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Study Title and Description

Baseline lipoprotein lipids and low-density lipoprotein cholesterol response to prescription omega-3 acid ethyl ester added to Simvastatin therapy.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Baseline lipoprotein lipids and low-density lipoprotein cholesterol response to prescription omega-3 acid ethyl ester added to Simvastatin therapy.
Author Maki KC., Dicklin MR., Davidson MH., Doyle RT., Ballantyne CM.
Country Provident Clinical Research, Glen Ellyn, Illinois, USA. kmaki@providentcrc.com
Year 2010
Numbers Pubmed ID: 20451686
14935 (internal)

Secondary Publication Information
UI Title Author Country Year
Efficacy and tolerability of adding prescription omega-3 fatty acids 4 g/d to simvastatin 40 mg/d in hypertriglyceridemic patients: an 8-week, randomized, double-blind, placebo-controlled study. Davidson MH., Stein EA., Bays HE., Maki KC., Doyle RT., Shalwitz RA., Ballantyne CM., Ginsberg HN. Radiant Research, 515 North State Street, Suite 2700, Chicago, IL 60610, USA. michaeldavidson@radiantresearch.com 2007
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 "Fish oil" (DHA+EPA) P-OM3 + Simvastin
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2 Placebo Placebo + Simvastin
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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) COMBOS
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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: Eligible patients were men or women between the ages of 18 and 79 years who had been receiving a stable dose of a statin for the control of LDL-C levels for =>8 weeks before screening and were judged to be in good health on the basis of a medical history, physical examination, electrocardiogram, and laboratory tests, including serum chemistry, hematology, and urinalysis. Major inclusion criteria included a mean fasting TG level _>200 and <500 mg/dL, and a mean LDL-C level below or within 10% of the patient's NCEP ATPIII goal. Major exclusion criteria included poorly controlled diabetes mellitus (glycosylated hemoglobin [HbAlc ] >8.0% at screening); history of a cardiovascular event, a revascularization procedure, or an aortic aneurysm or resection within 6 months of screening; history of pancreatitis; sensitivity to statins or omega-3 fatty acids; poorly controlled hypertension (resting blood pressure =>160 mm Hg systolic and/or =>100 mm Hg diastolic at 2 consecutive visits); serum creatinine level =>2.0 mg/dL; serum transaminase (aspartate aminotransferase lAST] or alanine aminotransferase [ALT]) >1.5 times the upper limit of normal (ULN) (45 U/L for ALT, 31 U/L for AST); or creatine kinase (CK) level >2 times the ULN.
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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 8 weeks
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Dyslipidemia ... mean fasting TG level _>200 and <500 mg/dL, and a mean LDL-C level below or within 10% of the patient's NCEP ATP III goal.
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... Baseline LDL
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Study start date(s) 2005
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 60.3 59.3
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10.1 10.8
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nd nd
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nd nd
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nd nd
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183.1 186.0
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mg/dL mg/dL
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184.3 183.5
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27.8 32.1
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89.2 92.3
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mg/dL mg/dL
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90.7 88.2
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21.6 23.2
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47.3 44.7
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mg/dL mg/dL
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46.0 43.3
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11.9 9.3
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282.0 286.7
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mg/dL mg/dL
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267.8 270.7
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75.8 77.5
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31.0 31.5
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5.4 5.5
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Male, percent 54.1 60.6
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Race 95.1 96.2
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1.6 2.3
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2.5 0
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0.8 2.3
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Comments about baseline data No data entered.
Baseline diet description nd nd
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Baseline omega-3 intake 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: 44679
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 122 132
Mean 282.0 286.7
SD 75.8 77.5
Median 267.8 270.7


8 weeks

N Analyzed 122 132
Mean 202.4 275.9
SD 77.4 98.9
Median 182.3 259.5
Outcome: lipid      Population: 44680
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 122 132
Mean 47.3 44.7
SD 11.9 9.3
Median 46.0 43.3


8 weeks

N Analyzed 122 132
Mean 49.1 44.0
SD 12.7 8.8
Median 48.0 44.0
Outcome: lipid      Population: 44681
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 122 132
Mean 89.2 92.3
SD 21.6 23.2
Median 90.7 88.2


8 weeks

N Analyzed 122 132
Mean 90.4 90.1
SD 19.7 24.3
Median 87.5 85.0
Outcome: lipid      Population: 44681
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 43 41


8 weeks

N Analyzed 43 41
Outcome: lipid      Population: 44681
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 40 46


8 weeks

N Analyzed 40 46
Outcome: lipid      Population: 44681
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 39 45


8 weeks

N Analyzed 39 45
Outcome: lipid      Population: 44682
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 122 132
Mean 4.0 4.3
SD 0.9 0.8
Median 3.9 4.2


8 weeks

N Analyzed 122 132
Mean 3.7 4.3
SD 1.0 0.9
Median 3.5 4.1

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) Any adverse event 51 122 8 weeks
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Placebo 63 132 8 weeks
"Fish oil" (DHA+EPA) Serious adverse events The 4 SAEs in the P-OM3 group were hospitalization for an exacerbation of congestive heart failure in a 68-year-old woman; hospitalization for supraventricular tachycardia in a 41-year-old man with a history of hypertension and supraventricular tachycardia; hospitalization for pneumonia in a 71-yearold woman with a history of chronic obstructive pulmonary disease; and elevated ALT and AST (98 and 68 U/L, respectively) in a 54-year-old woman. None of these SAEs were considered by the investigators to be related to study reatment. 4 122 8 weeks
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Placebo 1 132 8 weeks
"Fish oil" (DHA+EPA) Nasopharyngitis 4 122 8 weeks
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Placebo 3 132 8 weeks
"Fish oil" (DHA+EPA) Upper respiratory tract infection 4 122 8 weeks
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Placebo 1 132 8 weeks
"Fish oil" (DHA+EPA) Diarrhea 3 122 8 weeks
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Placebo 3 132 8 weeks
"Fish oil" (DHA+EPA) Dyspepsia 3 122 8 weeks
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Placebo 3 132 8 weeks
"Fish oil" (DHA+EPA) Bronchitis 2 122 8 weeks
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Placebo 2 132 8 weeks
"Fish oil" (DHA+EPA) Cystitis 2 122 8 weeks
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Placebo 1 132 8 weeks
"Fish oil" (DHA+EPA) Alanine aminotransferase elevation 2 122 8 weeks
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Placebo 1 132 8 weeks
"Fish oil" (DHA+EPA) Gastroenteritis 2 122 8 weeks
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Placebo 0 132 8 weeks

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? 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**) HIGH TC:HDL-C ratio significantly lower in P-OM3 arm at baseline (P=0.012)
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Was there incomplete COMPLIANCE with interventions across groups? LOW
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Group SIMILARITY AT BASELINE (**OMEGA-3**) UNCLEAR No information on baseline Omega 3 levels or baseline diet
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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.