關於含entacapone藥物(Stalevo®, Comtan®)安全性的最新資訊 Latest safety update on medications containing entacapone(Stalevo®, Comtan®)

    已知levodopa/carbidopa可引起高血壓和心悸等心血管系統方面的不良反應, 近日多項臨床試驗的綜合分析(meta-analysis)指出, 相對只服用levodopa/carbidopa的病人, 服用Stalevo®(levodopa/carbidopa與entacapone的複方制劑)的帕金遜病人有可能增加心肌梗塞及其他心血管事件(心臟病發﹑中風和心血管死亡)的風險。然而, 由於這些臨床試驗的設計並非針對心血管安全性的評估, 大部分的試驗期間過短且多數事件只發在某個試驗中, 再者, 大部分參加試驗的病人已有心血管方面的危險因子, 因此美國食物及藥物管理局(USFDA)目前沒有確認上述結果。在得出進一步的結論前, USFDA提醒醫生及其他衛生專業人士, 對於正在服用levodopa/carbidopa的病人, 如需增加Comtan®(entacapone), 應:

  • 遵照Stalevo®和Comtan®說明書上的資訊處方藥物。
  • 對於已正在用levodopa/carbidopa的病人, 如須加上entacapone, 應先對他們進行常規的心血管系統評估。
  • 告知病人該藥可能增加上述心血管事件發生的機會。

                                                                                                                                                                                                                                                                                         

    It is known that levodopa/carbidopa may induce cardiovascular adverse reactions such as hypertension and palpitation. Recent findings from meta-analysis of several clinical trials indicated increased risk of myocardial infarctions and cardiovascular events (heart attack, stroke, and cardiovascular deaths) in Parkinson’s Disease patients treated with Stalevo®(combination of levodopa/carbidopa and entacapone) compared to those receiving levodopa/carbidopa alone. United States Food and Drug Administration (USFDA) has not confirmed the above observation because none of these clinical trials was designed to evaluate cardiovascular safety and durations for most of these studies were too short. Besides, most of the patients under the trials had pre-existing cardiovascular risk factors. Lastly, many of these events occurred only in a one single trial. Therefore, while pending for further reviews on the above safety concern, USFDA would like the prescribers and healthcare professionals to be aware of the following advice when entacapone has to be added to those patients who are currently on levodopa/carbidopa

  • adhere to the recommendations as described on the prescribing information of Stalevo® and Comtan®.
  • conduct regular cardiovascular evaluations on patients of whom entacapone is necessitated to be added to their existing levodopa/carbidopa therapy.
  • remind your patients the above cardiovascular disease may occur.

  

參考資料/Reference and website:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm223423.htm

https://www.fda.gov/Drugs/DrugSafety/ucm223060.htm


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