Biopharmaceutical company Amarin this week announced the topline results of its REDUCE-IT trial, a global study that achieved 25 percent cardiovascular risk reduction in a population of 8,179 statin-treated adults with the daily use of Vascepa, also known as icosapent ethyl.
The study was designed to test the utility of 4 grams of Vascepa per day in heart patients whose LDL cholesterol continued to hover between 41 and 100 mg/dL, despite statin use, according to a release. Participants also suffered from a host of cardiovascular risk factors, including diabetes, already-established CVD and triglyceride levels of up to 499 mg/dL.
REDUCE-IT results are slated for presentation at the American Heart Association’s Scientific Sessions this November in Chicago, Illinois. The study, initially launched in 2011, was recently announced as a late-breaking trial for the event—something that can likely be attributed to its major, somewhat unexpected results.
“We are delighted with these topline study results,” John F. Thero, president and CEO of Amarin, said in the release. “Given Vascepa is affordably priced, orally administered and has a favorable safety profile, REDUCE-IT results could lead to a new paradigm in treatment to further reduce the significant cardiovascular risk that remains in millions of patients with LDL cholesterol controlled by statin therapy, as studied in REDUCE-IT.”
Risk reduction was met for the study’s primary composite endpoint, he said, meaning patients taking Vascepa were seeing a significantly lowered risk for major cardiac events like stroke, nonfatal MI and coronary revascularization. The researchers also noted results remained similar across a range of secondary endpoints.
Thero said that, given the positive topline results of REDUCE-IT, Amarin is increasing its number of sales reps across the country to more than 400. The team is also looking to expand into the international market and support regulatory efforts outside the U.S.
According to the release, REDUCE-IT results will be published later this fall in a “major peer-reviewed journal.” The study’s design was first published in March 2017 in Clinical Cardiology.
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.