University of Manitoba, Winnipeg, Manitoba, Canada.
University of Toronto, Toronto, Ontario, Canada.
Diabetes Obes Metab. 2019 Mar;21(3):691-699. doi: 10.1111/dom.13573. Epub 2018 Dec 5.
There is limited information concerning the effects of canagliflozin (CANA), a sodium-glucose co-transporter 2 inhibitor (SGLT2i) in a real-world clinical setting in Canada. CanCARE is a 12-month, prospective, observational analysis to demonstrate the effectiveness and safety of CANA in usual clinical practice in Canada.
SGLT2i-naïve adult patients with type 2 diabetes mellitus (T2DM) (n = 527) on a stable antihyperglycemic agent (AHA) regimen with glycated hemoglobin (A1C) ≥ 7%, an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m , were initiated on CANA as part of their usual treatment approach, and were followed for a period of 12 months. The primary effectiveness objective was the mean change in HbA1c from baseline to 6 and 12 months.
Significant improvement from baseline in mean HbA1c levels were observed at 6 months (-0.90%; 95% CI, -1.02, -0.78) and at 12 months (-1.04%; 95% CI, -1.15, -0.92), regardless of duration of diabetes or background AHA treatment regimen. Similarly, significant decreases in systolic blood pressure (-4.65 mm Hg); body weight (-3.24 kg), waist circumference (-2.91 cm) and body mass index (-1.15 kg/m ) were observed at 12 months. Additionally, 40.5% of patients achieved the double endpoint (≥0.5% HbA1c reduction and ≥ 3% weight loss), while 24.3% of patients achieved the triple composite endpoint (≥0.5% HbA1c reduction, ≥3% weight loss and ≥ 4 mm Hg systolic blood pressure reduction). No unexpected adverse events were reported.
CANA provided sustained clinically meaningful improvements in cardiometabolic parameters in this study in a real-world setting, confirming findings from randomized controlled trials.
关于卡格列净(CANA),一种钠-葡萄糖共转运蛋白 2 抑制剂(SGLT2i),在加拿大真实临床环境中的影响,相关信息有限。CanCARE 是一项为期 12 个月的前瞻性观察性分析,旨在展示 CANA 在加拿大常规临床实践中的疗效和安全性。
SGLT2i 初治的成年 2 型糖尿病(T2DM)患者(n=527),接受稳定的降糖药物(AHA)治疗方案,糖化血红蛋白(A1C)≥7%,估算肾小球滤过率(eGFR)≥60 mL/min/1.73m ,开始接受 CANA 治疗,并作为其常规治疗方法的一部分,随访 12 个月。主要有效性指标是从基线到 6 个月和 12 个月时 HbA1c 的平均变化。
在 6 个月(-0.90%;95%CI,-1.02,-0.78)和 12 个月(-1.04%;95%CI,-1.15,-0.92)时,与基线相比,HbA1c 水平均有显著改善,无论糖尿病病程或背景 AHA 治疗方案如何。同样,在 12 个月时,收缩压(-4.65 mmHg)、体重(-3.24 kg)、腰围(-2.91 cm)和体重指数(-1.15 kg/m )也有显著下降。此外,40.5%的患者达到双重终点(HbA1c 降低≥0.5%和体重减轻≥3%),而 24.3%的患者达到三重复合终点(HbA1c 降低≥0.5%、体重减轻≥3%和收缩压降低≥4 mmHg)。未报告意外不良事件。
在本研究的真实环境中,CANA 持续提供了有临床意义的代谢参数改善,证实了随机对照试验的结果。