Titrating lovaza from 4 to 8 to 12 grams/day in patients with primary hypertriglyceridemia who had triglyceride levels >500 mg/dl despite conventional triglyceride lowering therapy.
Level 4 - case-series / case-control
Uncontrolled prospective case series / dose-titration study without a control group
PubMed 23110706 · doi:10.1186/1476-511X-11-143
What was done
In 15 white patients (14 men, 1 woman; mean age 50 ± 7 years) with severe primary hypertriglyceridemia (triglycerides >500 mg/dl despite diet, glycemic control, and fibrates), Lovaza was administered at 4 g/day for 1 month. If triglycerides remained >500 mg/dl, the dose was increased to 8 g/day for 1 month, then to 12 g/day for 1 month, followed by a reduction back to 4 g/day for 4 months. Lipid levels and safety measures were evaluated throughout.
What was found
Five patients responded fully to 4 g/day, with mean triglycerides decreasing from 1390 mg/dl to 234 mg/dl (-83%), 135 mg/dl (-90%), and 158 mg/dl (-89%) at months 1, 2, and 3 (p < 0.0001), and non-HDL-C dropping by 45% to 53% (p <= 0.001). Among the 10 patients escalated to higher doses, 3 did not respond. In the remaining 7 patients, mean triglycerides dropped from 1075 mg/dl to 672 mg/dl (-37%, p=0.006) on 4 g/day, 577 mg/dl (-46%, p=0.0009) on 8 g/day, and 428 mg/dl (-60%, p < 0.0001) on 12 g/day; triglyceride levels on 12 g/day were significantly lower than on 8 g/day (p = 0.03). Non-HDL-C decreased by 11% on 4 g/day, 17% on 8 g/day (p = 0.01), and 22% on 12 g/day (p = 0.003). No abnormal safety test results were observed, and doses up to 12 g/day were well tolerated.
Why it matters
This study indicates that titrating prescription omega-3 fatty acids beyond standard doses up to 12 g/day may safely lower triglycerides in patients with severe hypertriglyceridemia refractory to 4 g/day therapy.
Limits
The study is limited by a very small sample size (n=15), lack of a control or placebo group, and open-label design. The study population was homogeneous (100% white, 93% male). Escalated doses were only evaluated for short durations (1 month per step), and hard clinical outcomes like pancreatitis reduction were not evaluated.
Cited by
- supports The standard prescription dosage for Lovaza (omega-3-acid ethyl esters) is 4 grams per day.