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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