Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia

Study Overview
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Brief Summary
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Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the good cholesterol) work better. Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL and other lipoproteins, in patients with high triglyceride levels. Study funding: This study is being funded by an investigator-initiated research grant from Glaxo Smith Kline.

Official Title
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Effects of Lovaza Monotherapy vs. Placebo on Composition and Function of HDL and Other Lipoproteins, and on Other Lipid-Related Parameters

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: Lovaza (Omega-3 acid ethyl esters)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Fasting TG 500-2000 mg/dL (off of TG-lowering medications-see below) Age 35-75 years Exclusion criteria: Use of Lovaza (2g/d or more) or high-dose dietary supplement omega-3 oil (4g/d or more) in the past 2 months Use of lipid therapy (statin, ezetimibe, fibrate, BAS, or niacin at therapeutic dose, 1g/d or higher) in the past 3 weeks (washout of prior therapy permitted) Anticipated need to change type or dose of BP medicine (all types allowed), of lipid-active diabetes medication (thiazolidinedione), of oral estrogen (BCP or HRT), or glucocorticoid during the study (16 + 2 weeks = 18 weeks total) Excess ethanol consumption (regular intake >4 drinks/d, or binges of >8 drinks at once for men, half these levels for women) Poorly controlled diabetes mellitus (A1c >9%) History of acute or chronic pancreatitis Use of exenatide (Byetta) or sitagliptin (Januvia), medications believed to increase the risk of acute pancreatitis History of significant unexplained or uncontrolled bleeding or bruising Poorly controlled blood pressure (>140/90mmHg, with or without treatment) Poorly controlled thyroid disease (TSH outside of normal range) Hepatic disease (ALT > 2.5x ULN, Dx of hepatitis or cirrhosis) Any contraindication or prior adverse reaction to Lovaza Active cancer (except basal cell or squamous cell skin cancer) Pregnancy, plan/desire to become pregnant, breast feeding Inability or unwillingness to provide informed consent

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lovaza<br>Lovaza 4g po qd | Drug: Lovaza (Omega-3 acid ethyl esters)<br>* 1g capsules, 4 capsules po daily<br>* Other names: Lovaza;|
| Placebo Comparator: Placebo<br>Matching placebo | Drug: Placebo<br>* Placebo matching active lovaza, 1 g capsules, 4 capsules po daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL Composition | HDL composition (protein and lipid) by size (gel filtration column) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL cholesterol composition by density subfraction | HDL composition by density gradient ultracentrifugation | 12 weeks | 
| Safety | Transaminases and glucose levels | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertriglyceridemia, omega-3 acid ethyl esters, high-density lipoproteins, fish oil