Highly Purified Omega-3 Fatty Acids for Secondary Prevention of Sudden Cardiac Death After Myocardial Infarction—Aims and Methods of the OMEGA-Study

Rauch, Bernhard; Schiele, Rudolf; Schneider, Steffen; Gohlke, H.; Diller, Frank; Gottwik, Martin; Steinbeck, Gerhard; Heer, Tobias; Katus, Hugo A.; Zimmer, R.; Erdoğan, Ali; Pfafferott, C.

doi:10.1007/s10557-006-0495-6

Cited by 44 publications

(22 citation statements)

References 66 publications

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“…Burr et al [34] based on a trial of 3114 men with angina, suggested that patients treated with fish oil capsules had a higher risk of sudden cardiac death than untreated control subjects [34]. A Norwegian study by Nilson et al [35] did not show a benefit of ω-3 PUFA supplementation in post-MI patients and in the recently presented OMEGA trial, consisting of 3851 patients with AMI from 104 centers in Germany, EPA/DHA did not show any further benefit on primary or secondary prevention when given together with other specific treatments (e.g., aspirin, clopidogrel, statins, betablockers, and angiotensin-converting enzyme inhibitors) [36].…”

Section: Polyunsaturated Fatty Acidsmentioning

confidence: 96%

Nutraceuticals and Atherosclerosis: Human Trials

Badimon

Vilahur

Padró

2010

Cardiovascular Therapeutics

194

111

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The high prevalence of obesity, atherosclerosis, and cardiovascular disease (CVD) is largely attributable to the contemporary lifestyle that is often sedentary and includes a diet high in saturated fats and sugars and low ingestion polyunsaturated fatty acids (PUFAs), fruit, vegetables, and fiber. Epidemiological studies have confirmed a strong association between fat intake, especially saturated- and transfatty acids, plasma cholesterol levels, and rate of coronary heart disease (CHD) mortality. In counterpart, beneficial cardiovascular effects have been reported in populations consuming the "healthy" Mediterranean-type diet. Indeed, many nutrients and phytochemicals in fruits, vegetables, and wine, including fiber, vitamins, minerals, antioxidants, have shown to be independently or jointly responsible for the apparent reduction in CVD risk. Therefore, in patients with overt CVD, efforts have focused on combining both drug treatments and nutrition interventions. Undoubtedly, the advances in the knowledge of both the disease processes and healthy dietary components have provided new avenues to develop pharmaceutical and/or dietary strategies to halt the development of vascular disease. In this regard, within the last years, pioneering nutritional strategies, such as nutraceuticals, have been developed aimed at reducing the main atherosclerotic risk factors and promoting cardiovascular health. Furthermore, a growing body of clinical evidence has demonstrated positive cardiovascular effects associated with dietary fibers, cholesterol-lowering natural agents, olive oil, omega-3 PUFAs, antioxidants, and polyphenols intake. Moreover, monounsaturated fatty acids intake has shown to modulate the expression of key atherosclerotic-related genes. Yet, in the case of antioxidants, some large clinical trials have failed to confirm such atheroprotective effects. Furthermore, there might be interactions between these natural food supplements and cardiovascular medications that cannot be overlooked. Hence, there is a need for a better understanding and more scientific evidence of the relative contribution of major nutraceutical constituents to the inhibition of the progression of atherosclerosis and its clinical consequences.

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Section: Polyunsaturated Fatty Acidsmentioning

confidence: 96%

Nutraceuticals and Atherosclerosis: Human Trials

Badimon

Vilahur

Padró

2010

Cardiovascular Therapeutics

194

111

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“…To establish transparency of design and analysis procedures, study design and methods of the OMEGA trial have previously been described in detail. 18 …”

Section: Definition Of End Points and Monitoringmentioning

confidence: 99%

OMEGA, a Randomized, Placebo-Controlled Trial to Test the Effect of Highly Purified Omega-3 Fatty Acids on Top of Modern Guideline-Adjusted Therapy After Myocardial Infarction

et al. 2010

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MD; for the OMEGA Study GroupBackground-There is no randomized, double-blind trial testing the prognostic effect of highly purified omega-3 fatty acids in addition to current guideline-adjusted treatment of acute myocardial infarction. Methods and Results-OMEGA is a randomized, placebo-controlled, double-blind, multicenter trial testing the effects of omega-3-acid ethyl esters-90 (1 g/d for 1 year) on the rate of sudden cardiac death in survivors of acute myocardial infarction, if given in addition to current guideline-adjusted treatment. Secondary end points were total mortality and nonfatal clinical events. Patients (nϭ3851; female, 25.6%; mean age, 64.0 years) were randomized in 104 German centers 3 to 14 days after acute myocardial infarction from October 2003 until June 2007. Acute coronary angiography was performed in 93.8% and acute percutaneous coronary intervention in 77.8% of all patients. During a follow-up of 365 days, the event rates were (omega and control groups) as follows: sudden cardiac death, 1.5% and 1.5% (Pϭ0.84); total mortality, 4.6% and 3.7% (Pϭ0.18); major adverse cerebrovascular and cardiovascular events, 10.4% and 8.8% (Pϭ0.1); and revascularization in survivors, 27.6% and 29.1% (Pϭ0.34). Conclusions-Guideline-adjusted treatment of acute myocardial infarction results in a low rate of sudden cardiac death and other clinical events within 1 year of follow-up, which could not be shown to be further reduced by the application of omega-3 fatty acids. Clinical Trial Registration-URL: http://www.clinicaltrials.gov.

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“…Study size was estimated based on previous registry data with SCD projected to occur in 1.9% in the group treated with omega-3 acid ethyl-esters 90 and 3.5% in the placebo group, and alpha of 2.5% and a power of 80% (Rauch et al, 2006). Primary analysis was by intention-to-treat, and SCD occurred in 1.5% of both verum and placebo groups, with other cardiovascular events also evenly distributed.…”

Section: Intervention Trials With Clinical Endpointsmentioning

confidence: 99%

Omega-3 fatty acids: antiarrhythmic, proarrhythmic or both?

Schacky¹

2008

Current Opinion in Clinical Nutrition and Metabolic Care

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This review focuses on developments after 2008, when the topic was last reviewed by the author. Pertinent publications were found by medline searches and in the author's personal data base. Prevention of atrial fibrillation (AF) was investigated in a number of trials, sparked by one positive report on the effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), considerations of upstream therapy, data from electrophysiologic laboratories and animal experiments. If EPA + DHA prevent postoperative AF, the effect is probably smaller than initially expected. The same is probably true for maintenance of sinus rhythm after cardioversion and for new-onset AF. Larger trials are currently ongoing. Prevention of ventricular arrhythmias was studied in carriers of an implanted cardioverterdefibrillator, with no clear results. This might have been due to a broad definition of the primary endpoint, including any ventricular arrhythmia and any action of the device. Epidemiologic studies support the contention that high levels of EPA + DHA prevent sudden cardiac death (SCD). However, since SCD is a rare occurrence, it is difficult to conduct an adequately powered trial. In patients with congestive heart failure, EPA + DHA reduced total mortality and rehospitalizations, but not SCD or presumed arrhythmic death. Of three trials in patients after a myocardial infarction, two were inadequately powered, and in one, the dose might have been too low. Taken together, while epidemiologic studies support an inverse relation between EPA + DHA and occurrence of SCD or arrhythmic death, demonstrating this effect in intervention trials remained elusive so far. A pro-arrhythmic effect of EPA + DHA has not been seen in intervention studies, and results of epidemiologic and animal studies also rather argue against such an effect. A different, and probably more productive, perspective is provided by a standardized analytical assessment of a person's status in EPA + DHA by use of the omega-3 index, EPA + DHA in red cell fatty acids. In populations with a high omega-3 index, SCD is rare. Intervention trials can become more effective by including a low omega-3 index into the inclusion criteria, thus creating a study population more likely to demonstrate an effect of EPA + DHA. This is especially relevant in case of rare endpoints, like new-onset AF or SCD.

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Highly Purified Omega-3 Fatty Acids for Secondary Prevention of Sudden Cardiac Death After Myocardial Infarction—Aims and Methods of the OMEGA-Study

Abstract: The recruitment-period started in October 2003 and is expected to last until December 2006. The results of the study are therefore expected for the beginning of 2008, when all patients will have completed the 12-months follow up-period.

Cited by 44 publications

References 66 publications

Nutraceuticals and Atherosclerosis: Human Trials

Nutraceuticals and Atherosclerosis: Human Trials

OMEGA, a Randomized, Placebo-Controlled Trial to Test the Effect of Highly Purified Omega-3 Fatty Acids on Top of Modern Guideline-Adjusted Therapy After Myocardial Infarction

Omega-3 fatty acids: antiarrhythmic, proarrhythmic or both?

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