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Study Title and Description

n-3 fatty acids in patients with multiple cardiovascular risk factors.



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 in patients with multiple cardiovascular risk factors.
Author Roncaglioni MC., Tombesi M., Avanzini F., Barlera S., Caimi V., Longoni P., Marzona I., Milani V., Silletta MG., Tognoni G., Marchioli R.
Country -- Not Found --
Year 2013
Numbers Pubmed ID: 23656645
16615 (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) 6244 patients
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2 No intervention 6269 patients
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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) Italy
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Funding source No Data on funding or affiliations
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Eligibility Criteria: at least one of the following: multiple cardiovascular risk factors, clinical evidence of atherosclerotic vascular disease, or any other condition putting the patient at high cardiovascular risk in opinion of patient's general practitioner
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Comment about Eligibility Criteria: multiple cardiovascular risk factors defined as at least four of the following(or for diabetic patients, one of the following): age >65 yrs, male sex, hypertension, hypercholesterolemia, current smoker, obesity, family history cardiovascular disease
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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 median 5 years
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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? ... Which subgroups? Yes ... age(<65 years vs >65 years), sex, atherosclerotic cardiovascular disease (yes vs. no), Diabetes + 1 cardiovascular risk factor (yes vs. no), >=4 CVD risk factor (yes vs. 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) 2004
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) No intervention Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 59.6 60.2
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84.6 84.6
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4.7 4.8
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Baseline characteristics, continuous 63.9 64.0
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skip skip
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9.3 9.6
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140.3 140.1
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skip skip
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15.2 15.1
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82.9 82.5
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skip 8.2
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8.2 nd
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nd 216.5
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215.6 mg/dL
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mg/dL 42.2
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43.9 132.5
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131.8 mg/dL
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mg/dL 36.1
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36.9 51.2
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50.9 mg/dL
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mg/dL 13.4
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13.3 mg/dL
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mg/dL 150
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150 29.4
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29.3 skip
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skip 5.0
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4.9 nd
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nd
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Male, percent 62.3 60.6
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Race nd
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Comments about baseline data No data entered.
Baseline diet description fish consumption (never=23.8%)(1 time/wk=43.3%)(2 times/wk=27.0)(>3times/wk=6.0%) fish consumption(never=24.1%)(1 time/wk=43.0%)(2 times/wk=27.3)(>3 times/wk=5.6%)
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Baseline omega-3 intake 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: death      Population: 51136
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Enrolled
Counts
Percentage


5 years

N Enrolled 6239 6266
Counts 142 137
Percentage 2.3 2.2
Outcome: death      Population: 51137
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Enrolled
Counts
Percentage


5 years

N Enrolled 6239 6266
Counts 82 76
Percentage 1.3 1.2
Outcome: arrhythmia      Population: 51138
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Enrolled
Counts
Percentage


5 years

N Enrolled 6239 6266
Counts 60 47
Percentage 1.0 0.8
Outcome: Death      Population: 51382
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Enrolled
Counts
Percentage


5 years

N Enrolled 6239 6266
Counts 348 337
Percentage 5.6 5.4
Outcome: Death      Population: 51383
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Enrolled
Counts
Percentage


5 years

N Enrolled 6239 6266
Counts 19 18
Percentage 0.3 0.3
Outcome: composite      Population: 51443
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Enrolled
Counts
Percentage


5 years

N Enrolled 6239 6266
Counts 733 745
Percentage 11.7 11.9
Outcome: composite      Population: 51443
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Enrolled
Counts
Percentage


5 years

N Enrolled 3890 3797
Counts 545 508
Percentage
Outcome: composite      Population: 51443
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Enrolled
Counts
Percentage


5 years

N Enrolled 2349 2469
Counts 187 237
Percentage
Outcome: cardiac      Population: 51444
Time Point Measure "Fish oil" (DHA+EPA) No intervention


5 years

N Enrolled 6239 6266
Counts 96 142
Percentage 1.5 2.3
Outcome: cardiac      Population: 51445
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Enrolled
Counts
Percentage


5 years

N Enrolled 6239 6266
Counts 10 13
Percentage 0.2 0.2
Outcome: cardiac      Population: 51445
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Enrolled
Counts
Percentage


5 years

N Enrolled
Counts
Percentage
Outcome: cardiac      Population: 51445
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Enrolled
Counts
Percentage


5 years

N Enrolled
Counts
Percentage
Outcome: cardiac      Population: 56292
Time Point Measure "Fish oil" (DHA+EPA) No intervention


5 years

N Enrolled 6239 6266
Counts 19 19
Percentage 0.3 0.3
Outcome: bp      Population: 51299
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Analyzed 6239 6266
Mean 140.3 140.1
SD 15.2 15.1
SE


5 years

N Analyzed
Mean
SD
SE
Outcome: bp      Population: 51378
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Analyzed 6239 6266
Mean 82.9 82.5
SD 8.2 8.2
SE


5 years

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 51379
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Analyzed
Mean
SD
SE


5 years

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 51380
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Analyzed
Mean
SD
SE


5 years

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 51381
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 years

N Analyzed
Mean
SD
SE


5 years

N Analyzed
Mean
SD
SE

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) Adverse Event 1 Gastrointestinal disorder 200 6239 5
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No intervention 186 6266 5
"Fish oil" (DHA+EPA) Adverse Event 1 Skin disorder 8 6239 5
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No intervention 17 6266 5
"Fish oil" (DHA+EPA) Adverse Event 1 Cancer 490 6239 5
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No intervention 453 6266 5
"Fish oil" (DHA+EPA) Adverse Event 1 Bleeding 16 6239 5
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No intervention 12 6266 5

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Low treatment was centrally assigned by means of telephone on the basis of a concealed, computer-generated randomization list, stratified according to general practitioner
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Was ALLOCATION adequately concealed (prior to assignment)? Low patients, general practitioners, coordination and statistical staff, and outcome assessors were unaware of the study assignments until the final analyses were completed
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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? Low
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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.