Fenoglide (Page 4 of 4)

14 CLINICAL STUDIES

14.1 Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia

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).

Table 2. Mean Percent Change in Lipid Parameters at End of Treatment*
Treatment Group Total-C LDL-C HDL-C TG
Pooled Cohort
Mean baseline lipid values (n=646)306.9 mg/dL213.8 mg/dL52.3 mg/dL191.0 mg/dL
All FEN (n=361)-18.7%†-20.6%†+11.0%†-28.9%†
Placebo (n=285)-0.4%-2.2%+0.7%+7.7%
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/dL227.7 mg/dL58.1 mg/dL101.7 mg/dL
All FEN (n=193)-22.4%†-31.4%†+9.8%†-23.5%†
Placebo (n=141)+0.2%-2.2%+2.6%+11.7%
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/dL219.8 mg/dL46.7 mg/dL231.9 mg/dL
All FEN (n=126)-16.8%†-20.1%†+14.6%†-35.9%†
Placebo (n=116)-3.0%-6.6%+2.3%+0.9%


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).

14.2 Hypertriglyceridemia

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).

Table 3. Effects of Fenofibrate in Patients With Hypertriglyceridemia
Study 1 Pla cebo Feno fibrate
Baseline TG levels 350 to 499 mg/dLNBaseline(Mean)Endpoint(Mean)% Change(Mean)NBaseline(Mean)Endpoint(Mean)% Change(Mean)
Triglycerides28449450-0.527432223-46.2*
VLDL Triglycerides193673502.719350178-44.1*
Total Cholesterol282552612.827252227-9.1*
HDL Cholesterol283536427344019.6*
LDL Cholesterol28120129122712813714.5
VLDL Cholesterol2799995.8279246-44.7*
Study 2 Pla cebo Feno fibrate
Baseline TG levels 500 to 1500 mg/dLNBaseline(Mean)Endpoint(Mean)% Change(Mean)NBaseline(Mean)Endpoint(Mean)% Change(Mean)
Triglycerides447107507.248726308-54.5*
VLDL Triglycerides2953757118.733543205-50.6*
Total Cholesterol442722710.448261223-13.8*
HDL Cholesterol4427285.048303622.9*
LDL Cholesterol4210090-4.24510313145.0*
VLDL Cholesterol4213714211.04512654-49.4*

=p less than 0.05 vs. placebo

16 HOW SUPPLIED/STORAGE AND HANDLING

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].

Manufactured by:
Catalent Pharma Solutions
Winchester, KY 40391

Manufactured for:

image of Sciele name

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

120 mg

image of 120 mg package label
(click image for full-size original)
FENOGLIDE fenofibrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6118(NDC:59630-495)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRATE) FENOFIBRATE 120 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 6000
POLOXAMER 188
MAGNESIUM STEARATE
Product Characteristics
Color white (White to off-white) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code FHI
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6118-0 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022118 04/28/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 repack, relabel

Revised: 05/2010 Physicians Total Care, Inc.

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.