Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure A Randomized Trial
Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure A Randomized Trial
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DOI：
10.7326/m21-0651
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发表时间：
2021-08-01
影响因子：
39.2
通讯作者：
Pitt, Bertram
中科院分区：
文献类型：
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作者：
Szarek, Michael;Bhatt, Deepak L.;Pitt, Bertram
背景：在SOLOIST-WHF （Sotagliflozin对2型糖尿病心衰加重后心血管事件的影响）试验中，Sotagliflozin是一种钠-葡萄糖共转运蛋白-1和钠-葡萄糖共转运蛋白-2抑制剂，与安慰剂相比，心血管死亡总发生率、心力衰竭住院率和心力衰竭急诊率降低了33%。目的：在SOLOIST-WHF试验中，确定索他列净是否能提高预先设定的存活天数和出院天数（DAOH）。设计：随机、双盲、安慰剂对照试验。（ClinicalTrials.gov: NCT03521934）设置：32个国家的306个试验点。参与者：1222例最近因心衰恶化住院的射血分数降低或保留的2型糖尿病患者。干预：每日一次200毫克sotagliflozin（可能增加剂量至400毫克）或配套安慰剂。测量：主要分析包括基于随机分组后研究者报告的发生率和入院时间的任何原因的住院情况。使用预先设定的泊松回归模型分析存活和出院天数及其反面（死亡和住院天数）。结果：尽管sotagliflozin组和安慰剂组中至少住院一次的患者比例相似（38.5%对41.4%），但sotagliflozin组中住院一次以上的患者较少（16.3%对22.1%）。索他列净组和安慰剂组分别有64例和76例死亡。索他列净组的DAOH发生率比安慰剂组高3%（比率比[RR]， 1.03 [95% CI, 1.00 ~ 1.06]; P = 0.027）。这种差异主要是由于死亡天数的减少（RR, 0.71 [CI， 0.52至0.99];P = 0.041），而不是由于任何原因住院天数的减少。在每100天的随访中，sotagliflozin组患者的存活和出院天数比安慰剂组多3%或2.9天（91.8天对88.9天）；这一差异反映了死亡天数的2.6天差异（6.3天对8.9天）和住院天数的0.3天差异（1.9天对2.2天）。局限性：除心力衰竭外，每次住院的主要原因未明确。结论：Sotagliflozin增加了DAOH，这一指标可以提供额外的以患者为中心的结果，以捕获疾病负担的总体。未来的研究需要在卫生经济学和患者生活质量方面量化增加DAOH的后果。
Background: In the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure) trial, sotagliflozin, a sodium-glucose cotransporter-1 and sodium-glucose cotransporter-2 inhibitor, reduced total occurrences of cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure relative to placebo by 33%.Objective: To determine whether sotagliflozin increased the prespecified efficacy outcome of days alive and out of the hospital (DAOH) in the SOLOIST-WHF trial.Design: Randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT03521934)Setting: 306 sites in 32 countries.Participants: 1222 patients with type 2 diabetes and reduced or preserved ejection fraction who were recently hospitalized for worsening heart failure.Intervention: 200 mg of sotagliflozin once daily (with a possible dose increase to 400 mg) or matching placebo.Measurements: The primary analysis included hospitalizations for any reason on the basis of investigator-reported incidence and duration of admissions after randomization. Days alive and out of the hospital and its converse (days dead and days in the hospital) were analyzed using prespecified Poisson regression models.Results: Although similar proportions of patients in the sotagliflozin and placebo groups were hospitalized at least once (38.5% vs. 41.4%), fewer patients in the sotagliflozin group were hospitalized more than once (16.3% vs. 22.1%). There were 64 and 76 deaths in the sotagliflozin and placebo groups, respectively. The DAOH rate in the sotagliflozin group was 3% higher than in the placebo group (rate ratio [RR], 1.03 [95% CI, 1.00 to 1.06]; P = 0.027). This difference was primarily driven by a reduction in the rate of days dead (RR, 0.71 [CI, 0.52 to 0.99]; P = 0.041) rather than by a reduction in the rate of days hospitalized for any cause. For every 100 days of follow-up, patients in the sotagliflozin group were alive and out of the hospital for 3% or 2.9 more days than those in the placebo group (91.8 vs. 88.9 days); this difference reflected a 2.6-day difference in days dead (6.3 vs. 8.9 days) and a 0.3-day difference in days in the hospital (1.9 vs. 2.2 days).Limitation: Other than heart failure, the primary reason for each hospitalization was unspecified.Conclusion: Sotagliflozin increased DAOH, a metric that may provide an additional patient-centered outcome to capture the totality of disease burden. Future studies are needed to quantify the consequences of increasing DAOH in terms of health economics and patient quality of life.