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Study Title and Description

n-3 fatty acids and cardiovascular events 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 n-3 fatty acids and cardiovascular events after myocardial infarction.
Author Kromhout D., Giltay EJ., Geleijnse JM.
Country Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands. daan.kromhout@wur.nl
Year 2010
Numbers Pubmed ID: 20929341
16613 (internal)

Secondary Publication Information
UI Title Author Country Year
n-3 fatty acids, ventricular arrhythmia-related events, and fatal myocardial infarction in postmyocardial infarction patients with diabetes. Kromhout D., Geleijnse JM., de Goede J., Oude Griep LM., Mulder BJ., de Boer MJ., Deckers JW., Boersma E., Zock PL., Giltay EJ. Division of Human Nutrition, Wageningen University, Wageningen, the Netherlands. daan.kromhout@wur.nl 2011
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Effects of n-3 fatty acids on major cardiovascular events in statin users and non-users with a history of myocardial infarction. Eussen SR., Geleijnse JM., Giltay EJ., Rompelberg CJ., Klungel OH., Kromhout D. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands. 2012
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Effect of low doses of n-3 fatty acids on cardiovascular diseases in 4,837 post-myocardial infarction patients: design and baseline characteristics of the Alpha Omega Trial. Geleijnse JM., Giltay EJ., Schouten EG., de Goede J., Oude Griep LM., Teitsma-Jansen AM., Katan MB., Kromhout D. Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands. marianne.geleijnse@wur.nl 2010
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 All n-3 PUFAs (ALA+DHA+EPA) EPA-DHA + ALA margarine
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2 "Fish oil" (DHA+EPA) EPA-DHA + ALA placebo margarine
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3 ALA EPA-DHA placebo + ALA margarine
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4 Placebo EPA-DHA placebo + ALA placebo margarine
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Factorial Design
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What is the name of this study? (e.g. DART, Physician's Health Study) Diet and reinfarction trial
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Country in which study conducted (where subjects live) Netherlands
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Funding source Industry only donated materials (eg, supplements)
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Eligibility Criteria: Men and women 60 to 80 years of age, who had had a clinical diagnosed MI up to 10 years before randomization. Exclusion criteria: daily consumption of <10 10 g of margarine, use of n-3 fatty-acid supplements, unintended weight loss of >5 kg in the previous year, and a diagnosis of cancer with an estimated life expectancy of <1 year.
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Study Population Secondary Prevention (history of CVD event)
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Comment about study design: intention to treat analysis. no lost-to-followup
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Duration of Intervention 40 months
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Cardiac disease ... myocardial infarction
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Conflict of interest No conflict of interest (explicitly stated)
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... statin users vs. non-users; patients with vs. without diabetes
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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) 2002
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Baseline Characteristics
Question All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 20.2 22.0 21.2 20.1
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Baseline characteristics, continuous 69.1 69.1 69.0 68.9
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5.5 5.6 5.6 5.6
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140.9 142.3 141.4 141.9
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22.1 21.6 21.2 21.6
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nd nd nd nd
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nd nd nd nd
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4.69 4.77 4.70 4.75
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mmol/L mmol/L mmol/L mmol/L
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0.96 0.98 0.95 0.99
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2.55 2.63 2.57 2.60
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mmol/L mmol/L mmol/L mmol/L
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0.81 0.84 0.83 0.87
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1.29 1.29 1.28 1.28
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mmol/L mmol/L mmol/L mmol/L
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0.33 0.35 0.34 0.34
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mmol/L mmol/L mmol/L mmol/L
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IQR 1.19-2.26 IQR 1.22-2.30 IQR 1.21-2.31 IQR 1.22-2.38
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27.8 27.7 27.8 27.8
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4.0 3.7 3.8 3.9
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nd nd nd nd
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1.64 1.63 1.65 1.69
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Male, percent 78.1 78.1 77.9 78.7
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Race nd nd nd nd
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Comments about baseline data No data entered.
Baseline diet description No data entered.
Baseline omega-3 intake median 130; IQR 50-120 median 120; IQR 60-200 median 130; IQR 60-200 median 120; IQR 60-200 intake of EPA-DHA outside the study treatment (mg/d)
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Does this study report baseline omega-3 biomarker data? No No No No
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Results & Comparisons


Results Data
Outcome: lipid      Population: 51848
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


41 months

N Analyzed
Outcome: lipid      Population: 51848
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


41 months

N Analyzed 947 920 930 943
Outcome: lipid      Population: 51848
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


41 months

N Analyzed 96 102 102 13
Outcome: lipid      Population: 51849
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


41 months

N Analyzed
Outcome: lipid      Population: 51849
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


41 months

N Analyzed 947 920 930 943
Outcome: lipid      Population: 51849
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


41 months

N Analyzed 96 102 102 113
Outcome: lipid      Population: 51850
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


41 months

N Analyzed
Outcome: lipid      Population: 51850
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


41 months

N Analyzed 947 920 930 943
Outcome: lipid      Population: 51850
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


41 months

N Analyzed 96 102 102 113
Outcome: death      Population: 51845
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 1212 1192 1197 1236
Outcome: death      Population: 51845
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 245 262 258 249
Outcome: death      Population: 51845
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 967 930 939 987
Outcome: Death      Population: 51846
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 1212 1192 1197 1236
Outcome: Death      Population: 51846
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 245 262 258 249
Counts 25 26 28 31
Proportions 10.2 9.9 10.9 249
Outcome: Death      Population: 51847
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 1212 1192 1197 1236
Outcome: Death      Population: 51847
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 245 262 258 249
Outcome: Death      Population: 51847
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 967 930 939 987
Outcome: cv      Population: 52286
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 1212 1192 1197 1236
Outcome: cv      Population: 52286
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 245 262 258 249
Outcome: cv      Population: 52286
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 967 930 939 987
Outcome: cv      Population: 52286
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 947 920 930 943
Counts 126 127 119 123
Proportions 13 14 13 13
Outcome: cv      Population: 52286
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 96 102 102 113
Counts 9 16 17 20
Proportions 9 16 17 18
Outcome: arrhythmia      Population: 52287
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 1212 1192 1197 1236
Outcome: arrhythmia      Population: 52287
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 245 262 258 249
Outcome: arrhythmia      Population: 52287
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 967 930 939 987
Outcome: cv      Population: 52301
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 1212 1192 1197 1236
Outcome: cv      Population: 52301
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 245 262 258 249
Outcome: cv      Population: 52301
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) "Fish oil" (DHA+EPA) ALA Placebo


40 months

N Analyzed 967 930 939 987

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
All n-3 PUFAs (ALA+DHA+EPA) GI problems 13 1212
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"Fish oil" (DHA+EPA) 18 1192
ALA 9 1197
Placebo 10 1236
All n-3 PUFAs (ALA+DHA+EPA) Incident prostate cancer % of men 15 946
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"Fish oil" (DHA+EPA) 11 931
ALA 8 933
Placebo 8 973
All n-3 PUFAs (ALA+DHA+EPA) Cancer mortality 30 1212
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"Fish oil" (DHA+EPA) 33 1192
ALA 32 1197
Placebo 27 1236
All n-3 PUFAs (ALA+DHA+EPA) Side effect reported to DSMB 0 1212
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"Fish oil" (DHA+EPA) 0 1192
ALA 1 1197
Placebo 3 1236

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 Low
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
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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? Moderate more people discontinued EPA-DHA (with ALA or ALA placebo) margarine
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Yes
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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 Low
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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 Low
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Quality Rating
No quality rating data was found.