關於saquinavir (Invirase®)和貝特類(fibrates)降脂藥物安全性的最新資訊 Latest safety updates on saquinavir (Invirase®) and lipid-regulating medication fibrates

  • 併用saquinavir (Invirase®)ritonavir可引致心律失常

        美國食物及藥物管理局(USFDA)及歐盟藥物管理局(EMA)同時發出通告, 指併用saquinavir(Invirase®)和ritonavir可影響心臟的電活動, 引起QT間期和/或PR間期延長, 從而造成一系列心律失常。QT間期延長可產生嚴重﹑甚至致命的尖端扭轉心律失常(torsades de pointes), 而PR間期延長可引致心臟完全傳導阻滯。然而, 目前認為併用這些治療HIV藥物的效益仍高於其風險。基於上述風險, 建議:

1.     對首次使用Invirase®的病人, 可降低首星期的起始劑量;

2.     當處方Invirase®, 仔細閱讀該藥的說明書;

3.     於開始治療前, 應進行心電圖檢測。此外, 根據病人的QT間期情況, 考慮按下列準則進行持續的心電圖監測:

    a. QT間期大於450msec的病人, 不應併用Invirase®和ritonavir;

    b. QT間期小於450msec的病人, 建議於開始治療3至4天後, 進行心電圖監測;

    c. 於開始治療後, 如QT間期大於480msec或較治療前延長了20msec, 應停止治療。

4.     教導病人如在服用Invirase®和ritonavir的期間出現心跳或心律不正常的症狀, 如頭暈﹑頭重腳輕﹑昏厥或心悸等, 須立即聯絡主診醫生。

 

  •  貝特類(fibrates)降脂藥物作為第二綫使用

    基於貝特類(fibrates)降脂藥物降低心血管風險的證據有限, 歐盟藥物管理局(EMA)藥物委員會(CHMP)對該類藥物作出風險-效益評估, 在評估後, EMA表示, 對於血脂代謝障礙的病人, 雖然使用fibrates(bezafibrate﹑ciprofibrate﹑fenofibrate以及gemfibrozil)的效益仍高於其風險, 然而, 除非病人患有嚴重的高甘油三脂血症, 或病人不能服用他汀類(statins)降脂藥物, 否則醫生不應將fibrates作為第一線藥物處方於初次診斷為患血脂代謝障礙的病人。

    此外, CHMP評估的部份數據指出, fenofibrate可與statin類藥物併用於某些只用statin不能充份控制血脂水平的情況。

         

                                                                                                                                                    

  • Concomitant use of saquinavir (Invirase®) and ritonavir may lead to abnormal arrhythmias

    Latest safety releases from the United States Food and Drug Administration (USFDA) and European Medicines Agency (EMA) informed that concomitant use of saquinavir (Invirase®) and ritonavir might affect the electrical activity of the heart through prolongation of QT and/or PR intervals causing the risk of arrhythmia. Prolonged QT intervals can lead to serious or even fatal torsades de pointes, while PR interval extensions can lead to complete heart block. Nevertheless, the benefit of continued use of these concurrent HIV treatments outweighs the risks.  In view of this risk, the followings are recommended for the prescribers as well as all other healthcare professionals

1.   Reduced the starting dose of Invirase® in treatment-naïve patients during the first week;

2.   Read the label of Invirase® carefully before prescribing it to their patients;

3.   erform an electrocardiogram (ECG) prior to initiation of treatment.  Consider ongoing ECG monitoring for their patients using the instruction below:

    a.  atients with a QT interval > 450 msec should not receive ritonavir-boosted Invirase®;

    b.  patients with a QT interval < 450 msec, an on-treatment ECG is suggested after approximately 3 to 4 days of therapy;

    c.  patients with a QT interval > 480 msec or with prolongation over pre-treatment by > 20 msec should discontinue treatment.

4.   Advise patients to contact their physicians immediately if they experience symptoms of an abnormal heart rate or rhythm e.g. or symptoms including dizziness, lightheadedness, fainting or heart palpitations while taking Invirase® and ritonavir.

                                                                                                                    

  • Fibrates are considered as second line antilipidemic agents

Limited evidence proves fibrates’ long-term benefits in reducing cardiovascular risks. After reviewing their benefits and risks, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of the four fibrates (bezafibrate, ciprofibrate, fenofibrate and gemfibrozil) continue to outweigh their risks in the treatment of patients with blood lipid disorders. However, doctors should not prescribe them to newly-diagnosed patients with blood lipid disorders as first-line treatment, except for patients with severe hypertriglyceridaemia or patients who cannot take statins.

For fenofibrate, the Committee noted additional new data and recommended that it can also be used together with a statin in some circumstances when a statin on its own has not been enough to completely control blood lipid levels.

 

 

參考資料/Reference and website:

https://www.fda.gov/Drugs/DrugSafety/ucm230096.htm

https://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/10/news_detail_001134.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1

https://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/10/news_detail_001135.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1


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