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

A highly bioavailable omega-3 free fatty acid formulation improves the cardiovascular risk profile in high-risk, statin-treated patients with residual hypertriglyceridemia (the ESPRIT trial).



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

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title A highly bioavailable omega-3 free fatty acid formulation improves the cardiovascular risk profile in high-risk, statin-treated patients with residual hypertriglyceridemia (the ESPRIT trial).
Author Maki KC., Orloff DG., Nicholls SJ., Dunbar RL., Roth EM., Curcio D., Johnson J., Kling D., Davidson MH.
Country Biofortis Clinical Research, Addison, Illinois. Electronic address: kevin.maki@mxns.com.
Year 2013
Numbers Pubmed ID: 23998969
14817 (internal)

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 Placebo
  • Comments Comments (
    0
    ) |
2 "Fish oil" (DHA+EPA) 2 g Omega-3 formulation in free fatty acid form (OM3-FFA)
  • Comments Comments (
    0
    ) |
3 "Fish oil" (DHA+EPA) 4 g Omega-3 formulation in free fatty acid form (OM3-FFA)
  • 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
    ) |
What is the name of this study? (e.g. DART, Physician's Health Study) ESPRIT TRIAL
  • Comments Comments (
    0
    ) |
Country in which study conducted (where subjects live) US
  • Comments Comments (
    0
    ) |
Funding source Industry funded
  • Comments Comments (
    0
    ) |
Eligibility Criteria: Participants included men and non pregnant,nonlactating women ≥18 years of age with fasting triglyceride (TG) levels ≥200 mg/dL and <500 mg/dL(after 4 weeks of the statin/diet lead-in)and at high risk for a future cardiovascular event.
  • 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 weeks
  • Comments Comments (
    0
    ) |
At baseline, did all subjects have (per eligibility criteria)...? ... Define: Dyslipidemia ... (TG) levels ≥200 mg/dL and <500 mg/dL
  • 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? Yes
  • Comments Comments (
    0
    ) |
Study start date(s) 2011
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 72.6 73.5 68.5
  • Comments Comments (
    0
    ) |
87.9 87.0 83.8
  • Comments Comments (
    0
    ) |
Baseline characteristics, continuous 61.5 60.9 60.1 nd
  • Comments Comments (
    0
    ) |
skip skip skip nd
  • Comments Comments (
    0
    ) |
9.6 10 9.2 nd
  • Comments Comments (
    0
    ) |
128.9 128.3 129.7 nd
  • Comments Comments (
    0
    ) |
skip skip skip nd
  • Comments Comments (
    0
    ) |
14.3 15 13.3 nd
  • Comments Comments (
    0
    ) |
76.1 75.7 77.1 nd
  • Comments Comments (
    0
    ) |
7.7 skip skip nd
  • Comments Comments (
    0
    ) |
32.7 8.9 9.0 nd
  • Comments Comments (
    0
    ) |
5.3 nd nd nd
  • Comments Comments (
    0
    ) |
174 179 178
  • Comments Comments (
    0
    ) |
29.5 mg/dL mg/dL
  • Comments Comments (
    0
    ) |
91.7 29.1 29.1
  • Comments Comments (
    0
    ) |
27.3 92.3 93.6
  • Comments Comments (
    0
    ) |
37.0 mg/dL mg/dL
  • Comments Comments (
    0
    ) |
26.8 26.0 27.6
  • Comments Comments (
    0
    ) |
skip 37.3 36.3
  • Comments Comments (
    0
    ) |
nd mg/dL mg/dL
  • Comments Comments (
    0
    ) |
mg/dL 26.5 22.4
  • Comments Comments (
    0
    ) |
mg/dL nd nd
  • Comments Comments (
    0
    ) |
mg/dL 33.3 33.3
  • Comments Comments (
    0
    ) |
nd skip 6.6
  • Comments Comments (
    0
    ) |
skip 6.2 nd
  • Comments Comments (
    0
    ) |
nd nd
  • Comments Comments (
    0
    ) |
Male, percent 56.7 57.2 63.4
  • Comments Comments (
    0
    ) |
Race 91.6 96.3 94.4 nd
  • Comments Comments (
    0
    ) |
4.7 3.3 2.3 nd
  • Comments Comments (
    0
    ) |
1.4 0 1.9 nd
  • Comments Comments (
    0
    ) |
2.3, included American Indian or Alaska native, native Hawaiian, or Pacific Islander, multiple, and other 1 1.4 nd
  • Comments Comments (
    0
    ) |
nd
  • Comments Comments (
    0
    ) |
nd
  • Comments Comments (
    0
    ) |
Comments about baseline data No data entered.
Baseline diet description statin therapy/National Cholesterol Education Program Therapeutic Lifestyle Changes diet statin therapy/National Cholesterol Education Program Therapeutic Lifestyle Changes diet statin therapy/National Cholesterol Education Program Therapeutic Lifestyle Changes diet
  • Comments Comments (
    0
    ) |
Baseline omega-3 intake nd 2g 4g
  • Comments Comments (
    0
    ) |
Does this study report baseline omega-3 biomarker data? Yes
  • Comments Comments (
    0
    ) |



Results & Comparisons


Results Data
Outcome: lipid      Population: 44466
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 211 209 207
Mean 91.7 92.3 93.6
SD 27.3 26.0 27.6


6 weeks

N Analyzed 211 209 207
Mean 92.8 96.6 94.2
SD 28.1 27.1 27.1
Outcome: lipid      Population: 44467
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 211 209 207
Mean 4.7 4.8 4.9
SD 1.1 1.1 1.3


6 weeks

N Analyzed 211 209 207
Mean 4.6 4.6 4.6
SD 1.2 1.3 1.5

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
Placebo Adverse Event 1 Gastrointestinal disorders (diarrhea and nausea) 19 215 6 weeks
  • Comments Comments (
    0
    ) |
"Fish oil" (DHA+EPA) 29 215 6 weeks
"Fish oil" (DHA+EPA) 58 216 6 weeks
Placebo Adverse Event 2 Infections and infestations 21 215 6 weeks
  • Comments Comments (
    0
    ) |
"Fish oil" (DHA+EPA) 14 215 6 weeks
"Fish oil" (DHA+EPA) 17 216 6 weeks
Placebo Adverse Event 3 Investigations 5 215 6 weeks
  • Comments Comments (
    0
    ) |
"Fish oil" (DHA+EPA) 7 215 6 weeks
"Fish oil" (DHA+EPA) 5 216 6 weeks
Placebo Adverse Event 4 Musculoskeletal and connective tissue disorders 11 215 6 weeks
  • Comments Comments (
    0
    ) |
"Fish oil" (DHA+EPA) 7 215 6 weeks
"Fish oil" (DHA+EPA) 10 216 6 weeks
Placebo Adverse Event 5 Nervous system disorders 3 215 6 weeks
  • Comments Comments (
    0
    ) |
"Fish oil" (DHA+EPA) 2 215 6 weeks
"Fish oil" (DHA+EPA) 8 216 6 weeks
Placebo Adverse Event 6 Respiratory, thoracic, and mediastinal disorders 3 215 6 weeks
  • Comments Comments (
    0
    ) |
"Fish oil" (DHA+EPA) 7 215 6 weeks
"Fish oil" (DHA+EPA) 8 216 6 weeks

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Unsure no randomization method mentioned in the study
  • Comments Comments (
    0
    ) |
Was ALLOCATION adequately concealed (prior to assignment)? Unsure
  • Comments Comments (
    0
    ) |
Were PARTICIPANTS adequately BLINDED? Yes double-blinded
  • Comments Comments (
    0
    ) |
Were OUTCOME ASSESSORS adequately BLINDED? Yes lab tests
  • Comments Comments (
    0
    ) |
Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data Yes
  • 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**) Yes
  • Comments Comments (
    0
    ) |
Was there incomplete COMPLIANCE with interventions across groups? Yes Mean (SD) compliance with study products was similar among treatment groups: 97.5% (8.2%), 96.8% (11.6%), and 96.2% (11.3%) of scheduled doses in the OO, OM3-FFA 2-g/d, and OM3-FFA 4-g/d groups, respectively.
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**OMEGA-3**) Yes
  • Comments Comments (
    0
    ) |
Additional Bias: Bias due to problems not covered elsewhere in the table. Unsure The use of an OO control was a potential limitation in the present trial because OO may have had nonneutral effects on some of the outcome variables.31 and 32 Several oils, including corn oil, mineral oil, and OO, have been used as controls in omega-3 trials, but none of these is truly inert. Favorable changes in lipid levels with corn oil and OO ingestion have been reported.33 Given the absence of a true "placebo," it is important to closely examine the changes from baseline in each treatment arm and not to rely solely on the placebo-corrected results to judge responses to therapy.
  • 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.