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Highly purified omega-3 polyunsaturated fatty acids are effective as adjunct therapy for secondary prevention of myocardial infarction.
Herz. 2006 Dec; 31 Suppl 3:49-59.HERZ

Abstract

Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI)-Prevenzione was the first large randomized trial to produce evidence that a pharmaceutical preparation of highly purified omega-3 polyunsaturated fatty acids (PUFAs), administered as an adjunct to other accepted interventions, had a favorable effect on hard clinical end-points in post-myocardial infarction patients. Much of the 20% all-cause mortality benefit recorded during the study could be attributed to a 45% reduction in sudden death--a fatal outcome that traditionally has proved resistant to medical intervention. These results were obtained with an omega-3 PUFA dose of 1 g/day, which is much lower than was routinely being used at the time the study was initiated (e.g. 4 g/day for hypertriglyceridemia). One consequence of this low-dose regimen was that the tolerability profile of omega-3 PUFAs during GISSI-Prevenzione was considered highly satisfactory, with low adverse event incidence rates and low rates of discontinuation due to adverse events. Time-course analysis established that much of the survival benefit of omega-3 PUFA treatment in GISSI-Prevenzione was realized during the early months of the trial. The beneficial effects of omega-3 PUFA treatment were observed on top of standard, secondary pharmacological prevention therapy like anti-platelet agents, statins, beta-blockers and angiotensin-converting enzyme (ACE) inhibitors. The benefits of omega-3 PUFA therapy were also apparent in patients at all standards of adherence to a healthy diet and may have been augmented in patients with the best dietary profile. Patients with diabetes mellitus (approximately 15% of the study cohort) appeared to benefit from omega-3 PUFAs to at least the same extent as the general study population; the treatment effect on sudden death was progressively more pronounced as left ejection fraction declined. Cost-effectiveness analyses undertaken from a third-party payer perspective for Italy revealed that the cost of low-dose treatment with highly purified omega-3 PUFAs was approximately Euro 25,000 per life-year gained.

Authors+Show Affiliations

Solvay Pharmaceuticals, Hannover, Germany.No affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

17575805

Citation

Verboom, Cees N., and Critical Analysis of GISSI-Prevenzione Trial. "Highly Purified Omega-3 Polyunsaturated Fatty Acids Are Effective as Adjunct Therapy for Secondary Prevention of Myocardial Infarction." Herz, vol. 31 Suppl 3, 2006, pp. 49-59.
Verboom CN, Critical Analysis of GISSI-Prevenzione Trial. Highly purified omega-3 polyunsaturated fatty acids are effective as adjunct therapy for secondary prevention of myocardial infarction. Herz. 2006;31 Suppl 3:49-59.
Verboom, C. N. (2006). Highly purified omega-3 polyunsaturated fatty acids are effective as adjunct therapy for secondary prevention of myocardial infarction. Herz, 31 Suppl 3, 49-59.
Verboom CN, Critical Analysis of GISSI-Prevenzione Trial. Highly Purified Omega-3 Polyunsaturated Fatty Acids Are Effective as Adjunct Therapy for Secondary Prevention of Myocardial Infarction. Herz. 2006;31 Suppl 3:49-59. PubMed PMID: 17575805.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Highly purified omega-3 polyunsaturated fatty acids are effective as adjunct therapy for secondary prevention of myocardial infarction. AU - Verboom,Cees N, AU - ,, PY - 2007/6/20/pubmed PY - 2007/7/12/medline PY - 2007/6/20/entrez SP - 49 EP - 59 JF - Herz JO - Herz VL - 31 Suppl 3 N2 - Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI)-Prevenzione was the first large randomized trial to produce evidence that a pharmaceutical preparation of highly purified omega-3 polyunsaturated fatty acids (PUFAs), administered as an adjunct to other accepted interventions, had a favorable effect on hard clinical end-points in post-myocardial infarction patients. Much of the 20% all-cause mortality benefit recorded during the study could be attributed to a 45% reduction in sudden death--a fatal outcome that traditionally has proved resistant to medical intervention. These results were obtained with an omega-3 PUFA dose of 1 g/day, which is much lower than was routinely being used at the time the study was initiated (e.g. 4 g/day for hypertriglyceridemia). One consequence of this low-dose regimen was that the tolerability profile of omega-3 PUFAs during GISSI-Prevenzione was considered highly satisfactory, with low adverse event incidence rates and low rates of discontinuation due to adverse events. Time-course analysis established that much of the survival benefit of omega-3 PUFA treatment in GISSI-Prevenzione was realized during the early months of the trial. The beneficial effects of omega-3 PUFA treatment were observed on top of standard, secondary pharmacological prevention therapy like anti-platelet agents, statins, beta-blockers and angiotensin-converting enzyme (ACE) inhibitors. The benefits of omega-3 PUFA therapy were also apparent in patients at all standards of adherence to a healthy diet and may have been augmented in patients with the best dietary profile. Patients with diabetes mellitus (approximately 15% of the study cohort) appeared to benefit from omega-3 PUFAs to at least the same extent as the general study population; the treatment effect on sudden death was progressively more pronounced as left ejection fraction declined. Cost-effectiveness analyses undertaken from a third-party payer perspective for Italy revealed that the cost of low-dose treatment with highly purified omega-3 PUFAs was approximately Euro 25,000 per life-year gained. SN - 0340-9937 UR - https://www.unboundmedicine.com/medline/citation/17575805/Highly_purified_omega_3_polyunsaturated_fatty_acids_are_effective_as_adjunct_therapy_for_secondary_prevention_of_myocardial_infarction_ L2 - https://medlineplus.gov/heartattack.html DB - PRIME DP - Unbound Medicine ER -