Yi-Meng He, Chen Zeng, Yu-Fan Zhang, Qi Wu, Xiao-Yu Zhou, Pi-Jun Yan, Yong Xu, Man Guo, Fang-Yuan Teng
{"title":"替西肽对2型糖尿病和肥胖症患者心力衰竭的影响：系统回顾和荟萃分析。","authors":"Yi-Meng He, Chen Zeng, Yu-Fan Zhang, Qi Wu, Xiao-Yu Zhou, Pi-Jun Yan, Yong Xu, Man Guo, Fang-Yuan Teng","doi":"10.1002/dmrr.70097","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aims</h3>\n \n <p>This systematic review and meta-analysis aimed to evaluate the effects of tirzepatide on heart failure in patients with type 2 diabetes mellitus (T2DM) and obesity.</p>\n </section>\n \n <section>\n \n <h3> Materials and Methods</h3>\n \n <p>An updated systematic search of the PubMed, Embase, The Cochrane Central Register of Controlled Trials, Scopus, Web of Science, and ClinicalTrials.gov databases for relevant studies, published from database inception to February 13, 2025, was performed using tirzepatide and heart failure-related search terms.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Eleven randomized controlled trials (RCTs) (funded by Eli Lilly and Co., Indianapolis, IN, USA) comprising 13,378 participants were included. Compared with placebo or other active glucose-lowering drugs, tirzepatide had a neutral effect on the overall risk for heart failure (risk ratio [RR] 0.63 [95% confidence interval (CI) 0.35–1.13]), but the effect was neither statistically nor clinically meaningful (absolute risk reduction [ARR] 0.17%, number needed to treat [NNT] 588; Food and Drug Administration (FDA) minimal important difference [MID] 1.5%). The certainty of evidence was rated as moderate according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria (<i>p</i> = 0.628; <i>I</i><sup>2</sup> = 0.0%). Subgroup analysis revealed different pooled estimates for heart failure outcomes in the ≤ 58 years of age subgroup (RR 0.40 [95% CI 0.17–0.96]) compared with the > 58 years' subgroup (RR 0.86 [95% CI 0.39–1.90]) (<i>p</i> for interaction = 0.201). Additionally, subgroup analysis comparing tirzepatide alone with tirzepatide in combination with other agents revealed different pooled estimates (<i>p</i> = 0.661; <i>I</i><sup>2</sup> = 0.0%), with an RR 0.43 (95% CI 0.20–0.88) and 2.25 (95% CI 0.51–9.87), respectively (<i>p</i> for interaction = 0.05). Subgroup analyses stratified according to different doses of tirzepatide, baseline body weight, body mass index, fasting plasma glucose, glycated haemoglobin, T2DM, obesity, or overweight, and intervention time indicated no association between tirzepatide use and the risk for heart failure.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Tirzepatide had no overall effect on heart failure outcomes in patients with T2DM or obesity. However, among patients ≤ 58 years of age, tirzepatide yielded a 60% relative risk reduction (i.e., RR = 0.40), while in patients undergoing monotherapy, it yielded a 57% relative risk reduction (i.e., RR = 0.43). Results of this systematic review and meta-analysis of RCTs support the safety of tirzepatide as a therapeutic option for the clinical management of T2DM or obesity.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>PROSPERO registration number, CRD42024620051</p>\n </section>\n </div>","PeriodicalId":11335,"journal":{"name":"Diabetes/Metabolism Research and Reviews","volume":"41 7","pages":""},"PeriodicalIF":6.0000,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effect of Tirzepatide on Heart Failure in Type 2 Diabetes Mellitus and Obesity: A Systematic Review and Meta-Analysis\",\"authors\":\"Yi-Meng He, Chen Zeng, Yu-Fan Zhang, Qi Wu, Xiao-Yu Zhou, Pi-Jun Yan, Yong Xu, Man Guo, Fang-Yuan Teng\",\"doi\":\"10.1002/dmrr.70097\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Aims</h3>\\n \\n <p>This systematic review and meta-analysis aimed to evaluate the effects of tirzepatide on heart failure in patients with type 2 diabetes mellitus (T2DM) and obesity.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Materials and Methods</h3>\\n \\n <p>An updated systematic search of the PubMed, Embase, The Cochrane Central Register of Controlled Trials, Scopus, Web of Science, and ClinicalTrials.gov databases for relevant studies, published from database inception to February 13, 2025, was performed using tirzepatide and heart failure-related search terms.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Eleven randomized controlled trials (RCTs) (funded by Eli Lilly and Co., Indianapolis, IN, USA) comprising 13,378 participants were included. Compared with placebo or other active glucose-lowering drugs, tirzepatide had a neutral effect on the overall risk for heart failure (risk ratio [RR] 0.63 [95% confidence interval (CI) 0.35–1.13]), but the effect was neither statistically nor clinically meaningful (absolute risk reduction [ARR] 0.17%, number needed to treat [NNT] 588; Food and Drug Administration (FDA) minimal important difference [MID] 1.5%). The certainty of evidence was rated as moderate according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria (<i>p</i> = 0.628; <i>I</i><sup>2</sup> = 0.0%). Subgroup analysis revealed different pooled estimates for heart failure outcomes in the ≤ 58 years of age subgroup (RR 0.40 [95% CI 0.17–0.96]) compared with the > 58 years' subgroup (RR 0.86 [95% CI 0.39–1.90]) (<i>p</i> for interaction = 0.201). Additionally, subgroup analysis comparing tirzepatide alone with tirzepatide in combination with other agents revealed different pooled estimates (<i>p</i> = 0.661; <i>I</i><sup>2</sup> = 0.0%), with an RR 0.43 (95% CI 0.20–0.88) and 2.25 (95% CI 0.51–9.87), respectively (<i>p</i> for interaction = 0.05). Subgroup analyses stratified according to different doses of tirzepatide, baseline body weight, body mass index, fasting plasma glucose, glycated haemoglobin, T2DM, obesity, or overweight, and intervention time indicated no association between tirzepatide use and the risk for heart failure.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>Tirzepatide had no overall effect on heart failure outcomes in patients with T2DM or obesity. However, among patients ≤ 58 years of age, tirzepatide yielded a 60% relative risk reduction (i.e., RR = 0.40), while in patients undergoing monotherapy, it yielded a 57% relative risk reduction (i.e., RR = 0.43). Results of this systematic review and meta-analysis of RCTs support the safety of tirzepatide as a therapeutic option for the clinical management of T2DM or obesity.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Trial Registration</h3>\\n \\n <p>PROSPERO registration number, CRD42024620051</p>\\n </section>\\n </div>\",\"PeriodicalId\":11335,\"journal\":{\"name\":\"Diabetes/Metabolism Research and Reviews\",\"volume\":\"41 7\",\"pages\":\"\"},\"PeriodicalIF\":6.0000,\"publicationDate\":\"2025-10-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetes/Metabolism Research and Reviews\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/dmrr.70097\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes/Metabolism Research and Reviews","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/dmrr.70097","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
引用次数: 0
摘要
目的：本系统综述和荟萃分析旨在评估替西肽对2型糖尿病（T2DM）合并肥胖患者心力衰竭的影响。材料和方法：对PubMed、Embase、Cochrane Central Register of Controlled Trials、Scopus、Web of Science和ClinicalTrials.gov数据库进行更新的系统检索，检索从数据库建立到2025年2月13日发表的相关研究，使用tizepatide和心力衰竭相关搜索词。结果：纳入11项随机对照试验（RCTs）（由Eli Lilly and Co., Indianapolis， IN， USA资助），包括13,378名受试者。与安慰剂或其他活性降糖药物相比，替西帕肽对心力衰竭总体风险的影响为中性（风险比[RR] 0.63[95%可信区间（CI） 0.35-1.13]），但其影响在统计学和临床意义上均无统计学意义（绝对风险降低[ARR] 0.17%，需要治疗的人数[NNT] 588；美国食品和药物管理局（FDA）最小重要差异[MID] 1.5%）。根据建议评估、发展和评价分级（GRADE）标准，证据的确定性被评为中等（p = 0.628; I2 = 0.0%）。亚组分析显示，≤58岁亚组的心力衰竭结局汇总估计（RR 0.40 [95% CI 0.17-0.96]）与> 58岁亚组（RR 0.86 [95% CI 0.39-1.90]）存在差异（相互作用p = 0.201）。此外，比较单独使用替西帕肽与联合使用其他药物的亚组分析显示了不同的汇总估计（p = 0.661; I2 = 0.0%）， RR分别为0.43 （95% CI 0.20-0.88）和2.25 (95% CI 0.51-9.87)（相互作用p = 0.05）。根据替西帕肽的不同剂量、基线体重、体重指数、空腹血糖、糖化血红蛋白、2型糖尿病、肥胖或超重以及干预时间进行分层的亚组分析显示，使用替西帕肽与心力衰竭风险之间没有关联。结论：替西帕肽对T2DM或肥胖患者的心力衰竭结局没有总体影响。然而，在≤58岁的患者中，替西帕肽产生了60%的相对风险降低（即RR = 0.40），而在接受单一治疗的患者中，它产生了57%的相对风险降低（即RR = 0.43）。本系统综述和随机对照试验的荟萃分析结果支持替西帕肽作为T2DM或肥胖临床治疗选择的安全性。试验注册：普洛斯彼罗注册号，CRD42024620051。
Effect of Tirzepatide on Heart Failure in Type 2 Diabetes Mellitus and Obesity: A Systematic Review and Meta-Analysis
Aims
This systematic review and meta-analysis aimed to evaluate the effects of tirzepatide on heart failure in patients with type 2 diabetes mellitus (T2DM) and obesity.
Materials and Methods
An updated systematic search of the PubMed, Embase, The Cochrane Central Register of Controlled Trials, Scopus, Web of Science, and ClinicalTrials.gov databases for relevant studies, published from database inception to February 13, 2025, was performed using tirzepatide and heart failure-related search terms.
Results
Eleven randomized controlled trials (RCTs) (funded by Eli Lilly and Co., Indianapolis, IN, USA) comprising 13,378 participants were included. Compared with placebo or other active glucose-lowering drugs, tirzepatide had a neutral effect on the overall risk for heart failure (risk ratio [RR] 0.63 [95% confidence interval (CI) 0.35–1.13]), but the effect was neither statistically nor clinically meaningful (absolute risk reduction [ARR] 0.17%, number needed to treat [NNT] 588; Food and Drug Administration (FDA) minimal important difference [MID] 1.5%). The certainty of evidence was rated as moderate according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria (p = 0.628; I2 = 0.0%). Subgroup analysis revealed different pooled estimates for heart failure outcomes in the ≤ 58 years of age subgroup (RR 0.40 [95% CI 0.17–0.96]) compared with the > 58 years' subgroup (RR 0.86 [95% CI 0.39–1.90]) (p for interaction = 0.201). Additionally, subgroup analysis comparing tirzepatide alone with tirzepatide in combination with other agents revealed different pooled estimates (p = 0.661; I2 = 0.0%), with an RR 0.43 (95% CI 0.20–0.88) and 2.25 (95% CI 0.51–9.87), respectively (p for interaction = 0.05). Subgroup analyses stratified according to different doses of tirzepatide, baseline body weight, body mass index, fasting plasma glucose, glycated haemoglobin, T2DM, obesity, or overweight, and intervention time indicated no association between tirzepatide use and the risk for heart failure.
Conclusions
Tirzepatide had no overall effect on heart failure outcomes in patients with T2DM or obesity. However, among patients ≤ 58 years of age, tirzepatide yielded a 60% relative risk reduction (i.e., RR = 0.40), while in patients undergoing monotherapy, it yielded a 57% relative risk reduction (i.e., RR = 0.43). Results of this systematic review and meta-analysis of RCTs support the safety of tirzepatide as a therapeutic option for the clinical management of T2DM or obesity.
期刊介绍：
Diabetes/Metabolism Research and Reviews is a premier endocrinology and metabolism journal esteemed by clinicians and researchers alike. Encompassing a wide spectrum of topics including diabetes, endocrinology, metabolism, and obesity, the journal eagerly accepts submissions ranging from clinical studies to basic and translational research, as well as reviews exploring historical progress, controversial issues, and prominent opinions in the field. Join us in advancing knowledge and understanding in the realm of diabetes and metabolism.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
