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Lipofen (Fenofibrate) - Summary

 


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LIPOFEN SUMMARY

LIPOFEN™
(fenofibrate capsules)

LIPOFEN™ (fenofibrate capsules), is a lipid regulating agent available as hard gelatin capsules for oral administration. Each hard gelatin capsule contains 50, 100 or 150 mg of fenofibrate.

LIPOFEN™ (fenofibrate capsules) is indicated for the following:

Treatment of Hypercholesterolemia

LIPOFEN™ is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb).

Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological intervention alone has been inadequate (see National Cholesterol Education Program (NCEP) Treatment Guidelines, below).

Treatment of Hypertriglyceridemia

LIPOFEN™ is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.

Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of LIPOFEN™ therapy on reducing this risk has not been adequately studied.

Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2.

The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS).
See all Lipofen indications & dosage >>

LIPOFEN NEWS HIGHLIGHTS

Published Studies Related to Lipofen (Fenofibrate)

Atorvastatin and fenofibrate have comparable effects on VLDL-apolipoprotein C-III kinetics in men with the metabolic syndrome. [2008.10]

Effects of fenofibrate and ezetimibe, both as monotherapy and in coadministration, on cholesterol mass within lipoprotein subfractions and low-density lipoprotein peak particle size in patients with mixed hyperlipidemia. [2008.06]

Effect of fenofibrate on kidney function: a 6-week randomized crossover trial in healthy people. [2008.06]

Fenofibrate reduces fasting and postprandial inflammatory responses among hypertriglyceridemia patients with the metabolic syndrome. [2008.06]

The effects of orlistat and fenofibrate, alone or in combination, on high-density lipoprotein subfractions and pre-beta1-HDL levels in obese patients with metabolic syndrome. [2008.06]

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Clinical Trials Related to Lipofen (Fenofibrate)

A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia [Active, not recruiting]

Evaluation of Efficacy and Safety of Omacor (Omega-3-Acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by 2 Extensions [Completed]

Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids [Completed]

Use of Fenofibrate for Primary Biliary Cirrhosis [Recruiting]

The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART) [Completed]

more >>

Page last updated: 2008-11-02

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