Cardiovascular risk with non-steroidal anti-inflammatory drugs: clinical implications.

Cardiovascular risk with non-steroidal anti-inflammatory drugs: clinical implications.
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DOI:
10.1007/s40264-014-0207-2
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发表时间:
2014-11
期刊:
影响因子:
4.2
通讯作者:
Holt, Robert J.
Holt, Robert J.
中科院分区:
医学2区
文献类型:
--
作者:
Bello, Alfonso E.;Holt, Robert J.

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2014年2月,美国食品和药物管理局(FDA)召开了一次咨询委员会会议,讨论了与非甾体抗炎药(NSAID)心血管风险相关的累积数据以及对该类别处方标签的潜在影响。委员会建议(尽管并非一致):(1)当前数据不支持萘普生比其他非甾体抗炎药具有较低血栓事件风险的结论; (2)心血管血栓事件风险无潜伏期; (3) 某些患者群体发生事件的风险较高; (4) 正在进行的主要试验仍在进行中,旨在进一步解决这些问题。讨论了 FDA 审议以及最近发表的荟萃分析和观察性研究的临床意义。根据目前掌握的信息,没有足够的证据可以得出结论,已批准的非甾体抗炎药之间在心血管事件的可能性方面存在显着差异。建议采取一种平衡与非甾体抗炎药相关的主要风险的方法。临床医生应继续使用当前 FDA NSAID 标签语言来指导他们对个体患者的决策,直到 FDA 做出改变。
In February 2014, the US Food and Drug Administration (FDA) convened an advisory committee meeting to discuss the accumulated data relating to the cardiovascular risk of non-steroidal anti-inflammatory drugs (NSAIDs) and the potential implications on the class prescription labeling. The committee recommended, though not unanimously, that (1) the current data does not support the conclusion that naproxen has a lower risk of thrombotic events than other NSAIDs; (2) there is no latency period for the risk of cardiovascular thrombotic events; (3) there are some patient populations at increased risk for events; and (4) equipoise remains in the major ongoing trial designed to address these issues further. The clinical implications of the FDA deliberations as well as the recently published meta-analyses and observational studies are discussed. With the information available today, there is insufficient evidence to conclude that there are significant differences between the approved NSAIDs with regard to the potential for cardiovascular events. An approach for balancing the major risks associated with NSAIDs is suggested. Clinicians should continue to use the current FDA NSAID labeling language to guide their decision making for individual patients until such time as the FDA makes changes.
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