤6.5% 和体重减轻≥10% 且无低血糖的复合终点的比例：T2D持续时间（≤5年、>5-10年或>10年）、性别、HbA1c（≤8.5%或>8.5%）、年龄(2)：这项对 SURPASS-1 至 -5 的事后分析评估了接受 5、10 或 15 毫克替扎帕肽与安慰剂或活性比较药治疗的 T2D 成年研究参与者。缺失的 HbA1c 和体重值由重复测量的混合模型估算。在达到综合终点的参与者比例方面，采用逻辑回归法比较替扎帕肽与对照药：在所有亚组中，接受替扎帕肽 5 毫克、10 毫克和 15 毫克治疗的参试者达到综合终点的中位数分别约为 30%、45% 和 54%；这在所有基线亚组中是一致的，只是达到综合终点的女性比例高于男性。最常见的治疗突发不良事件为胃肠道不良事件：结论：在这项事后分析中，无论基线特征如何，替扎帕肽都能达到血糖控制和体重减轻且无低血糖的综合结果。这可能有助于临床医生在不同人群中选择合适的治疗方法：试验注册：ClinicalTrials.gov：NCT03954834、NCT03987919、NCT03882970。NCT03730662和NCT04039503。

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来源期刊

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.