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N Engl J Med:卡格列净治疗2型糖尿病的安全性以及心血管事件和肾脏事件风险评估

2017-06-14 fengxiangxin MedSci原创

卡格列净(Canagliflozin)属于选择性纳-葡萄糖共转运体2(SGLT2)抑制剂,通过阻断肾脏对血糖的重吸收及增加尿液中血糖的排泄,来降低机体血糖水平。同时卡格列净还能降低血压,减轻体重以及减少糖尿病患者的蛋白尿。研究者报告了卡格列净治疗的安全性以及对心血管、肾的影响。

卡格列净(Canagliflozin)属于选择性纳-葡萄糖共转运体2(SGLT2)抑制剂,通过阻断肾脏对血糖的重吸收及增加尿液中血糖的排泄,来降低机体血糖水平。同时卡格列净还能降低血压,减轻体重以及减少糖尿病患者的蛋白尿。研究者报告了卡格列净治疗的安全性以及对心血管、肾的影响。

近日,pubmed推荐了一篇来自医学顶级杂志N Engl J Med的研究,研究者用CANVAS程序从两个试验中整合了包括10142名存在高心血管疾病风险的2型糖尿病患者的数据。在每个试验中,参与者被随机分配接受卡格列净或安慰剂治疗,平均随访时间为188.2周。主要复合终点为心血管疾病导致死亡、非致死性心肌梗死或非致命性中风。

参与者中女性占35.8%,参与者的平均年龄为63.3岁,糖尿病平均病程为13.5年,有心血管病史的参与者占65.6%。研究者分析发现卡格列净组发生主要复合终点的比率低于安慰剂组(分别为26.9 和31.5/1000病人年;风险比:0.86;95%置信区间:0.75-0.97;非劣效性P<0.001;P = 0.02)。虽然在预先设定的假设测试序列基础上肾脏预后不具有统计学意义,但是研究结果表明,卡格列净对阻止蛋白尿进展可能有益处(风险比:0.73;95% 置信区间:0.67-0.79),以及对肾小球滤过率持续减少40%的复合终点(需要肾脏替代治疗,或死于肾脏事件)可能有益处(风险比:0.60;95% 置信区间:0.47 - 0.77)。不良反应与先前报道的卡格列净风险一致,但是截肢风险较先前的报到风险增加(分别为6.3 和3.4/1000病人年;风险比:1.97;95% 置信区间:1.41-2.75),截肢部位主要在脚趾或跖骨水平。

所以,结论为在两个试验涉及的高心血管疾病风险2型糖尿病病人中,接受卡格列净治疗的患者较那些接受安慰剂的患者有较低的心血管事件风险,但是截肢风险增加,主要在脚趾或跖骨水平。

原始出处:

Neal, B., V. Perkovic, K.W. Mahaffey, et al., Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med, 2017 Jun 12. doi: 10.1056/NEJMoa1611925.

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    2018-01-16 spoonycyy
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    2017-08-15 haouestc
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    2017-06-17 lou.minghong

    感觉还是二甲双胍最安全。

    0

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