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Study Title and Description

Effects of stable fish oil and simvastatin on plasma lipoproteins in patients with hyperlipidemia.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effects of stable fish oil and simvastatin on plasma lipoproteins in patients with hyperlipidemia.
Author Liu M, Agneta Wallmon, Rolf Wallin, Tom Saldeen
Country
Year 2003
Numbers 15025 (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)
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2 "Fish oil" (DHA+EPA) Fish oil + Simvastin
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3 No intervention Simvastin
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4 No intervention
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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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Country in which study conducted (where subjects live) Sweden
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Funding source No Data on funding or affiliations
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Eligibility Criteria: Patients with hyperlipidemia, fasting TC>6.2 mmol/L and/or fasting TG>1.8 mmol/L, were studied. The subjects had their first diagnosis of hyperlipidemia. Subjects with previously known lipid changes undergoing treatment were excluded, as well as subjects with allergy to statins, or with diabetes mellitus, liver, or renal disease, or other diseases that might influence lipid metabolism, and pregnant women. Participation in another drug study during the last month, and treatment with antimycotic drugs or antibiotics that might interfere with the effects of statins, or with other drugs that may influence lipid metabolism, were further reasons for exclusion. Patients with cancer or other serious diseases were also excluded. Subjects with obesity, high BMI, high blood pressure or insulin resistance were not excluded.
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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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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Dyslipidemia ... fasting TC>6.2 mmol/L and/or fasting TG>1.8 mmol/L
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... Simvastin
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Study start date(s) 2001 (approx)
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) No intervention No intervention Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 60 62 63 57
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9 7 8 10
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nd nd nd nd
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nd nd nd nd
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nd nd nd nd
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7.00 6.69 7.04 6.77
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mmol/L mmol/L mmol/L mmol/L
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1.08 0.97 0.81 0.75
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4.67 4.49 4.46 4.50
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mmol/L mmol/L mmol/L mmol/L
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0.99 0.93 0.67 0.72
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1.53 1.43 1.66 1.53
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mmol/L mmol/L mmol/L mmol/L
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0.41 0.32 0.58 0.43
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1.66 1.75 1.54 1.61
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mmol/L mmol/L mmol/L mmol/L
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0.78 0.76 0.95 0.83
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nd nd nd nd
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nd nd nd nd
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Male, percent 48.3 21.1 22.2 22.7 30.7
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Race nd nd nd nd
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Comments about baseline data All subjects were asked to decrease their intake of fat milk, cream, and fat cheese. Most subjects reported that they followed this advice.
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Baseline diet description nd nd nd nd
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Baseline omega-3 intake nd nd nd nd
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Does this study report baseline omega-3 biomarker data? Yes
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Results & Comparisons


Results Data
Outcome: lipid      Population: 44704
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) No intervention No intervention


0 weeks

N Analyzed 29 19 18 22
Mean 1.53 1.43 1.66 1.53
SD 0.41 0.32 0.58 0.43


12 weeks

N Analyzed 29 19 18 22
Mean 1.64 1.53 1.70 1.58
SD 0.48 0.36 0.54 0.47
Outcome: lipid      Population: 44705
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) No intervention No intervention


0 weeks

N Analyzed 29 19 18 22
Mean 1.66 1.75 1.54 1.61
SD 0.78 0.76 0.95 0.83


12 weeks

N Analyzed 29 19 18 22
Mean 1.15 1.21 1.40 1.55
SD 0.45 0.46 0.75 0.75
Outcome: lipid      Population: 44706
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) No intervention No intervention


0 weeks

N Analyzed 29 19 18 22
Mean 4.67 4.49 4.46 4.50
SD 0.99 0.93 0.67 0.72


12 weeks

N Analyzed 29 19 18 22
Mean 4.35 3.21 3.05 4.04
SD 0.96 1.15 0.70 0.84
Outcome: lipid      Population: 44707
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) No intervention No intervention


0 weeks

N Analyzed 29 19 18 22
Mean 3.20 3.28 3.02 3.11
SD 0.78 0.87 1.10 0.74


12 weeks

N Analyzed 29 19 18 22
Mean 2.81 2.15 2.01 2.74
SD 0.93 0.79 0.87 0.65

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) Any adverse event No adverse effects of simvastatin or fish oil were observed. No significant changes in liver enzymes, serum concentrations of CK, or plasma glucose was found. 0 29 12 weeks
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"Fish oil" (DHA+EPA) 0 19 12 weeks
No intervention 0 18 12 weeks
No intervention 0 22 12 weeks

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? UNCLEAR
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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 HIGH After randomization, but before the start of the experiment several subjects, mainly males, in the simvastation groups and in the low fat diet group dropped out.
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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**) LOW
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Was there incomplete COMPLIANCE with interventions across groups? LOW
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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.
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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.