Université de Lorraine, Inserm, Centre d'Investigations Cliniques, Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.
Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal.
Eur J Endocrinol. 2021 May 4;184(6):783-790. doi: 10.1530/EJE-20-1484.
Patients with insulin-treated type 2 diabetes (T2D) have a high risk of major adverse cardiovascular events. Sodium-glucose cotransporter inhibitors (SGLTi) improve outcomes without hypoglycaemic risk.
To study the effect of SGLTi in patients with T2D with and without background insulin treatment in outcome-driven RCTs.
Random effects models.
A total of 54 374 patients with T2D were included in the analysis, of which 26 551 (48.8%) were treated with insulin. For 3P-MACE in patients without insulin treatment, the HR (95% CI) for the effect of SGLTi vs placebo was 0.93 (0.81-1.05), with moderate heterogeneity (I2 = 49.2%, Q statistic P = 0.11). In insulin-treated patients, the HR (95% CI) was 0.88 (0.82-0.95), without evidence of heterogeneity (I2 =0.0%, Q statistic P =0.91). The pooled effect evidenced a 10% reduction of 3P-MACE with SGLTi (HR: 0.90, 95% CI: 0.85-0.96), without SGLTi-by-insulin interaction P = 0.53. For the composite outcome of HF hospitalisation or cardiovascular death in patients without insulin treatment, the HR (95% CI) for the effect of SGLTi vs placebo was 0.77 (0.61-0.92), with marked heterogeneity (I2 = 66.8%, Q statistic P = 0.02). In insulin-treated patients, the HR (95% CI) was 0.77 (0.68-0.86), without significant heterogeneity (I2 = 31.7%, Q statistic P = 0.25). The pooled effect evidenced a 23% reduction of HF hospitalisations or cardiovascular death with SGLTi (HR: 0.77, 95% CI: 0.68-0.85), without SGLTi-by-insulin interaction P = 0.98.
SGLTi reduces cardiovascular events regardless of insulin use. However, the treatment effect is more homogeneous among insulin-treated patients, supporting the use of SGLTi for the treatment of patients with T2D requiring insulin for glycaemic control.
接受胰岛素治疗的 2 型糖尿病（T2D）患者发生主要不良心血管事件的风险较高。钠-葡萄糖共转运蛋白抑制剂（SGLTi）可改善预后而无低血糖风险。
研究 SGLTi 在伴有和不伴有背景胰岛素治疗的 T2D 患者中，在以结局为导向的 RCT 中的作用。
采用随机效应模型。
共纳入 54374 例 T2D 患者，其中 26551 例（48.8%）接受胰岛素治疗。对于无胰岛素治疗的患者，3P-MACE 的 SGLTi 与安慰剂相比的 HR（95%CI）为 0.93（0.81-1.05），存在中度异质性（I2=49.2%，Q 统计量 P=0.11）。在胰岛素治疗的患者中，HR（95%CI）为 0.88（0.82-0.95），无异质性证据（I2=0.0%，Q 统计量 P=0.91）。汇总效应显示 SGLTi 可使 3P-MACE 降低 10%（HR：0.90，95%CI：0.85-0.96），无 SGLTi-胰岛素交互作用 P=0.53。对于无胰岛素治疗的患者，HF 住院或心血管死亡的复合结局，SGLTi 与安慰剂相比的 HR（95%CI）为 0.77（0.61-0.92），存在显著异质性（I2=66.8%，Q 统计量 P=0.02）。在胰岛素治疗的患者中，HR（95%CI）为 0.77（0.68-0.86），无显著异质性（I2=31.7%，Q 统计量 P=0.25）。汇总效应显示 SGLTi 可使 HF 住院或心血管死亡降低 23%（HR：0.77，95%CI：0.68-0.85），无 SGLTi-胰岛素交互作用 P=0.98。
SGLTi 可降低心血管事件，无论是否使用胰岛素。然而，胰岛素治疗患者的治疗效果更具同质性，支持 SGLTi 用于治疗需要胰岛素控制血糖的 T2D 患者。
