While LOVAZA®’s method of action is not understood (12.1), clinical trials demonstrated efficacy in lowering triglycerides in individuals with very high TG levels (14.1).
Clinical Studies
Severe Hypertriglyceridemia
The effects of LOVAZA® 4 grams/day were assessed in 2 randomized, placebo-controlled, double-blind, parallel-group trials of 84 adult subjects (42 on LOVAZA®, 42 on placebo) with very high TG levels. Subjects whose baseline TG levels were between 500 and 2,000 mg/dL were enrolled in these 2 trials of 6 and 16 weeks’ duration. The median TG and LDL-C levels in these subjects were 792 mg/dL and 100 mg/dL, respectively. Median high-density lipoprotein cholesterol (HDL-C) level was 23 mg/dL.
The changes in the major lipoprotein lipid parameters for the groups receiving LOVAZA® or placebo are shown in Table 2.
Table 2. Median Baseline and Percent Change from Baseline in Lipid Parameters in Subjects with Severe Hypertriglyceridemia (≥500 mg/dL)
|
Parameter |
LOVAZA® |
Placebo |
Difference |
||
|
BL |
% Change |
BL |
% Change |
||
|
TG |
816 |
-44.9 |
788 |
+6.7 |
-51.6 |
|
Non-HDL-C |
271 |
-13.8 |
292 |
-3.6 |
-10.2 |
|
TC |
296 |
-9.7 |
314 |
-1.7 |
-8 |
|
VLDL-C |
175 |
-41.7 |
175 |
-0.9 |
-40.8 |
|
HDL-C |
22 |
+9.1 |
24 |
0 |
+9.1 |
|
LDL-C |
89 |
+44.5 |
108 |
-4.8 |
+49.3 |
BL = Baseline (mg/dL); % Change = Median Percent Change from Baseline;
Difference = LOVAZA® Median % Change – Placebo Median % Change. TC = Total cholesterol.
VLDL-C = Very-low-density lipoprotein (VLDL) cholesterol.
LOVAZA® 4 grams/day reduced median TG, VLDL-C, and non-HDL-C levels and increased median HDL-C from baseline relative to placebo. Treatment with LOVAZA® to reduce very high TG levels may result in elevations in LDL-C and non-HDL-C in some individuals. Patients should be monitored to ensure that the LDL-C level does not increase excessively.
The effect of LOVAZA® on the risk of pancreatitis has not been determined.
The effect of LOVAZA® on cardiovascular mortality and morbidity has not been determined.