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Study Title and Description

Atorvastatin in Factorial with Omega-3 EE90 Risk Reduction in Diabetes (AFORRD): a randomised controlled trial.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Atorvastatin in Factorial with Omega-3 EE90 Risk Reduction in Diabetes (AFORRD): a randomised controlled trial.
Author Holman RR., Paul S., Farmer A., Tucker L., Stratton IM., Neil HA.
Country Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology & Metabolism, Churchill Hospital, Headington, Oxford, UK. rury.holman@dtu.ox.ac.uk
Year 2009
Numbers Pubmed ID: 19002433
14908 (internal)

Secondary Publication Information
UI Title Author Country Year
Impact of atorvastatin and omega-3 ethyl esters 90 on plasma plant sterol concentrations and cholesterol synthesis in type 2 diabetes: a randomised placebo controlled factorial trial. Neil HA., Ceglarek U., Thiery J., Paul S., Farmer A., Holman RR. NIHR School of Primary Care Research, Division of Public Health & Primary Health Care, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, UK. andrew.neil@wolfson.ox.ac.uk 2010
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 "Fish oil" (DHA+EPA) +Atorvastatin
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2 "Fish oil" (DHA+EPA)
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3 Placebo +Atorvastatin
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4 Placebo
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5 "Fish oil" (DHA+EPA) combined +/- atorvastatin
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6 Placebo combined +/-atorvastatin
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Factorial Design
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What is the name of this study? (e.g. DART, Physician's Health Study) AFORRD
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Country in which study conducted (where subjects live) UK
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Funding source Industry funded
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Eligibility Criteria: patients with type 2 diabetes for at least 3 months, aged ≥18 years, with no known CVD events, and not thought by their general practitioner to be at high enough CVD risk to require immediate lipid-lowering therapy
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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 4 months
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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? No men and female
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Study start date(s) 2004
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 100 100 100 100 100 100 100
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Baseline characteristics, continuous skip skip 64 skip nd nd nd
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63 64 55-72 65
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57-72 55.5-72 139.4 57-73
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138.8 skip skip 139.8
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15.5 135.7 14.8 skip
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77.4 15.5 78.2 15.9
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skip 76.9 skip 78.8
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9.9 skip 9.2 skip
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5.1 8.9 5.0 9.2
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mg/dL 5.0 0.9 5.0
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0.9 mmol/L 3.2 mmol/L
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3.3 0.8 mmol/L 1
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mmol/L 3.1 0.7 3.1
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0.8 mmol/L mmol/L mmol/L
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1.6 0.7 1.5 0.8
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1.1-2.1 1.5 1.1-2.3 1.1
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30.8 mmol/L 30.9 mmol/L
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skip 1.0-2.2 skip 0.9
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6.6 30.8 6.0 mmol/L
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87.5 skip 88.4 1.5
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Kg 6.5 Kg 1.2-2.2
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20.6 87.8 18.6 30.6
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1.1 18.6 1.1 skip
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0.9 1.1 mmol/L 5.8
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mmol/L mmol/L 0.9 87.3
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skip 0.7 mmol/L Kg
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mmol/L 18.5
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Male, percent 55% 56% 61% 58%
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Race 91 91 92 88
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Comments about baseline data No data entered.
Baseline diet description omega-3 EE90 (Omacor, 2 g/day)+atorvastatin (Lipitor, 20 mg/day) omega-3 EE90 (Omacor, 2 g/day) atorvastatin (Lipitor, 20 mg/day)+olive oil (2 g/day) olive oil (2 g/day)
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Baseline omega-3 intake 2g Omega-3 2g Omega-3 0 0
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Does this study report baseline omega-3 biomarker data? No data entered.



Results & Comparisons


Results Data
Outcome: lipid      Population: 44666
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


4 months

N Enrolled 371 361
Proportion 58.0% 57.3%
P value 0.87
Outcome: lipid      Population: 44668
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


4 months

N Enrolled 371 361
Proportion 65.2% 60.4%
P value 0.18
Outcome: lipid      Population: 44577
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 163 160 169 166 371 361
Mean 1.2 1.2 1.2 1.2
SD 0.3 0.3 0.2 0.3


4 months

N Analyzed 163 160 169 166 371 361
Mean 1.1 1.2 1.1 1.2
SD 0.3 0.3 0.2 0.3
Outcome: lipid      Population: 44578
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 163 160 169 166 371 361
Median nd nd
Mean 3.3 3.1 3.2 3.2
SD 0.8 0.7 0.7 0.8


4 months

N Analyzed 163 160 169 166 371 361
Mean 1.7 3.1 1.8 3.1
SD 0.5 0.7 0.5 0.8
Outcome: bp      Population: 44579
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 163 160 169 166 371 361
Mean 145 144 148 149 nd nd
SD 19 18 18 19


4 months

N Analyzed 163 160 169 166 371 361
Mean 142 140 143 145
SD 17 20 21 16
Outcome: bp      Population: 44580
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 163 160 169 166 371 361
Mean 81 81 83 82
SD 10 9 10 10


4 months

N Analyzed 163 160 169 166 371 361
Mean 80 79 83 81
SD 11 11 12 9
Outcome: lipid      Population: 44581
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Placebo "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 163 160 169 166 371 361
Median 1.6 1.6 1.5 1.5
25th Percentile 1.2 1.1 1.1 1.2
75th Percentile 2.2 2.3 2.3 2.2


4 months

N Analyzed 163 160 169 166 371 361
Median 1.1 1.4 1.2 1.5
25th Percentile 0.8 1.0 0.9 1.1
75th Percentile 1.5 2.2 1.7 2.1

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) Adverse Event 1 Serious adverse 34 200 4 months
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"Fish oil" (DHA+EPA) 20 197 ibid
Placebo 15 201 ibid
Placebo 18 202 ibid
"Fish oil" (DHA+EPA)
Placebo
"Fish oil" (DHA+EPA) Lower respiratory tract infection 13 200 4 months
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"Fish oil" (DHA+EPA) 14 197 ibid
Placebo 18 201 ibid
Placebo 12 202 ibid
"Fish oil" (DHA+EPA)
Placebo
"Fish oil" (DHA+EPA) Cough 12 200 4 months
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"Fish oil" (DHA+EPA) 15 197 ibid
Placebo 13 201 ibid
Placebo 14 202 ibid
"Fish oil" (DHA+EPA)
Placebo
"Fish oil" (DHA+EPA) Back pain 14 200 4 months
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"Fish oil" (DHA+EPA) 10 197 ibid
Placebo 13 201 ibid
Placebo 10 202 ibid
"Fish oil" (DHA+EPA)
Placebo
"Fish oil" (DHA+EPA) Diabetes mellitus inadequate control 12 200 4 months
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"Fish oil" (DHA+EPA) 12 197 ibid
Placebo 15 201 ibid
Placebo 8 202 ibid
"Fish oil" (DHA+EPA)
Placebo
"Fish oil" (DHA+EPA) Diarrhoea 15 200 4 months
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"Fish oil" (DHA+EPA) 9 197 ibid
Placebo 8 201 ibid
Placebo 15 202 ibid
"Fish oil" (DHA+EPA)
Placebo
"Fish oil" (DHA+EPA) Urinary tract infection 14 200 4 months
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"Fish oil" (DHA+EPA) 7 197 ibid
Placebo 11 201 ibid
Placebo 12 202 ibid
"Fish oil" (DHA+EPA)
Placebo

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Yes Computerised central randomisation was used to allocate
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Was ALLOCATION adequately concealed (prior to assignment)? Yes Patients and study staff weremasked to studymedication group assignment and patientswere asked to swallow capsules whole to avoid unmasking.
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Were PARTICIPANTS adequately BLINDED? Yes Patients and study staff weremasked to studymedication group assignment and patientswere asked to swallow capsules whole to avoid unmasking.
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Were OUTCOME ASSESSORS adequately BLINDED? Yes lab tests
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data Yes dropouts and withdrawals are about 10% of total in each arm.
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? Yes Only combined result for Omega-3 EE90 ± atorvastatin and Placebo ± atorvastatin are reported at follow-up
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INTENTION-TO-TREAT analysis? (Yes/No) Unsure No ITT stated. Not all participants were analyzed in the group to which they were assigned.
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Group SIMILARITY AT BASELINE (**GENERAL**) Yes
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Was there incomplete COMPLIANCE with interventions across groups? No compliance is about 91%.
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Unsure baseline omega-3 status was not reported
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Additional Bias: Bias due to problems not covered elsewhere in the table. Yes 1. Although study results were based on a rigorously conducted short-term trial, author cannot exclude the possibility that the results are due to chance. 2. As triacylglycerol lowering and Blood-pressure reduction appear to be dose dependent, with up to a 30% reduction reported in hypertriacylglycerolaemic patients given omega-3 EE90 4 g/day daily [42], the 2 g/day dose used in AFORRD may have been too small.
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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 Not Applicable
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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 Not Applicable
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Quality Rating
No quality rating data was found.