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基于基线估计肾小球滤过率的坎格列净对主要不良心血管事件的影响:CANVAS 项目和 CREDENCE 试验的西班牙裔亚组汇总分析。

Effects of canagliflozin on major adverse cardiovascular events by baseline estimated glomerular filtration rate: Pooled Hispanic subgroup analyses from the CANVAS Program and CREDENCE trial.

机构信息

University of Maryland School of Medicine, Baltimore, Maryland, USA.

Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.

出版信息

Diabetes Obes Metab. 2022 Jan;24(1):12-20. doi: 10.1111/dom.14539. Epub 2021 Sep 23.

Abstract

AIM

To assess the risk of major adverse cardiovascular events (MACE) of canagliflozin in Hispanic patients with type 2 diabetes (T2D) and high cardiovascular risk or nephropathy with varying levels of kidney function.

MATERIALS AND METHODS

This post hoc analysis included integrated, pooled data from the CANVAS Program and CREDENCE trial. The effects of canagliflozin versus placebo on major adverse cardiovascular events (MACE; i.e. cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke) were assessed in subgroups by baseline estimated glomerular filtration rate (eGFR; <45, 45-60, and >60 mL/min/1.73 m ) overall and in the Hispanic cohort. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using Cox regression models, with subgroup by treatment interaction terms added to test for heterogeneity.

RESULTS

A total of 14 543 participants were included; 3029 (20.8%) self-identified as Hispanic. In the overall population, canagliflozin reduced the risk of MACE compared with placebo (HR, 0.83; 95% CI, 0.75, 0.92), with no heterogeneity observed across eGFR subgroups (interaction P = .22). In the Hispanic cohort, canagliflozin also reduced the risk of MACE (HR, 0.71; 95% CI, 0.55, 0.92), with no heterogeneity by baseline eGFR (interaction P = .25), including among the Hispanic participants at highest risk with a baseline eGFR of less than 45 mL/min/1.73 m .

CONCLUSION

Canagliflozin reduced the risk of MACE overall, and among Hispanic participants with T2D and high cardiovascular risk or nephropathy in the CANVAS Program and CREDENCE trial, without heterogeneity by baseline eGFR.

摘要

目的

评估卡格列净在伴有不同肾功能水平的 2 型糖尿病(T2D)和高心血管风险或肾病的西班牙裔患者中的主要不良心血管事件(MACE)风险。

材料和方法

本事后分析包括 CANVAS 计划和 CREDENCE 试验的综合、汇总数据。使用 Cox 回归模型评估卡格列净与安慰剂对 MACE(即心血管死亡、非致死性心肌梗死和非致死性卒中)的影响,根据基线估计肾小球滤过率(eGFR;<45、45-60 和>60mL/min/1.73m )和西班牙裔队列对总体亚组进行评估。使用 Cox 回归模型估计风险比(HR)和 95%置信区间(CI),并添加治疗亚组交互项以检验异质性。

结果

共纳入 14543 名参与者,其中 3029 名(20.8%)自我认定为西班牙裔。在总体人群中,与安慰剂相比,卡格列净降低了 MACE 的风险(HR,0.83;95%CI,0.75,0.92),未观察到 eGFR 亚组之间存在异质性(交互 P=0.22)。在西班牙裔队列中,卡格列净也降低了 MACE 的风险(HR,0.71;95%CI,0.55,0.92),基线 eGFR 无异质性(交互 P=0.25),包括基线 eGFR 低于 45mL/min/1.73m 的西班牙裔患者风险最高的人群。

结论

卡格列净降低了总体 MACE 风险,在 CANVAS 计划和 CREDENCE 试验中,伴有高心血管风险或肾病的 T2D 西班牙裔患者中,与基线 eGFR 无关。

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