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恩格列净对伴有心房颤动的心力衰竭和肾脏结局的疗效:来自 EMPA-REG OUTCOME 试验的数据。

Efficacy of empagliflozin on heart failure and renal outcomes in patients with atrial fibrillation: data from the EMPA-REG OUTCOME trial.

机构信息

Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg/Saar, Germany.

Boehringer Ingelheim International GmbH, Ingelheim, Germany.

出版信息

Eur J Heart Fail. 2020 Jan;22(1):126-135. doi: 10.1002/ejhf.1663. Epub 2019 Dec 9.

Abstract

AIMS

Atrial fibrillation (AF) is common in patients with diabetes and heart failure (HF) and increases the future risk of adverse cardiovascular (CV) outcomes. This analysis from the EMPA-REG OUTCOME trial explores CV and renal outcomes in patients with vs. without AF at baseline and assesses the benefits of empagliflozin.

METHODS AND RESULTS

Analyses were conducted on patients distinguished by the presence (n = 389) or absence (n = 6631) of AF at baseline. Outcome events were more frequent in patients with AF than those without AF. Empagliflozin compared to placebo reduced CV death or HF hospitalisation consistently in patients with AF [hazard ratio (HR) 0.58, 95% confidence interval (CI) 0.36-0.92] and without AF (HR 0.67, 95% CI 0.55-0.82, P  = 0.56). Similar results were observed for the components of this endpoint, all-cause mortality, new or worsening nephropathy, first introduction of loop diuretics, or occurrence of oedema. The absolute number of prevented events was higher in patients with AF, resulting in larger absolute treatment effects of empagliflozin. New loop diuretics or oedema were associated with increased rates of subsequent events, and rates appeared lower in those randomised to empagliflozin.

CONCLUSIONS

In patients with type 2 diabetes mellitus and established CV disease, those with AF at baseline had higher rates of adverse HF outcomes than those without AF. Irrespective of the presence of AF, empagliflozin reduced HF-related and renal events. The absolute number of prevented events is higher in patients with AF than without AF. Patients with diabetes, CV disease and AF may especially benefit from use of empagliflozin.

摘要

目的

心房颤动(AF)在糖尿病和心力衰竭(HF)患者中很常见,并增加了未来不良心血管(CV)结局的风险。这项来自 EMPA-REG OUTCOME 试验的分析探讨了基线时伴有和不伴有 AF 的患者的 CV 和肾脏结局,并评估了恩格列净的获益。

方法和结果

根据基线时是否存在 AF(n=389)或不存在 AF(n=6631)对患者进行了分析。与无 AF 患者相比,AF 患者的结局事件更为频繁。与安慰剂相比,恩格列净在 AF 患者(风险比 [HR] 0.58,95%置信区间 [CI] 0.36-0.92)和无 AF 患者(HR 0.67,95% CI 0.55-0.82,P=0.56)中一致降低了 CV 死亡或 HF 住院的风险。对于该终点的组成部分,全因死亡率、新发或恶化的肾病、首次使用袢利尿剂或水肿的发生,也观察到了类似的结果。AF 患者中预防事件的绝对数量更高,导致恩格列净的绝对治疗效果更大。新的袢利尿剂或水肿与后续事件的发生率增加相关,而随机分配到恩格列净组的患者的发生率似乎更低。

结论

在 2 型糖尿病和已确诊的 CV 疾病患者中,基线时存在 AF 的患者的不良 HF 结局发生率高于无 AF 的患者。无论是否存在 AF,恩格列净均可降低 HF 相关和肾脏事件。AF 患者的预防事件绝对数量高于无 AF 的患者。患有糖尿病、CV 疾病和 AF 的患者可能特别受益于恩格列净的使用。

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