Re: Amarin
posted on
Apr 05, 2018 10:27AM
Amarin's Vascepa has not been previously tested in a rigorous trial designed for cardiovascular outcomes. That critique you posted has valid points, but mainly relies on the conculsion of a meta-analysis of several past trials.
From the REDUCE-IT study rationale: "REDUCE-IT enrolled men or women age ≥45 years with established cardiovascular disease or age ≥50 years with diabetes mellitus and 1 additional risk factor. Randomization required fasting triglycerides ≥150 mg/dL and <500 mg/dL and LDL-C >40 mg/dL and ≤100 mg/dL with stable statin (± ezetimibe) ≥4 weeks prior to qualifying measurements."
So it is not just anyone taking Vascepa in REDUCE-IT, but those w/ truly elevated plasma TG at cardiovascular risk that are being investigated. It is already accepted that TG above 500 mg/dl needs to be lowered due to risk for pancreatisis, etc. However, proving that there is cardiovascular benefit, with prescription EPA (i.e. Vascepa) will be a HUGE validation of the TG hypothesis. Positive results in REDUCE-IT could lead to increased acknowledgement, awareness and motivation to reduced TG in those in the 150 to 500 mg/dl range.
Also, to tie this in with HDL......high TG correlates with low HDL-cholesterol. Cholesterol ester transfer protein (CETP) catalyzes the reciprocal transfer of TG from TG-rich lipoproteins (i.e. VLDL, chyolomicrons) with cholesterol ester (CE) from HDL. So lowering plasma TG would be expected to raise HDL-cholesterol.