| Highly purified omega-3 polyunsaturated fatty acids are effective as adjunct therapy for secondary prevention of myocardial infarction. | |
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MedLine Citation:
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PMID: 17575805 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Cees N Verboom; |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Herz Volume: 31 Suppl 3 ISSN: 0340-9937 ISO Abbreviation: Herz Publication Date: 2006 Dec |
Date Detail:
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Created Date: 2007-06-19 Completed Date: 2007-07-11 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 7801231 Medline TA: Herz Country: Germany |
Other Details:
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Languages: eng Pagination: 49-59 Citation Subset: IM |
Affiliation:
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Solvay Pharmaceuticals, Hannover, Germany. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Chemotherapy, Adjuvant Dietary Fats / therapeutic use* Fatty Acids, Omega-3 / economics, therapeutic use* Female Humans Italy / epidemiology Male Middle Aged Myocardial Infarction / drug therapy, economics, epidemiology*, prevention & control* Randomized Controlled Trials as Topic Risk Assessment / methods* Risk Factors Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Dietary Fats; 0/Fatty Acids, Omega-3 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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