评估非类固醇抗炎药物的心血管安全性
1From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA; and Clinical and Translational Science Center, Harvard Medical School, Boston, MA. eantman@rics.bwh.harvard.edu.
Circulation
|May 24, 2017
概括
在上市后的4期随机对照试验 (RCT) 评估药物的心血管安全性. 对关节炎的非类固醇抗炎药物 (NSAIDs) 的试验具有挑战性,低剂量西莱科西布显示出类似的心血管风险,但减少了疼痛缓解.
科学领域:
- 药理学
- 心血管医学
- 临床试验设计
背景情况:
- 非心血管药物可能会对心血管健康产生负面影响.
- 美国食品和药物管理局要求在销售后进行4期随机对照试验 (RCT),以解决严重的心血管安全问题.
- 当代的第四阶段RCT优先考虑使用非劣质设计而不是疗效.
研究的目的:
- 在上市后的第四阶段RCT中研究影响心血管安全性的因素.
- 评估在关节炎中进行和解释非类固醇抗炎药物 (NSAIDs) 心血管安全试验的挑战.
- 为了比较切莱科西布与其他NSAIDs的心血管风险和疗效.
主要方法:
- 对心血管安全的第四阶段RCT规划阶段选择的分析.
- 评估影响心血管安全信号的因素,包括协议遵守率和退学率.
- 对关节炎中使用的NSAID进行现有第4期RCT的审查.
主要成果:
- 协议的遵守和研究的保留对心血管安全信号的偏差和解释有重大影响.
- 在治疗关节炎的NSAID试验中,难以比较止痛效果和维持患者的坚持性和持续性.
- 在低风险人群中,低剂量切莱科西布的心血管风险与NSAID相比较,对循环氧基酶-2的抑制较小,但对止痛效果有所降低.
结论:
- 第四阶段RCT中的方法选择对心血管安全性评估具有重要影响.
- 进行和解释NSAID心血管安全试验需要仔细考虑疗效,坚持和保留.
- 在选择NSAIDs,特别是celecoxib时,心血管安全性和止痛功效之间的平衡至关重要.
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