title: Effects of adding prescription omega-3 acid ethyl esters to simvastatin (20 mg/day) on lipids and lipoprotein particles in men and women with mixed dyslipidemia.
abstract: Prescription omega-3 acid ethyl esters (P-OM3) are commonly used for treatment of very high triglyceride levels, often in combination with a statin, to lower persistent hypertriglyceridemia. This randomized, crossover trial evaluated 6 weeks of combination therapy with simvastatin 20 mg/day plus P-OM3 4 g/day or placebo in 39 men and women (average age 58 years) with a triglyceride concentration 200 to 600 mg/dl and non-high-density lipoprotein (non-HDL) cholesterol greater than their National Cholesterol Education Program treatment goals after a 5-week diet lead-in. Non-HDL cholesterol decreased from baseline (209 mg/dl) by 40% for P-OM3 + simvastatin compared with 34% for placebo + simvastatin (p <0.001). Favorable changes for P-OM3 + simvastatin versus placebo + simvastatin were also observed for very low-density lipoprotein (VLDL) cholesterol (-42% vs -22%), triglyceride (-44% vs -29%), total cholesterol (-31% vs -26%), HDL cholesterol (+16% vs +11%), apolipoprotein B (-32% vs -28%), total cholesterol:HDL cholesterol ratio (-39% vs -33%), triglyceride:HDL cholesterol ratio (-51% vs -37%), and systolic (-5.0 vs 0.3 mm Hg) and diastolic (-3.3 vs -1.8 mm Hg) blood pressures (p <0.05 for all). VLDL particle concentration and size decreased and LDL particle size increased significantly more with P-OM3 + simvastatin than with placebo + simvastatin (all p <0.05). Changes in LDL cholesterol, LDL particle concentration, HDL particle size and concentration, and apolipoprotein A-I did not differ significantly between treatments. In conclusion, P-OM3 + simvastatin appears to be a useful therapeutic option for the management of mixed dyslipidemia.
authors.affiliation: Provident Clinical Research, Glen Ellyn, Illinois, USA. KMAKI@ProvidentCRC.com
authors.forename: Kevin C
authors.initials: KC
authors.lastname: Maki
authors.forename: James M
authors.initials: JM
authors.lastname: McKenney
authors.forename: Matthew S
authors.initials: MS
authors.lastname: Reeves
authors.forename: Barry C
authors.initials: BC
authors.lastname: Lubin
authors.forename: Mary R
authors.initials: MR
authors.lastname: Dicklin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D008076:Cholesterol, HDL / Q000187:drug effects; D015243:Cholesterol, VLDL / Q000187:drug effects; D018592:Cross-Over Studies; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000188:drug therapy; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015228:Hypertriglyceridemia / Q000097:blood / Q000188:drug therapy*; D008074:Lipoproteins / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D012737:Sex Factors; D019821:Simvastatin / Q000627:therapeutic use*; D013997:Time Factors; D014280:Triglycerides / Q000097:blood
chemical_list: D000924:Anticholesteremic Agents; D008076:Cholesterol, HDL; D015243:Cholesterol, VLDL; D015525:Fatty Acids, Omega-3; D008074:Lipoproteins; D014280:Triglycerides; D019821:Simvastatin