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NEJM:超重或肥胖患者给予氯卡色林治疗的心血管安全性分析

2018-09-20 xing.T MedSci原创

由此可见,在超重或肥胖患者的高危人群中,氯卡色林可促进持续的体重减轻,与安慰剂相比,并未增加主要心血管事件的发生率。

氯卡色林是一种调节食欲的选择性5-羟色胺2C受体激动剂,已经被证明对超重或肥胖患者的体重管理有效。但氯卡色林的血管安全性和功效尚不明确。近日,顶级医学期刊NEJM上针对这一问题发表了一篇研究文章。

研究人员随机分配了12000名患有动脉粥样硬化性血管疾病或多种心血管危险因素的超重或肥胖患者,分别接受氯卡色林(10 mg,每日两次)或安慰剂治疗。在中期分析中评估了主要心血管事件(心血管死亡、心肌梗死卒中的复合事件)的主要安全性结局,以排除1.4的非劣效性边界。如果满足非劣效性,则在试验结束时评估主要心血管功效结局(主要心血管事件、心力衰竭、不稳定心绞痛住院治疗或冠状动脉血运重建[延长的主要心血管事件]的复合事件)的优势。

在治疗1年时,氯卡色林组中5135名患者中有1986名(38.7%)患者和安慰剂组中5083名患者中有883名(17.4%)患者体重至少减轻5%(比值比为3.01; 95%置信区间[CI]为2.74至3.30; P<0.001)。与安慰剂组相比,氯卡色林组患者的心脏危险因素(包括血压、心率、血糖控制和血脂)值略高。在中位随访3.3年期间,氯卡色林组的主要安全性结局发生率为每年2.0%,安慰剂组为每年2.1%(风险比为0.99; 95%CI为0.85至1.14; 非劣效性P<0.001;延长的主要心血管事件发生率分别为每年4.1%和每年4.2%(风险比为0.97; 95%CI为0.87至1.07; P=0.55)。特别感兴趣的不良事件并不常见,两组患者的发病率基本相似,但氯卡色林组有较多患者出现严重低血糖(13 vs. 4,P=0.04)。

由此可见,在超重或肥胖患者的高危人群中,氯卡色林可促进持续的体重减轻,与安慰剂相比,并未增加主要心血管事件的发生率。
 
原始出处:
 

Erin A. Bohula,et al.Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients.N Engl J Med 2018; https://www.nejm.org/doi/full/10.1056/NEJMoa1808721
 
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    2018-09-22 12282355m97暂无昵称

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    2018-09-21 12282355m97暂无昵称

    学习了

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    2018-09-21 12282355m97暂无昵称

    学习了

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    2018-09-20 ylzr123

    认真学习,把间接经验应用到临床实践中去,然后再总结出新思路。给点赞啦

    0

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