Saturday, October 05, 2013 11:23:37 AM
go seek, the question doubters pose is "Why approve something that has yet to show efficacy in patient outcomes?"
That is not entirely true as we have the JELIS trial as an example where benefit has been documented. One may argue whether or not those benefits are important or significant, but in the end, EPA and statin did show synergy over statin alone.
Another point people miss is about the reduction in cardio-risk markers. They say 'Well, Niaspan reduces markers and it didn't show clear outcome benefit.'
Not only does EPA show marker reduction, in the literature, it shows that it gets into our cardiovascular tissues and improves their stability and lowers their inflammation. Niacin doesn't do this, it is not an integral part of our inflammation pathway as is EPA. EPA gets into plaques almost immediately.
In Type II Diabetes Mellitus patients, EPA reduces Carotid Intima-Media thickness
It induces rapid regression of atherosclerosis
It reverses the pathogenesis of atherosclerosis
It went head to head against another marker lowering drug, Zetia, and outperformed it in MACE and vessel improvement
So many studies show that EPA benefits atherosclerosis, it would be the height of foolishness to delay approval based on all the science that is out there that leads one to believe that it will show great therapeutic benefit for patients. It would do more harm to delay approval than to approve.
Sudan IV staining to show the build up of fatty lesions in mice fed a western type diet of high fat/cholesterol vs one with a western diet AND EPA.
That is not entirely true as we have the JELIS trial as an example where benefit has been documented. One may argue whether or not those benefits are important or significant, but in the end, EPA and statin did show synergy over statin alone.
Another point people miss is about the reduction in cardio-risk markers. They say 'Well, Niaspan reduces markers and it didn't show clear outcome benefit.'
Not only does EPA show marker reduction, in the literature, it shows that it gets into our cardiovascular tissues and improves their stability and lowers their inflammation. Niacin doesn't do this, it is not an integral part of our inflammation pathway as is EPA. EPA gets into plaques almost immediately.
In Type II Diabetes Mellitus patients, EPA reduces Carotid Intima-Media thickness
It induces rapid regression of atherosclerosis
It reverses the pathogenesis of atherosclerosis
It went head to head against another marker lowering drug, Zetia, and outperformed it in MACE and vessel improvement
So many studies show that EPA benefits atherosclerosis, it would be the height of foolishness to delay approval based on all the science that is out there that leads one to believe that it will show great therapeutic benefit for patients. It would do more harm to delay approval than to approve.
Sudan IV staining to show the build up of fatty lesions in mice fed a western type diet of high fat/cholesterol vs one with a western diet AND EPA.
