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首页> 外文期刊>Cardiology >Glycosylated Hemoglobin as a Surrogate for the Prevention of Cardiovascular Events in Cardiovascular Outcome Trials Comparing New Antidiabetic Drugs to Placebo
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Glycosylated Hemoglobin as a Surrogate for the Prevention of Cardiovascular Events in Cardiovascular Outcome Trials Comparing New Antidiabetic Drugs to Placebo

机译：糖基化血红蛋白作为预防心血管结果试验中的心血管事件的替代物，将新的抗糖尿病药物与安慰剂进行比较

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Background and Objectives: The value of glycosylated hemoglobin (HbA1c) as a surrogate marker for the prevention of cardiovascular outcomes on antidiabetic drugs is debated. The 2008 FDA guidance led to multiple large clinical trials to evaluate the effect of new antidiabetic drugs versus placebo on major adverse cardiac events (MACE). The aim of this study was to evaluate the relation between MACE and HbA1c decrease between antidiabetic drug and placebo across the spectrum of cardiovascular outcome trials (CVOT). Methods: In this systematic review, we included randomized controlled trials that compared an antidiabetic drug to placebo in addition to current standard of care with the primary intention of demonstrating cardiovascular safety. We investigated the relationship between MACE decrease on antidiabetic drug and HbA1c reduction on antidiabetic drug using the coefficient correlation. We also studied the effects of potential confounders on MACE decrease. Results: Fourteen eligible trials including 128,149 patients were included, 12,114 of whom experienced MACE. Mean achieved HbA1c absolute reductions on antidiabetic treatment versus placebo varied from 0.29 to 1%. The decrease of MACE on antidiabetic drug was significantly correlated with mean HbA1c reduction ( r = 0.88, 95% CI: 0.67–0.96, p < 0.001) and weight loss ( r = 0.81, 95% CI: 0.46–0.94, p < 0.001). In a bivariate model including weight loss, only HbA1c reduction remained significantly correlated with the decrease of MACE on antidiabetic drug ( p = 0.019). Conclusion: Across CVOT, the decrease in MACE incidence on various antidiabetic drugs is significantly correlated with HbA1c reduction. This meta-analysis supports HbA1c as an appropriate surrogate endpoint for cardiovascular events. Our analysis supports that changes in HbA1c should be taken into account while interpreting effects of new antidiabetic drugs on cardiovascular outcomes.
机译：背景和目标：借鉴了糖基化血红蛋白（HBA1C）作为预防抗糖尿病药物的心血管结果的替代标志物的价值。 2008年FDA指南导致多次大型临床试验，评价新的抗糖尿病药物对安慰剂对主要不利心脏事件（MACE）的影响。本研究的目的是评估术抗糖尿病药物和安慰剂之间的斜率和HBA1C之间的关系，跨心血管结果试验（CVOT）。方法：在该系统审查中，除了目前的护理标准之外，我们还包括随机对照试验，使抗糖尿病药物与安慰剂进行了初步的护理标准。我们调查了使用系数相关性的抗糖尿病药物和HBA1c对抗糖尿病药物的降低的关系。我们还研究了潜在混淆对梅斯的影响下降。结果：14项符合条件的试验，包括128,149名患者，其中12,114人经历了梅斯。意思是达到的HBA1C绝对减少抗糖尿病治疗与安慰剂不同0.29〜1％。抗糖尿病药物上的术术减少与平均HBA1C还原显着相关（R = 0.88,95％CI：0.67-0.96，P <0.001）和减肥（R = 0.81,95％CI：0.46-0.94，P <0.001 ）。在包括体重减轻的二抗体模型中，与抗糖尿病药物上的术术减少只有HBA1C减少仍然显着相关（P = 0.019）。结论：在CVOT中，各种抗糖尿病药物上的均率下降与HBA1C减少显着相关。该元分析支持HBA1C作为心血管事件的适当代理终点。我们的分析支持HBA1C的变化应考虑在诠释新的抗糖尿病药物对心血管结果的影响。

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