About "nightmares"
Nightmares are constructs by the brain during sleep and unless you believe as Hindus, that dreams are a higher consciousness , they do not accurately represent reality.
In the case of PCSK9 drugs which increase hepatic absorption of LDL-C from the bloodstream, their rationale is based on the notion that lowering LDL-C is the key to lowering CVD risk. An opinion currently championed by the FDA. To whit, the FDA is giving the the PCSK9 drugs a free pass regarding running clinical outcomes trials because the FDA feels there is sufficient evidence LDL-C is a surrogate for heart health. Maybe they could explain their thinking to the 50% or more patients whose initial heart attack occurs despite the fact the fact they have normal or low LDL-Cs. Also the JUPITER trial which is the FDA's most revered and impressive statin outcomes trial was conducted on patients with low normal LDL-Cs.
So where is the beef in the LDL-C argument? Facts are clinicians are too busy, or too lazy to do some real research on the whole LDL-C question. The FDA is at least 15 years behind in its knowledge of CVD..What the hay, its only the number one killer.
Facts are there is much more support for the inflammatory basis of atherosclerosis..vast amounts of research..And there is the FDA busting Amarin's chops. LDL-C is no doubt important in an indirect role. LDL-C is a lipid and like all lipids is subject to oxidation as are all energy rich compounds. Evidence shows LDL-C is not atherogenic in its non oxidized state. How could it be, it is hydrophobic. EPA is known to retard the oxidation of LDL-C as well moderate systemic inflammation, actions far more important than cutting down the amount of cholesterol.
The problem is one of education. No body in the FDA, and few in clinical medicine are truly educated. My prediction is that PCSK9 drugs will turn out to be failures, providing very minimal effects.
":>) JL
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