降胆固醇新药有望被批

现在公认的是肉、奶油和鸡蛋不会导致胆固醇增高，但医学界主流还是认为胆固醇，尤其是“坏胆固醇”（低密度脂蛋白，Low-density lipoprotein ，LDL）是心血管资本疾病的主要元凶。为什么LDL高大家不管，但如果你高了，如何降，就是个医学界的问题（俗称治标不治本）。

美国食品药物管理局（Food and Drug Administration，FDA）专家小组最近批准两个美国大制药公司的一种降胆固醇新药。按惯例，局里会盖个章，照批不误。

做了些总结。

【1】：
有效成分是PCSK9 inhibitors。有效率47%，据言兑讲题心脏病引起的心肌梗塞导致的死亡大幅抑制，大范围临床试验还没完，要到2017，不知道专家小组为什么推荐。

效果在哪？现有的他汀类药物（Statins ）对降低胆固醇里的坏胆固醇，LDL（低密度脂蛋白），已经有显著效果，但有些问题。有人对药有反应，肌肉剧疼，不少人出于遗传因素对他汀类药物对毫无效果。而新药则有效。新药的机制是“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”，当今先进手段的常招，厂家一定自豪。

【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

另外一个难得的特点是如果把新药和他汀类药物一块用，不会冲突，效果会叠加，对此，医学界更为推崇。但支持反对的双方的观点任较对立：



不过，有两点是真的，一是一旦被批，药厂又要赚大钱了。二是美国人都有个误解，以为吃了药，病就治好了，可以接着啥都瞎吃，后果是心血管病不会减少（不过难死）。


【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

[颐和园]

这药也贵得离谱了。我吃他汀类药物，挺灵，也不肌肉疼，一个月不到4美金。

[益生菌]

为什么LDL高大家不管，
____________________
唯有借助于“胆固醇导致心脏病”这样的弥天大谎，才能够使药物降胆固醇这种赚钱骗局，年复一年继续下去。