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Study Title and Description

Impact of atorvastatin plus n-3 PUFA on metabolic, inflammatory and coagulative parameters in metabolic syndrome without and with type 2 diabetes mellitus



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Impact of atorvastatin plus n-3 PUFA on metabolic, inflammatory and coagulative parameters in metabolic syndrome without and with type 2 diabetes mellitus
Author zz_REJECT_Avellone G, Valentina Guarnotta, Vincenzo Di Garbo, Giovanni Abruzzese, Domenico Campisi, Antonio Pinto, Giuseppina Pizzo, Giuseppe Licata
Country Department of Clinical Medicine, Lipid and Thrombosis Research Centre, University of Palermo, Palermo, Italy
Year 2009
Numbers Pubmed ID: No PMID
15195 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 All n-3 PUFAs (ALA+DHA+EPA) (n-3 PUFAs + 20 mg atorvastatin)
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2 Placebo (20 mg atorvastatin)
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Cross-over
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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: The eligibility criteria of the study included men and women between the ages of 45 and 65 years, with MS, diagnosed according to the NCEP ATP III criteria26 with a slightly impaired glucose tolerance, and MS associated to T2DM. Patients included in the study were outpatients at the first visit, never treated for dyslipidemic disorders. We included in the study a sample of patients representative of the average population with T2DM and MS.
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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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If crossover trial, duration of washout period 8 weeks
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At baseline, did all subjects have (per eligibility criteria)...? Diabetes and/or metabolic syndrome*
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... metabolic syndrome, type 2 diabetes
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Study start date(s) 2007 (Approx)
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Baseline Characteristics
Question All n-3 PUFAs (ALA+DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 49.18
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type 2 diabetes
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50.82
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metabolic syndrome
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Baseline characteristics, continuous 49 (ms) / 48 (d)
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3.5 (ms) / 3.2 (d)
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136 (ms) / 140 (d)
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5.5 (ms) / 5.5 (d)
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86 (ms) / 88 (d)
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2.8 (ms) / 3.0 (d)
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nd
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220.8 (ms) / 230 (d)
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mg/dL
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16.5 (ms) / 20 (d)
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149.7 (ms) / 151.6 (d)
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mg/dL
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13.8 (ms) / 12.0 (d)
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31.6 (ms) / 30 (d)
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mg/dL
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4.0 (ms) / 6.0 (d)
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198 (ms) / 242 (d)
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mg/dL
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11 (ms) / 25.2 (d)
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35.2 (ms) / 33.5 (d)
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2.5 (ms) / 3.0 (d)
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Male, percent 61, 50%
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Race nd
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Comments about baseline data ms = metabolic syndrome group, d = type 2 diabetes group
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Baseline diet description isocaloric diet
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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: lipid      Population: 44809
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 weeks

N Analyzed 62 (group A) / 60 (group B)
Mean
SD
SE
N Analyzed (Group B)
Mean (Group A)
Mean (Group B)
SD (Group A)
SD (Group B)




N Analyzed
Mean
SD
SE
N Analyzed (Group B)
Mean (Group A)
Mean (Group B)
SD (Group A)
SD (Group B)


8 weeks

N Analyzed
Mean
SD
SE
N Analyzed (Group B)
Mean (Group A)
Mean (Group B)
SD (Group A)
SD (Group B)
Outcome: lipid      Population: 44809
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 weeks

N Analyzed (Group A) 31 31
N Analyzed (Group B) 31 31
Mean (Group A) 174.5 174.5
Mean (Group B) 178.2 178.5
SD (Group A) 12.5 12.5
SD (Group B) 12 12


8 weeks

N Analyzed (Group A) 31 31
N Analyzed (Group B) 31 31
Mean (Group A) 130 176.5
Mean (Group B) 136.5 178
SD (Group A) 8.8 11.5
SD (Group B) 12 11.5
Outcome: lipid      Population: 44809
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 weeks

N Analyzed (Group A) 30 30
N Analyzed (Group B) 30 30
Mean (Group A) 240.3 240.3
Mean (Group B) 210 210
SD (Group A) 20.7 20.7
SD (Group B) 22.9 22.9


8 weeks

N Analyzed (Group A) 30 30
N Analyzed (Group B) 30 30
Mean (Group A) 150 188
Mean (Group B) 141 198.5
SD (Group A) 15.3 20.5
SD (Group B) 18 20.8
Outcome: lipid      Population: 45069
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 weeks

N Analyzed (Group A) nd nd
N Analyzed (Group B)
Mean (Group A)
Mean (Group B)
SD (Group A)
SD (Group B)


8 weeks

N Analyzed (Group A) nd nd
N Analyzed (Group B)
Mean (Group A)
Mean (Group B)
SD (Group A)
SD (Group B)
Outcome: lipid      Population: 45069
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 weeks

N Analyzed (Group A) 31 31
N Analyzed (Group B) 31 31
Mean (Group A) 30.5 30.5
Mean (Group B) 34.5 34.5
SD (Group A) 4.5 4.5
SD (Group B) 4.2 4.2


8 weeks

N Analyzed (Group A) 31 31
N Analyzed (Group B) 31 31
Mean (Group A) 40 34
Mean (Group B) 41 35
SD (Group A) 3.9 3.8
SD (Group B) 3.5 4.5
Outcome: lipid      Population: 45069
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 weeks

N Analyzed (Group A) 30 30
N Analyzed (Group B) 30 30
Mean (Group A) 34.3 34.3
Mean (Group B) 31.5 31.5
SD (Group A) 5.5 5.5
SD (Group B) 4.6 4.6


8 weeks

N Analyzed (Group A) 30 30
N Analyzed (Group B) 30 30
Mean (Group A) 39.2 32
Mean (Group B) 39 33.5
SD (Group A) 4 4
SD (Group B) 5 4
Outcome: lipid      Population: 45095
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 weeks

N Analyzed (Group A) nd nd
N Analyzed (Group B)
Mean (Group A)
Mean (Group B)
SD (Group A)
SD (Group B)


8 weeks

N Analyzed (Group A) nd nd
N Analyzed (Group B)
Mean (Group A)
Mean (Group B)
SD (Group A)
SD (Group B)
Outcome: lipid      Population: 45095
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 weeks

N Analyzed (Group A) 31 31
N Analyzed (Group B) 31 31
Mean (Group A) 92.6 92.6
Mean (Group B) 90.3 90.3
SD (Group A) 13.6 13.6
SD (Group B) 13 13


8 weeks

N Analyzed (Group A) 31 31
N Analyzed (Group B) 31 31
Mean (Group A) 84.7 90.4
Mean (Group B) 85.2 86.7
SD (Group A) 13 13
SD (Group B) 15 13.5
Outcome: lipid      Population: 45095
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA) Placebo


0 weeks

N Analyzed (Group A) 30 30
N Analyzed (Group B) 30 30
Mean (Group A) 86.2 86.2
Mean (Group B) 91 91
SD (Group A) 9.8 9.8
SD (Group B) 11.9 11.9


8 weeks

N Analyzed (Group A) 30 30
N Analyzed (Group B) 30 30
Mean (Group A) 90.8 92.4
Mean (Group B) 90.3 90.9
SD (Group A) 10.8 12.5
SD (Group B) 11.2 11.8

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
All n-3 PUFAs (ALA+DHA+EPA) Adverse Event 1 No adverse events were observed.
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Placebo

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)? HIGH
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Were PARTICIPANTS adequately BLINDED? HIGH
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Were OUTCOME ASSESSORS adequately BLINDED? HIGH
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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) No
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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**) LOW
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Additional Bias: Bias due to problems not covered elsewhere in the table. LOW
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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 No
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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
No quality rating data was found.