Abstract
BackgroundExtended-release niacin/laropiprant (ERN/LRPT) reduces flushing and preserves the lipid-modifying effects of ERN. This study compared the efficacy and safety of ERN/LRPT plus simvastatin (ERN/LRPT+SIMVA) with atorvastatin (ATORVA) in patients with mixed hyperlipidemia. MethodsAfter a 4-week placebo run-in, 2340 patients (LDL-C ≥130 and ≤190mg/dL, TG≥150 and ≤500mg/dL and above NCEP ATP III risk-based LDL-C goal) were randomized to 1 of 6 treatment arms: ERN/LRPT 1g/20mg+SIMVA (10 or 20mg), or ATORVA (10, 20, 40, or 80mg) once daily. ResultsAt Week 12, ERN/LRPT+SIMVA was superior to ATORVA in decreasing LDL-C/HDL-C (primary endpoint) at each pre-specified dose comparison: ERN/LRPT+SIMVA 20mg vs. ATORVA 10mg (−13.2%; p<0.001); ERN/LRPT+SIMVA 40mg vs. ATORVA 20mg (−10.8%; p<0.001); ATORVA 40mg (−5.1%; p<0.001); and ATORVA 80mg (−4.2%; p=0.007). At Week 12, ERN/LRPT+SIMVA was superior to ATORVA in increasing HDL-C and reducing TG for all pre-specified treatment comparisons, and reducing non-HDL-C and LDL-C for the ERN/LRPT+SIMVA 20mg versus ATORVA 10mg and ERN/LRPT+SIMVA 40mg versus ATORVA 20-mg dose comparisons, but not the ERN/LRPT+SIMVA 40mg versus ATORVA 40- and 80-mg dose comparisons. Adverse experiences (AEs) typically associated with niacin (flushing, pruritus, increased glucose, increased uric acid) were more common with ERN/LRPT+SIMVA, and hepatic-related laboratory AEs were more common with ATORVA. ConclusionERN/LRPT+SIMVA was generally superior to ATORVA in improving lipid parameters after 12weeks and was generally well tolerated in patients with mixed hyperlipidemia.
Published Version
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