Prospective randomized comparison between omega-3 fatty acid supplements plus simvastatin versus simvastatin alone in Korean patients with mixed dyslipidemia: lipoprotein profiles and heart rate variability.
BACKGROUND
This study was designed to evaluate the effects of omega-3 fatty acids supplements and simvastatin on lipoproteins and heart rate variability (HRV), a surrogate parameter of cardiac autonomic function, in patients with mixed dyslipidemia.


METHODS
This study was a prospective, randomized, open-label study. Among the 171 patients screened, 62 who met the inclusion criteria after 6 weeks on a strict diet therapy were randomized into two treatment groups. The inclusion criteria were mixed dyslipidemia with a high triglyceride level (200-499 mg per 100 ml) and a total cholesterol level >200 mg per 100 ml. After a run-in period of 6 weeks, the patients were randomized into two groups and given a combination treatment with 4 g of omega-3 fatty acids (four 1 g Omacor (eicosapentaenoic acid, 465 mg; docosahexaenoic acid, 375 mg; other omega-3 fatty acids, 60 mg; others 100 mg, Gun-il Pharmacy, Seoul, Korea)) and 20 mg of simvastatin daily or a monotherapy of 20 mg simvastatin for 6 weeks. In the combination therapy group, seven patients dropped out, and in the simvastatin alone therapy group, five patients dropped out during the study period.


RESULTS
After 6 weeks of drug treatment, triglyceride levels decreased by 41.0% in the combination treatment group and 13.9% in the simvastatin monotherapy group (from 309.2 ± 95 mg per 100 ml to 177.7 ± 66 versus 294.6 ± 78 mg per 100 ml to 238.3 ± 84 mg per 100 ml, respectively, P = 0.0007). No significant changes in the HRV parameters were observed in either group.


CONCLUSIONS
The combination of omega-3 fatty acids plus simvastatin, which achieved a significantly greater reduction of triglycerides without adverse reactions, should be considered as an optimal treatment option for patients with mixed dyslipidemia.
Kim
Sang-Hyun
SH
Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.
Kim
Min-Kyung
MK
Lee
Hae-Young
HY
Kang
Hyun-Jae
HJ
Kim
Yong-Jin
YJ
Kim
Hyo-Soo
HS
D000328:Adult; D000368:Aged; D044466:Asian People; D002784:Cholesterol / Q000097:blood; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000008:administration & dosage; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000188:drug therapy*; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage*; D005260:Female; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage*; D008074:Lipoproteins / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D056910:Republic of Korea; D019821:Simvastatin / Q000008:administration & dosage*; D014280:Triglycerides / Q000097:blood
D004338:Drug Combinations; D015525:Fatty Acids, Omega-3; D000960:Hypolipidemic Agents; D008074:Lipoproteins; D014280:Triglycerides; D004281:Docosahexaenoic Acids; D002784:Cholesterol; D015118:Eicosapentaenoic Acid; D019821:Simvastatin; C405603:Omacor