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Study Title and Description

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.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title 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.
Author Rauch B., Schiele R., Schneider S., Diller F., Victor N., Gohlke H., Gottwik M., Steinbeck G., Del Castillo U., Sack R., Worth H., Katus H., Spitzer W., Sabin G., Senges J.
Country Institut für Herzinfarktforschung Ludwigshafenan der Universität Heidelberg, Germany. rauch@zar-kardio-ludwigshafen.de
Year 2010
Numbers Pubmed ID: 21060071
15544 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 "Fish oil" (DHA+EPA)
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2 Placebo
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Parallel (Omega-3 vs. Control; Omega-3 + X vs. X)
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What is the name of this study? (e.g. DART, Physician's Health Study) OMEGA
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Country in which study conducted (where subjects live) Germany
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Funding source Industry funded
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Eligibility Criteria: Minimum age of 18 who were admitted to hospital for acute STEMI or non-STEMI and gave written informed consent to participate in the study.
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Study Population Secondary Prevention (history of CVD event)
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Duration of Intervention 1 YEAR
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Cardiac disease ... Myocardial infarction
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... patients with DM, patients >70 years of age, patients without acute revascularization, and patients with an ejection fraction <35%
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Study start date(s) 2003
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 27.6 26.4
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50.5 48.5
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66.9 66.1
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100 13.5
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20.1 17.4
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5.8 5.1
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Baseline characteristics, continuous skip skip nd
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64 64 nd
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(54,72) IQR (54,72) IQR nd
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skip 140 nd
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140 (120,160) IQR nd
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(120,160) IQR nd nd
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nd nd nd
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nd nd nd
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nd nd nd
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nd nd nd
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nd nd
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nd skip
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skip 27.3
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27.6 (24.9,30.1) IQR
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(25.1,30.4) IQR nd
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nd
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Male, percent 75.1 73.7 nd
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Race nd nd nd
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Comments about baseline data No data entered.
Baseline diet description nd nd
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Baseline omega-3 intake nd nd
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Does this study report baseline omega-3 biomarker data? No No No
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Results & Comparisons


Results Data
Outcome: arrhythmia      Population: 45634
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Enrolled 1919 1885
Counts 16 2
Outcome: arrhythmia      Population: 45591
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Analyzed 1919 1885
Mean 1.5 1.5
Outcome: Death      Population: 45592
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Analyzed 1919 1885
Mean 4.6 3.7
Outcome: Death      Population: 45592
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Analyzed
Mean
Outcome: Death      Population: 45592
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Analyzed
Mean
Outcome: Death      Population: 45592
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Analyzed
Mean
Outcome: Death      Population: 45592
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Analyzed
Mean
Outcome: cv      Population: 45597
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Analyzed 1919 1885
Mean 27.6 29.1
Outcome: lipid      Population: 45637
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Analyzed 1919 1885
Mean 2.46 2.46
Outcome: lipid      Population: 45638
Time Point Measure "Fish oil" (DHA+EPA) Placebo


1 years

N Analyzed 1919 1885
Mean 1.37 1.43

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Yes Randomization was done in blocks of 8 drug containers (4 omega, 4 control).
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Was ALLOCATION adequately concealed (prior to assignment)? Yes Each container was labelled with a 4 digit number that concealed the actual treatment
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Were PARTICIPANTS adequately BLINDED? Yes Blinding was maintained until general unblinding of the study after closure of the database.
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Were OUTCOME ASSESSORS adequately BLINDED? Yes The appearance of the drugs or the drug containers did not allow patients and physicians to deduce the study arm. Every container was labeled with a 4-digit number that concealed the actual treatment and was documented by the investigator on the patient's case report form.
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data Yes dropout rates are less than 1% in both arms
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? Unsure In the method section, author only defined clinical outcomes which are all reported. Lipid and TG are also reported but no baseline information were given.
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INTENTION-TO-TREAT analysis? (Yes/No) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) Yes
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Was there incomplete COMPLIANCE with interventions across groups? No Compliance in both groups are higher than 90%.
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Group SIMILARITY AT BASELINE (**OMEGA-3**) No Data
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Additional Bias: Bias due to problems not covered elsewhere in the table. Unsure Stated in the discussion section: high levels of fish consumption during the study could have influenced the clinical event rate during follow-up.
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If outcome assessor blinding risk of bias is different for different outcomes (eg, lipids vs. MI), choose HIGH risk of bias and describe in Notes
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If attrition risk of bias is different for different outcomes (eg, lipids vs. MI) or different time points (eg, 1 year vs. 5 years), choose HIGH risk of bias and describe in Notes
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Quality Rating
No quality rating data was found.