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索格列净对早期死亡率和心力衰竭相关事件的影响:SOLOIST-WHF 的事后分析。

Effect of Sotagliflozin on Early Mortality and Heart Failure-Related Events: A Post Hoc Analysis of SOLOIST-WHF.

机构信息

Department of Internal Medicine (Emeritus), University of Michigan School of Medicine, Ann Arbor, Michigan, USA.

Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

出版信息

JACC Heart Fail. 2023 Aug;11(8 Pt 1):879-889. doi: 10.1016/j.jchf.2023.05.026.

DOI:10.1016/j.jchf.2023.05.026
PMID:37558385
Abstract

BACKGROUND

Approximately 25% of patients admitted to hospitals for worsening heart failure (WHF) are readmitted within 30 days.

OBJECTIVES

The authors conducted a post hoc analysis of the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post-WHF) trial to evaluate the efficacy of sotagliflozin versus placebo to decrease mortality and HF-related events among patients who began study treatment on or before discharge from their index hospitalization.

METHODS

The main endpoint of interest was cardiovascular death or HF-related event (HF hospitalization or urgent care visit) occurring within 90 and 30 days after discharge for the index WHF hospitalization. Treatment comparisons were by proportional hazards models, generating HRs, 95% CIs, and P values.

RESULTS

Of 1,222 randomized patients, 596 received study drug on or before their date of discharge. Sotagliflozin reduced the main endpoint at 90 days after discharge (HR: 0.54 [95% CI: 0.35-0.82]; P = 0.004) and at 30 days (HR: 0.49 [95% CI: 0.27-0.91]; P = 0.023) and all-cause mortality at 90 days (HR: 0.39 [95% CI: 0.17-0.88]; P = 0.024). In subgroup analyses, sotagliflozin reduced the 90-day main endpoint regardless of sex, age, estimated glomerular filtration rate, N-terminal pro-B-type natriuretic peptide, left ventricular ejection fraction, or mineralocorticoid receptor agonist use. Sotagliflozin was well-tolerated but with slightly higher rates of diarrhea and volume-related events than placebo.

CONCLUSIONS

Starting sotagliflozin before discharge in patients with type 2 diabetes hospitalized for WHF significantly decreased cardiovascular deaths and HF events through 30 and 90 days after discharge, emphasizing the importance of beginning sodium glucose cotransporter treatment before discharge.

摘要

背景

约 25%因心力衰竭恶化(WHF)而住院的患者在 30 天内再次入院。

目的

作者对 SOLOIST-WHF(索格列净对 WHF 后 2 型糖尿病患者心血管事件的影响)试验进行了事后分析,以评估索格列净与安慰剂相比,在指数住院期间出院或出院前开始研究治疗的患者中,降低死亡率和与 HF 相关事件的疗效。

方法

主要关注的终点是指数 WHF 住院后 90 和 30 天内发生的心血管死亡或与 HF 相关的事件(HF 住院或紧急护理就诊)。治疗比较采用比例风险模型,生成 HR、95%CI 和 P 值。

结果

在 1222 名随机患者中,有 596 名患者在出院日期或之前接受了研究药物。索格列净降低了出院后 90 天的主要终点(HR:0.54 [95%CI:0.35-0.82];P=0.004)和 30 天(HR:0.49 [95%CI:0.27-0.91];P=0.023)以及 90 天的全因死亡率(HR:0.39 [95%CI:0.17-0.88];P=0.024)。亚组分析显示,无论性别、年龄、估算肾小球滤过率、N 末端 B 型利钠肽前体、左心室射血分数或盐皮质激素受体激动剂的使用如何,索格列净均降低了 90 天的主要终点。索格列净耐受性良好,但腹泻和容量相关事件的发生率略高于安慰剂。

结论

在因 WHF 住院的 2 型糖尿病患者出院前开始使用索格列净,可显著降低出院后 30 天和 90 天的心血管死亡和 HF 事件发生率,强调在出院前开始钠-葡萄糖共转运蛋白治疗的重要性。

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