title: Baseline lipoprotein lipids and low-density lipoprotein cholesterol response to prescription omega-3 acid ethyl ester added to Simvastatin therapy.
abstract: The present post hoc analysis of data from the COMBination of prescription Omega-3 with Simvastatin (COMBOS) study investigated the predictors of the low-density lipoprotein (LDL) cholesterol response to prescription omega-3 acid ethyl ester (P-OM3) therapy in men and women with high (200 to 499 mg/dl) triglycerides during diet plus simvastatin therapy. Subjects (n = 256 randomized) received double-blind P-OM3 4 g/day or placebo for 8 weeks combined with diet and open-label simvastatin 40 mg/day. The percentage of changes from baseline (with diet plus simvastatin) in lipids was evaluated by tertiles of baseline LDL cholesterol and triglyceride concentrations. The baseline LDL cholesterol tertile was a significant predictor of the LDL cholesterol response (p = 0.022 for the treatment by baseline tertile interaction). The median LDL cholesterol response in the P-OM3 group was +9.5% (first tertile, <80.4 mg/dl), -0.9% (second tertile), and -6.4% (third tertile, > or =99.0 mg/dl). Non-high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglyceride responses did not vary significantly by baseline LDL cholesterol tertile. The reductions in very-low-density lipoprotein cholesterol concentrations were greater than the increases in LDL cholesterol, where present, resulting in a net decrease in the concentration of cholesterol carried by atherogenic particles (non-high-density lipoprotein cholesterol) in all baseline LDL cholesterol tertiles. In conclusion, these results suggest that the increase in LDL cholesterol that occurred with the addition of P-OM3 to simvastatin therapy in subjects with mixed dyslipidemia was confined predominantly to those with low LDL cholesterol levels while receiving simvastatin monotherapy.
authors.affiliation: Provident Clinical Research, Glen Ellyn, Illinois, USA. kmaki@providentcrc.com
authors.forename: Kevin C
authors.initials: KC
authors.lastname: Maki
authors.forename: Mary R
authors.initials: MR
authors.lastname: Dicklin
authors.forename: Michael H
authors.initials: MH
authors.lastname: Davidson
authors.forename: Ralph T
authors.initials: RT
authors.lastname: Doyle
authors.forename: Christie M
authors.initials: CM
authors.lastname: Ballantyne
mesh_terms: D000368:Aged; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006949:Hyperlipidemias / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011336:Probability; D018570:Risk Assessment; D012720:Severity of Illness Index; D019821:Simvastatin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D008078:Cholesterol, LDL; D015525:Fatty Acids, Omega-3; D000960:Hypolipidemic Agents; D019821:Simvastatin