ST LOUIS (MD Consult) - The manufacturers of Plavix and the US Food and Drug Administration (FDA) are working to obtain a better understanding of the effects of genetic factors and other drugs—especially the proton pump inhibitors(PPI)—on the effectiveness of clopidogrel.

The FDA is aware of published reports that clopidogrel (marketed as Plavix) is less effective in some patients than in others. Differences in effectiveness may be because of genetic differences in the way the body metabolizes clopidogrel or because using certain other drugs concurrently can interfere with how the body metabolizes clopidogrel. These studies should lead to a better understanding about how to optimize the use of clopidogrel.

The FDA recognizes the importance of obtaining these data promptly. The drug manufacturers have agreed to a timeline for completing the studies. The FDA will review the new information and communicate its conclusions and recommendations to the public. It could take several months to complete the studies and analyze the results. Until further information is available, the FDA recommends the following:

• Health care providers should continue to prescribe and patients should continue to take clopidogrel as directed because clopidogrel has demonstrated benefits in preventing blood clots that could lead to a heart attack or stroke.
  
   
• Health care providers should re-evaluate the need for starting or continuing treatment with a PPI, including Prilosec OTC, in patients taking clopidogrel.
  
   
• Patients taking clopidogrel should consult their health care provider if they are currently taking or considering taking a PPI, including Prilosec OTC. 

圣路易斯 (MD Consult)—— 氯吡格雷的制造商和美国食品与药物管理局(FDA)正致力于深入研究遗传因素和其他药物[尤其是质子泵抑制剂（PPI）]对氯吡格雷疗效的影响。

FDA注意到在一些已发表报告中氯吡格雷(商品名为波立维)对某些患者的疗效较差。这种疗效差异可能是由机体在代谢氯吡格雷方式上的遗传差异引起或者由于同时服用某种其他药物干扰了机体对氯吡格雷的代谢而引起。这些研究将使我们对如何优化使用氯吡格雷有更好的认识。

FDA认识到迅速获得这些数据的重要性。该药制造商已经同意在一个时间期限内完成这些研究。随后，FDA将对新信息进行审查评估并将结论和建议公布于众。完成这些研究和分析结果需要几个月的时间。在进一步信息出现之前，FDA有如下建议：

• 由于已证实氯吡格雷可有效预防血栓形成 (可致心脏病发作或卒中) ，因此医生应继续处方氯吡格雷，并且患者应在指导下继续服用。
• 对服用氯吡格雷的患者，医生应该重新评价开始或继续使用PPI（包括非处方药奥美拉唑）治疗的必要性。
• 服用氯吡格雷的患者如果正在服用或考虑服用PPI（包括非处方药奥美拉唑），应该咨询医生。

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