Impact of expanded FDA indication for icosapent ethyl on enhanced cardiovascular residual risk reduction.

Boden, William E; Baum, Seth; Toth, Peter P; Fazio, Sergio; Bhatt, Deepak L

Hypertriglyceridemia is associated with increased cardiovascular disease (CVD) risk. The Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT) demonstrated that the purified, stable ethyl ester of eicosapentaenoic acid, icosapent ethyl (IPE), added to statins reduced CVD events by 25% (p < 0.001), leading to an expanded indication in the USA. IPE is now approved as an adjunct to maximally tolerated statins to reduce CVD event risk in adults with triglyceride (TG) levels ≥150 mg/dl and either established CVD or diabetes mellitus plus ≥2 additional CVD risk factors. The new indication allows co-administration of IPE for elevated TG levels with statin treatment, enabling effective residual risk reduction in a broader at-risk population beyond what can be achieved with intensive low-density lipoprotein cholesterol control alone.