Download Julie Lonsdale, Head of Medicines Performance POSITION

POSITION STATEMENT FOR OMACOR PRESCRIBING IN POST MI PATIENTS
The prescribing of Omacor® in the NHS for patients post MI in primary care in Lancashire is
not recommended.
Overview
NICE clinical guidelines (NICE CG481) mention the use of Omacor® post MI. A detailed
review of the guideline shows that the supporting evidence is not strong for this indication.
The evidence base supporting the recommendation in NICE CG 48 is derived from the
GISSI Prevenzione study2. The trial was published in 1999 and data collection took place in
Italy during the mid to late 90s. During this period, the use of secondary prevention
measures widely used today (e.g. statins, aspirin and beta-blockers) was much lower. There
is also speculation that the positive effects of a Mediterranean diet on the trial population in
combination with a much lower use of alternative secondary prevention measures is likely to
have resulted in the trial overestimating the benefits of Omacor®.
A Cochrane systematic review3 of trials included 36,913 participants and 41 cohort analyses.
Pooled trial results did not show a reduction in the risk of total mortality or combined
cardiovascular events in those taking additional omega 3 fats (with significant statistical
heterogeneity). A sensitivity analysis, which retained only studies at low risk of bias, reduced
heterogeneity and again suggested no significant effect of omega 3 fatty acids.
This position statement was approved by the Cardiac Clinical Advisory Group on 13th March
2013 and the Lancashire Medicines Management Group on the 11th April 2013.
Recommendation
A diet high in omega-3 fatty acids should be encouraged; however, other secondary
prevention measures should be prioritised over Omacor® for the Lancashire population.
Patients should be encouraged to achieve the required level of omega 3 fatty acids by
dietary means rather than through prescribing of Omacor®.
References
1.
2.
3.
NICE clinical guideline 48: Secondary prevention in primary and secondary care for
patients following a myocardial infarction. May 2007
Marchioli R for the GISSI Prevenzione Investigators. Dietary supplementation with n-3
polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the
GISSI-Prevenzione trial. Lancet.1999; 354:447-455.
Cochrane Review. Omega 3 fatty acids for prevention and treatment of cardiovascular
disease. Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No.:
CD003177
April 2013
Julie Lonsdale, Head of Medicines Performance
Review Date: April 2015