Enormous progress has been made in the management of acute myocardial infarction (MI) in the past 35 years.1 By common agreement, however, the single most significant factor contributing to this progress has been the development of an extensive and well-proven repertoire of medical therapies. The use of intravenous thrombolytics, aspirin, beta-blockers and angiotensin-converting enzyme (ACE) inhibitors has had a transforming influence on the immediate- and longer-term prospects for MI patients.
Patients who have survived an acute MI are nevertheless a high-risk group with a life expectancy sometimes half that of their peers who have not experienced a similar event2 and a greatly increased risk for subsequent major cardiovascular events and death.3,4 It is likely, however, that sudden cardiac death is a major contributor to this situation.5 Sudden death has proved resistant to therapeutic innovation to a greater degree than atherothrombotic coronary disease. The need for an effective medical therapy to prevent sudden death is thus clear. A candidate therapy has recently emerged in the form of concentrated and highly purified omega-3 polyunsaturated fatty acids (PUFAs) (omega-3 (or n-3).
In the Gruppo Italiano per lo Studio della Sopravvivenza nell™Infarto Miocardico (GISSI)- Prevenzione study, use of highly purified omega-3 PUFAs at a dose of 1g per day was associated with a 45% reduction in risk of sudden death.7,8 This is an effect size that exceeds that of any other medical therapy studied for impact on sudden death and, importantly, was recorded in a trial in which total mortality was reduced significantly.6,7
The results of GISSI-Prevenzione identify highly purified, concentrated formulations of omega-3 PUFAs as an important addition to the treatment armamentarium in the secondary prevention of MI:
- they address a major unmet need;
- they are easily administered and well tolerated; and
- they are appropriate for the general population of post-MI patients.
OMACOR is one such preparation. On the basis of the GISSI-Prevenzione results, OMACOR has been registered as ├óÔé¼´åİadjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy™, in several countries.9OMACOR is a pharmaceutical preparation of highly purified and concentrated omega-3 PUFAs containing 90% omega-3 PUFAs (omega-3 PUFAs) per gram.
Results of the GISSI - Prevenzione Trial
GISSI-Prevenzione was an investigator-led multicentre study undertaken to examine the impact of highly purified omega-3 PUFAs on outcomes post-MI in the context of contemporary preventive practice. The study was therefore designed to be as inclusive as possible. No age limits were specified and exclusion criteria were kept to a minimum. Patients with a recent MI (├óÔÇ░┬ñ3 months) were eligible to participate in GISSIPrevenzione provided they had no condition associated with poor short-term prognosis, no known contraindications to the study medications and no known congenital coagulation defect.7
Drugs were prescribed according to prevailing standard practice. In addition, patients were encouraged to adhere to recommended preventive measures, including a Mediterranean-style diet with a high content of fruit, fish and fibre, and a relatively low content of saturated fats.
- E Braunwald, ├óÔé¼┼øEvolution of the Management of Acute Myocardial Infarction: A 20th Century Saga├óÔé¼┼Ñ, Lancet, 352 (1998), pp. 1,771├óÔé¼ÔÇ£1,774.
- S Capewell, B M Livingston, K MacIntyre K, et al., ├óÔé¼┼øTrends in Case-fatality in 117,718 Patients Admitted with Acute Myocardial Infarction in Scotland├óÔé¼┼Ñ, Eur. Heart J., 21 (2000), pp. 1,833├óÔé¼ÔÇ£1,840.
- S M Haffner, S Lehto, T R─é┬Ânnemaa, et al., ├óÔé¼┼øMortality from Coronary Heart Disease in Subjects with Type-2 Diabetes and in Non-diabetic Subjects With and Without Prior Myocardial Infarction├óÔé¼┼Ñ, N. Engl. J. Med., 339 (1998), pp. 229├óÔé¼ÔÇ£234.
- F C Lampe, P H Whincup, S G Wannamethee, et al., ├óÔé¼┼øThe Natural History of Prevalent Ischaemic Heart Disease in Middle-aged Men├óÔé¼┼Ñ, Eur. Heart J., 21 (2000), pp. 1,052├óÔé¼ÔÇ£1,062.
- M de Lorgeril and P Salen, ├óÔé¼┼øDiet as Preventive Medicine in Cardiology├óÔé¼┼Ñ, Curr. Opin. Cardiol., 15 (2000), pp. 364├óÔé¼ÔÇ£370.
- S G Priori, E Aliot, C Blomstrom-Lundqvist, et al., ├óÔé¼┼øTask Force on Sudden Cardiac Death of the European Society of Cardiology├óÔé¼┼Ñ, Eur. Heart J., 22 (2001), pp. 1,374├óÔé¼ÔÇ£1,450.
- GISSI-Prevenzione Investigators, ├óÔé¼┼øDietary Supplementation with N-3 Polyunsaturated Fatty Acids and Vitamin E After Myocardial Infarction: Results of the GISSI-Prevenzione Trial├óÔé¼┼Ñ, Lancet, 354 (1999), pp. 447├óÔé¼ÔÇ£455.
- R Marchioli, F Barzi, E Bomba, et al., ├óÔé¼┼øEarly Protection Against Sudden Death by N-3 Polyunsaturated Fatty Acids After Myocardial Infarction: Time-course Analysis of the Results of Gruppo Italiano per lo Studio Della Sopravvivenza nell™Infarto Miocardico (GISSI)-Prevenzione├óÔé¼┼Ñ, Circulation, 105 (2002), pp. 1,897├óÔé¼ÔÇ£1,903.
- Omacor SmPC, Solvay Pharmaceuticals GmBH.
- R Marchioli, on behalf of the GISSI-Prevenzione Investigators, ├óÔé¼┼øTreatment with N-3 Polyunsaturated Fatty Acids After Myocardial Infarction: Results of GISSI-Prevenzione Trial├óÔé¼┼Ñ, Eur. Heart J. Suppl., 3 (2001) (Suppl. D), pp. D85├óÔé¼ÔÇ£D97.
- D Wood, de Backer, O Faergemann, et al., ├óÔé¼┼øPrevention of Coronary Heart Disease in Clinical Practice: Recommendations of the Second Joint Task Force of European and Other Societies on Coronary Prevention├óÔé¼┼Ñ, Eur. Heart J., 19 (1998), pp. 1,434├óÔé¼ÔÇ£1,503.
- M L Burr, ├óÔé¼┼øReflections on the Diet and Reinfarction Trial (DART)├óÔé¼┼Ñ, Eur. Heart J. Suppl., 3 (2001) (Suppl. D), pp. D75├óÔé¼ÔÇ£D78. 13. S C Smith,
- S N Blair, M H Criqui, et al., ├óÔé¼┼øPreventing Heart Attack and Death in Patients with Coronary Disease├óÔé¼┼Ñ, J. Am. Coll. Cardiol., 26 (1995), pp. 292├óÔé¼ÔÇ£294.
- S C Smith, S N Blair, R O Bonow, et al., ├óÔé¼┼øAHA/ACC Guidelines for Preventing Heart Attack and Death in Patients with Atherosclerotic Cardiovascular Disease: 2001 Update. A Statement for Healthcare Professionals from the American Heart Association and the American College of Cardiology├óÔé¼┼Ñ, Circulation, 104 (2001), pp. 1,577├óÔé¼ÔÇ£1,579.
- M G Franzosi, M Brunetti, R Marchioli, et al., ├óÔé¼┼øCost-effectiveness Analysis of N-3 Polyunsaturated Fatty Acids (PUFA) After Myocardial Infarction├óÔé¼┼Ñ, Pharmacoeconomics, 19 (2001), pp. 411├óÔé¼ÔÇ£420.
- T O Tengs , M E Adams, J S Pliskin, et al., ├óÔé¼┼øFive-hundred Life-saving Interventions and Their Cost-effectiveness├óÔé¼┼Ñ, Risk Analysis, 15 (1995), pp. 369├óÔé¼ÔÇ£390.
- G Boriani, M Biffi, C Martignani, et al., ├óÔé¼┼øCost-effectiveness of Implantable Cardioverter-defibrillators├óÔé¼┼Ñ, Eur. Heart J., 22 (2001), pp. 990├óÔé¼ÔÇ£996.