钠-葡萄糖协同转运蛋白 2 抑制剂在射血分数保留的心力衰竭不同定义中的疗效。
Efficacy of SGLT2-inhibitors across different definitions of heart failure with preserved ejection fraction.
机构信息
Department of Internal Medicine, University of Genova, Genova, Italy.
Division of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
出版信息
J Cardiovasc Med (Hagerstown). 2023 Aug 1;24(8):537-543. doi: 10.2459/JCM.0000000000001504.
AIMS
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have been evaluated in phase 3 randomized-controlled trials (RCTs) that enrolled individuals with heart failure and preserved ejection fraction (HFpEF) based on detailed clinical, biochemical, and echocardiographic criteria (hereafter HF-RCTs), and in cardiovascular outcomes trials (CVOTs) in diabetic patients, in which the diagnosis of HFpEF relied on medical history.
METHODS AND RESULTS
We performed a study-level meta-analysis of the efficacy of SGLT2i across different definitions of HFpEF. Three HF-RCTs (EMPEROR-Preserved, DELIVER, and SOLOIST-WHF) and four CVOTs (EMPA-REG OUTCOME, DECLARE-TIMI 58, VERTIS-CV, and SCORED) were included, for a total of 14 034 patients. SGLT2i reduced the risk of cardiovascular death or heart failure hospitalization (HFH) in all RCTs pooled together [risk ratio 0.75, 95% confidence interval (95% CI) 0.63-0.89, NNT 19], in HF-RCTs (risk ratio 0.71, 95% CI 0.52-0.97, NNT 13), and in CVOTs (risk ratio 0.78, 95% CI 0.60-0.99, NNT 26). SGLT2i also decreased the risk of HFH in all RCTs (risk ratio 0.81, 95% CI 0.73-0.90, NNT 45), in HF-RCTs (risk ratio 0.81, 95% CI 0.72-0.93, NNT 37), and in CVOTs (risk ratio 0.78, 95% CI 0.61-0.99, NNT 46). By contrast, SGLT2i were not superior to placebo for cardiovascular death or all-cause death in all RCTs, HF-RCTs, or CVOTs. Results were comparable after excluding one RCT at a time. Meta-regression analysis confirmed that the type of RCT (HF-RCT vs. CVOT) did not influence the SGLT2i effect.
CONCLUSIONS
In RCTs, SGLT2i improved the outcomes of patients with HFpEF regardless of how the latter was diagnosed.
目的
钠-葡萄糖协同转运蛋白 2 抑制剂（SGLT2i）已在基于详细临床、生化和超声心动图标准（以下简称 HF-RCTs）纳入射血分数保留的心力衰竭（HFpEF）患者的 3 期随机对照试验（RCTs）和纳入糖尿病患者的心血管结局试验（CVOTs）中进行了评估，HFpEF 的诊断依赖于病史。
方法和结果
我们对不同 HFpEF 定义下 SGLT2i 的疗效进行了研究水平的荟萃分析。纳入了 3 项 HF-RCTs（EMPEROR-Preserved、DELIVER 和 SOLOIST-WHF）和 4 项 CVOTs（EMPA-REG OUTCOME、DECLARE-TIMI 58、VERTIS-CV 和 SCORED），共纳入 14034 例患者。SGLT2i 降低了所有 RCT 汇总的心血管死亡或心力衰竭住院（HFH）风险[风险比 0.75，95%置信区间（95%CI）0.63-0.89，NNH 19]，HF-RCTs 中[风险比 0.71，95%CI 0.52-0.97，NNH 13]和 CVOTs 中[风险比 0.78，95%CI 0.60-0.99，NNH 26]。SGLT2i 还降低了所有 RCTs 的 HFH 风险[风险比 0.81，95%CI 0.73-0.90，NNH 45]、HF-RCTs 中的风险[风险比 0.81，95%CI 0.72-0.93，NNH 37]和 CVOTs 中的风险[风险比 0.78，95%CI 0.61-0.99，NNH 46]。相比之下，SGLT2i 在所有 RCTs、HF-RCTs 或 CVOTs 中并未优于安慰剂用于心血管死亡或全因死亡。每次排除一项 RCT 后，结果均具有可比性。荟萃回归分析证实 RCT 类型（HF-RCT 与 CVOT）并不影响 SGLT2i 的作用。
结论
在 RCTs 中，SGLT2i 改善了 HFpEF 患者的结局，无论后者如何诊断。
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