Cardiovascular, Metabolic, and Safety Outcomes with Semaglutide by Baseline Age: Post Hoc Analysis of SUSTAIN 6 and PIONEER 6.

IF 3.8 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2024-11-09 DOI:10.1007/s13300-024-01659-7

Stephen C Bain, Nicolas Belmar, Søren T Hoff, Mansoor Husain, Søren Rasmussen, Tina Vilsbøll, Mark C Petrie

{"title":"Cardiovascular, Metabolic, and Safety Outcomes with Semaglutide by Baseline Age: Post Hoc Analysis of SUSTAIN 6 and PIONEER 6.","authors":"Stephen C Bain, Nicolas Belmar, Søren T Hoff, Mansoor Husain, Søren Rasmussen, Tina Vilsbøll, Mark C Petrie","doi":"10.1007/s13300-024-01659-7","DOIUrl":null,"url":null,"abstract":"Introduction: The high risk of cardiovascular events in people with type 2 diabetes increases with age. The cardiovascular effects of once-weekly subcutaneous and once-daily oral semaglutide versus placebo in people with type 2 diabetes at high cardiovascular risk were investigated in the SUSTAIN 6 and PIONEER 6 cardiovascular outcomes trials, respectively. It is unknown whether the effects of semaglutide are age dependent.Methods: This post hoc analysis evaluated cardiovascular, metabolic, and safety outcomes with semaglutide versus placebo in age subgroups (≤ 60; > 60 to ≤ 65; > 65 to ≤ 70; and > 70 years) pooled from SUSTAIN 6 and PIONEER 6. Major adverse cardiovascular events (composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), changes from baseline in glycated hemoglobin A1c (HbA1c) and body weight, and adverse events were analyzed.Results: Semaglutide reduced major adverse cardiovascular events and its components versus placebo across age subgroups (most hazard ratios < 1.0; pinteraction > 0.05). The treatment difference in HbA1c reduction was greater in those aged ≤ 60 years than in older subgroups (pinteraction = 0.01). Reductions in body weight with semaglutide versus placebo were consistent across age subgroups (pinteraction = 0.124). Serious adverse events or severe hypoglycemic episodes did not differ between semaglutide and placebo across age subgroups.Conclusion: Semaglutide consistently reduced major adverse cardiovascular events and body weight versus placebo across age subgroups; its safety profile did not differ with age. These results suggest that relaxing HbA1c targets based solely on age may not always be required for people with type 2 diabetes.Trial registration: SUSTAIN 6 (NCT01720446) and PIONEER 6 (NCT02692716) are registered at ClinicalTrials.gov.","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13300-024-01659-7","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction: The high risk of cardiovascular events in people with type 2 diabetes increases with age. The cardiovascular effects of once-weekly subcutaneous and once-daily oral semaglutide versus placebo in people with type 2 diabetes at high cardiovascular risk were investigated in the SUSTAIN 6 and PIONEER 6 cardiovascular outcomes trials, respectively. It is unknown whether the effects of semaglutide are age dependent.

Methods: This post hoc analysis evaluated cardiovascular, metabolic, and safety outcomes with semaglutide versus placebo in age subgroups (≤ 60; > 60 to ≤ 65; > 65 to ≤ 70; and > 70 years) pooled from SUSTAIN 6 and PIONEER 6. Major adverse cardiovascular events (composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), changes from baseline in glycated hemoglobin A_1c (HbA_1c) and body weight, and adverse events were analyzed.

Results: Semaglutide reduced major adverse cardiovascular events and its components versus placebo across age subgroups (most hazard ratios < 1.0; p_interaction > 0.05). The treatment difference in HbA_1c reduction was greater in those aged ≤ 60 years than in older subgroups (p_interaction = 0.01). Reductions in body weight with semaglutide versus placebo were consistent across age subgroups (p_interaction = 0.124). Serious adverse events or severe hypoglycemic episodes did not differ between semaglutide and placebo across age subgroups.

Conclusion: Semaglutide consistently reduced major adverse cardiovascular events and body weight versus placebo across age subgroups; its safety profile did not differ with age. These results suggest that relaxing HbA_1c targets based solely on age may not always be required for people with type 2 diabetes.

Trial registration: SUSTAIN 6 (NCT01720446) and PIONEER 6 (NCT02692716) are registered at ClinicalTrials.gov.

查看原文本刊更多论文

按基线年龄分类的塞马鲁肽心血管、代谢和安全性结果：SUSTAIN 6 和 PIONEER 6 的事后分析。

导言：2 型糖尿病患者发生心血管事件的高风险随着年龄的增长而增加。SUSTAIN 6和PIONEER 6心血管结局试验分别研究了每周一次皮下注射和每天一次口服塞马鲁肽与安慰剂相比对心血管高风险2型糖尿病患者的心血管影响。目前尚不清楚塞马鲁肽的作用是否与年龄有关：这项事后分析评估了SUSTAIN 6和PIONEER 6试验中汇总的年龄分组（≤60岁；＞60岁至≤65岁；＞65岁至≤70岁；＞70岁）中使用塞马鲁肽与安慰剂的心血管、代谢和安全性结果。对主要心血管不良事件（心血管死亡、非致死性心肌梗死和非致死性中风的复合）、糖化血红蛋白 A1c (HbA1c) 和体重与基线相比的变化以及不良事件进行了分析：结果：在各年龄亚组中，塞马鲁肽与安慰剂相比减少了主要心血管不良事件及其组成部分（大多数危险比交互作用>0.05）。与年龄较大的亚组相比，年龄小于 60 岁的患者在降低 HbA1c 方面的治疗差异更大（交互作用 = 0.01）。与安慰剂相比，不同年龄亚组服用塞马鲁肽后体重的降低幅度一致（pinteraction = 0.124）。不同年龄亚组的严重不良事件或严重低血糖发作在塞马鲁肽与安慰剂之间没有差异：结论：与安慰剂相比，塞马鲁肽可持续减少各年龄亚组的主要心血管不良事件和体重；其安全性并不因年龄而异。这些结果表明，2型糖尿病患者并不一定需要仅根据年龄放宽HbA1c目标值：SUSTAIN 6 (NCT01720446) 和 PIONEER 6 (NCT02692716) 已在 ClinicalTrials.gov 注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.