Source: Drug Information Network
Recently, Amarin Corporation announced the main results of the Vascepa (icosapent ethyl) cardiovascular (CV) outcome test REDUCE-IT, which reached its primary endpoint and multiple secondary endpoints.
Studies have also shown that the mechanism of action of Vascepa is not related to the reduction of triglycerides. The results of the REDUCE-IT study were also published in the New England Journal of Medicine.
About Vascepa: Vascepa (icosapent ethyl) capsule is a single-molecule formulation consisting of omega-3 fatty acids in the form of ethyl esters (commonly known as EPA). Vascepa is not fish oil but comes from fish. It is produced through a rigorous and complex FDA-regulated manufacturing process that effectively eliminates impurities and separates and protects single-molecule active ingredients from degradation. Vascepa (called AMR101) has been designated by the FDA as a new chemical entity. Amarin has obtained several patents internationally because of the unique clinical features of Vascepa. Vascepa reduces TG levels without increasing LDL-C levels.
About REDUCE-IT: REDUCE-IT is a global study involving 8,179 adult patients who were treated with statins and had a higher risk of CV. The trials showed that the primary endpoint achieved was a reduction in the relative risk of the first major adverse cardiovascular event (MACE) by 25% (HR, 0.75; 95%) in the intention-to-treat population. CI: 0.68-0.83; p<0.001).
The key secondary endpoint achieved was a 26% reduction in the relative risk of cardiovascular death, non-fatal heart attack, and non-fatal stroke in the intention-to-treat population (HR, 0.74; 95% CI: 0.65-0.83; p<0.001) . Other secondary endpoints include a 20% reduction in cardiovascular risk, a 31% reduction in the risk of fatal or non-fatal heart attacks, a 28% reduction in the risk of fatal or non-fatal stroke, and an acute or urgent risk of coronary revascularization. Reduced by 35%, the risk of hospitalization for unstable angina decreased by 32%.
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