Cerivastatin indications

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-632-7753

List of indications

Indications

• Exclusion of secondary conditions
• Hypertriglyceridemic patients

Frequency of lipid determinations

Acute coronary events patients

Treatment response assessment

Chylomicron elevation

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Indications

BAYCOL® (cerivastatin sodium tablets) is indicated as an adjunct to diet to reduce elevated Total C, LDLC, apo B, and TG and to increase HDL-C levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb) when the response to dietary restriction of saturated fat and cholesterol and other non-pharmacological measures alone has been inadequate. Therapy with lipidaltering drugs should be a component of multiple risk factor intervention in those patients at significantly high risk for atherosclerotic vascular disease due to hypercholesterolemia. Return to top

Exclusion of secondary conditions

Before considering therapy with lipid-altering agents, secondary causes of hypercholesterolemia, e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism, should be excluded and a lipid profile performed to measure Total-C, HDL-C, and triglycerides (TG). For patients with TG of 400 mg/dL or less, LDL-C can be estimated using the following equation:

LDL-C = [Total-C] minus [HDL-C + TG/5] Return to top

Hypertriglyceridemic patients

For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be directly measured by preparative ultracentrifugation. In many hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases, BAYCOL® (cerivastatin sodium tablets) is not indicated. Return to top

Frequency of lipid determinations

Lipid determinations should be performed at intervals of no less than four weeks. Return to top

Acute coronary events patients

At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C level is ≥ 130 mg/dL (NCEP-ATP II). Return to top

Treatment response assessment

Since the goal of treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy. Return to top

Chylomicron elevation

Although BAYCOL® may be useful to reduce elevated LDL-cholesterol levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (Type IIb hyperlipoproteinemia), it has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia types I, III, IV, or V). Return to top

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The content of this page is taken from the FDA package insert for this drug and should not be edited.