Cardiovascular medicine
An omega-3 polyunsaturated fatty acid concentrate administered
for one year decreased triglycerides in simvastatin treated patients
with coronary heart disease and persisting hypertriglyceridaemia
P N Durrington, D Bhatnagar, M I Mackness, J Morgan, K Julier, M A Khan, M France
University
Department of Medicine, Manchester Royal Infirmary, Oxford Road,
Manchester M13 9WL, UK
Correspondence to: Professor Durrington pdurrington{at}hq.cmht.nwest.nhs.uk
Accepted 12 September
2000
BACKGROUND
Omega-3 fatty acids, such
as those present in fish oil, have been reported to prolong life in
myocardial infarction survivors. These fatty acids can decrease serum
triglyceride concentrations, but so far the doses used in trials
examining their effects on coronary end points have had only minimal
triglyceride lowering effects.
OBJECTIVE
To examine the triglyceride
lowering effectiveness, safety, and tolerability of Omacor, a
concentrate of omega-3, long chain, polyunsaturated fatty acids from
fish oil (84% of the total as opposed to an average of 35% in fish
oil) over one year in patients with established coronary heart disease
(CHD) and persisting hypertriglyceridaemia, despite receiving
simvastatin in doses similar to those employed in the Scandinavian
simvastatin survival study.
SUBJECTS AND METHODS
59 patients with
CHD, receiving simvastatin 10-40 mg daily with serum triglycerides
> 2.3 mmol/l, were randomised to receive Omacor 2 g twice a day or
placebo for 24 weeks in a double blind trial. Forty six patients
accepted the offer of active treatment for a further 24 weeks in an
open phase of the trial.
RESULTS
There was a sustained
significant decrease in serum triglycerides by 20-30% (p < 0.005)
and in very low density lipoprotein (VLDL) cholesterol by 30-40%
(p < 0.005) in patients receiving active Omacor at three, six, and
12 months compared either to baseline or placebo. Omacor did not have
any deleterious effect on low density or high density lipoprotein
cholesterol or on biochemical and haematological safety tests. There
was no adverse effect on glycaemic control in patients with diabetes,
who showed a decrease in serum triglyceride, which was at least as
great as in non-diabetic patients. One patient receiving placebo died
of acute myocardial infarction. Three patients withdrew from the trial
(two on placebo and one on active treatment). Omacor was generally well tolerated.
CONCLUSION
Omacor was found to be a
safe and effective means of lowering serum triglycerides over one year
in patients with CHD and combined hyperlipidaemia, whose triglycerides
remained elevated despite simvastatin treatment.
Keywords: coronary heart disease; hypertriglyceridaemia; polyunsaturated fat; statin treatment
© 2001 by Heart
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