ADA recommends all diabetics have LDL less than 100, those with risk factors less than 70. So most diabetics are on statins that have high Trigs (150), low HDL (40), this goes along with JELIS subgroup. There are about 25 million Diabetics and about 75 million prediabetics in US.
Agree 100%. Why doesn't FDA and others take JELIS seriously. It was a study of 18,645 Japaneese patients on statin + placebo or statin + pure EPA (same as Vescepa). So what if statins were Simvastatin or Pravastatin at lower doses, there was 19% reduction in CV events in pts treated with EPA study wide. In the Trig over 150 and HDL less than 40 (who were mostly diabetics), there was a 53% drop in CV events. Study wasn't perfect but give me a break!! My practice is mostly urban, almost all patients are medicaid or medicaid sub-programs.There are lots of Diabetics with high Trigs and low HDL, strong FH of heart disease, and obesity. It's not a perfect world, Reduce-It results not in yet, but looking at JELIS with 53% CV reductions, I think a large number of my patients with Diabetes could benefit from Vascepa. Unfortunately this won't happen, its not approved for the majority, won't be covered by Medicaid/Medicare or regular insurance and they don't have money to buy it. Some of my patients won't be here when Reduce-It finishes due to a negative upcoming PDUFA!!!!!