Lipid-altering efficacy and safety profile of co-administered extended release niacin/laropiprant and simvastatin versus atorvastatin in patients with mixed hyperlipidemia.

Abstract

BACKGROUND:

Extended-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.

METHODS:

After a 4-week placebo run-in, 2340 patients (LDL-C ≥ 130 and ≤ 190 mg/dL, TG ≥ 150 and ≤ 500 mg/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 80 mg) once daily.

RESULTS:

At 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 40 mg vs. ATORVA 20mg (-10.8%; p<0.001); ATORVA 40 mg (-5.1%; p<0.001); and ATORVA 80 mg (-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 40 mg versus ATORVA 20-mg dose comparisons, but not the ERN/LRPT+SIMVA 40 mg 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.

CONCLUSION:

ERN/LRPT+SIMVA was generally superior to ATORVA in improving lipid parameters after 12 weeks and was generally well tolerated in patients with mixed hyperlipidemia.

• Authors: Fabian Chen, Darbie Maccubbin, Lizhen Yan, Waheeda Sirah, Erluo Chen, Christine McCrary Sisk, Michael Davidson, Peder Blomqvist, James M McKenney
• Journal: International journal of cardiology (Int J Cardiol) Vol. 167 Issue 1 Pg. 225-31 (Jul 15 2013) ISSN: 1874-1754 [Electronic] Netherlands
• PMID: 22305632 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011. Published by Elsevier Ireland Ltd.

Chemical References

• Delayed-Action Preparations
• Heptanoic Acids
• Hypolipidemic Agents
• Indoles
• Lipids
• MK-0524
• Pyrroles
• Niacin
• Atorvastatin
• Simvastatin

Topics

• Adult
• Aged
• Atorvastatin
• Delayed-Action Preparations (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Heptanoic Acids (administration & dosage, adverse effects)
• Humans
• Hyperlipidemias (blood, drug therapy)
• Hypolipidemic Agents (administration & dosage, adverse effects)
• Indoles (administration & dosage, adverse effects)
• Lipids (blood)
• Male
• Middle Aged
• Niacin (administration & dosage)
• Pyrroles (administration & dosage, adverse effects)
• Simvastatin (administration & dosage)
• Treatment Outcome