Amarin's REDUCE-IT Data For Vascepa May Be Game-Changing, But Not Without Controversy

CVOT results for Amarin's fish-oil pill show an unprecedented reduction in cardiovascular deaths. While questions have been raised about an LDL increase in the placebo group, an investigator says the overall results are too good to be explained by a well-known mineral oil effect.

Human heart. 3d illustration.

Amarin Corp. PLC has the first successful cardiovascular outcomes trial for a drug added on to statin therapy in the REDUCE-IT trial of the company’s fish oil-derived Vascepa (icosapent ethyl), but an increase in LDL cholesterol in the placebo arm has raised some concern about the full data presented at the American Heart Association (AHA) annual meeting.

Vascepa, indicated for the treatment of hypertriglyceridemia, showed a 25% relative risk reduction in cardiovascular events in the outcomes trial known as REDUCE-IT, including a 20% reduction in CV death.

The highly anticipated cardiovascular outcomes trial (CVOT) results revealed in a late-breaker presentation at the AHA Scientific Sessions on Nov. 10 in Chicago showed dramatic reductions in major cardiovascular events...

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