Amarin Corp Plc (AMRN)

[hamkypamky]

https://www.tctmd.com/news/new-aha-guidance-omega-3-fatty-acids-high-triglycerides

For managing hypertriglyceridemia (200-499 mg/dL), the AHA experts state that prescription-strength omega-3 fatty acids, either with eicosapentaenoic acid (EPA) or EPA plus docosapentaenoic acid (DHA), would be expected to yield a 20% to 30% reduction in triglycerides without any increase in LDL cholesterol. For individuals with severe hypertriglyceridemia, 4 g/day of omega-3 fatty acids will reduce triglycerides by more than 30%, but LDL cholesterol may increase in agents that contain DHA. The goal for patients with severe hypertriglyceridemia is to reduce decrease triglycerides to less than 500 mg/dL and decrease the risk of pancreatitis.

“One of the surprising findings of this analysis is that the prescription omega-3 fatty acids containing DHA did not increase LDL cholesterol in studies of people with triglycerides less than 500 mg/dL,” said Skulas-Ray. In prior studies suggesting that DHA-containing agents may increase LDL cholesterol, researchers did not stratify by patient populations, such as those with and without severe hypertriglyceridemia. “The results we reviewed suggest to me that LDL increases proportionally to the degree of triglyceride reduction, not as a result of the prescription agent containing DHA,” she said.

Since 2004, several types of prescription-strength omega-3 fatty acid products have been approved by the FDA for lowering triglycerides, including Vascepa (Amarin), Lovaza (GlaxoSmithKline), Epanova (AstraZeneca), and two generic products. Their use in the treatment of high triglycerides recently received a massive boost with the publication of REDUCE-IT, a 2018 study testing 4 g/day of Amarin’s icosapent ethyl, a highly purified EPA ethyl ester. In that trial of patients with high triglycerides (135 to 499 mg/dL) also at high risk for cardiovascular disease, the addition of the omega-3 fatty acid on top of statin therapy reduced major adverse cardiovascular events by 25%.

“When we began writing this advisory, the results of REDUCE-IT were not yet available,” Skulas-Ray told TCTMD. “We delayed publication in order to include results of this trial. Omega-3 fatty acids are not always part of the discussion regarding triglyceride management, and this was likely due to the lack of studies evaluating effects prescription dosing of omega-3 fatty acids on hard endpoints in a population with elevated triglycerides. The results of REDUCE-IT changed that.”

They COULD be replacing V with generic L or L but they should not be replacing with generic 03 (non prescription). The AHA's recommendation not mine.