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Study Title and Description

Effects of B vitamins and omega 3 fatty acids on cardiovascular diseases: a randomised placebo controlled trial.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effects of B vitamins and omega 3 fatty acids on cardiovascular diseases: a randomised placebo controlled trial.
Author Galan P., Kesse-Guyot E., Czernichow S., Briancon S., Blacher J., Hercberg S.
Country UMR U557 Inserm, U1125 Inra, Cnam, Université Paris 13, CRNH IdF, F-93017 Bobigny, France. p.galan@uren.smbh.univ-paris13.fr
Year 2010
Numbers Pubmed ID: 21115589
15268 (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) +B vitamins
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2 "Fish oil" (DHA+EPA)
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3 Placebo +B vitamins
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4 Placebo
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5 "Fish oil" (DHA+EPA) Combined
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6 Placebo Combined
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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) SU.FOL.OM3
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Country in which study conducted (where subjects live) ... Specify Other(s) [Separate countries with commas]: ... France
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Funding source Industry funded
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Eligibility Criteria: h/o CVD (acute coronary event, including ACS, or cerebral ischemic event, excluding TIA, w/in 12 mo), 45-80 y. Exclude disease or treatment that might interfere with metabolism of homocysteine or n-3 FA (eg, methotrexate), SCr >200 mcmol/L, CrCl <40 ml/min
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Study Population Secondary Prevention (history of CVD event)
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Duration of Intervention Median 4.7 years (mean 4.2, SD 1.0)
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Cardiac disease ... Coronary event w/in 12 mo, including MI, ACS or suspected ACS
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Cerebrovascular disease ... CVA (not TIA)
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Does the study report a subgroup analysis for an outcome of interest? No
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Study start date(s) 2003
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 45.2 (28.4 unstable angina) 47.4 (29.2 unstable angina) 46.3 (27.0 unstable angina) 45.0 (29.4 unstable angina) 46 (28% unstable angina)
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26.4 23.4 26.7 25.6 26
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Baseline characteristics, continuous 61.5 61.4 61.4 61.4 60.9
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9.3 9.3 8.7 8.9 8.8
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133.1 134.1 133.5 132.6
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21.4 21.9 22.2 20.0
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83.6 84.0 84.0 82.6
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13.2 12.9 13.7 12.1
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27.6 27.5 27.7 27.5
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4.4 4.0 4.0 3.8
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mmol/L 4.5 4.6 4.5
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4.5 (IQR 3.9, 5.3) (IQR 3.9, 5.3) (IQR 3.9, 5.1)
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(IQR 3.9, 5.3) 2.7 2.7 2.6
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mmol/L (IQR 2.2, 3.3) (IQR 2.2, 3.2) (IQR 2.2, 3.2)
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2.7 1.2 1.2 1.1
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(IQR 2.2, 3.3) (IQR 1.0, 1.3) (IQR 1.0, 1.4) (IQR 1.0, 1.3)
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mmol/L 1.2 1.3 1.1
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1.2 (IQR 0.9, 1.6) (IQR 0.9, 1.7) (IQR 0.9, 1.7)
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(IQR 1.0, 1.4)
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mmol/L
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1.2
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(IQR 0.9, 1.6)
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Male, percent 79.5 79.2 79.9 79.2 79.4
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Race nd
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Comments about baseline data No data entered.
Baseline diet description nd
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Baseline omega-3 intake nd
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Does this study report baseline omega-3 biomarker data? Yes
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Results & Comparisons


Results Data
Outcome: composite      Population: 45085
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


4.7 median years

Counts 81 76
N Analyzed 1253 1248
Percentage 6.5 6.1
Outcome: Death      Population: 45087
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


4.7 median years

Counts 58 59
N Analyzed 1253 1248
Percentage 4.7 4.7
Outcome: cardiac      Population: 45088
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


4.7 median years

Counts 51 53
N Analyzed 1253 1248
Percentage 4.1 4.2
Outcome: cardiac      Population: 45088
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


4.7 median years

N Analyzed nd (~933) nd (~930)
Percentage 5.6 6.0
Note Includes SCD. Estimated from figure. Includes SCD. Estimated from figure.
Outcome: cerebro      Population: 45089
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


4.7 median years

Counts 29 28
N Analyzed 1253 1248
Percentage 2.3 2.2
Outcome: cerebro      Population: 45090
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


4.7 median years

Counts 40 43
N Analyzed 1253 1248
Percentage 3.2 3.4
Outcome: cv      Population: 45091
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


4.7 median years

Counts 152 156
N Analyzed 1253 1248
Percentage 12.2 12.5
Outcome: cv      Population: 45108
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


4.7 median years

N Analyzed nd
Percentage
Note
Outcome: cv      Population: 45108
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


4.7 median years

N Analyzed nd (~933) nd (~930)
Percentage 8.6 9.6
Note Estimated from figure Estimated from figure
Outcome: bp      Population: 45097
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 620 633 622 626
Mean 83.1 83.8 83.4 82.4
SD 12.2 12.3 12.7 11.9


4.7 median years

Mean nd nd nd nd
Outcome: bp      Population: 45098
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


0 years

Mean nd nd nd nd
N Analyzed 620 633 622 626


4.7 median years

Mean nd nd nd nd
Outcome: bp      Population: 45099
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 620 633 622 626
Mean 133.1 134.2 133.5 132.7
SD 21.3 22.0 22.2 20.0


4.7 median years

Mean nd nd nd nd

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) SE leading to Tx stop "chiefly GI disturbances, nausea, and cutaneous reactions)
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"Fish oil" (DHA+EPA)
Placebo
Placebo 1.6% 626
"Fish oil" (DHA+EPA) 2% 1253 Median 4.7 y
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? Unclear
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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**) Low
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Was there incomplete COMPLIANCE with interventions across groups? Low
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Low
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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.