There are about 15 million US diabetics being told by their doctors they have an elevated chance of a fatal heart attack, and many of those will be in the next five years. Nothing beyond current practices can really prevent this except a stringent lifestyle and possibly Vascepa. There are five endocrinologists on the FDA ADCOMM and they get to consider that Vascepa reduces LDL-C on statins and reduces triglycerides quite effectively. NO other treatment does this and it is the dogma endo's live by, (reduce LDL-C and triglycerides for diabetics, look it up, it's all true). And V reduces inflammation far more than any other treatment. Denying the ANCHOR indication in this light makes so little sense it makes me blush. And since Vascepa is safer than almost any other drug on the planet it makes me mad to think there is any percentage chance of a delay.
You are 100% correct. Diabetes carries an exceptionally high burden of disease, including a higher mortality from CVD. Primary cardiovascular prevention is particularly important in this population because diabetic individuals suffering a first MI are much more likely to die than are their nondiabetic counterparts. Adherence to lipid guidelines is crucial to improving clinical outcomes in diabetic patients. A number of roadblocks to the successful implementation of lipid guidelines have been identified. Among the most common are failure to recognize that 1) the borderline LDL cholesterol elevations common in diabetic patients are associated with substantial cardiovascular risk because of their small, dense composition and the high CHD risk already present in this population; 2) seemingly mild abnormalities in LDL cholesterol interact with other lipid abnormalities to further heighten risk; and 3) intensive LDL cholesterol reduction in this setting results in significant reductions in cardiovascular morbidity and mortality. Indeed, the opportunity to substantially improve cardiovascular outcomes by assessing and treating the atherogenic diabetic dyslipidemia characteristic of this population should not be missed.
LDL Cholesterol Lowering in Type 2 Diabetes: What Is the Optimum Approach? (Search this title)
Frenzy: It doesn;t makes sense and everything you say should cause this indication to be approved long as they look at it and frame it the way you have.
But the FDA sometimes doesn;t frame things the same way we do! We have a good chance, but this meeting will talk about outcomes and its role here no matter whether we like it or not.
And hopefully when these panel eggheads stop talking, they will be unwilling to cast doubt on the LDL/TRI arguments for positive benefits. get ahold of that roster and pick thru the perspectives of the panel members I tell ya. The FDA sets the panel ya know!
I am off to vacation-for a week--no buys and no sells---shares held locked down--carry on the debate! Becaue debate is always good!