产品标签与品牌icosapent乙烯用户的现实安全数据的比较:使用MarketScan数据进行精选分析
John R Nelson1, Richard A Hansen1, Handrean Soran1
1California Cardiovascular Institute, Fresno, CA, USA (Dr Nelson); Independent Real World Evidence Consultant, Athens, GA, USA (Dr Hansen); Manchester University Hospital NHS Foundation Trust, Manchester, United Kingdom (Dr Soran); Amarin Pharma, Inc., Bridgewater, NJ, USA (Drs Justice, Abrahamson, Hannachi, and Philip); Amarin Pharma, Inc., Zug, Switzerland (Drs Justice, Abrahamson, Hannachi, and Philip); Clinical Research and Adult Diabetes sections, Joslin Diabetes Center, Department of Medicine, Harvard Medical School, Boston, MA, USA (Dr Ganda); Tehran Heart Center, Cardiovascular Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (Dr Hosseini).
在现实环境中,Icosapent ethyl (IPE) 可能耐受良好,现实世界的证据显示事件率低于临床试验. 这表明,对于患有高甘油三水平的患者来说,安全性概况有利.
科学领域:
- 心血管医学 心血管医学
- 药物监督 药物监督 药物监督
- 现实世界的证据.
背景情况:
- REDUCE-IT试验显示,icosapent ethyl (IPE) 降低了心血管事件,但注意到心房动/动,出血,便秘和的风险增加.
- 与IPE相关的这些不良事件的真实发病率尚未得到充分确立.
研究的目的:
- 为了比较与icosapent ethyl (IPE) 相关的关键不良事件的频率,在现实环境中与临床试验数据进行比较.
- 在现实患者群体中评估IPE的耐受性.
主要方法:
- 现实世界证据 (RWE) 来自MarketScan商业索赔数据库,分析了IPE新用户长达4年的时间.
- 使用ICD-10代码识别了不良事件.
- 在RWE,REDUCE-IT试验和产品标签之间比较了事件的累积发生率.
主要成果:
- 与REDUCE-IT试验相比,现实世界的证据 (RWE) 表明不良事件发生的趋势与REDUCE-IT试验相似.
- 然而,RWE对累积发病率的估计始终较低,从试验或产品标签上报告的三分之一到五分之一不等.
结论:
- 在现实世界的临床实践中,icosapent ethyl (IPE) 似乎被很好地容忍.
- 在现实数据中观察到的较低事件率表明,在受控试验环境之外,潜在的更有利的安全概况.
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