在6个随机的安慰剂对照试验中,塞莱科西布的心血管风险:交叉试验安全性分析
Scott D Solomon1, Janet Wittes, Peter V Finn
1Cardiovascular Division, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA. ssolomon@rics.bwh.harvard.edu
Circulation
|April 2, 2008
概括
心血管风险随着塞莱科克西布的剂量增加而增加,最大的风险是每天两次服用400毫克. 患有较高基线心血管风险的患者经历了不成比例地更大的 celecoxib 副作用.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 以前的研究表明,使用环氧化原酶-2 抑制剂会增加心血管风险.
- 有限的数据存在于赛莱科克西布剂量或基线心血管状况对风险的影响.
研究的目的:
- 为了评估与三种剂量方案的赛莱科克西布相关的心血管风险.
- 评估基线心血管风险和赛莱科西布对心血管事件的影响之间的关系.
主要方法:
- 来自6项安慰剂对照试验的数据的患者层面的综合分析.
- 包括7950名患者,计划跟踪至少3年.
- 评估的切莱科克西布剂量为400毫克四次一天,200毫克两次一天和400毫克两次一天.
主要成果:
- 综合终点的综合危险比率为1.6 (95% CI,1.1至2.3).
- 心血管风险随着赛莱科克西布剂量显著增加 (P=0.0005).
- 最高的风险与400毫克BID剂量相关 (HR,3.1;95%CI,1.5至6.1),最低的风险与400毫克QD (HR,1.1;95%CI,0.6至2.0).
- 患有较高基线心血管风险的患者表现出不成比例地更大的赛莱科克西布相关不良事件 (相互作用的P=0.034).
结论:
- 有证据表明,基于赛莱科西布剂量和患者的基线心血管风险,心血管风险差异存在.
- 这些发现可能有助于指导选择性循环氧化酶-2抑制受益的患者的治疗决策.
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