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

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