European Commission approval for icosapent ethyl to reduce CV riskNews - Mar. 30, 2021
Icosapent ethyl has received approval from the European Commission (EC) to reduce the risk of CV events in high risk, statin-treated adults with elevated triglycerides (≥150 mg/dL) and either established CVD or diabetes and at least one additional CV risk factor.
The EC approval is based on efficacy and safety data from the REDUCE-IT trial . The REDUCE-IT trial enrolled >8000 patients who were at high risk of heart attack, stroke or other MACE, despite being on statin therapy. Patients had LDL-C controlled to between 41-100 mg/dL by statin therapy, triglycerides between 135-499 mg/dL and either established CVD or diabetes mellitus and at least one other risk factor for CVD. Patients were randomized to icosapent ethyl (4g daily) or placebo. The median follow-up period was ~5 years. The results showed a 25% relative risk reduction of first occurrence of MACE with icosapent ethyl compared to placebo (P<0.001).
The 2019 ESC/EAS Dyslipidemia Management Guidelines recommend the use of icosapent ethyl in high-risk, statin-treated patients .