This is the old version of SRDR. The next, SRDRplus is available! Registration of your SRDRPlus account is free and approval is automatic. Click Here to register an SRDRPlus account.

Advanced Search

Study Preview



Study Title and Description

Effects of long chain omega-3 fatty acids on metalloproteinases and their inhibitors in combined dyslipidemia patients.



Key Questions Addressed
1 RCTs and other Comparative studies
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Effects of long chain omega-3 fatty acids on metalloproteinases and their inhibitors in combined dyslipidemia patients.
Author Derosa G., Maffioli P., D'Angelo A., Salvadeo SA., Ferrari I., Fogari E., Gravina A., Mereu R., Randazzo S., Cicero AF.
Country University of Pavia, Department of Internal Medicine and Therapeutics, P.le C. Golgi, 2 - 27100, Pavia, Italy. giuseppe.derosa@unipv.it
Year 2009
Numbers Pubmed ID: 19397392
21681084 (pubmed)

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)
  • Comments Comments (
    0
    ) |
2 Placebo sucrose, mannitol and mineral salts
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Parallel (Omega-3 vs. Control; Omega-3 + X vs. X)
  • Comments Comments (
    0
    ) |
Country in which study conducted (where subjects live) Italy
  • Comments Comments (
    0
    ) |
Funding source Industry only donated materials (eg, supplements)
  • Comments Comments (
    0
    ) |
Eligibility Criteria: Caucasian patients aged ≥ 18 years of either sex were eligible for inclusion in the study if they had combined dyslipidemia (defined by the International Lipid Information Bureau), identified by total cholesterol (TC) > 200 mg/dl and triglycerides (Tg) > 200 mg/dl, and who had never previously taken lipid-lowering medications. Patients were excluded if they had a genetic condition affecting lipid metabolism (e.g., familial hypercholesterolemia, type III hyperlipidemia, LPL deficiency, etc.); a history of microalbuminuria or nephrotic syndrome; an impaired hepatic function (defined as plasma aminotransferase and/or γ-glutamyltransferase level higher than the upper limit of normal for age and sex); an impaired renal function (defined as serum creatinine level higher than the upper limit of normal for age and sex); thyroid diseases; endocrine or metabolic disease; a history of alcohol or drug abuse; a neoplastic, infectious or autoimmune disease; poor mental condition or if they were taking any other drug that was able to influence lipid metabolism. Patients with serious cardiovascular disease (e.g., New York Heart Association class I–IV congestive heart failure or a history of myocardial infarction or stroke) or cerebrovascular conditions in 6 months before study enrollment were also excluded.
  • Comments Comments (
    0
    ) |
Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
  • Comments Comments (
    0
    ) |
Duration of Intervention 6 months
  • Comments Comments (
    0
    ) |
At baseline, did all subjects have (per eligibility criteria)...? ... Define: Dyslipidemia ... total cholesterol (TC) > 200 mg/dl and triglycerides (Tg) > 200 mg/dl
  • Comments Comments (
    0
    ) |
Conflict of interest No conflict of interest (explicitly stated)
  • Comments Comments (
    0
    ) |
Does the study report a subgroup analysis for an outcome of interest? No
  • Comments Comments (
    0
    ) |
Does the study report a regression analysis with interaction terms for an outcome of interest? No
  • Comments Comments (
    0
    ) |
Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
  • Comments Comments (
    0
    ) |
Study start date(s) nd
  • Comments Comments (
    0
    ) |


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 51.3 50.7
  • Comments Comments (
    0
    ) |
7.2 6.8
  • Comments Comments (
    0
    ) |
128.4 129.6
  • Comments Comments (
    0
    ) |
6.5 6.8
  • Comments Comments (
    0
    ) |
80.6 81.4
  • Comments Comments (
    0
    ) |
6.8 7.1
  • Comments Comments (
    0
    ) |
223.4 227.5
  • Comments Comments (
    0
    ) |
mg/dL mg/dL
  • Comments Comments (
    0
    ) |
15.7 16.3
  • Comments Comments (
    0
    ) |
148.5 149.9
  • Comments Comments (
    0
    ) |
mg/dL mg/dL
  • Comments Comments (
    0
    ) |
7.2 7.5
  • Comments Comments (
    0
    ) |
38.4 39.7
  • Comments Comments (
    0
    ) |
mg/dL mg/dL
  • Comments Comments (
    0
    ) |
4.2 5.1
  • Comments Comments (
    0
    ) |
182.6 189.3
  • Comments Comments (
    0
    ) |
mg/dL mg/dL
  • Comments Comments (
    0
    ) |
39.7 41.8
  • Comments Comments (
    0
    ) |
26.2 26.0
  • Comments Comments (
    0
    ) |
1.3 1.1
  • Comments Comments (
    0
    ) |
Male, percent 48.8 49.7
  • Comments Comments (
    0
    ) |
Race 100 100
  • Comments Comments (
    0
    ) |
Comments about baseline data Dietitian and/or specialist doctor periodically provided instruction on dietary intake recording procedures as part of a behavior modification program and then later used the subject’s food diaries for counseling.
  • Comments Comments (
    0
    ) |
Baseline diet description nd
  • Comments Comments (
    0
    ) |
Baseline omega-3 intake nd
  • Comments Comments (
    0
    ) |
Does this study report baseline omega-3 biomarker data? No
  • Comments Comments (
    0
    ) |



Results & Comparisons


Results Data
Outcome: bp      Population: 52576
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 168 165
Mean 128.4 129.6
SD 6.5 6.8


3 months

N Analyzed 166 163
Mean 126.1 129.2
SD 6.2 6.7


6 months

N Analyzed 164 162
Mean 126.9 128.1
SD 6.3 6.6
Outcome: bp      Population: 52577
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 168 165
Mean 80.6 81.4
SD 6.8 7.1


3 months

N Analyzed 166 163
Mean 79.8 81.1
SD 6.6 7.0


6 months

N Analyzed 164 162
Mean 80.2 80.8
SD 6.7 6.9
Outcome: lipid      Population: 52578
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 168 165
Mean 148.5 149.9
SD 7.2 7.5


3 months

N Analyzed 166 163
Mean 145.4 147.9
SD 6.9 7.1


6 months

N Analyzed 164 162
Mean 147.4 148.1
SD 7.0 6.5
Outcome: lipid      Population: 52579
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 168 165
Mean 38.4 39.7
SD 4.2 5.1


3 months

N Analyzed 166 163
Mean 41.7 40.2
SD 5.8 5.3


6 months

N Analyzed 164 162
Mean 43.2 40.6
SD 6.3 5.4
Outcome: lipid      Population: 52580
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 168 165
Mean 182.6 189.3
SD 39.7 41.8


3 months

N Analyzed 166 163
Mean 152.6 185.6
SD 29.4 40.3


6 months

N Analyzed 164 162
Mean 116.2 182.1
SD 24.6 39.5

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? LOW
  • Comments Comments (
    0
    ) |
Was ALLOCATION adequately concealed (prior to assignment)? LOW
  • Comments Comments (
    0
    ) |
Were PARTICIPANTS adequately BLINDED? LOW
  • Comments Comments (
    0
    ) |
Were OUTCOME ASSESSORS adequately BLINDED? LOW
  • Comments Comments (
    0
    ) |
Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data LOW
  • Comments Comments (
    0
    ) |
Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
  • Comments Comments (
    0
    ) |
INTENTION-TO-TREAT analysis? (Yes/No) Yes
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**GENERAL**) LOW
  • Comments Comments (
    0
    ) |
Was there incomplete COMPLIANCE with interventions across groups? UNCLEAR compliance not reported
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**OMEGA-3**) UNCLEAR
  • Comments Comments (
    0
    ) |
Additional Bias: Bias due to problems not covered elsewhere in the table.
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.