林格利平与安慰剂对2型糖尿病和高心血管和脏风险的成年人主要心血管事件的影响:CARMELINA随机临床试验
在PubMed上查看摘要
概括
此摘要是机器生成的。在高风险的2型糖尿病患者中,与安慰剂相比,林格利平的心血管安全性不差. 这种DPP-4抑制剂在高危人群中没有显著改变心血管或结局.
科学领域
- 心血管医学
- 肝脏病学
- 内分泌学
背景情况
- 2型糖尿病 (T2DM) 显著增加心血管疾病 (CV) 的风险.
- 现有的二基酶4 (DPP-4) 抑制剂显示心血管安全性,但试验往往排除患有慢性病 (CKD) 的高风险患者.
- 需要对具有显著心血管和风险的T2DM患者进行DPP-4抑制剂的评估.
研究的目的
- 在患有高风险心血管和事件的2型糖尿病 (T2DM) 患者中评估DPP-4抑制剂linagliptin的心血管 (CV) 和结局.
- 确定与安慰剂相比,林格利普丁对主要心血管不良事件的非劣势.
主要方法
- 一个随机的,安慰剂控制的,多中心的试验,涉及T2DM的成年人,高心血管风险 (血管疾病史,高蛋白尿) 和高风险 (降低EGFR,蛋白尿).
- 参与者除了接受标准治疗外,还接受了林格利平 (每天5mg) 或安慰剂,随访时间中位数为2.2年.
- 主要终点:心血管死亡,非致命的心肌梗塞或非致命中风的组合. 二次终点:综合性死亡,末期病 (ESRD) 或持续40%的EGFR降低.
主要成果
- 在初级复合心脏病结局方面,林格利平与安慰剂无差异 (危险比率 [HR],1. 02;95% CI,0. 89-1. 17;P < . 001).
- 主要心血管结局的发生率为linagliptin的12. 4%,而安慰剂的12. 1%.
- 对于脏综合结果 (HR,1. 04;95% CI,0. 89-1. 22;P=0. 62) 没有显著的差异,发生在9. 4%的利纳利普丁组和8. 8%的安慰剂组中.
结论
- 在T2DM和高CV和脏风险的成年人中,在中位数2.2年内,加上常规护理的林格利平对于主要的CV不良事件显示出非劣势.
- 与安慰剂相比,在这种高风险队列中,林格利平没有显著影响结局.
- 这项研究提供了临床证据证明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明,临床证据表明.
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