However, in post hoc analyses, it was observed that among subjects with high baseline TG levels [≥1.69 mmol/L (150 mg/dL)] and low HDL-C levels [<1.03 mmol/L (40 mg/dL)] who exhibited the highest risk of coronary events, there was a nominally significant 53% reduction in events [HR 0.47, 95% confidence interval (CI) 0.23–0.98; P = 0.043]. 38 Of note, the benefits seen in JELIS were consistent in both the secondary and primary prevention cohorts enrolled.
Similar findings were observed in a post hoc analysis of the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides and Impact on Global Health Outcomes (AIM-HIGH) Trial among 522 subjects (15%) who were in both the highest TG [>2.24 mmol/L (198 mg/dL)] and lowest HDL-C [<0.85 mmol/L (33 mg/dL)] tertiles, where extended-release niacin showed a trend toward benefit [hazard ratio (HR) = 0.74, P = 0.073]. 27 Clearly, additional outcomes studies in patients optimally treated with statins and pre-selected for hypertriglyceridaemia are needed.
39 Now along comes REDUCE-IT and ethyl eicosapentaenoic acid in atherosclerotic cardiovascular disease event reduction: a new era in dyslipidaemia therapeutics Against this backdrop of disappointing and inconclusive randomized secondary prevention trials directed at reducing ASCVD residual risk beyond LDL-C reduction and the inconsistent findings of prior studies of OM3FA, we now have the remarkable findings from the first, prospective, placebo-controlled, randomized trial (REDUCE-IT) of icosapent ethyl (an ethyl ester of eicosapentaenoic acid) showing a highly significant treatment effect on both the trial primary outcome measure and several prespecified secondary endpoints. 40 Among the 8179 participants with high CV risk (of whom 71% had established cardiovascular disease, 29% comprised a primary prevention cohort, and 58% had T2DM), the baseline LDL-C levels were well-controlled with statins [median value, 1.94 mmol/L (75.0 mg/dL)], while TG levels were moderately elevated [median value, 2.44 mmol/L (216.0 mg/dL)]. 40 The comparative baseline characteristics between the icosapent ethyl and placebo groups are shown in Table 1 .