坎格列净对糖尿病患者心力衰竭住院的影响：基于心力衰竭风险的基线分析。
Effect of Canagliflozin on Heart Failure Hospitalization in Diabetes According to Baseline Heart Failure Risk.
机构信息
Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA.
Department of Cardiology, Texas Heart Institute, Houston, Texas, USA.
出版信息
JACC Heart Fail. 2023 Jul;11(7):825-835. doi: 10.1016/j.jchf.2023.03.025. Epub 2023 May 24.
BACKGROUND
In the CANVAS (Canagliflozin Cardiovascular Assessment Study) program, canagliflozin reduced the risk of heart failure (HF) hospitalization among individuals with type 2 diabetes mellitus (T2DM).
OBJECTIVES
The purpose of this study was to evaluate heterogeneity in absolute and relative treatment effects of canagliflozin on HF hospitalization according to baseline HF risk as assessed by diabetes-specific HF risk scores (WATCH-DM [Weight (body mass index), Age, hyperTension, Creatinine, HDL-C, Diabetes control (fasting plasma glucose) and QRS Duration, MI and CABG] and TRS-HF [TIMI Risk Score for HF in Diabetes]).
METHODS
Participants in the CANVAS trial were categorized into low, medium, and high risk for HF using the WATCH-DM score (for participants without prevalent HF) and the TRS-HF score (for all participants). The outcome of interest was time to first HF hospitalization. The treatment effect of canagliflozin vs placebo for HF hospitalization was compared across risk strata.
RESULTS
Among 10,137 participants with available HF data, 1,446 (14.3%) had HF at baseline. Among participants without baseline HF, WATCH-DM risk category did not modify the treatment effect of canagliflozin (vs placebo) on HF hospitalization (P interaction = 0.56). However, the absolute and relative risk reduction with canagliflozin was numerically greater in the high-risk group (cumulative incidence, canagliflozin vs placebo: 8.1% vs 12.7%; HR: 0.62 [95% CI: 0.37-0.93]; P = 0.03; number needed to treat: 22) than in the low- and intermediate-risk groups. When overall study participants were categorized according to the TRS-HF score, a statistically significant difference in the treatment effect of canagliflozin across risk strata was observed (P interaction = 0.04). Canagliflozin significantly reduced the risk of HF hospitalization by 39% in the high-risk group (HR: 0.61 [95% CI: 0.48-0.78]; P < 0.001; number needed to treat: 20) but not in the intermediate- or low-risk groups.
CONCLUSIONS
Among participants with T2DM, the WATCH-DM and TRS-HF can reliably identify those at high risk for HF hospitalization and most likely to benefit from canagliflozin.
背景
在 CANVAS（坎格列净心血管评估研究）项目中，坎格列净降低了 2 型糖尿病患者心力衰竭（HF）住院的风险。
目的
本研究旨在评估根据糖尿病特异性 HF 风险评分（WATCH-DM[体重（体重指数）、年龄、高血压、肌酐、HDL-C、糖尿病控制（空腹血糖）和 QRS 持续时间、MI 和 CABG]和 TRS-HF[TIMI HF 风险评分在糖尿病]）评估的基线 HF 风险，坎格列净对 HF 住院的绝对和相对治疗效果的异质性。
方法
CANVAS 试验的参与者根据 WATCH-DM 评分（用于无既往 HF 患者）和 TRS-HF 评分（用于所有参与者）分为 HF 低、中、高危。主要结局为首次 HF 住院时间。比较坎格列净与安慰剂治疗 HF 住院的疗效。
结果
在 10137 名有 HF 数据的参与者中，1446 名（14.3%）基线时存在 HF。在无基线 HF 的参与者中，WATCH-DM 风险类别并未改变坎格列净（与安慰剂相比）对 HF 住院的治疗效果（P 交互=0.56）。然而，坎格列净的绝对和相对风险降低在高危组中数值更大（累积发生率，坎格列净与安慰剂：8.1%比 12.7%；HR：0.62[95%CI：0.37-0.93]；P=0.03；需要治疗的人数：22），而在低危和中危组中则较小。当根据 TRS-HF 评分对所有研究参与者进行分类时，观察到坎格列净在不同风险水平上的治疗效果存在统计学显著差异（P 交互=0.04）。坎格列净可显著降低高危组 HF 住院风险 39%（HR：0.61[95%CI：0.48-0.78]；P<0.001；需要治疗的人数：20），但在中危或低危组中无此作用。
结论
在 2 型糖尿病患者中，WATCH-DM 和 TRS-HF 可可靠地识别出 HF 住院风险高且最有可能从坎格列净中获益的患者。
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