1 INDICATIONS AND USAGE
Pravastatin sodium tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
Reduce the risk of MI, revascularization,
and cardiovascular mortality in hypercholesterolemic patients without
clinically evident CHD. (1.1)
Reduce the risk of total mortality by
reducing coronary death, MI, revascularization, stroke/TIA, and the
progression of coronary atherosclerosis in patients with clinically
evident CHD. (1.1)
Reduce elevated Total-C, LDL-C, ApoB, and
TG levels and to increase HDL-C in patients with primary
hypercholesterolemia and mixed dyslipidemia. (1.2)
Reduce elevated serum TG levels in
patients with hypertriglyceridemia.(1.2)
Treat patients with primary
dysbetalipoproteinemia who are not responding to diet.
(1.2)
Treat children and adolescent patients
ages 8 years and older with heterozygous familial hypercholesterolemia
after failing an adequate trial of diet therapy.
(1.2)
Limitations of use:
Pravastatin sodium tablets have not been studied in Fredrickson
Types I and V
dyslipidemias. (1.3)
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 indicated 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.
1.1 Prevention of Cardiovascular Disease
In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets are indicated to:
reduce the risk of myocardial infarction
(MI).
reduce the risk of undergoing myocardial
revascularization procedures.
reduce the risk of cardiovascular
mortality with no increase in death from non-cardiovascular causes.
In patients with clinically evident CHD, pravastatin sodium tablets are indicated to:
reduce the risk of total mortality by
reducing coronary death.
reduce the risk of MI.
reduce the risk of undergoing myocardial
revascularization procedures.
reduce the risk of stroke and
stroke/transient ischemic attack (TIA).
slow the progression of coronary
atherosclerosis.
1.2 Hyperlipidemia
Pravastatin sodium tablets are indicated:
as an adjunct to diet to reduce elevated
total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C),
apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase
high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia
and mixed dyslipidemia (Fredrickson Types IIa and IIb).1
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.
as an adjunct to diet and lifestyle
modification for treatment of heterozygous familial hypercholesterolemia
(HeFH) in children and adolescent patients ages 8 years and older if
after an adequate trial of diet the following findings are present:
a. LDL-C remains 190 mg/dL or
b. LDL-C remains 160 mg/dL and:
there is a positive family history of
premature cardiovascular disease (CVD) or
two or more other CVD risk factors are
present in the patient.
1.3 Limitations of Use
Pravastatin sodium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).