Icosapent ethyl, a highly purified prescription formulation of the omega-3 oil eicosapentaenoic acid, has been indicated to decrease triglycerides and have anti-inflammatory, antioxidative, and plaque-stabilizing properties. The REDUCE-IT RENAL analyses analyzed the full REDUCE-IT cardiovascular outcomes study patient population in prespecified and post hoc analyses across subgroups of epidermal growth factor receptor (eGFR) categories. The primary endpoint (5-point major adverse CV events [MACE] consisting of nonfatal myocardial infarction [MI], stroke, CV death, unstable angina requiring hospitalization, and coronary revascularization) and key secondary endpoint (3-point MACE consisting of nonfatal MI, stroke, and CV death) events were consistently decreased when reviewing data cut by prespecified baseline eGFR categories; eGFR <60 mL/min/1.73 m2 (n = 1,816); eGFR ≥60 to <90 mL/min/1.73 m2 (n = 4455); and eGFR ≥90 mL/min/1.73 m2 (n = 1,902).
Comparable consistent CV risk-reduction benefits were observed across posthoc analyses by finer cuts of eGFR categories. Primary and key secondary endpoint MACE rates augmented with diminishing eGFR were compared to the total patient population studied in REDUCE-IT, resulting in correspondingly favorable relative risk reductions and numerically greater absolute risk reductions with icosapent ethyl versus placebo compared with the overall patient population. The ADRs were greater with decreasing eGFR, but total adverse events occurred at analogous rates with icosapent ethyl versus placebo. A safety profile comparable to the full REDUCE-IT study cohort was observed for icosapent ethyl compared with placebo across the eGFR subgroups.
In a press release, Dr. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor of Medicine at Harvard Medical School, chief investigator of REDUCE-IT, and senior author of the REDUCE-IT RENAL analyses, stated, “In the REDUCE-IT RENAL analyses, we not only studied outcomes following icosapent ethyl administration, which were greatly improved, but equally importantly, we also examined the event rates in at-risk patients with compromised renal function, which clearly demonstrate that those patients urgently need additional solutions for cardiovascular risk reduction.”
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