AimsType 2 diabetes (T2D) and heart failure (HF) frequently coexist, but whether clinical outcomes and treatment effects of sodium–glucose cotransporter 2 inhibitors (SGLT2i) vary in relation to background glucose‐lowering therapy (GLT) in this population is uncertain.Methods and resultsDELIVER randomized patients with HF and left ventricular ejection fraction (LVEF) >40% to dapagliflozin or placebo. The primary outcome was a composite of worsening HF (HF hospitalization or urgent HF visit) or cardiovascular death. In this pre‐specified analysis of participants with T2D, treatment effects were assessed by number and class of background GLT(s). Of 3150 participants with T2D at baseline, 22.9% were on no GLT, 36.5% were treated with 1 GLT, and 40.6% with ≥2 GLTs. During follow‐up (median: 2.3 years), treatment benefits of dapagliflozin (vs. placebo) on the primary outcome were consistent irrespective of the number of background GLTs (0 GLTs: hazard ratio [HR] 0.71, 95% confidence interval [CI] 0.50–1.00; 1 GLT: HR 1.04, 95% CI 0.80–1.34; ≥2 GLTs: HR 0.71, 95% CI 0.56–0.90; pinteraction = 0.59). Similar findings were observed among participants with (HR 0.73, 95% CI 0.59–0.92) and without background metformin use (HR 0.89, 95% CI 0.72–1.11; pinteraction = 0.22) and in participants with (HR 0.89, 95% CI 0.69–1.16) and without background insulin use (HR 0.78, 95% CI 0.65–0.95; pinteraction = 0.45). Dapagliflozin was well‐tolerated irrespective of the number of background GLTs.ConclusionsDapagliflozin safely and consistently improved clinical outcomes among individuals with T2D and HF with LVEF >40% irrespective of the number and class of background GLTs, and the benefits were not influenced by concomitant metformin or insulin use. These data bolster contemporary guidelines supporting first‐line SGLT2i among individuals with T2D and HF, irrespective of background GLT.

中文翻译：

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根据背景降糖治疗，达格列净对射血分数轻度降低或保留的糖尿病合并心力衰竭患者的影响：DELIVER 试验的预先指定分析


2 型糖尿病 (T2D) 和心力衰竭 (HF) 经常共存，但在该人群中钠-葡萄糖协同转运蛋白 2 抑制剂 (SGLT2i) 的临床结果和治疗效果是否与背景降糖治疗 (GLT) 相关，尚不确定。方法和结果将心力衰竭且左心室射血分数 (LVEF) > 40% 的患者随机分配至达格列净或安慰剂组。主要结局是心力衰竭恶化（心力衰竭住院或心力衰竭紧急就诊）或心血管死亡的复合结果。在这项针对 T2D 参与者的预先指定分析中，治疗效果通过背景 GLT 的数量和类别进行评估。在 3150 名基线患有 T2D 的参与者中，22.9% 没有接受 GLT，36.5% 接受 1 个 GLT 治疗，40.6% 接受≥2 个 GLT 治疗。在随访期间（中位数：2.3 年），无论背景 GLT 数量如何，达格列净（相对于安慰剂）对主要结局的治疗益处都是一致的（0 GLT：风险比 [HR] 0.71，95% 置信区间 [CI ] 0.50–1.00；1 个 GLT：HR 1.04，95% CI 0.80–1.34；≥2 个 GLT：HR 0.71，95% CI 0.56–0.90；在（HR 0.73，95% CI 0.59–0.92）和未使用二甲双胍背景的参与者（HR 0.89，95% CI 0.72–1.11；pinteraction = 0.22）和（HR 0.89，95% CI 0.69）参与者中观察到类似的结果–1.16）且无胰岛素使用背景（HR 0.78，95% CI 0.65–0.95；pinteraction = 0.45）。无论背景 GLT 的数量如何，达格列净均具有良好的耐受性。 结论 对于 LVEF > 40% 的 T2D 和心力衰竭患者，无论背景 GLT 的数量和类别如何，达格列净均能安全、持续地改善临床结果，并且其益处不受同时服用二甲双胍的影响。或使用胰岛素。 这些数据支持了支持 T2D 和 HF 患者一线 SGLT2i 的当代指南，无论 GLT 背景如何。