The effects of fenofibrate at a dose equivalent to 120 mg Fenoglide per day were assessed from four randomized, placebo-controlled, double-blind, parallel-group studies including patients with the following mean baseline lipid values: total-C 306.9 mg/dL; LDL-C 213.8 mg/dL; HDL-C 52.3 mg/dL; and triglycerides 191.0 mg/dL. Fenofibrate therapy lowered LDL-C, Total-C, and the LDL-C/HDL-C ratio. Fenofibrate therapy also lowered triglycerides and raised HDL-C (see Table 2).
|Mean baseline lipid values (n=646)||306.9 mg/dL||213.8 mg/dL||52.3 mg/dL||191.0 mg/dL|
|All FEN (n=361)||-18.7%†||-20.6%†||+11.0%†||-28.9%†|
|Baseline LDL-C greater than 160 mg/dL and TG less than 150 mg/dL (Type IIa)|
|Mean baseline lipid values (n=334)||307.7 mg/dL||227.7 mg/dL||58.1 mg/dL||101.7 mg/dL|
|All FEN (n=193)||-22.4%†||-31.4%†||+9.8%†||-23.5%†|
|Baseline LDL-C greater than 160 mg/dL and TG less than or equal to 150 mg/dL (Type IIb)|
|Mean baseline lipid values (n=242)||312.8 mg/dL||219.8 mg/dL||46.7 mg/dL||231.9 mg/dL|
|All FEN (n=126)||-16.8%†||-20.1%†||+14.6%†||-35.9%†|
p= less than 0.05 vs. placebo
In a subset of the subjects, measurements of apo B were conducted. Fenofibrate treatment significantly reduced apo B from baseline to endpoint as compared with placebo (-25.1% vs. 2.4%, p less than 0.0001, n=213 and 143 respectively).
The effects of fenofibrate on serum triglycerides were studied in two randomized, double-blind, placebo-controlled clinical trials of 147 hypertriglyceridemic patients. Patients were treated for eight weeks under protocols that differed only in that one entered patients with baseline triglyceride (TG) levels of 500 to 1500 mg/dL, and the other TG levels of 350 to 500 mg/dL. In patients with hypertriglyceridemia and normal cholesterolemia with or without hyperchylomicronemia, treatment with fenofibrate at dosages equivalent to 120 mg Fenoglide (fenofibrate) Tablets per day decreased primarily very low density lipoprotein (VLDL) triglycerides and VLDL cholesterol. Treatment of patients with elevated triglycerides often results in an increase of low density lipoprotein (LDL) cholesterol (see Table 3).
=p less than 0.05 vs. placebo
|• NDC 54868-6118-0:||120 mg White to off-white oval tablets. Debossed “FHI”; bottle of 30 tablets|
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
Catalent Pharma Solutions
Winchester, KY 40391
Atlanta, GA 30328
FEN-PI-04 Rev. 04/08
© Sciele Pharma, Inc. All rights reserved.
Repackaging and Relabeling by:
Physicians Total Care, Inc.
Tulsa, OK 74146
PRINCIPAL DISPLAY PANEL
FENOGLIDE (fenofibrate) tablet
|FENOGLIDE fenofibrate tablet|
|Labeler — Physicians Total Care, Inc. (194123980)|
|Physicians Total Care, Inc.||194123980||repack, relabel|
Revised: 05/2010 Physicians Total Care, Inc.
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