1 INDICATIONS AND USAGE
Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
Reduce the risk of total
mortality by reducing CHD deaths and reduce the risk of non-fatal
myocardial infarction, stroke, and the need for revascularization
procedures in patients at high risk of coronary events. (1.1)
Reduce elevated total-C, LDL-C,
Apo B, TG and increase HDL-C in patients with primary hyperlipidemia
(heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2)
Reduce elevated TG in patients
with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary
dysbetalipoproteinemia. (1.2)
Reduce total-C and LDL-C in
adult patients with homozygous familial hypercholesterolemia. (1.2)
Reduce elevated total-C, LDL-C,
and Apo B 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, 1.3)
Limitations of Use
Simvastatin tablets USP has not been studied in Fredrickson Types I and V dyslipidemias. (1.4)
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. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets USP can be started simultaneously with diet.
1.1 Reductions in Risk of CHD Mortality and Cardiovascular Events
In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets USP are indicated to:
Reduce the risk of total
mortality by reducing CHD deaths.
Reduce the risk of non-fatal
myocardial infarction and stroke.
Reduce the need for coronary
and non-coronary revascularization procedures.
1.2 Hyperlipidemia
Simvastatin tablets USP are indicated to:
Reduce elevated total
cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C),
apolipoprotein B (Apo B), and triglycerides (TG), and to increase
high-density lipoprotein cholesterol (HDL-C) in patients with primary
hyperlipidemia (Fredrickson type IIa, heterozygous familial and
nonfamilial) or mixed dyslipidemia (Fredrickson type IIb).
Reduce elevated TG in patients
with hypertriglyceridemia (Fredrickson type lV hyperlipidemia).
Reduce elevated TG and VLDL-C
in patients with primary dysbetalipoproteinemia (Fredrickson type III
hyperlipidemia).
Reduce total-C and LDL-C in
patients with homozygous familial hypercholesterolemia (HoFH) as an
adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if
such treatments are unavailable.
1.3 Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH)
Simvastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present:
1.LDL cholesterol remains 190 mg/dL; or
2.LDL cholesterol remains 160 mg/dL and
3.There is a positive family
history of premature cardiovascular disease (CVD) or
4.Two or more other CVD risk
factors are present in the adolescent patient.
The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C <130 mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined.
1.4 Limitations of Use
Simvastatin tablets USP have not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).