TY - JOUR
T1 - Prescription omega-3 acid ethyl esters plus simvastatin 20 and 80 mg
T2 - effects in mixed dyslipidemia
AU - Maki, Kevin C.
AU - Lubin, Barry C.
AU - Reeves, Matthew S.
AU - Dicklin, Mary R.
AU - Harris, William S.
N1 - Funding Information:
This study was funded as an Investigator Initiated Trial by GlaxoSmithKline Pharmaceuticals, Research Triangle Park, NC. Drs. Maki and Harris have received research funding and consulting/speaking fees from GlaxoSmithKline Pharmaceuticals. Drs. Lubin and Reeves have received research funding from GlaxoSmithKline Pharmaceuticals. Dr. Dicklin has no conflicts of interest to report.
PY - 2009/2
Y1 - 2009/2
N2 - Background: Prescription omega-3 acid ethyl esters (P-OM3) plus simvastatin 20 and 40 mg/day improves lipids in subjects with mixed dyslipidemia, but no previous studies have examined P-OM3 with the maximum prescribed dose of simvastatin (80 mg). Objective: To assess the effects of P-OM3 + simvastatin 80 mg versus P-OM3 + simvastatin 20 mg or placebo + simvastatin 20 mg on non-high-density lipoprotein cholesterol (non-HDL-C) and other lipid concentrations. Methods: Subjects with mixed dyslipidemia who had completed a 12-week double-blind crossover study of simvastatin 20 mg/day + either placebo or P-OM3 4 g/day were enrolled. An analysis (n = 14) was performed following the first six weeks of the extension, during which all subjects received open-label P-OM3 + open-label simvastatin 80 mg/day. Results: P-OM3 + simvastatin 80 mg resulted in significantly larger reductions from baseline (P < .05 for all) versus P-OM3 + simvastatin 20 mg and placebo + simvastatin 20 mg, respectively, for non-HDL-C (-51.0%, -40.8%, -34.9%), low-density lipoprotein cholesterol (-48.0%, -35.5%, -38.0%), total cholesterol (TC) (-42.6%, -31.9%, -27.1%), the TC/HDL-C ratio (-52.9%, -44.3%, -36.2%), and apolipoprotein B (-42.6%, -32.6%, -30.5%). P-OM3 + simvastatin (80- and 20-mg doses, respectively) resulted in significantly larger changes from baseline (P < .05 for all) versus placebo in very low-density lipoprotein cholesterol (-50.7%, -47.9%, -23.0%), triglycerides (TG; -58.6%, -54.7%, -32.0%), HDL-C (24.5%, 20.7%, 17.9%), and the TG/HDL-C ratio (-66.5%, -62.3%, -42.5%). Conclusion: These results suggest non-HDL-C, TG (both 50% to 60%), and HDL-C (∼25%) concentrations can be markedly improved by a combination of P-OM3 (4 g/day) and simvastatin (80 mg/day) in subjects with mixed dyslipidemia.
AB - Background: Prescription omega-3 acid ethyl esters (P-OM3) plus simvastatin 20 and 40 mg/day improves lipids in subjects with mixed dyslipidemia, but no previous studies have examined P-OM3 with the maximum prescribed dose of simvastatin (80 mg). Objective: To assess the effects of P-OM3 + simvastatin 80 mg versus P-OM3 + simvastatin 20 mg or placebo + simvastatin 20 mg on non-high-density lipoprotein cholesterol (non-HDL-C) and other lipid concentrations. Methods: Subjects with mixed dyslipidemia who had completed a 12-week double-blind crossover study of simvastatin 20 mg/day + either placebo or P-OM3 4 g/day were enrolled. An analysis (n = 14) was performed following the first six weeks of the extension, during which all subjects received open-label P-OM3 + open-label simvastatin 80 mg/day. Results: P-OM3 + simvastatin 80 mg resulted in significantly larger reductions from baseline (P < .05 for all) versus P-OM3 + simvastatin 20 mg and placebo + simvastatin 20 mg, respectively, for non-HDL-C (-51.0%, -40.8%, -34.9%), low-density lipoprotein cholesterol (-48.0%, -35.5%, -38.0%), total cholesterol (TC) (-42.6%, -31.9%, -27.1%), the TC/HDL-C ratio (-52.9%, -44.3%, -36.2%), and apolipoprotein B (-42.6%, -32.6%, -30.5%). P-OM3 + simvastatin (80- and 20-mg doses, respectively) resulted in significantly larger changes from baseline (P < .05 for all) versus placebo in very low-density lipoprotein cholesterol (-50.7%, -47.9%, -23.0%), triglycerides (TG; -58.6%, -54.7%, -32.0%), HDL-C (24.5%, 20.7%, 17.9%), and the TG/HDL-C ratio (-66.5%, -62.3%, -42.5%). Conclusion: These results suggest non-HDL-C, TG (both 50% to 60%), and HDL-C (∼25%) concentrations can be markedly improved by a combination of P-OM3 (4 g/day) and simvastatin (80 mg/day) in subjects with mixed dyslipidemia.
KW - Dyslipidemia
KW - Hypercholesterolemia
KW - Omega-3 fatty acids
KW - Statins
KW - Triglycerides
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U2 - 10.1016/j.jacl.2008.12.007
DO - 10.1016/j.jacl.2008.12.007
M3 - Article
C2 - 21291786
AN - SCOPUS:59249107912
VL - 3
SP - 33
EP - 38
JO - Journal of Clinical Lipidology
JF - Journal of Clinical Lipidology
SN - 1933-2874
IS - 1
ER -