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

Future Cardiol. 2021 Jan;17(1):155-174. doi: 10.2217/fca-2020-0106. Epub 2020 Sep 22.

Abstract

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.

Keywords: cardiovascular disease; eicosapentaenoic acid; heart diseases; hypertriglyceridemia; icosapent ethyl; triglycerides.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cardiovascular Diseases* / epidemiology
  • Cardiovascular Diseases* / prevention & control
  • Eicosapentaenoic Acid / analogs & derivatives
  • Eicosapentaenoic Acid / therapeutic use
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors* / therapeutic use
  • Hypertriglyceridemia* / drug therapy
  • Risk Reduction Behavior

Substances

  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • eicosapentaenoic acid ethyl ester
  • Eicosapentaenoic Acid