Highly Purified Omega-3 Fatty Acids for Secondary Prevention of Sudden Cardiac Death After Myocardial Infarction—Aims and Methods of the OMEGA-Study (original) (raw)
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Omega-3 fatty acids, acute coronary syndrome, and sudden death
2008
Omega-3 fatty acids (FAs) are currently recommended to reduce the risk of cardiovascular diseases. These recommendations are based on randomized trials, prospective cohort studies, and case-control data and are supported by experimental studies in humans, animals, and isolated cells. Raising tissue levels of omega-3 FAs reduces the risk of sudden cardiac death, most likely due to reduced susceptibility to fatal arrhythmias, but the effect of these FAs on the risk of myocardial infarction per se is less clear. Reductions in nonfatal events have not typically been seen in randomized trials, but case-control and prospective cohort studies support such an effect. Future studies should assess tissue levels of omega-3 FAs to more precisely estimate exposure and to more clearly define the relations between omega-3 status and the risk of fatal or nonfatal cardiovascular diseases.
Exploring newer cardioprotective strategies: ω-3 fatty acids in perspective
Thrombosis and haemostasis, 2010
In the 1980s, observational retrospective studies showed an inverse relation between coronary heart disease (CHD) and consumption of fish containing fatty acids that belong to the omega (ω)-3 family. Large case-control studies and prospective intervention trials consistently showed that ω-3 fatty acids supplementation lowers fatal myocardial infarction (MI) and sudden cardiac death. By analysing the strengths of the results of individual studies and how the meta-analyses agree with them, putting together relevant backgrounds, and identifying open questions, the following findings/directions emerge. (i) Dietary and non-dietary intake of ω-3 fatty acids reduces overall mortality, mortality due to MI, and sudden death in patients with CHD; (ii) Fish oil consumption directly or indirectly affects cardiac electrophysiology. Fish oil reduces heart rate, a major risk factor for sudden death; (iii) Among patients with implantable cardioverter defibrillators, ω-3 fatty acids do not reduce th...
BMC Cardiovascular Disorders, 2019
Background: The purpose of this review is to examine the effect of Omega-3 Fatty acids on mortality, morbidity, and adverse events in patients with acute myocardial infarction (AMI). Methods: Data Sources: MEDLINE, EMBASE, and the Cochrane Library through May 2018. Study Selection: Randomized Controlled trials (RCT). Certainty of evidence was assessed with the GRADE system. Interventions: omega 3 fatty acids against placebo or no treatment. Primary and secondary outcomes: All-cause death, cardiovascular death, new AMI, stroke, need for therapeutic angioplasty or Bypass , new diagnosis of cancer and incidence of adverse events. Results: For the efficacy endpoints we included 10 RCT (24,414 patients). Omega 3 fatty acids probably make little or no difference to all-cause mortality (4 studies 9141 patients RR 1.06-CI95% 0.90 to 1.27, moderate certainty), cardiovascular mortality (3 studies 4304 patients RR 0.93-CI95% 0.63 to 1.37, moderate certainty), new AMI (RR 1.24 CI95% 0.71 to 2.14-moderate certainty), any cardiovascular event (RR 0.95 95%CI 0.86 to 1.05; low certainty due to risk of bias and imprecision), and stroke (RR 1.2 95%CCI 0,66-2,19-moderate certainty). Regarding adverse events, we are uncertain if Omega 3 fatty acids improve/reduce non severe adverse events (RR 1.39 95% CI 0.36 to 5.34; very low certainty). There is probably little or no difference in the outcome suspension due to adverse events (RR 1. 19 CI 95% 0.97 to 1.47; moderate certainty). Conclusions: For adult patients with AMI, omega 3 fatty-acids probably yield no benefit to patient important outcomes.
Early Protection Against Sudden Death by n-3 Polyunsaturated Fatty Acids After Myocardial Infarction
Circulation, 2002
Background — Our purpose was to assess the time course of the benefit of n-3 polyunsaturated fatty acids (PUFAs) on mortality documented by the GISSI-Prevenzione trial in patients surviving a recent (<3 months) myocardial infarction. Methods and Results — In this study, 11 323 patients were randomly assigned to supplements of n-3 PUFAs, vitamin E (300 mg/d), both, or no treatment (control) on top of optimal pharmacological treatment and lifestyle advice. Intention-to-treat analysis adjusted for interaction between treatments was carried out. Early efficacy of n-3 PUFA treatment for total, cardiovascular, cardiac, coronary, and sudden death; nonfatal myocardial infarction; total coronary heart disease; and cerebrovascular events was assessed by right-censoring follow-up data 12 times from the first month after randomization up to 12 months. Survival curves for n-3 PUFA treatment diverged early after randomization, and total mortality was significantly lowered after 3 months of tre...
Heart & Lung: The Journal of Acute and Critical Care, 2013
Introduction: Omega-3 polyunsaturated fatty acids (PUFA) have demonstrated to have antiarrhythmic properties. However, randomized studies have shown inconsistent results. Objective: We aimed to analyze the effect of omega-3 PUFA on preventing potentially fatal ventricular arrhythmias and sudden cardiac death. Methods: Randomized trials comparing omega-3 PUFA to placebo and reporting sudden cardiac death (SCD) or first implanted cardioverter-defibrillator (ICD) event for ventricular tachycardia or fibrillation were included in this study. A meta-analysis using a random effects model was performed and results were expressed in terms of Odds Ratio (OR) and 95% Confidence Interval (CI) after evaluating for interstudy heterogeneity using I 2. The reported data were extracted on the basis of the intention-to-treat principle. Results: A total of 32,919 patients were included in nine trials; 16,465 patients received omega-3 PUFA and 16,454 received placebo. When comparing omega-3 PUFA to placebo, there was nonsignificant risk reduction of SCD or ventricular arrhythmias (OR ¼ 0.82 [95% CI: 0.60e1.21], p ¼ 0.21 I 2 ¼ 49.7%). Conclusion: Dietary supplementation with omega-3 PUFA does not affect the risk of SCD or ventricular arrhythmias.
Atherosclerosis Supplements, 2013
Background: Although omega-3 fatty acids have well documented properties which would reduce the cardiovascular (CV) disease risk, the evidence from randomized controlled trials (RCTs) remains inconclusive. We performed a meta-analysis of the available RCTs for investigating the CV preventive effect of administrating at least 1 gram/day, and for at least 1 year, omega-3 fatty acid supplements to patients with existing CV disease. Methods: RCTs published up to March 2013 were searched from PubMed, EMBASE, and the Cochrane Library. Two of us independently reviewed and selected eligible trials. Results: Of 360 articles retrieved, 11 randomized, double-blind, placebo controlled trials fulfilling inclusion criteria, overall involving 15,348 patients with a history of CV disease, were considered in the final analyses. No statistically significant association was observed for all-cause mortality (RR, 0.89; 95% CI, 0.78 to 1.02) and stroke (RR, 1.31; 95% CI, 0.90 to 1.90). Conversely, statistically significant protective effects were observed for cardiac death (RR, 0.68; 95% CI, 0.56 to 0.83), sudden death (RR, 0.67; 95% CI, 0.52 to 0.87), and myocardial infarction (RR, 0.75; 95% CI, 0.63 to 0.88). Conclusion: Overall, our results supply evidence that long-term effect of high dose omega-3 fatty acid supplementation may be beneficial for the onset of cardiac death, sudden death and myocardial infarction among patients with a history of cardiovascular disease.
Omega-3 Fatty Acids and Cardiovascular Diseases
Since the expeditions to Greenland by Bang and Dyerberg starting in the late 1960s, a diet rich of omega-3 fatty acids was suggested as the main responsible for the very low incidence of myocardial infarction in the Inuit population when compared to Danish controls. A few decades after, omega-3 fatty acids have been reported as associated with an antiatherogenic blood lipid pattern, reduced platelet reactivity, and fewer cardiovascular events. Proposed mechanisms for the protective role of omega 3 fats against cardiovascular diseases include blood pressure lowering; altered lipid profile, especially reduced serum triglyceride concentration; reduced thrombotic tendency; antiinflammatory effects; anti-arrhythmic effects including heart rate reduction; improved vascular endothelial function; increased plaque stability; increased paraoxonase levels and improved insulin sensitivity. Unfortunately, while previous randomized clinical trials presented some enthusiastic results regarding a strong positive role of omega-3 fatty acids in preventing death, myocardial infarction, stroke and ventricular arrhythmias, recent ones failed to confirm such benefits on broader populations. Moreover, different dosages of either eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) or both, administered either through dietary counseling or tablet supplement, were used while collecting evidences. Systematic reviews and meta-analyses added further confusion to the existing controversy as they often reported conflicting findings.
European Journal of Clinical Pharmacology, 2008
Purpose Current strategies for avoiding atrial fibrillation (AF) are of limited value. We aim to assess the relationship between omega-3 fatty acids (n-3 PUFA) and AF occurrence in post-myocardial infarction (MI) patients. Methods A population study, linking hospital discharge records, prescription databases, and vital statistics, was conducted and included all consecutive patients with MI (ICD-9: 410) in six Italian local health authorities over a 3year period. A propensity score (PS)-based, 5-to-1, greedy 1:1 matching algorithm was used to check consistency of results. Sensitivity analysis was performed to assess the robustness of findings. Results N-3 PUFA reduced the relative risk of the hospitalization for AF [hazard ratio (HR) 0.19, 95% CI 0.07-0.51] and was associated with a further and complementary reduction in all-cause mortality (HR 0.15, 95% CI 0.05-0.46). PS-based matched analysis and sensitivity analysis confirmed the main results. Conclusion n-3 PUFA reduced both all-cause mortality and incidence of 1-year AF in patients hospitalized with MI.
Omega 3 Fatty Acids and Cardiovascular Outcomes
Circulation: Cardiovascular Quality and Outcomes, 2012
Background— Early trials evaluating the effect of omega 3 fatty acids (ω-3 FA) reported benefits for mortality and cardiovascular events but recent larger studies trials have variable findings. We assessed the effects of ω-3 FA on cardiovascular and other important clinical outcomes. Methods and Results— We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials for all randomized studies using dietary supplements, dietary interventions, or both. The primary outcome was a composite of cardiovascular events (mostly myocardial infarction, stroke, and cardiovascular death). Secondary outcomes were arrhythmia, cerebrovascular events, hemorrhagic stroke, ischemic stroke, coronary revascularization, heart failure, total mortality, nonvascular mortality, and end-stage kidney disease. Twenty studies including 63030 participants were included. There was no overall effect of ω-3 FA on composite cardiovascular events (relative risk [RR]=0.96; 95% confidence interval [C...