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Study Title and Description

One-year treatment with ethyl esters of n-3 fatty acids in patients with hypertriglyceridemia and glucose intolerance: reduced triglyceridemia, total cholesterol and increased HDL-C without glycemic alterations.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title One-year treatment with ethyl esters of n-3 fatty acids in patients with hypertriglyceridemia and glucose intolerance: reduced triglyceridemia, total cholesterol and increased HDL-C without glycemic alterations.
Author zz_Sirtori CR., Crepaldi G., Manzato E., Mancini M., Rivellese A., Paoletti R., Pazzucconi F., Pamparana F., Stragliotto E.
Country Center E. Grossi Paoletti, University of Milano, Milan, Italy.
Year 1998
Numbers Pubmed ID: 9622285
16829 (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)
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Observational: Prospective, longitudinal, comparative study
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Country in which study conducted (where subjects live) Italy
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Funding source Industry funded
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Eligibility Criteria: The study protocol allowed the selection of patients of both sexes, males aged 45-75 y and females aged 55-80 y, with hyperlipoproteinemias type IIB or IV (23) associated with at least one additional risk factor: impaired glucose tolerance, NIDDM, or arterial hypertension. Patients with severe intercurrent ailments, kidney or renal disease, intestinal malabsorption, duodenal ulcer not responsive to therapy, obese individuals with a body mass index (in kg/m2)  30, as well as noncompliant or unreliable patients were excluded from the study. All patients with a history of vascular or nonvascular brain disease (including epilepsy and alcoholism), severe hyperlipidemia needing drug treatment, severe hypertension (DBP > 1 10 mm Hg, SBP > 180 mm Hg under antihypertensive treatment), myocardial infarction in the preceding 3 mo, or unstable angina were 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 6 months
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At baseline, did all subjects have (per eligibility criteria)...? Diabetes and/or metabolic syndrome*
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Hypertension ... Patients treated with antihypertensive drugs or who on more than one occasion in the past year had had a systolic blood pressure (SBP)  160 mm Hg, a diastolic blood pressure (DBP)  95 mm Hg, or both, independent of drug treatment, were considered to have arterial hypertension.
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Dyslipidemia ... Patients with significant and stable triacylglycerol elevations (> 2.26 mmollL, or 200 mg/dL) were selected. These were defined as type IIB if serum total cholesterol was > 7.21 mmol/L (270 mg/dL) and type IV if cholesterol was ı 7.21 mmol/L (270 mg/dL). Patients with total cholesterol concentrations > 7.76 mmollL (300 mg/dL) with triacylglycerol concentrations  4.52 mmolIL (400 mg/dL) were excluded for ethical reasons.
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Other ... Impaired glucose tolerance
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Conflict of interest No Data regarding conflict of interest
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... NIDDM and type of hyperlipoproteinemia
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Does the study report a regression analysis with interaction terms for an outcome of interest? No
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Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
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Baseline Characteristics
Question All n-3 PUFAs (ALA+DHA+EPA) Total Comments
AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 100
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Baseline characteristics, continuous nd
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Male, percent 62.2
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Race nd
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Comments about baseline data No data entered.
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 No
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Results & Comparisons


Results Data
Outcome: lipid      Population: 51899
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed
Mean nd


12 months

N Analyzed
Mean nd
Outcome: lipid      Population: 51899
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 123
Mean 41
SD 8.43


12 months

N Analyzed 123
Mean 44.4
SD 11.3
Outcome: lipid      Population: 51899
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 164
Mean 40.9
SD 10.6


12 months

N Analyzed 164
Mean 42.9
SD 10.8
Outcome: lipid      Population: 51899
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 70
Mean 37.7
SD 9.1


12 months

N Analyzed 70
Mean 41.2
SD 9.6
Outcome: lipid      Population: 51899
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 86
Mean 37.7
SD 8.4


12 months

N Analyzed 86
Mean 41.5
SD 9.13
Outcome: lipid      Population: 51900
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 868
Mean 135


12 months

N Analyzed 798
Mean 138
Outcome: lipid      Population: 51900
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 123
Mean 149


12 months

N Analyzed 123
Mean 150
Outcome: lipid      Population: 51900
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 164
Mean 146


12 months

N Analyzed 164
Mean 142
Outcome: lipid      Population: 51900
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 70
Mean 109


12 months

N Analyzed 70
Mean 115
Outcome: lipid      Population: 51900
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 86
Mean 104


12 months

N Analyzed 86
Mean 132
Outcome: lipid      Population: 51901
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed
Mean nd
SD


12 months

N Analyzed
Mean nd
SD
Outcome: lipid      Population: 51901
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 123
Mean 295
SD 85.5


12 months

N Analyzed 123
Mean 248
SD 176.7
Outcome: lipid      Population: 51901
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 164
Mean 284.7
SD 77.1


12 months

N Analyzed 164
Mean 219.6
SD 114.3
Outcome: lipid      Population: 51901
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 70
Mean 302.8
SD 77.5


12 months

N Analyzed 70
Mean 212
SD 83.1
Outcome: lipid      Population: 51901
Time Point Measure All n-3 PUFAs (ALA+DHA+EPA)


6 months

N Analyzed 86
Mean 304
SD 76.3


12 months

N Analyzed 86
Mean 244.2
SD 106.2

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 In the open phase, 15 patients manifested 17 events: 8 events in seven patients treated with in the n-3 EE for 12 months and 9 events in eight patients treated with n-3 EE only in the last 6 months. The most frequent side effects were at the GI level, i.e. halitosis, nausea, vomiting, diarrhea and epigastric pain. 17 15 6 months
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Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated?
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Was ALLOCATION adequately concealed (prior to assignment)?
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Were PARTICIPANTS adequately BLINDED?
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Were OUTCOME ASSESSORS adequately BLINDED?
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)?
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INTENTION-TO-TREAT analysis? (Yes/No)
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Group SIMILARITY AT BASELINE (**GENERAL**)
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Was there incomplete COMPLIANCE with interventions across groups?
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Group SIMILARITY AT BASELINE (**OMEGA-3**)
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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.