Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure
Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure
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DOI：
10.1056/nejmoa2030183
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发表时间：
2021-01-14
影响因子：
158.5
通讯作者：
Pitt, Bertram
中科院分区：
文献类型：
--
作者：
Bhatt, Deepak L.;Szarek, Michael;Pitt, Bertram
糖尿病患者和近期恶化的心力衰竭导致住院的患者被随机分配接受索他列净或安慰剂。在中位9个月时，sotagliflozin组因心血管原因死亡、因心力衰竭住院和紧急就诊的总人数明显低于安慰剂组。背景：钠-葡萄糖共转运蛋白2 （SGLT2）抑制剂可降低稳定性心力衰竭患者因心力衰竭住院或心血管原因死亡的风险。然而，在失代偿性心力衰竭发作后不久开始使用SGLT2抑制剂的安全性和有效性尚不清楚。方法：我们进行了一项多中心、双盲试验，在该试验中，近期因心衰恶化住院的2型糖尿病患者被随机分配接受索他列净或安慰剂治疗。主要终点是心血管原因和因心力衰竭住院和紧急就诊的总死亡人数（首次和后续事件）。由于赞助商的资金损失，试验提前结束。结果共有1222例患者接受了随机分组（608例到sotagliflozin组，614例到安慰剂组），中位随访时间为9.0个月；48.8%的患者在出院前服用第一剂sotagliflozin或安慰剂，51.2%的患者在出院后2天服用中位剂量。在这些患者中，发生了600例主要终点事件（sotagliflozin组245例，安慰剂组355例）。sotagliflozin组的主要终点事件发生率（每100患者年发生的事件数）低于安慰剂组(51.0 vs. 76.3；风险比为0.67；95%可信区间[CI]， 0.52 ~ 0.85
Patients with diabetes and recent worsening heart failure that had led to hospitalization were randomly assigned to receive sotagliflozin or placebo. At a median of 9 months, the total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure was significantly lower with sotagliflozin than with placebo.Background Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure or death from cardiovascular causes among patients with stable heart failure. However, the safety and efficacy of SGLT2 inhibitors when initiated soon after an episode of decompensated heart failure are unknown.Methods We performed a multicenter, double-blind trial in which patients with type 2 diabetes mellitus who were recently hospitalized for worsening heart failure were randomly assigned to receive sotagliflozin or placebo. The primary end point was the total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure (first and subsequent events). The trial ended early because of loss of funding from the sponsor.Results A total of 1222 patients underwent randomization (608 to the sotagliflozin group and 614 to the placebo group) and were followed for a median of 9.0 months; the first dose of sotagliflozin or placebo was administered before discharge in 48.8% and a median of 2 days after discharge in 51.2%. Among these patients, 600 primary end-point events occurred (245 in the sotagliflozin group and 355 in the placebo group). The rate (the number of events per 100 patient-years) of primary end-point events was lower in the sotagliflozin group than in the placebo group (51.0 vs. 76.3; hazard ratio, 0.67; 95% confidence interval [CI], 0.52 to 0.85; P