CAJ | 학술논문

罗格列酮是噻唑烷二酮类降糖药,是一种胰岛素增敏剂,可以改善胰岛素敏感性,其心血管安全性一直备受关注.RECORD试验结果及重新审查的结果支持最初的临床试验结论,罗格列酮及含罗格列酮的复方制剂与常规二甲双胍/磺脲类治疗相比,不会增加心血管不良事件风险;BARI2D试验的事后分析结果也同样显示罗格列酮治疗与主要缺血性心血管事件风险增加无关.鉴于最新数据显示,没有明确证据表明罗格列酮会增加心血管风险,美国食物和药物管理局(FDA)于2013年7月公开表示决定取消对其处方和销售限制.
라격렬동시새서완이동류강당약,시일충이도소증민제,가이개선이도소민감성,기심혈관안전성일직비수관주.RECORD시험결과급중신심사적결과지지최초적림상시험결론,라격렬동급함라격렬동적복방제제여상규이갑쌍고/광뇨류치료상비,불회증가심혈관불량사건풍험;BARI2D시험적사후분석결과야동양현시라격렬동치료여주요결혈성심혈관사건풍험증가무관.감우최신수거현시,몰유명학증거표명라격렬동회증가심혈관풍험,미국식물화약물관리국(FDA)우2013년7월공개표시결정취소대기처방화소수한제.
Rosiglitazone is one of thiazolidinediones (TZD),an antidiabetic agent which improves insulin sensitivity,but the cardiovascular safety of the drug remains controversial.The new re-evaluation of the RECORD trial has suggested that rosiglitazone-containing drugs do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines,such as mefformin and sulfonylurea.The post hoc analysis of the BARI 2D also indicates that rosiglitazone may not relate with the increased risk of major ischemic cardiovascular events.According to these new results,there is no clear evidence that rosiglitazone may increase cardiovascular risk.The U.S.Food and Drug Administration announced in July 2013 that it is requiring the removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines.