el-group study of 254 adult patients (122 on LOVAZA and 132 on placebo) with persistent high triglycerides (200 to 499 mg/dL) despite simvastatin therapy (Table 1). Patients were treated with open-label simvastatin 40 mg per day for 8 weeks prior to randomization to control their LDL-C to no greater than 10% above NCEP ATP III goal and remained on this dose throughout the study. Following 8 weeks of open-label treatment with simvastatin, patients were randomized to either LOVAZA 4 g per day or placebo for an additional 8 weeks with simvastatin co-therapy. The median baseline triglyceride and LDL-C levels in these patients were 268 mg/dL and 89 mg/dL, respectively. Median baseline non-HDL-C and HDL-C levels were 138 mg/dL and 45 mg/dL, respectively.
The changes in the major lipoprotein lipid parameters for the groups receiving LOVAZA plus simvastatin and placebo plus simvastatin are shown in Table 1.
Table 1. Response to the Addition of LOVAZA 4 g per day to On-going Simvastatin 40 mg per day Therapy in Patients With High Triglycerides (200 to 499 mg/dL) Parameter LOVAZA + Simvastatin
N = 122 Placebo + Simvastatin
N = 132 Difference P-Value
BL EOT Median % Change BL EOT Median % Change
Non-HDL-C 137 123 -9.0 141 134 -2.2 -6.8 <0.0001
TG 268 182 -29.5 271 260 -6.3 -23.2 <0.0001
TC 184 172 -4.8 184 178 -1.7 -3.1 <0.05
VLDL-C 52 37 -27.5 52 49 -7.2 -20.3 <0.05
Apo-B 86 80 -4.2 87 85 -1.9 -2.3 <0.05
HDL-C 46 48 +3.4 43 44 -1.2 +4.6 <0.05
LDL-C 91 88 +0.7 88 85 -2.8 +3.5 =0.05
BL = Baseline (mg/dL); EOT = End of Treatment (mg/dL); Median % Change = Median Percent Change from Baseline; Difference = LOVAZA Median % Change – Placebo Median % Change
LOVAZA 4 g per day significantly reduced non-HDL-C, TG, TC, VLDL-C, and Apo-B levels and increased HDL-C and LDL-C from baseline relative to placebo.
Very High Triglycerides
Monotherapy
The effects of LOVAZA 4 g per day were assessed in 2 randomized, placebo-controlled, double-blind, parallel-group studies of 84 adult patients (42 on LOVAZA, 42 on placebo) with very high triglyceride levels (Table 2). Patients whose baseline triglyceride levels were between 500 and 2,000 mg/dL were enrolled in these 2 studies of 6 and 16 weeks’ duration. The median triglyceride and LDL-C levels in these patients were 792 mg/dL and 100 mg/dL, respectively. Median HDL-C level was 23.0 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 Patients With Very High TG Levels (≥500 mg/dL) Parameter LOVAZA
N = 42 Placebo
N = 42 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 -8.0
VLDL-C 175 -41.7 175 -0.9 -40.8
HDL-C 22 +9.1 24 0.0 +9.1
LDL-C 89 +44.5 108 -4.8 +49.3
BL = Baseline (mg/dL); % Chg = Median Percent Change from Baseline; Difference = LOVAZA Median % change – Placebo Median % Change
LOVAZA 4 g per 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 in patients with very high TG levels has not been eva luated.
The effect of LOVAZA on cardiova |
