-blind, parallel-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. 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 grams 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 or placebo plus simvastatin are shown in Table 3.
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 grams 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.
Table 3. Response to the Addition of LOVAZA 4 grams per day to Ongoing 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
LOVAZA (omega-3-acid ethyl esters) capsules are supplied as 1-gram transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation LOVAZA.
Bottles of 60: NDC 0173-0783-01
Bottles of 120: NDC 0173-0783-02
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.
See FDA-approved patient labeling (17.2).
Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information.
Manufactured for GlaxoSmithKline by:
Catalent Pharma Solutions
2725 Scherer Drive
St. Petersburg, FL 33716-1016
Accucaps Industries Limited
2125 Ambassador Drive
Windsor, Ontario, Canada N9B 3R5
Banner Pharmaceuticals Inc.
4125 Premier Drive
High Point, NC 27265
Distributed by:
GlaxoSmithKline
Research Triangle Park, NC 27709
LOVAZA is a registered trademark of the GlaxoSmithKline group of companies.
©2010 GlaxoSmithKline. All rights reserved.
December 2010
LVZ:6PI
PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
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PATIENT INFORMATION
LOVAZA (lō-vā-ză)
(omega-3-acid ethyl esters) Capsules
Read the Patient Information that comes with LOVAZA before you start taking it, and each time you get a refill. There may be new information. This leaflet does not take the pla
