Austin, Texas—Patients with kidney disease and elevated high-sensitivity C-reactive protein (hsCRP) are at increased risk for cardiovascular disease. Vascepa® (icosapent ethyl), a high-purity ethyl ester of the omega-3 fatty acid, eicosapentaenoic acid, is approved at 4 g per day as an adjunct to diet to reduce triglycerides in adults with triglyceride level ≥500 mg/dL.
Krishnaswami Vijsyaraghavan, MD, and colleagues conducted an ad hoc analysis of data from the ANCHOR trial to assess participants with reduced kidney function, defined as estimated glomerular filtration rate <90 mL/min/1.73 m2 for ≥3 months, and elevated hsCRP ≥2.0 mg/L at baseline. Results of the analysis were reported during a poster session at the NKF 2018 Spring Clinical Meetings in a poster titled Icosapent Ethyl Reduces Potentially Atherogenic Lipid and Inflammatory Markers in High-Risk Statin-Treated Patients with Persistent High Triglycerides, eGFR <90 mL/min/1.73m2, and Elevated High-Sensitivity C-Reactive Protein ≥2.0 mg/L.
The 12-week ANCHOR trial included 702 randomized patients treated with statins who were at increased risk for cardiovascular disease; triglyceride levels were 200 to 499 mg/dL despite low-density protein cholesterol (LDL-C) control. The ad hoc analysis included 152 ANCHOR participants; mean age was 64 years, 54% were male, and 99% were white. Patients were randomized to icosapent ethyl 4 g per day (n=72) or placebo (n=80).
Triglyceride levels among patients in the icosapent ethyl group were reduced by 16.9% (P<.0001) with no increase in LDL-C, and improvements in other potentially atherogenic and inflammatory parameters compared with patients in the placebo group. At baseline, serum creatinine was 0.9 mg/dL, eGFR was 72.4 mL/min/1.73 m2, and albumin was 4.5 g/dL; corresponding values at 12 weeks were 0.9 mg/dL, 78.5 mL/min/1.73 m2, and 4.4 g/dL (all % change vs placebo, P≥.05). Levels of eicosapentaenoic acid increased by 662.7% in plasma and 622.0% in red blood cells versus placebo (P<.0001 for both).
In conclusion, the researchers said, “In statin-treated patients with reduced kidney function and elevated hsCRP with persistent high triglycerides, icosapent ethyl 4 g/day reduced triglycerides and other atherogenic and inflammatory markers without raising LDL-C vs placebo.”
Source: Vijayaraghavan K, Szelip HM, Ballantyne, CM, et al. Icosapent ethyl reduces potentially atherogenic lipid and inflammatory markers in high-risk statin-treated patients with persistent high triglycerides, eGFR <90 mL/min/1.73 m2, and elevated high-sensitivity C-reactive protein ≥2.0 mg/L. Abstract of a poster presented at the National Kidney Foundation 20187 Spring Clinical Meetings, April 10-14, 2018, Austin, Texas.
The analysis was sponsored by Amarin Pharma, Inc.