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Study Title and Description

Early protection against sudden death by n-3 polyunsaturated fatty acids after myocardial infarction: time-course analysis of the results of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI)-Prevenzione.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Early protection against sudden death by n-3 polyunsaturated fatty acids after myocardial infarction: time-course analysis of the results of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI)-Prevenzione.
Author Marchioli R., Barzi F., Bomba E., Chieffo C., Di Gregorio D., Di Mascio R., Franzosi MG., Geraci E., Levantesi G., Maggioni AP., Mantini L., Marfisi RM., Mastrogiuseppe G., Mininni N., Nicolosi GL., Santini M., Schweiger C., Tavazzi L., Tognoni G., Tucci C., Valagussa F.
Country Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy. marchioli@negrisud.it
Year 2002
Numbers Pubmed ID: 11997274
15484 (internal)

Secondary Publication Information
UI Title Author Country Year
Efficacy of n-3 polyunsaturated fatty acids according to clinical characteristics of patients with recent myocardial infarction: insights from the GISSI-Prevenzione trial. Marchioli R., Marfisi RM., Borrelli G., Chieffo C., Franzosi MG., Levantesi G., Maggioni AP., Nicolosi GL., Scarano M., Silletta MG., Schweiger C., Tavazzi L., Tognoni G. Consorzio Mario Negri Sud, Santa Maria Imbaro (CH), Italy. marchioli@negrisud.it 2007
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Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. -- Not Found -- -- Not Found -- 1999
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 "Fish oil" (DHA+EPA) +-vitamin E. (N=5666)
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2 No intervention +-vitamin E. (N=5668)
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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) GISSI-Prevention
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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: patients surviving recent (< 3 months) myocardial infarction
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Comment about Eligibility Criteria: Patients with no contraindications to supplements, provide written consent, have no unfavorable short-term outlook
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Study Population Secondary Prevention (history of CVD event)
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Comment about study design: 4 arms: FO, vit e, FO + vit e, control. Also patients adhere to recommended preventive treatments (aspirin, B-blockers...)
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Duration of Intervention 3.5 years
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Other ... myocardial infarction
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... HTN vs no HTN, female vs male. But note "effect of n-3 PUFAs on mortality was generally consistent in various subgroups of patients"(Marchioli)
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Does the study report a regression analysis with interaction terms for an outcome of interest? ... Which predictors/variables? Yes ... n-3 interaction with vitamin E is NS
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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) 1993
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) No intervention Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 14.2 15.0
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11.6 11.9
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18.8 19.4
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Baseline characteristics, continuous 59.4 59.4
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skip nd
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nd nd
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nd nd
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nd 211.6
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210.2 mg/dL
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mg/dL 138.5
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137.3 mg/dL
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mg/dL 41.7
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41.5 mg/dL
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mg/dL 161.9
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162.6 mg/dL
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mg/dL BMI>30(13.8%)
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BMI >30 (14.7%) skip
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skip nd
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nd
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Male, percent 84.7 85.1
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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? No No No
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Results & Comparisons


Results Data
Outcome: Death      Population: 45541
Time Point Measure "Fish oil" (DHA+EPA) No intervention


42 months

Counts 477 554
Percentage 8.4 9.8


6 months

Counts 102 130
Percentage 1.8 2.3


3 months

Counts 63 88
Percentage 1.1 1.6


9 months

Counts 140 180
Percentage 2.5 3.2


12 months

Counts 178 212
Percentage 3.1 3.8
Outcome: Death      Population: 45542
Time Point Measure "Fish oil" (DHA+EPA) No intervention


42 months

Counts 247 306
Percentage 4.4 5.4
N Analyzed 5666 5668


6 months

Counts 66 95
Percentage 1.2 1.7
N Analyzed 5666 5668


12 months

Counts 112 149
Percentage 2.0 2.6
N Analyzed 5666 5668


3 months

Counts 45 65
Percentage 0.8 1.2
N Analyzed 5666 5668


9 months

Counts 86 134
Percentage 1.5 2.4
N Analyzed 5666 5668
Outcome: death      Population: 46293
Time Point Measure "Fish oil" (DHA+EPA) No intervention


42 months

Counts 209 258
Percentage 3.7 4.6
N Analyzed 5666 5668


6 months

Counts 60 80
Percentage 1.1 1.4
N Analyzed 5666 5668


12 months

Counts 99 127
Percentage 1.8 2.2
N Analyzed 5666 5668


3 months

Counts 42 56
Percentage 0.7 1.0
N Analyzed 5666 5668


9 months

Counts 76 115
Percentage 1.3 2.0
N Analyzed 5666 5668
Outcome: arrhythmia      Population: 46294
Time Point Measure "Fish oil" (DHA+EPA) No intervention


42 months

Counts 111 154
Percentage 2.0 2.7
N Analyzed 5666 5668


9 months

Counts 45 72
Percentage 0.8 1.3
N Analyzed 5666 5668


12 months

Counts 59 78
Percentage 1.0 1.4
N Analyzed 5666 5668


3 months

Counts 26 37
Percentage 0.5 0.7
N Analyzed 5666 5668


6 months

Counts 33 52
Percentage 0.6 0.9
N Analyzed 5666 5668
Outcome: cerebro      Population: 46296
Time Point Measure "Fish oil" (DHA+EPA) No intervention


42 months

N Enrolled
Counts 92 77
Percentage 1.6 1.4


0 months

N Enrolled
Counts
Percentage




N Enrolled
Counts
Percentage


12 months

N Enrolled
Counts 28 25
Percentage 0.5 0.4




N Enrolled
Counts
Percentage




N Enrolled
Counts
Percentage




N Enrolled
Counts
Percentage




N Enrolled
Counts
Percentage
Outcome: death      Population: 50997
Time Point Measure "Fish oil" (DHA+EPA) No intervention


42 months

Counts 310 370
Percentage 5.5 6.5
N Analyzed 5666 5668


12 months

Counts 139 166
Percentage 2.5 2.9
N Analyzed 5666 5668


3 months

Counts 55 76
Percentage 1.0 1.3
N Analyzed 5666 5668


6 months

Counts 84 107
Percentage 1.5 1.9
N Analyzed 5666 5668


9 months

Counts 110 148
Percentage 1.9 2.6
N Analyzed 5666 5668
Outcome: lipid      Population: 45767
Time Point Measure "Fish oil" (DHA+EPA) No intervention


42 months

Mean 140 139
N Analyzed 5666 5668


0 months

Mean 136 137
N Analyzed 5666 5668


6 months

Mean 150 148
N Analyzed 5666 5668


12 months

Mean 141 141
N Analyzed 5666 5668


18 months

Mean 140 140
N Analyzed 5666 5668


30 months

Mean 140 140
N Analyzed 5666 5668
Outcome: lipid      Population: 45768
Time Point Measure "Fish oil" (DHA+EPA) No intervention


42 months

Mean 47 47
N Analyzed 5666 5668


0 months

Mean 41 41
N Analyzed 5666 5668


6 months

Mean 44.5 45
N Analyzed 5666 5668


12 months

Mean 45.5 46
N Analyzed 5666 5668


18 months

Mean 46 45
N Analyzed 5666 5668


30 months

Mean 46.5 46
N Analyzed 5666 5668
Outcome: lipid      Population: 45769
Time Point Measure "Fish oil" (DHA+EPA) No intervention


42 months

Mean 150 160
N Analyzed 5666 5668


0 months

Mean 162 162
N Analyzed 5666 5668


6 months

Mean 162 167
N Analyzed 5666 5668


12 months

Mean 155 160
N Analyzed 5666 5668


18 months

Mean 151 161
N Analyzed 5666 5668


30 months

Mean 152 161
N Analyzed 5666 5668

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) Adverse Event 1 gastrointestinal disturbances(4.9% FO, 2.9% control)
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No intervention
"Fish oil" (DHA+EPA) Adverse Event 1 nausea(1.4% FO, 0.4% control)
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No intervention

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Low used a multicentre, open-label design, in which patients were randomly allocated to four treatment groups
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Was ALLOCATION adequately concealed (prior to assignment)? High open label design
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Were PARTICIPANTS adequately BLINDED? High open label design
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Were OUTCOME ASSESSORS adequately BLINDED? High open label design
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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 Intention-to-treat analyses were done according to a factorial design (two-way) and by treatment group (four-way).
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Group SIMILARITY AT BASELINE (**GENERAL**) Low baseline demographic and clinical characteristics were well-balanced across the groups
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Was there incomplete COMPLIANCE with interventions across groups? Low measured compliance by refilling drug supplies every 3 months.
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Group SIMILARITY AT BASELINE (**OMEGA-3**) unclear baseline n-3 not reported
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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
Guideline Used Overall Rating