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[ACCE2012]利拉利汀对非裔2型糖尿病患者安全有效

2012-05-31 段梦 爱唯医学网

   一项纳入226例非裔2型糖尿病患者的多中心、随机、安慰剂对照试验显示,Linagliptin(利拉利汀)治疗与高血糖显著改善相关。   美国小石城阿肯色糖尿病与内分泌中心的医学研究主管James R. Thrasher博士在第21届美国临床内分泌医师协会年会(AACE2012, 5月23~27日, 美国费城)上报告了这项研究,他介绍到,非裔美国人一生中发生糖尿病的可能性增加77%

   一项纳入226例非裔2型糖尿病患者的多中心、随机、安慰剂对照试验显示,Linagliptin(利拉利汀)治疗与高血糖显著改善相关。

  美国小石城阿肯色糖尿病与内分泌中心的医学研究主管James R. Thrasher博士在第21届美国临床内分泌医师协会年会(AACE2012, 5月23~27日, 美国费城)上报告了这项研究,他介绍到,非裔美国人一生中发生糖尿病的可能性增加77%,并且在临床试验中对降糖药物应答不佳。

利拉利汀
 
  Linagliptin(利拉利汀)是一种每日用药1次的二肽基肽酶-4(DPP-4)抑制剂,已被批准用于治疗2型糖尿病。与其他DPP-4抑制剂不同,对于肾脏或肝脏受损患者不需调整利拉利汀的剂量。

  该研究中,患者被随机分配至利拉利汀5 mg/d或安慰剂治疗24周。54%的患者为男性,平均年龄为54岁,平均体重指数为32.7 kg/m2。近2/3(72%)的患者有高血压。疗效分析集中包含接受利拉利汀治疗的100例患者和接受安慰剂的111例患者,利拉利汀和安慰剂组的基线糖化血红蛋白A1c(HbA1c)分别为8.6%和8.7%。多数患者已接受二甲双胍或一种磺脲类药物治疗,研究过程中这些治疗无变化。12%的患者未接受过任何治疗。

  结果显示,24周时,利拉利汀和安慰剂组平均HbA1c分别降低了0.88%和0.24%,具有高度统计学差异(P=0.0002)。利拉利汀组达到HbA1c低于7.0%的患者数是安慰剂组的3倍以上(28.0% vs. 8.7%),达到HbA1c降幅≥0.5%的患者数接近安慰剂组的2倍(55.3% vs. 28.3%)。在纳入106例接受利拉利汀治疗的患者和120例接受安慰剂患者的安全性分析中,多数不良事件为轻度或中度,并且被视为与研究药物无关。最常见的不良事件为高血糖(利拉利汀组和安慰剂组发生率分别为2.8%和9.2%)和鼻咽炎(两组发生率分别为3.8%和5.0%)。利拉利汀组1例患者和安慰剂组2例患者发生严重不良事件。利拉利汀组3例患者和安慰剂组1例患者发生低血糖。无一事件需要外部辅助治疗。

  Thrasher博士披露接受了勃林格殷格翰和礼来的研究资助,并且担任这两家公司的讲师,其中勃林格殷格翰是利拉利汀的生产商。

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    2013-02-13 hxj0117
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    2012-09-26 hxj0117
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