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 Hypeerlipidemia
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).