钠-葡萄糖共转运蛋白 2 抑制剂与 2 型糖尿病患者心力衰竭风险降低的相关性：一项真实世界的全国范围内基于人群的队列研究。
Association between sodium glucose co-transporter 2 inhibitors and a reduced risk of heart failure in patients with type 2 diabetes mellitus: a real-world nationwide population-based cohort study.
机构信息
Department of Medical Sciences, Ajou University Graduate School, Suwon, Republic of Korea.
Department of Internal Medicine, Incheon Medical Center, Incheon, Republic of Korea.
出版信息
Cardiovasc Diabetol. 2018 Jun 23;17(1):91. doi: 10.1186/s12933-018-0737-5.
BACKGROUND
Recently, two large randomized controlled trials which only included patients with underlying cardiovascular disease (CVD) or patients at high risk for CVD showed that two sodium glucose co-transporter 2 inhibitors (SGLT-2is) significantly reduced hospitalization for heart failure (hHF), with an early separation in the survival curves for hHF. There were concerns whether SGLT-2i use could protect hHF in patients without CVD and how soon SGLT-2i-treated patients show a lower risk of hHF. Thus, we aimed to evaluate whether the heart failure protective effect of SGLT-2i differs depending on the underlying CVD and the prescription period compared with dipeptidyl peptidase-4 inhibitors (DPP-4i).
METHODS
We performed a nationwide retrospective observational study to estimate the effect of SGLT-2i on HF. The 59,479 SGLT-2i new-users were matched with same number of DPP-4i new-users through propensity score matching using 53 confounding variables. Kaplan-Meier (K-M) curves and Cox proportional hazards regression analyses were used to estimate the risk of hospitalization for hHF.
RESULTS
The incidence rates of hHF were 0.83 and 1.13 per 100 person-years in SGLT-2i-treated patients and DPP-4i-treated patients, respectively. The hazard ratios of hHF were 0.66 (95% confidence interval 0.58-0.75) in SGLT-2i-treated patients compared with the DPP-4i-treated patients. Among the patients with underlying CVD, SGLT-2i-treated patients were associated with a lower risk of hHF from 30 days to 3 years after initiating drugs compared with DPP-4i. However, SGLT-2i use only showed a lower risk of hHF with a significant difference 3 years after drug initiation among patients without underlying CVD.
CONCLUSIONS
Our findings suggest that SGLT-2i reduced hHF compared with DPP-4i. A heart failure protective effect of SGLT-2i use vs. DPP-4i use was shown 30 days after initiating the SGLT-2i among patients with established CVD, but this effect appeared later in patients without established CVD.
背景
最近，两项仅纳入存在心血管疾病（CVD）或 CVD 高危患者的大型随机对照试验表明，两种钠-葡萄糖共转运蛋白 2 抑制剂（SGLT-2i）可显著降低心力衰竭（HF）住院率，HF 患者的生存曲线出现早期分离。人们担心 SGLT-2i 是否能保护无 CVD 的 HF 患者，以及 SGLT-2i 治疗患者多久后 HF 风险降低。因此，我们旨在评估 SGLT-2i 是否与二肽基肽酶-4 抑制剂（DPP-4i）相比，根据潜在 CVD 和处方时间的不同，对 HF 有不同的保护作用。
方法
我们进行了一项全国性回顾性观察性研究，以评估 SGLT-2i 对 HF 的影响。通过使用 53 个混杂变量进行倾向评分匹配，将 59479 名 SGLT-2i 新使用者与相同数量的 DPP-4i 新使用者相匹配。使用 Kaplan-Meier（K-M）曲线和 Cox 比例风险回归分析来估计 HF 住院风险。
结果
SGLT-2i 治疗患者的 HF 发生率为每 100 人年 0.83 例，DPP-4i 治疗患者为 1.13 例。与 DPP-4i 治疗患者相比，SGLT-2i 治疗患者的 HF 风险比为 0.66（95%置信区间 0.58-0.75）。在存在 CVD 的患者中，与 DPP-4i 相比，SGLT-2i 治疗患者在开始药物治疗后 30 天至 3 年内 HF 风险较低。然而，在无 CVD 的患者中，SGLT-2i 治疗仅在药物开始后 3 年显示出 HF 风险显著降低。
结论
我们的研究结果表明，与 DPP-4i 相比，SGLT-2i 降低了 HF。在患有既定 CVD 的患者中，开始使用 SGLT-2i 后 30 天，SGLT-2i 与 DPP-4i 相比显示出 HF 保护作用，但在无既定 CVD 的患者中，这种作用出现较晚。
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