Diabetes Care:降低高CV事件风险T2DM患者DFU相关截肢率就用…

2018-11-22 佚名 环球医学网

英国、美国、澳大利亚和丹麦学者在《Diabetes Care》发表了LEADER试验结果,考察了利拉鲁肽对具有较高心血管事件风险的2型糖尿病患者糖尿病相关足溃疡(DFU)和相关并发症的影响。

英国、美国、澳大利亚和丹麦学者在《Diabetes Care》发表了LEADER试验结果,考察了利拉鲁肽对具有较高血管事件风险的2型糖尿病患者糖尿病相关足溃疡(DFU)和相关并发症的影响。

目的:DFUs及其后遗症可造成较大的患者和社会负担。确定个体降糖药物对DFUs有效性的长期数据缺乏。使用LEADER(Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results)试验中的现有数据,研究者进行了一项事后分析,评估利拉鲁肽vs安慰剂对具有较高血管(CV)事件风险的2型糖尿病患者DFUs及其后遗症发生率的影响。

研究设计和方法:LEADER试验(NCT01179048)是一项随机、双盲、多中心CV结局试验,评估了利拉鲁肽(1.8mg/d)vs安慰剂添加到标准治疗,为期5年。试验期间系统性收集了DFUs的信息,通过审查病例叙事,事后评估了DFU并发症。

结果:中位随访期3.8年,利拉鲁肽组和安慰剂组报告DFU至少发作1次的患者比例相似(3.8%(176/4668)vs 4.1%(191/4672);风险比(HR),0.92;95% CI,0.75~1.13;P=0.41)。DFU相关并发症的分析证实,与安慰剂相比,利拉鲁肽组的截肢显着降低(HR,0.65;95% CI,0.45~0.95;P=0.03)。然而,主要分析中,足部感染、底层结构受累或末梢血运重建无差异。

结论:LEADER试验中,与安慰剂相比,具有较高CV事件风险的2型糖尿病患者使用利拉鲁肽治疗不会增加DFU事件风险,与显着较低的DFU相关截肢风险相关。该相关性可能由偶然造成,因此需要进一步调查。

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    2018-11-28 drj2003
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