藥物警訊

Long-term Antiplatelet Therapy: Safety Announcement - Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death

AUDIENCE: Cardiology, Hematology, Surgery

ISSUE: FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents. These stents are small, medicine-coated tubes inserted into narrowed arteries in the heart to keep them open and maintain blood flow to the heart. Clopidogrel and prasugrel are important medicines used to prevent heart attacks, strokes, and other clot-related diseases.

FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses.

BACKGROUND: The Dual Antiplatelet Therapy (DAPT) trial was published in the New England Journal of Medicine on November 16, 2014. FDA has not reviewed the trial results or reached any conclusions based on the findings from this clinical trial. We are communicating this safety information while we continue to evaluate the results from this trial and other available data. We will communicate our final conclusions and recommendations when our evaluation is complete.

RECOMMENDATION: Health care professionals should not change the way they prescribe these drugs at this time. Patients should not stop taking these drugs because doing so may result in an increased risk of heart attacks, blood clots, strokes, and other major cardiovascular problems.

Read the Complete MedWatch Safty Alert, including link to the Safety Announcement at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA發布藥物安全警訊，依據一項臨床試驗之初步資料顯示，使用雙重抗血小板藥物治療30個月可降低心臟病發及支架血栓形成風險，但相較於12個月之療程，整體死亡風險較高。此臨床試驗為比較植入塗藥冠狀動脈支架後使用雙重抗血小板藥物治療，包含aspirin加clopidogrel或prasugrel，療程為30個月與12個月之差異。這些體積小、含藥的支架放置於狹窄的心臟動脈中得維持血流順暢，clopidogrel和prasugrel則是用於預防心臟病發、中風及其他與血栓相關疾病之重要用藥。FDA認為依照適應症使用clopidogrel和prasugrel治療之利仍大於弊。

背景

雙重抗血小板藥物治療 (DAPT) 試驗於2014年11月16日發表於New England Journal od Medicine期刊。針對此臨床試驗之發現，FDA尚無任何定論。FDA正持續分析及評估試驗結果和其他資料，若有任何結論或建議將再告知。

建議

針對這些藥物，醫療人員目前不需改變處方方式。病人也不應自行停藥，停藥可能會導致心臟病發、血栓、中風或其他主要心血管疾病之風險增加。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部