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

• Status: Withdrawn
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: GlaxoSmithKline

Criteria

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