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Study Title and Description

Effect of n-3 fatty acids and statins on oxidative stress in statin-treated hypercholestorelemic and normocholesterolemic women.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effect of n-3 fatty acids and statins on oxidative stress in statin-treated hypercholestorelemic and normocholesterolemic women.
Author Carrepeiro MM., Rogero MM., Bertolami MC., Botelho PB., Castro N., Castro IA.
Country Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Sciences, University of São Paulo, São Paulo, Brazil.
Year 2011
Numbers Pubmed ID: 21561620
14896 (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) (no statin)
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2 "Fish oil" (DHA+EPA) +statin
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3 Placebo (no statin)
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4 Placebo +statin
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5 All arms (XO study)
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design ... Describe: Other ... Randomized cross-over within subgroups based on existing statin use
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Country in which study conducted (where subjects live) ... Specify Other(s) [Separate countries with commas]: ... Brazil
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Funding source No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: Female, generally healthy, 40-80 yo. Controlled or absent cholesterolemia and hypertension, absent or moderate alcohol consumption. Exclude DM, CV intervention, kidney failure, HRT, dietary supplements w/in 6 mo.
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Study Population Primary Prevention, Healthy
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Comment about study design: 100% post-menopausal (though unclear if this was by design).
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Duration of Intervention 6 weeks
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If crossover trial, duration of washout period 90 days
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... Statin use pre- (>6 mo) and during study (vs. no)
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Study start date(s) 2008 (approx)
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo All arms (XO study) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 0
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nd
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50% on statins
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nd
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0
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nd
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0
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nd
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nd
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nd
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0
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nd
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nd
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nd
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Baseline characteristics, continuous 61.3
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7.8
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nd
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nd
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nd
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208
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mg/dL
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36.8
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134.8
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mg/dL
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34.1
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50.1
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mg/dL
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12.4
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117.5
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mg/dL
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48.5
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28.2
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4.8
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nd
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Male, percent 0
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Race 65
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14
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5
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"100" (Brazil)
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0
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American Indian 16
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Comments about baseline data Among those on statins (n=20): Atorvastatin 33%, Simvastatin 57%, Rosuvastatin 5%, Pravastatin 5% (but clearly percentages don't make sense for n=20 or for 18 with data on dosage); "Dosage" (nd how standardized): 9 mg/d 5%, 10 mg/d 35%, 20 mg/d 40%, 40 mg/d 10%, nd 10%.
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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 data entered.



Results & Comparisons


Results Data
Outcome: lipid      Population: 44525
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo All arms (XO study)


0 years

N Analyzed 23 20 23 20 43
Mean 136.04 133.39 144.50 116.88 134.78
SD nd nd nd nd 34.09


6 months

N Analyzed 23 20 23 20 43
Mean 149.04 121.77 154.85 121.38 nd
SD nd nd nd nd
Outcome: lipid      Population: 44526
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo All arms (XO study)


0 years

N Analyzed 23 20 23 20 43
Mean 101.20 140.05 112.92 120.84 117.47
SD nd nd nd nd 48.47


6 months

N Analyzed 23 20 23 20
Mean 92.96 107.90 109.08 115.74
SD nd nd nd nd 51.27
Outcome: lipid      Population: 44528
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo All arms (XO study)


0 years

N Analyzed 23 20 23 20 43
Mean 52.44 50.10 49.58 50.63 50.14
SD nd nd nd nd 12.38


6 months

N Analyzed 23 20 23 20 43
Mean 53.60 52.95 52.08 51.63 nd
SD nd nd nd nd nd

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) Adverse events not reported
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"Fish oil" (DHA+EPA)
Placebo
Placebo
All arms (XO study)

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Unclear
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Was ALLOCATION adequately concealed (prior to assignment)? Unclear
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Were PARTICIPANTS adequately BLINDED? Low For n-3 vs. placebo only
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Were OUTCOME ASSESSORS adequately BLINDED? Low For n-3 vs. placebo only
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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 But incomplete analysis for HDL
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INTENTION-TO-TREAT analysis? (Yes/No) High Non-completers omitted
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Group SIMILARITY AT BASELINE (**GENERAL**) Low For n-3 vs. placebo only
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Was there incomplete COMPLIANCE with interventions across groups? Low Mean plasma EPA rose significantly in n-3 arms but not placebo arms
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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. Yes Statin subgroups treated as randomized factors, but really just matched. To be expected, matching failed to make baseline lipoprotein concentrations similar.
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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.