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Study Title and Description

Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis.
Author Yokoyama M., Origasa H., Matsuzaki M., Matsuzawa Y., Saito Y., Ishikawa Y., Oikawa S., Sasaki J., Hishida H., Itakura H., Kita T., Kitabatake A., Nakaya N., Sakata T., Shimada K., Shirato K.
Country Kobe University, Kobe, Japan. yokoyama@med.kobe-u.ac.jp
Year 2007
Numbers Pubmed ID: 17398308
14793 (internal)

Secondary Publication Information
UI Title Author Country Year
Preventive effects of eicosapentaenoic acid on coronary artery disease in patients with peripheral artery disease. Ishikawa Y., Yokoyama M., Saito Y., Matsuzaki M., Origasa H., Oikawa S., Sasaki J., Hishida H., Itakura H., Kita T., Kitabatake A., Nakaya N., Sakata T., Shimada K., Shirato K., Matsuzawa Y. Kakogawa Municipal Hospital, Kakogawa, Japan. y_ishikawa@city.kakogawa.hyogo.jp 2010
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Reduction in the recurrence of stroke by eicosapentaenoic acid for hypercholesterolemic patients: subanalysis of the JELIS trial. Tanaka K., Ishikawa Y., Yokoyama M., Origasa H., Matsuzaki M., Saito Y., Matsuzawa Y., Sasaki J., Oikawa S., Hishida H., Itakura H., Kita T., Kitabatake A., Nakaya N., Sakata T., Shimada K., Shirato K. Department of Neurology, Toyama University Hospital, 2630 Sugitani, Toyama, Toyama, 930-0194, Japan. kortaro@med.u-toyama.ac.jp 2008
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 EPA EPA+statin (atorvastatin or simvastatin)
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2 All arms (XO study)
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3 No intervention
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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) JELIS
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Country in which study conducted (where subjects live) Japan
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Funding source Industry funded
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Eligibility Criteria: Inclusion criteria: Total cholesterol concentration of 6·5 mmol/L or greater, which corresponded to a LDL cholesterol of 4·4 mmol/L or greater. Exclusion criteria: acute myocardial infarction within the past 6 months, unstable angina pectoris, a history or complication of serious heart disease (such as severe arrhythmia, heart failure, cardiomyopathy, valvular disease, or congenital disease), cardiovascular reconstruction within the past 6 months, cerebrovascular disorders within the past 6 months, complications of serious hepatic or renal disease, malignant disease, uncontrollable diabetes, hyperlipidaemia due to other disorders, hyperlipidaemia caused by drugs such as steroid hormones, haemorrhage (including haemo philia, capillary fragility, gastrointestinal ulcer, urinary tract haemorrhage, haemoptysis, and vitreous haemorrhage), haemorrhagic diathesis, hypersensitivity to the study drug formulation, patients’ intention to undergo surgery, and judgment by the physician in charge that a patient was inappropriate for the study.
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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 5 years
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Dyslipidemia ... total cholesterol concentration of 6·5 mmol/L or greater, which corresponded to a LDL cholesterol of 4·4 mmol/L or greater
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Conflict of interest ... Specify Conflict of interest stated ... 'M Yokoyama received travel costs from Mochida Pharmaceutical Co Ltd, Tokyo, Japan, to participate in the scientific meeting. Other authors have no conflicts of interest.'
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... Primary prevention group (dyslipidemic but no CAD), secondary prevention group (dyslipidemic with CAD) from main JELIS article, peripheral artery disease reported in Ishikawa et al. 2010
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Does the study report a regression analysis with interaction terms for an outcome of interest? ... Which predictors/variables? Yes ... test for heterogeneity in effects of age, sex, BMI, previous CAD, smoking, diabetes, hypertension, total cholesterol, triglyceride, HDL, LDL
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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) 1996
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Baseline Characteristics
Question EPA All arms (XO study) No intervention Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 16 16
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100 100
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6 5
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5 5
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Baseline characteristics, continuous 61 61
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8 9
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135 135
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21 21
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79 79
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13 13
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7.11 7.11
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mmol/L mmol/L
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0.67 0.68
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4.69 4.70
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mmol/L mmol/L
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0.76 0.75
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1.52 1.51
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mmol/L mmol/L
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0.46 0.44
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mmol/L mmol/L
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1.73 1.74
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(IQR 1.23, 2.48) (IQR 1.25,2.49)
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24 24
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3 3
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Male, percent 32 31
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Race 100 100
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not explicitly stated, but study set in Japan not explicitly stated, but study set in Japan
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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
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Results & Comparisons


Results Data
Outcome: composite      Population: 44425
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 9326 9319
Counts 0 0


5 years

N Enrolled 9326 9319
Counts 262 324
Outcome: composite      Population: 44425
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 7503 7478
Counts 0 0


5 years

N Enrolled 7503 7478
Counts 104 127
Outcome: composite      Population: 44425
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 1823 1841
Counts 0 0


5 years

N Enrolled 1823 1841
Counts 158 197
Outcome: composite      Population: 44425
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 117 106
Counts 0 0


5 years

N Enrolled 117 106
Counts 9 18
Outcome: arrhythmia      Population: 44431
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 9326 9319
Counts 0 0


5 years

N Enrolled 9326 9319
Counts 18 17
Outcome: arrhythmia      Population: 44431
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 7503 7478
Counts 0 0


5 years

N Enrolled 7503 7478
Counts 5 4
Outcome: arrhythmia      Population: 44431
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 1823 1841
Counts 0 0


5 years

N Enrolled 1823 1841
Counts 13 13
Outcome: Death      Population: 44432
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 9326 9319
Counts 0 0


5 years

N Enrolled 9326 9319
Counts 11 14
Outcome: Death      Population: 44432
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 7503 7478
Counts 0 0


5 years

N Enrolled 7503 7478
Counts 6 6
Outcome: Death      Population: 44432
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 1823 1841
Counts 0 0


5 years

N Enrolled 1823 1841
Counts 5 8
Outcome: cardiac      Population: 44433
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 9326 9319
Counts 0 0


5 years

N Enrolled 9326 9319
Counts 71 93
Outcome: cardiac      Population: 44433
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 7503 7478
Counts 0 0


5 years

N Enrolled 7503 7478
Counts 40 51
Outcome: cardiac      Population: 44433
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 1823 1841
Counts 0 0


5 years

N Enrolled 1823 1841
Counts 31 42
Outcome: cardiac      Population: 44434
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 9326 9319
Counts 0 0


5 years

N Enrolled 9326 9319
Counts 147 193
Outcome: cardiac      Population: 44434
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 7503 7478
Counts 0 0


5 years

N Enrolled 7503 7478
Counts 59 70
Outcome: cardiac      Population: 44434
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 1823 1841
Counts 0 0


5 years

N Enrolled 1823 1841
Counts 88 123
Outcome: cv      Population: 44435
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 9326 9319
Counts 0 0


5 years

N Enrolled 9326 9319
Counts 191 222
Outcome: cv      Population: 44435
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 7503 7478
Counts 0 0


5 years

N Enrolled 7503 7478
Counts 64 74
Outcome: cv      Population: 44435
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Enrolled 1823 1841
Counts 0 0


5 years

N Enrolled 1823 1841
Counts 127 148
Outcome: bp      Population: 60321
Time Point Measure EPA All arms (XO study) No intervention


4.6 years

N Analyzed
Mean
SD
SE


0 years

N Analyzed
Mean
SD
SE
Outcome: bp      Population: 60321
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Analyzed 8841 nd 8862
Mean 135 nd 135
SD 21 nd 21
SE


4.6 years

N Analyzed 8841 nd 8862
Mean 133 nd 133
SD 14 nd 13
SE
Outcome: bp      Population: 60321
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Analyzed 485 nd 457
Mean 139 nd 139
SD 25 nd 22
SE


4.6 years

N Analyzed 485 nd 457
Mean 138 nd 138
SD 15 nd 14
SE
Outcome: bp      Population: 60322
Time Point Measure EPA All arms (XO study) No intervention


4.6 years

N Analyzed
Mean
SD
SE


0 years

N Analyzed
Mean
SD
SE
Outcome: bp      Population: 60322
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Analyzed 8841 8862
Mean 79 79
SD 13 13
SE


4.6 years

N Analyzed 8841 8862
Mean 78 78
SD 8 8
SE
Outcome: bp      Population: 60322
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Analyzed 485 nd 457
Mean 80 nd 79
SD 15 nd 13
SE


4.6 years

N Analyzed 485 nd 457
Mean 78 nd 78
SD 9 nd 8
SE
Outcome: lipid      Population: 60324
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Analyzed 8841 8862
Mean 4.7 4.7
SD 0.77 0.75
SE


4.6 years

N Analyzed 8841 8862
Mean 3.54 3.54
SD 0.77 0.75
SE
Outcome: lipid      Population: 60324
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Analyzed 485 457
Mean 4.65 4.65
SD 0.65 0.65
SE


4.6 years

N Analyzed 485 457
Mean 3.38 3.36
SD 0.7 0.67
SE
Outcome: lipid      Population: 60325
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Analyzed 8841 8862
Mean 1.52 1.51
SD 0.46 0.44
SE


4.6 years

N Analyzed 8841 8862
Mean 1.54 1.54
SD 0.39 0.39
SE
Outcome: lipid      Population: 60325
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Analyzed 457 457
Mean 1.51 1.51
SD 0.44 0.55
SE


4.6 years

N Analyzed 485 457
Mean 1.48 1.51
SD 0.70 0.39
SE
Outcome: lipid      Population: 60326
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Analyzed 8841 8862
Median 1.73 1.73
25th Percentile 1.23 1.23
75th Percentile 2.48 2.49


4.6 years

N Analyzed 8841 8862
Median 1.47 1.57
25th Percentile 1.09 1.17
75th Percentile 2.01 2.13
Outcome: lipid      Population: 60326
Time Point Measure EPA All arms (XO study) No intervention


0 years

N Analyzed 485 457
Median 1.80 1.80
25th Percentile 1.30 1.37
75th Percentile 2.44 2.48


4.6 years

N Analyzed 485 457
Median 1.44 1.61
25th Percentile 1.10 1.21
75th Percentile 1.89 2.18

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
EPA Adverse Event 1 Newly diagnosed cancer 242 9326 mean 4.6 years
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All arms (XO study) 218 9319 mean 4.6 years
No intervention
EPA Adverse Event 2 Abnormal laboratory data (CPK or GOT or glucose) 378 9326 mean 4.6 years
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All arms (XO study) 322 9319 mean 4.6 years
No intervention

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? High Participants not blinded
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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)? Low
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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? Unclear
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Unclear
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Additional Bias: Bias due to problems not covered elsewhere in the table.
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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.