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, LIPITOR can be started simultaneously with diet.
LIPITOR is an inhibitor of HMG-CoA reductase (statin) indicated as an adjunct therapy to diet to:
Reduce
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 non-fatal MI, fatal and non-fatal stroke, revascularization
procedures, hospitalization for CHF, and angina in patients with CHD (1.1).
Reduce
elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult
patients with primary hyperlipidemia (heterozygous familial 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 boys and postmenarchal girls,
10 to 17 years of age, with heterozygous familial hypercholesterolemia
after failing an adequate trial of diet therapy (1.2).
Limitations of Use
LIPITOR has not been studied in Fredrickson Types I and V dyslipidemias.
1.1 Prevention of Cardiovascular Disease
In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, LIPITOR is indicated to:
Reduce
the risk of myocardial infarction
Reduce
the risk of stroke
Reduce
the risk for revascularization procedures and angina
In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, LIPITOR is indicated to:
Reduce
the risk of myocardial infarction
Reduce
the risk of stroke
In patients with clinically evident coronary heart disease, LIPITOR is indicated to:
Reduce
the risk of non-fatal myocardial infarction
Reduce
the risk of fatal and non-fatal stroke
Reduce
the risk for revascularization procedures
Reduce
the risk of hospitalization for CHF
Reduce
the risk of angina
1.2 Hyperlipidemia
LIPITOR is indicated:
As an
adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels
and to increase HDL-C in patients with primary hypercholesterolemia
(heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson
Types IIa and IIb);
As an
adjunct to diet for the treatment of patients with elevated serum TG
levels (Fredrickson Type IV);
For
the treatment of patients with primary dysbetalipoproteinemia (Fredrickson
Type III) who do not respond adequately to diet;
To
reduce total-C and LDL-C in patients with homozygous familial
hypercholesterolemia as an adjunct to other lipid-lowering treatments
(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 boys and
postmenarchal girls, 10 to 17 years of age, with heterozygous familial
hypercholesterolemia if after an adequate trial of diet therapy the
following findings are present:
LDL-C
remains
190 mg/dL or
LDL-C
remains
160 mg/dL and:
there is a positive family history of premature cardiovascular disease or
two or more other CVD risk factors are present in the pediatric patient
1.3 Limitations of Use
LIPITOR has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).