降膽固醇新藥有望被批

現在公認的是肉、奶油和雞蛋不會導致膽固醇增高，但醫學界主流還是認為膽固醇，尤其是“壞膽固醇”（低密度脂蛋白，Low-density lipoprotein ，LDL）是心血管資本疾病的主要元凶。為什麽LDL高大家不管，但如果你高了，如何降，就是個醫學界的問題（俗稱治標不治本）。

美國食品藥物管理局（Food and Drug Administration，FDA）專家小組最近批準兩個美國大製藥公司的一種降膽固醇新藥。按慣例，局裏會蓋個章，照批不誤。

做了些總結。

【1】：
有效成分是PCSK9 inhibitors。有效率47%，據言兌講題心髒病引起的心肌梗塞導致的死亡大幅抑製，大範圍臨床試驗還沒完，要到2017，不知道專家小組為什麽推薦。

效果在哪？現有的他汀類藥物（Statins ）對降低膽固醇裏的壞膽固醇，LDL（低密度脂蛋白），已經有顯著效果，但有些問題。有人對藥有反應，肌肉劇疼，不少人出於遺傳因素對他汀類藥物對毫無效果。而新藥則有效。新藥的機製是“PCSK9 inhibitors work by blocking a protein in the liver that helps regulate LDL cholesterol”，“the new drugs cut LDL to a greater degree. They also lowered patients' risk of heart attack or death by about half”，當今先進手段的常招，廠家一定自豪。

【2】：
Sanofi and Regeneron Pharmaceuticals’ drug, alirocumab. Yesterday, they backed a second PCSK9 inhibitor, Amgen’s evolocumab
These PCSK9 inhibitors are being touted "one of the biggest developments in a long time in cardiology" and "a triumph of the modern genetic revolution."

Critics aren't so sure: they have expressed concerns about the safety and efficacy of this new class of medicines, pointing out that the long-term safety data isn't in yet and that it's unclear whether these drugs will have an impact on heart attacks and death

Experts are expecting PCSK9 inhibitors to be the biggest blockbuster heart drugs since statins emerged in the 1980s

The studies we have so far only looked at lab test results on LDL levels. In other words, they did not test for whether the drugs had an impact on real-world endpoints, like death and disease

Krumholz noted that the medical community has been fooled many times by early studies that "make your blood tests look better but they don't actually make patients better."

The drugs are expected to come with a price tag of $7,000 to $12,000 per patient per year

另外一個難得的特點是如果把新藥和他汀類藥物一塊用，不會衝突，效果會疊加，對此，醫學界更為推崇。但支持反對的雙方的觀點任較對立：



不過，有兩點是真的，一是一旦被批，藥廠又要賺大錢了。二是美國人都有個誤解，以為吃了藥，病就治好了，可以接著啥都瞎吃，後果是心血管病不會減少（不過難死）。


【1】FDA Advisers Recommend Approval of 2nd New Cholesterol Drug
【2】There's still a lot we don't know about the new cholesterol-lowering drugs

[頤和園]

這藥也貴得離譜了。我吃他汀類藥物，挺靈，也不肌肉疼，一個月不到4美金。

[益生菌]

為什麽LDL高大家不管，
____________________
唯有借助於“膽固醇導致心髒病”這樣的彌天大謊，才能夠使藥物降膽固醇這種賺錢騙局，年複一年繼續下去。