Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia (ELLF)

Sanford Research

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hypertriglyceridemia

Treatments: Drug: Lovaza

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00959842

GSK - LVZ 112860 (Other Grant/Funding Number)

LVZ 112860

Details and patient eligibility

About

This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).

Full description

This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).

Enrollment: 15 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-79 years
• Stable does of statins ≥ 8 weeks prior to screening
• Good health by medical history, physical exam, electrocardiogram, laboratory test (e.g., serum chem., urinalysis)
• Mean fasting serum triglyceride of two most recent tests in medical record ≥ 200 and < 500 mg/dL
• Mean LDL-cholesterol of two most recent tests in medical record ≤ 1.1 × NCEP ATP III goal

Exclusion criteria

• Medications, vitamin pills, nutritional supplements or herbal preparations deemed exclusionary per primary investigator for possible interference
• Poorly controlled diabetes mellitus (e.g. [HbA1c] > 8.0%)
• History of a cardiovascular event
• Past revascularization procedure
• Past aortic aneurysm or an aortic dissection < 6 months prior to screening
• History of pancreatitis
• Sensitivity to any statin OR to omega-3 fatty acids or fish products
• Poorly controlled hypertension (i.e.: >=160 systolic (resting) and/or >=100 diastolic (resting)) at 2 consecutive visits
• Serum Creatinine ≥ 2.0 mg/dL
• Serum transaminase > 1.5 × upper limit of normal (ULN); including aspartate aminotransferase [AST] or alanine aminotransferase [ALT]; 31 U/L for AST, 45 U/L for ALT
• Creatine Kinase (CK) > 3.0 × ULN
• Taking other triglyceride lowering drugs (e.g., niacin, fibrates) or fish oil supplements providing more than 500 mg of EPA+DHA per day
• Contraindications for Lovaza per product insert
• Women who are pregnant or nursing

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Lovaza

Experimental group

Description:

Lovaza was given as the only agent; there was no comparator agent or arm

Treatment:

Drug: Lovaza