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FDA检索了DAPT试验以及其他有关氯吡格雷的大型、长期临床试验结果，目的是探索氯吡格雷是否增加死亡危险及癌症相关死亡。FDA还对其他长期临床试验进行了荟萃分析，以评估氯吡格雷对全因死亡率的影响。 结果表明，与短期氯吡格雷联合阿司匹林的DAPT或单纯阿司匹林治疗（≤6个月）相比，长期（≥12个月）的DAPT似乎并未改变总死亡危险。此外，长期DAPT没有明显增加癌症相关死亡危险或癌症相关不良事件。FDA正在与氯吡格雷制造商合作更新标签，以反映上述死亡荟萃分析的结果。 鉴于此，FDA做出如下推荐意见：患者不应停用氯吡格雷或其他抗血小板药物，因为这么做有可能导致心梗及血栓危险增高；如果你对氯吡格雷有任何问题或担忧请咨询你的健康保健专员。健康保健专员在开始治疗前应考虑现有抗血小板药物的利弊。 附：英文原文 Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death An FDA review has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer. In order to investigate the increased risk of death and cancer-related death reported with clopidogrel in the DAPT trial, FDA examined the results of the DAPT trial and other large, long-term clinical trials of clopidogrel with data available on rates of death, death from cancer, or cancer reported as an adverse event. FDA performed meta-analyses of other long-term clinical trials to assess the effects of clopidogrel on death rates from all causes. The results indicate that long-term (12 months or longer) dual antiplatelet therapy with clopidogrel and aspirin do not appear to change the overall risk of death when compared to short-term (6 months or less) clopidogrel and aspirin, or aspirin alone. Also, there was no apparent increase in the risks of cancer-related deaths or cancer-related adverse events with long-term treatment. FDA is working with the manufacturers of clopidogrel to update the label to reflect the results of the mortality meta-analysis. Clopidogrel is an antiplatelet medicine used to prevent blood clots in patients who have had a heart attack, stroke, or problems with the circulation in the arms and legs. It works by helping to keep the platelets in the blood from sticking together and forming clots that can occur with certain medical conditions. Patients should not stop taking clopidogrel or other antiplatelet medicines because doing so may result in an increased risk of heart attacks and blood clots. Talk with your health care professional if you have any questions or concerns about clopidogrel. Health care professionals should consider the benefits and risks of available antiplatelet medicines before starting treatment. See the Drug Safety Communication for more information, including Additional Information for Patients, Caregivers, and Health Care Professionals, and a Data Summary. 【来源：ACC News Story（November 6，2015）】 |
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