SGLT-2 抑制剂与心血管风险：CVD-REAL 分析。

SGLT-2 Inhibitors and Cardiovascular Risk: An Analysis of CVD-REAL.

机构信息

University of North Carolina, Chapel Hill, North Carolina; Baim Institute of Clinical Research, Boston, Massachusetts.

Karolinska Institutet, Stockholm, Sweden.

出版信息

J Am Coll Cardiol. 2018 Jun 5;71(22):2497-2506. doi: 10.1016/j.jacc.2018.01.085.

DOI:10.1016/j.jacc.2018.01.085

PMID:29852973

Abstract

BACKGROUND

Prior studies found patients treated with sodium-glucose co-transporter-2 inhibitors (SGLT-2i) had lower rates of death and heart failure (HF). Whether the benefits of SGLT-2i vary based upon the presence of cardiovascular disease (CVD) is unknown.

OBJECTIVES

This study sought to determine the association between initiation of SGLT-2i therapy and HF or death in patients with and without CVD.

METHODS

The CVD-REAL (Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors) study was a multinational, observational study in which adults with type 2 diabetes were identified. Patients prescribed an SGLT-2i or other glucose-lowering drugs (GLDs) were matched based on a propensity score for initiation of an SGLT-2i. Hazard ratios (HRs) for the risk of death, HF, and HF or death in patients with and without established CVD were estimated for each country and pooled.

RESULTS

After propensity score matching, 153,078 patients were included in each group. At baseline, 13% had established CVD. Compared with therapy using other GLDs, initiation of an SGLT-2i was associated with lower risk of death in patients with and without CVD (HR: 0.56; 95% confidence interval [CI]: 0.44 to 0.70; and HR: 0.56; 95% CI: 0.50 to 0.63, respectively). There were also associations between SGLT-2i and lower risk of HF (HR: 0.72; 95% CI: 0.63 to 0.82; and HR: 0.61; 95% CI: 0.48 to 0.78, respectively) and the composite of HF or death (HR: 0.63; 95% CI: 0.57 to 0.70; and HR: 0.56; 95% CI: 0.50 to 0.62, respectively) observed in patients with and without established CVD.

CONCLUSIONS

In this large, multinational, observational study, initiation of SGLT-2i was associated with lower risk of death and HF regardless of pre-existing CVD. Ongoing clinical trials will provide further evidence regarding the benefit of SGLT-2i in patients without established CVD. (Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors [CVD-REAL]; NCT02993614).

摘要

背景

先前的研究发现，接受钠-葡萄糖共转运蛋白 2 抑制剂（SGLT-2i）治疗的患者死亡率和心力衰竭（HF）发生率较低。SGLT-2i 的益处是否因心血管疾病（CVD）的存在而有所不同尚不清楚。

目的

本研究旨在确定 SGLT-2i 治疗开始时与 CVD 患者和无 CVD 患者 HF 或死亡的相关性。

方法

CVD-REAL（新使用 SGLT-2i 的患者心血管结局的比较效果）研究是一项多国观察性研究，其中确定了患有 2 型糖尿病的成年人。根据 SGLT-2i 起始的倾向评分，对服用 SGLT-2i 或其他降糖药物（GLD）的患者进行匹配。为每个国家估计并汇总了有和无已确诊 CVD 的患者死亡、HF 和 HF 或死亡的风险比（HR）。

结果

在倾向评分匹配后，每组纳入 153078 名患者。基线时，13%的患者有已确诊的 CVD。与其他 GLD 治疗相比，无论是否存在 CVD，开始使用 SGLT-2i 均与较低的死亡率相关（HR：0.56；95%置信区间 [CI]：0.44 至 0.70；和 HR：0.56；95% CI：0.50 至 0.63）。SGLT-2i 与 HF 风险降低也相关（HR：0.72；95% CI：0.63 至 0.82；和 HR：0.61；95% CI：0.48 至 0.78），以及 HF 或死亡的综合风险降低（HR：0.63；95% CI：0.57 至 0.70；和 HR：0.56；95% CI：0.50 至 0.62）在有和无已确诊 CVD 的患者中观察到。

结论

在这项大型的多国观察性研究中，无论是否存在预先存在的 CVD，开始使用 SGLT-2i 均与较低的死亡率和 HF 风险相关。正在进行的临床试验将提供关于 SGLT-2i 在无已确诊 CVD 的患者中的获益的进一步证据。（新使用 SGLT-2i 的患者心血管结局的比较效果 [CVD-REAL]；NCT02993614）。