Amarin Corporation’s Vascepa provided a statistically significant 30% risk reduction in total (first and subsequent) cardiovascular events compared to placebo in the statin-treated patient population studied in REDUCE-IT, as presented in a cardiovascular outcomes study.
Deepak L. Bhatt , who was the study’s principal investigator, said: “From a patient’s perspective — and from my perspective as a physician — we care about repeat events and the risk of surviving a first stroke or heart attack only to go on to have a subsequent, and potentially fatal, event. The degree of benefit that this analysis reveals is quite large, especially considering that this is an additional layer of benefit on top of what statin and other therapies have already provided.”
John F. Thero, president and CEO of Amarin said: “We believe that the robustly positive cardiovascular outcomes results demonstrated with Vascepa opens the door to a new era in preventative cardiovascular care which can potentially benefit millions of at-risk patients. Just as the REDUCE-IT results demonstrated that the effects of Vascepa are unprecedented in reducing cardiovascular risk in at-risk patients, as separately published, the mechanism of action of the unique small molecule, single active ingredient in Vascepa is multifactorial and differentiated from any other therapy.”
The study had 8,179 patients who, despite stable statin therapy, had elevated triglyceride levels (at least 135 mg/dL) and either documented cardiovascular disease or diabetes with other cardiovascular risk factors.