1
INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.
Atorvastatin calcium tablets is an inhibitor of HMG-CoA reductase (statin) indicate d as an adjunct therapy to die t to: (1) Re duce the risk of MI, stroke, revascularization procedures, and angina in patients without CHD, but with multiple risk factors (1.1).
Reduce the risk of MI and stroke in patients with type 2 diabetes without CHD, but with multiple risk factors (1.1).
Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk factors (1.1)
Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in patients with CHD (1.1).
Reduceelevated total-C, LDL-C, apoB, andTG levels and increaseHDL-C in adult patientswith primaryhyperlipidemia (heterozygousfamilial and nonfamilial) and mixed dyslipidemia (1.2).
Reduce elevated TG in patients with hypertriglyceridemia and primary dysbetalipoproteinemia (1.2).
Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) (1.2).
Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients 10 to 17 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy (1.2)
Limitations of Use:
Atorvastatin calcium tablets has not beenstudied in Fredrickson Types I and V dyslipidemias. (1)
1.1
Prevention of Cardiovascular Disea
s
e
In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease suchas age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets areindicated to:
Reduce the risk of myocardialinfarction
Reduce the risk ofstroke
Reduce the risk for revascularization procedures andangina
In adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors forcoronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to:
Reduce the risk of myocardialinfarction
Reduce the risk ofstroke
In adult patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to:
Reduce the risk of non-fatal myocardialinfarction
Reduce the risk of fatal and non-fatalstroke
Reduce the risk for revascularizationprocedures
Reduce the risk of hospitalization for CHF
Reduce the risk ofangina
1.2
Hyperlipidemia
Atorvastatin calcium tablets are indicated:
As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to
increase HDL-C in adult patients withprimaryhypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb);
As an adjunct to diet for the treatment of adult patients with elevated serum TG levels (Fredrickson TypeIV);
For the treatment of adult patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respondadequatelyto diet;
To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to otherlipidloweringtreatments (e.g., LDL apheresis) or if such treatments are unavailable;
As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age,withheterozygous familial hypercholesterolemia (HeFH) if after an adequate trial of diet therapy the following findings are present:
LDL-C remains
190 mg/dLor
LDL-C remains
160 mg/dLand:
there is a positive family history of premature cardiovascular diseaseor
two or more other CVD risk factors are present in the pediatricpatient
1.3
Limitations of Use
Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I andV).