INDICATIONS & USAGE SECTION
Treatment of Hypercholesterolemia
Fenofibrate tablets, USP are 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 interventions alone has been inadequate (See National Cholesterol Education Program [NCEP] Treatment Guidelines, below).
Treatment of Hypertriglyceridemia
Fenofibrate tablets, USP are 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 fenofibrate tablet, USP 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).
Fredrickson Classification of Hyperlipoproteinemias
C = cholesterol
TG = triglycerides
LDL = low density lipoprotein
VLDL = very low density lipoprotein
IDL = intermediate density lipoprotein
Lipid Elevation
Type
Lipoprotein Elevated
Major
Minor
I (rare)
chylomicrons
TG
C
IIa
LDL
C
-
IIb
LDL, VLDL
C
TG
III (rare)
IDL
C, TG
-
IV
VLDL
TG
C
V (rare)
chylomicrons, VLDL
TG
NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories
CHD = coronary heart disease
Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of < 100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory.
Almost all people with 0 to 1 risk factor have 10-year risk < 10%; thus, 10-year risk assessment in people with 0 to 1 risk factor is not necessary.
Risk Category
LDL Goal (mg/dL)
LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL)
LDL Level at Which to Consider Drug Therapy (mg/dL)
CHD or CHD risk equivalents (10-years risk > 20%)
< 100
100
130 (100 to 129: drug optional)
2+ Risk Factors (10-year risk
20%)
< 130
130
10-year risk 10% to 20%:
130 10-year risk < 10%:
160
0 to 1 Risk Factor
< 160
160
190 (160 to 189: LDL- lowering drug optional)
After the LDL-C goal has been achieved, if the TG is still
200 mg/dL, non HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.