Kosiborod Mikhail, Gause-Nilsson Ingrid, Xu John, Sonesson Christian, Johnsson Eva
Department of Cardiology, Saint Luke's Mid America Heart Institute and University of Missouri, Kansas City, MO, USA.
AstraZeneca, Gothenburg, Mölndal, Sweden.
J Diabetes Complications. 2017 Jul;31(7):1215-1221. doi: 10.1016/j.jdiacomp.2017.02.001. Epub 2017 Feb 10.
We investigated the efficacy and safety of dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, in patients with type 2 diabetes mellitus (T2DM) and heart failure (HF).
Data for patients randomized to dapagliflozin 10mg or placebo with a history of HF were pooled from five clinical trials. HbA, weight and systolic blood pressure (SBP; two studies) were examined up to 52weeks using longitudinal repeated-measures models. Composite cardiovascular outcomes, hospitalizations for HF (HHF), and adverse events (AEs) were also assessed.
Patients (mean age 64years, T2DM duration ~14years, HbA 8.2%, ~50% with New York Heart Association Class ≥II) received dapagliflozin (N=171) or placebo (N=149). Dapagliflozin produced clinically meaningful placebo-adjusted reductions in HbA (-0.55%; 95% confidence interval [CI]: -0.80, -0.30), weight (-2.67kg; 95% CI: -3.88, -1.47), and SBP (-2.05mmHg; 95% CI: -5.68, 1.57) over 52weeks. HHF was rare, but numerically lower with dapagliflozin (n=1 [0.6%]) vs placebo (n=7 [4.7%]). Point estimates for hazard ratios of composite cardiovascular outcomes favored dapagliflozin vs placebo, although 95% CIs crossed unity.
Dapagliflozin produced clinically meaningful reductions in HbA, weight, and SBP in patients with T2DM and HF, and was well tolerated.
我们研究了钠-葡萄糖协同转运蛋白2抑制剂达格列净在2型糖尿病（T2DM）合并心力衰竭（HF）患者中的疗效和安全性。
汇总五项临床试验中随机分配至10mg达格列净或安慰剂组且有HF病史患者的数据。使用纵向重复测量模型在长达52周的时间内检查糖化血红蛋白、体重和收缩压（两项研究）。还评估了复合心血管结局、因HF住院（HHF）和不良事件（AE）。
患者（平均年龄64岁，T2DM病程约14年，糖化血红蛋白8.2%，约50%为纽约心脏协会分级≥II级）接受达格列净（N = 171）或安慰剂（N = 149）治疗。在52周内，达格列净在糖化血红蛋白方面产生了具有临床意义的安慰剂校正降低（-0.55%；95%置信区间[CI]：-0.80，-0.30）、体重方面降低（-2.67kg；95%CI：-3.88，-1.47）以及收缩压方面降低（-2.05mmHg；95%CI：-5.68，1.57）。HHF很少见，但达格列净组在数值上低于安慰剂组（n = 1 [0.6%]）对比安慰剂组（n = 7 [4.7%]）。复合心血管结局的风险比点估计值有利于达格列净对比安慰剂，尽管95%CI包含1。
达格列净使T2DM合并HF患者的糖化血红蛋白、体重和收缩压产生了具有临床意义的降低，且耐受性良好。
