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Study Title and Description

Effects of a high-dose concentrate of n-3 fatty acids or corn oil introduced early after an acute myocardial infarction on serum triacylglycerol and HDL cholesterol.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effects of a high-dose concentrate of n-3 fatty acids or corn oil introduced early after an acute myocardial infarction on serum triacylglycerol and HDL cholesterol.
Author Nilsen DW., Albrektsen G., Landmark K., Moen S., Aarsland T., Woie L.
Country Department of Medicine, the Division of Cardiology, the Central Hospital in Rogaland, Stavanger, Norway. dnilsen1@chello.no
Year 2001
Numbers Pubmed ID: 11451717
2783 (internal)

Secondary Publication Information
UI Title Author Country Year
Clinical outcome and atherothrombogenic risk profile after prolonged wash-out following long-term treatment with high doses of n-3 PUFAs in patients with an acute myocardial infarction. Grundt H., Nilsen DW., Hetland Ø., Mansoor MA. Department of Medicine, Rogaland Central Hospital, P.O. Box 8100, Stavanger 4068, and University of Bergen, Norway. heidi@madlalia.no 2004
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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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Country in which study conducted (where subjects live) Norway
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Funding source No Data on funding or affiliations
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Eligibility Criteria: Eligibility was based on 1) verified MI by World Health Organization criteria (29), 2) age > 18 y, 3) discontinuation of a regular supplementation of other fish-oil products, and 4) signed informed consent. Exclusion criteria consisted of 1) assumed noncompliance to protocol; 2) expected survival <2 y because of severe heart failure (New York Heart Association class IV), malignancy, or other reasons; 3) ongoing gastrointestinal bleeding or verified stomach ulcer; 4) thrombocytopenia or blood platelets <100 x10^9 /L; 5) liver insufficiency; 6) participation in any other study; and 7) residence outside the recruitment area of this study
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Comment about Eligibility Criteria: All patients were included between the fourth and the eighth day after an acute MI
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Study Population Secondary Prevention (history of CVD event)
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Duration of Intervention 6 weeks
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Other ... MI
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Conflict of interest No Data regarding conflict of interest
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Does the study report a subgroup analysis for an outcome of interest? No
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Does the study report a regression analysis with interaction terms for an outcome of interest? No
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Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
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Study start date(s) 1995
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 32.9 8.7
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nd nd
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nd nd
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28.6 22.8
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nd nd
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21.3 25.3
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previous MI previous MI
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8.0 10.0
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"revascularizations" "revascularizations"
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10.0 7.4
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"heart failure" "heart failure"
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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Baseline characteristics, continuous nd nd
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124.5 122.1
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Range(90,195) Range(80-190)
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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nd nd
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25.9 26.0
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Range(16.9,41.8) Range(19.4,33.6)
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nd nd
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Male, percent 76.7 82.0
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Race nd nd
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Comments about baseline data All patients had acute MI
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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
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Results & Comparisons


Results Data
Outcome: cardiac      Population: 55986
Time Point Measure "Fish oil" (DHA+EPA) Placebo


18 median months

Counts 26 23
N Analyzed 150 150
Percentage 17.3 15.3


29 median months

Counts 32 28
N Analyzed 150 150
Percentage 21.3 18.7
Outcome: cardiac      Population: 55987
Time Point Measure "Fish oil" (DHA+EPA) Placebo


18 median months

Counts 42 36
N Analyzed 150 150
Percentage 28 24


29 median months

Counts 52 49
N Analyzed 150 150
Percentage 34.7 32.7
Outcome: Death      Population: 55988
Time Point Measure "Fish oil" (DHA+EPA) Placebo


18 median months

Counts 11 11
N Analyzed 150 150
Percentage 7.3 7.3


29 median months

Counts 21 18
N Analyzed 150 150
Percentage 14 12
Outcome: cv      Population: 55989
Time Point Measure "Fish oil" (DHA+EPA) Placebo


18 median months

Counts 43 49
N Analyzed 150 150
Percentage 28.7 32.7


29 median months

Counts 54 57
N Analyzed 150 150
Percentage 36 39
Outcome: lipid      Population: 55990
Time Point Measure "Fish oil" (DHA+EPA) Placebo


baseline years

N Analyzed 120 121
Mean 1.64 1.55
SD 0.82 0.81


6 weeks

N Analyzed 120 121
Percent change in level


0.5 years

N Analyzed 120 121
Mean
SD


1 years

N Analyzed 120 121
Mean
SD
Outcome: lipid      Population: 56049
Time Point Measure "Fish oil" (DHA+EPA) Placebo


baseline years

N Analyzed 119 120
Mean 1.08 1.16
SD 0.30 0.35


6 weeks

N Analyzed 119 120
Mean
SD


0.5 years

N Analyzed 119 120
Percent change in level


1 years

N Analyzed 119 120
Percent change in level

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) nd
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Placebo

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Low
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Was ALLOCATION adequately concealed (prior to assignment)? Low
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Were PARTICIPANTS adequately BLINDED? Low
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Were OUTCOME ASSESSORS adequately BLINDED? Low
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data High 29 month data was supposed to be for last 100 included patients, but there is only data for 85 with no explanation
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? Yes No HDL and total, but no LDL
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INTENTION-TO-TREAT analysis? (Yes/No) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) Low
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Was there incomplete COMPLIANCE with interventions across groups? Unsure
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Unsure
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Additional Bias: Bias due to problems not covered elsewhere in the table. No
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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.