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Study Title and Description

n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia.



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 outcomes in patients with dysglycemia.
Author Bosch J., Gerstein HC., Dagenais GR., Díaz R., Dyal L., Jung H., Maggiono AP., Probstfield J., Ramachandran A., Riddle MC., Rydén LE., Yusuf S.
Country -- Not Found --
Year 2012
Numbers Pubmed ID: 22686415
15442 (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 Factorial Design
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What is the name of this study? (e.g. DART, Physician's Health Study) ORIGIN
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Country in which study conducted (where subjects live) Canada
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Funding source Industry funded
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Eligibility Criteria: Eligibility criteria were an age of at least 50 years; a diagnosis of diabetes with receipt of no more than one oral glucose-lowering drug, impaired glucose tolerance (plasma glucose level at 2 hours, =7.8 mM [140 mg per deciliter] and <11.1 mM [200 mg per deciliter] after a 75-g oral glucose load), or impaired fasting glucose (range, =6.1 mM [110 mg per deciliter] to <7.0 mM [126 mg per deciliter]); a history of myocardial infarction, stroke, or revascularization; angina with documented ischemia; a ratio of urinary albumin to creatinine of more than 30 mg per gram; left ventricular hypertrophy; 50% or more stenosis of a coronary, carotid, or lower-limb artery on angiography; or an ankle–brachial index of less than 0.9. Participants were excluded if they were unwilling to discontinue use of a nonstudy preparation of n–3 fatty acids, had a locally measured glycated hemoglobin level of 9% or more, had undergone coronary-artery bypass grafting within the previous 4 years with no intervening cardiovascular event, had severe heart failure, or had a cancer that might affect survival.
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Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
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Duration of Intervention 2 years
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At baseline, did all subjects have (per eligibility criteria)...? Diabetes and/or metabolic syndrome*
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Hypertension ...
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Cardiac disease ...
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Cerebrovascular disease ...
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Peripheral vascular disease ...
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Arrhythmia ...
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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) 2003
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 78.7 80.3
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Baseline characteristics, continuous 63.5 63.6
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7.8 7.9
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145.6 146.0
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21.8 21.8
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84.1 84.2
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12.1 12.1
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189 190
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mg/dL mg/dL
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46 47
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112 112
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mg/dL mg/dL
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40 40
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46 46
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mg/dL mg/dL
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12 12
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mg/dL mg/dL
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142 140
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IQR 99, 196 IQR 97, 195
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29.8 29.9
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5.3 5.2
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Male, percent 4105/6281 (65.4%) 4045/6255 (64.7%)
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Race nd nd
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Comments about baseline data No data entered.
Baseline diet description No data entered.
Baseline omega-3 intake EPA-DHA 210.0 mg/d EPA-DHA 209.3 mg/d
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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: Death      Population: 45472
Time Point Measure "Fish oil" (DHA+EPA) Placebo


6+ years

N Enrolled 6281 6255
Counts 951 964
Percentage 15.1 15.4
Rate (per 100 pt-yrs) 2.57 2.62
Outcome: cardiac      Population: 45473
Time Point Measure "Fish oil" (DHA+EPA) Placebo


6+ years

N Enrolled 6281 6255
Counts 344 316
Percentage 5.5 5.1
Outcome: cerebro      Population: 45474
Time Point Measure "Fish oil" (DHA+EPA) Placebo


6+ years

N Enrolled 6281 6255
Counts 314 336
Percentage 5.0 5.4
Outcome: cv      Population: 45476
Time Point Measure "Fish oil" (DHA+EPA) Placebo


6+ years

N Enrolled 6281 6155
Counts 866 896
Percentage 13.8 14.3
Outcome: death      Population: 56927
Time Point Measure "Fish oil" (DHA+EPA) Placebo


6+ years

Counts 574 581
N Analyzed 6281 6255
Rate (per 100 pt-yrs) 1.55 1.58
Percentage 9.1 9.3
Outcome: composite      Population: 56928
Time Point Measure "Fish oil" (DHA+EPA) Placebo


6+ years

Counts 1034 1017
N Analyzed 6281 6255
Rate (per 100 pt-yrs) 2.92 2.88
Percentage 16.5 16.3
Outcome: cardiac      Population: 56929
Time Point Measure "Fish oil" (DHA+EPA) Placebo


6+ years

Counts 331 320
Percentage 5.3 5.1
Rate (per 100 pt-yrs) 0.91 0.88
N Analyzed 6281 6255
Outcome: cardiac      Population: 56930
Time Point Measure "Fish oil" (DHA+EPA) Placebo


6+ years

Counts 724 725
Percentage 11.5 11.6
Rate (per 100 pt-yrs) 2.11 2.12
N Analyzed 6281 6255
Outcome: PVD      Population: 56931
Time Point Measure "Fish oil" (DHA+EPA) Placebo


6+ years

Counts 52 47
Percentage 0.8 0.8
Rate (per 100 pt-yrs) 0.14 0.13
N Analyzed 6281 6255
Outcome: bp      Population: 45477
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 6281 6255
Mean 145.6 146.0
SD 21.8 21.8


6+ years

N Analyzed 6281 6255
Outcome: bp      Population: 45478
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 6281 6255
Mean 84.1 84.2
SD 12.1 12.1


6+ years

N Analyzed 6281 6255
Outcome: lipid      Population: 45479
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 6281 6255
Mean 112 112
SD 40 40


6+ years

N Analyzed 6281 6255
Outcome: lipid      Population: 45480
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 6281 6255
Mean 46 46
SD 12 12


6+ years

N Analyzed 6281 6255
Outcome: lipid      Population: 45481
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 years

N Analyzed 6281 6255
Median 142 140


6+ years

N Analyzed 6281 6255

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? Unsure
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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) No
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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**) LOW
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Additional Bias: Bias due to problems not covered elsewhere in the table. LOW
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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 Not Applicable
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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.