by Craig Weatherby

The positive results of a clinical trial from Korea add to the extensive research linking omega-3 fatty acids from fish (EPA and DHA) to reduced cardiovascular risks.
Persuasive evidence suggests that people who consume more omega-3s than their peers are substantially less likely to suffer a stroke or a second heart attack (The evidence is weaker for preventing a first heart attack).
Omega-3s also reduce the risk of “sudden cardiac death” …the class of fatal cardiac incidents that result from an arrhythmia and account for half of all heart-related mortalities (Mozaffarian D 2008).
Higher intakes of omega-3s have been linked to improvements in key risk factors for heart disease or death, including blood lipid (fat and cholesterol) profiles, tendency toward thrombosis (clotting), high blood pressure, arrhythmias, and vascular function.
And a growing body of evidence suggests that lifestyle changesincluding increased omega-3 intake from fatty fish or fish oil supplementscan rival the effects of statins:

The positive outcomes of seven clinical trials published during the past decade indicate that omega-3s can further improve blood lipid profiles in patients already taking a statin drug (Durrington PN et al. 2001; Hong H et al. 2004; Davidson MH et al. 2007; Maki KC et al. 2008; Bays HE et al. 2010; Bays HE et al. 2010; Maki KC et al. 2010)
These additional benefits include sharper drops in patients' triglyceride levels, as well as sharper reductions in blood levels of all “non-HDL” cholesterol… a change known to reduce the risk of adverse cardiovascular events more than the reductions in total and “bad” (LDL and VLDL) cholesterol delivered by statin drugs.
There may be limits to how much additional risk-reduction omega-3s can provide to patients who are already taking an “optimal” combination of drugs, including… see “Omega-3s Can't Boost Heart Patients' Drug Cocktail”.
But it's safer to combine omega-3s and statins than to combine statins with other prescription drugs used in “combo therapy” (e.g., fibrates).
And diets rich in omega-3s benefit vascular, brain, immune, and metabolic health as well as heart health… so they make sense even for heart patients who are already receiving optimal drug therapy.
Clinical trial confirms benefit of adding omega-3s to statin therapy
Researchers at Seoul National University Hospital recruited 62 people with mixed dyslipidemia for a partially controlled (randomized, open-label) clinical trial lasting six weeks
The term “mixed dyslipidemia” means a deadly combination of low levels of HDL (“good”) cholesterol and high levels of triglycerides and LDL (“bad”) cholesterol.
Mixed dyslipidemia is most often seen in people suffering from or developing obesity or diabetes, and metabolic syndrome … and it's associated with a significantly increased risk of cardiovascular disease.
Statin drugs alone cannot “cure” mixed dyslipidemia, because high levels of triglycerides and low levels of HDL cholesterol usually persist even after a statin drug lowers a patient's high LDL levels.
The participants were divided into two groups, each assigned to a different daily regimen:
  • Control Group – 20mg of simvastatin (Zocor)
  • Test Group – 20mg of simvastatin (Zocor) plus 4 grams of omega-3s (1.86 grams EPA + 1.4 grams DHA).
There were seven dropouts from the combination therapy group and five from the simvastatin-only group … with compliance being good among the 50 remaining participants.
After six weeks, blood levels of triglycerides dropped by 41 percent in the omega-3 + statin group, versus only 13.9 percent in the statin-only group.
As the authors wrote, “The combination of omega-3 fatty acids plus simvastatin, which achieved a significantly greater reduction of triglycerides [than simvastatin alone] without adverse reactions, should be considered as an optimal treatment option for patients with mixed dyslipidemia.” (Kim SH et al. 2010)
Additionally, both groups showed significant reductions in LDL (“bad”) cholesterol levels, while neither group showed reductions in HDL (“good”) cholesterol levels.
The Korean team penned a clear conclusion:

“… a combination therapy of omega-3 fatty acids and simvastatin showed few adverse events. Thus, it could be considered as good therapeutic choice for patients with mixed dyslipidemia, lowering triglycerides by 40 percent without mitigating [reducing] LDL [“bad”] cholesterol reduction by statins.”
The study was funded by the Innovative Research Institute for Cell Therapy (IRICT) and the Clinical Research Center for Ischemic Heart Disease in South Korea.
  • Bays HE, Maki KC, McKenney J, Snipes R, Meadowcroft A, Schroyer R, Doyle RT, Stein E. Long-term up to 24-month efficacy and safety of concomitant prescription omega-3-acid ethyl esters and simvastatin in hypertriglyceridemic patients. Curr Med Res Opin. 2010 Apr;26(4):907-15.

  • Bays HE, McKenney J, Maki KC, Doyle RT, Carter RN, Stein E. Effects of prescription omega-3-acid ethyl esters on non--high-density lipoprotein cholesterol when coadministered with escalating doses of atorvastatin. Mayo Clin Proc. 2010 Feb;85(2):122-8.

  • Davidson MH, Stein EA, Bays HE, Maki KC, Doyle RT, Shalwitz RA, Ballantyne CM, Ginsberg HN; COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators. Efficacy and tolerability of adding prescription omega-3 fatty acids 4 g/d to simvastatin 40 mg/d in hypertriglyceridemic patients: an 8-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2007 Jul;29(7):1354-67.

  • Durrington PN, Bhatnagar D, Mackness MI, Morgan J, Julier K, Khan MA, France M. An omega-3 polyunsaturated fatty acid concentrate administered for one year decreased triglycerides in simvastatin treated patients with coronary heart disease and persisting hypertriglyceridaemia. Heart. 2001 May;85(5):544-8.

  • Hong H, Xu ZM, Pang BS, Cui L, Wei Y, Guo WJ, Mao YL, Yang XC. Effects of simvastain combined with omega-3 fatty acids on high sensitive C-reactive protein, lipidemia, and fibrinolysis in patients with mixed dyslipidemia. Chin Med Sci J. 2004 Jun;19(2):145-9.

  • Kim SH, Kim MK, Lee HY, Kang HJ, Kim YJ, Kim HS. 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. Eur J Clin Nutr. 2010 Sep 29. [Epub ahead of print]

  • Maki KC, Dicklin MR, Davidson MH, Doyle RT, Ballantyne CM; COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators. Baseline lipoprotein lipids and low-density lipoprotein cholesterol response to prescription omega-3 acid ethyl ester added to Simvastatin therapy. Am J Cardiol. 2010 May 15;105(10):1409-12. Epub 2010 Mar 30.

  • Maki KC, McKenney JM, Reeves MS, Lubin BC, Dicklin MR. 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. Am J Cardiol. 2008 Aug 15;102(4):429-33. Epub 2008 May 22. Erratum in: Am J Cardiol. 2008 Nov 15;102(10):1425.

  • Mozaffarian D. Fish and n-3 fatty acids for the prevention of fatal coronary heart disease and sudden cardiac death. Am J Clin Nutr. 2008 Jun;87(6):1991S-6S.