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Study Title and Description

Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study).



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study).
Author Ballantyne CM., Bays HE., Kastelein JJ., Stein E., Isaacsohn JL., Braeckman RA., Soni PN.
Country Baylor College of Medicine and the Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA. cmb@bcm.tmc.edu
Year 2012
Numbers Pubmed ID: 22819432
14942 (internal)

Secondary Publication Information
UI Title Author Country Year
Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study). Ballantyne CM., Bays HE., Kastelein JJ., Stein E., Isaacsohn JL., Braeckman RA., Soni PN. Baylor College of Medicine and the Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA. cmb@bcm.tmc.edu 2012
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 EPA 2g/day
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2 Placebo
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3 EPA 4g/day
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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) ANCHOR
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Country in which study conducted (where subjects live) US
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Funding source Industry funded
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Eligibility Criteria: >18 years of age at high risk for CVD (patients with clinical coronary heart disease [CHD] or CHD risk equivalents [10-year risk ≥20%]) as defined by the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guidelines. On stable statin therapy (atorvastatin, rosuvastatin, or simvastatin with or without ezetimibe) for ≥4 weeks at doses expected to produce "optimal" LDLC levels for high-risk patients (≥40 and <100 mg/dL). Patients who had A1c >9.5% or were being treated with antidiabetes medication that had not been stable for ≥4 weeks at screening were excluded from the ANCHOR 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 12 weeks
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... DM
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Baseline Characteristics
Question EPA Placebo EPA Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 73 73 73
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Baseline characteristics, continuous 61.8 61.2 61.1
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9.42 10.05 10.03
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nd nd nd
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nd nd nd
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nd nd nd
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mg/dL mg/dL mg/dL
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169.0 168.0 167.0
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IQR(34.0) IQR(38.0) IQR(38.0)
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mg/dL mg/dL mg/dL
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82.0 84.0 82.0
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IQR(24.0) IQR(27.0) IQR(25)
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mg/dL mg/dL mg/dL
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38.0 39.0 37.0
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IQR(13.0) IQR(12.0) IQR(12)
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mg/dL mg/dL mg/dL
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254.0 259.0 264.8
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IQR(92.5) IQR(81.0) IQR(93.0)
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32.9 33.0 32.7
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4.98 5.04 4.99
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nd nd nd
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Male, percent 61 62 61
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Race 96 96 97
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Comments about baseline data Baseline data from Ballantyne 2012
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Baseline diet description "Stable diet" during run-in period
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Baseline omega-3 intake nd nd nd
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Does this study report baseline omega-3 biomarker data? No
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Results & Comparisons


Results Data
Outcome: lipid      Population: 44777
Time Point Measure EPA Placebo EPA


0 weeks

N Analyzed 234 227 226
Median 38 39 37
IQR 13 12 12


12 weeks

N Analyzed 234 227 226
Median 38 40 37
IQR 11 14 13
Outcome: lipid      Population: 44778
Time Point Measure EPA Placebo EPA


0 weeks

N Analyzed 233 226 225
Median 82 84 82
IQR 24 27 25


12 weeks

N Analyzed 233 226 225
Median 87 88.5 83
IQR 27 31 31
Outcome: lipid      Population: 44779
Time Point Measure EPA Placebo EPA


0 weeks

N Analyzed 234 227 226
Median 254.0 259.0 264.8
IQR 92.5 81.0 93.0


12 weeks

N Analyzed 234 227 226
Median 244.3 269.5 220.8
IQR 117.0 149.5 92.0

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
EPA Adverse Event 1 At least one "treatment-emergent adverse event" 106 236 12 weeks
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Placebo 112 233 12 weeks
EPA 106 233 12 weeks

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)? 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? Unsure
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Unsure
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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.