Omega-3 Fatty Acids Effect on Major Cardiovascular Events in Patients at High Cardiovascular Risk

To the Editor The results of the STRENGTH trial showed conclusively that omega-3 CA, a carboxylic acid formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), did not improve cardiovascular outcomes compared with corn oil placebo. In contrast, REDUCE-IT demonstrated improved cardiovascular outcomes with 4 g/d of icosapent ethyl, a highly purified ethyl ester of eicosapentaenoic acid, compared with a pharmaceutical-grade mineral oil placebo. Similarly, the randomized JELIS trial demonstrated a statistically significant decrease in major adverse coronary events with an even lower dose of icosapent ethyl, 1.8 g/d, with no placebo. Furthermore, 1.8 g/d of icosapent ethyl has also been shown to significantly reduce plaque progression rates on intravascular ultrasound in the CHERRY trial, again with no placebo. The authors of STRENGTH suggested that the beneficial effect on cardiovascular outcomes seen in REDUCE-IT may have been due to an increase in event rates in patients randomized to the mineral oil placebo group. However, a review of 80 studies using mineral oil showed no consistent evidence that mineral oil affected medication absorption, efficacy, or clinical outcomes. Based on our analysis over many years of follow-up of patients in REDUCE-IT, close monitoring of changes in lipids and other biomarkers, analysis by the independent data and safety monitoring board, and independent analyses from the US Food and Drug Administration and from Health Canada, no ...
Source: JAMA - Category: General Medicine Source Type: research