Atorvastatin

Hypercholesterolaemia Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.

g. LDL apheresis) or if such treatments are unavailable. 1), as an adjunct to correction of other risk factors.

LIPITOR (atorvastatin calcium) is indicated in adults as an adjunct to lifestyle changes, including diet for: • the reduction of elevated total cholesterol (total-C), LDL-C, triglycerides (TG), apolipoprotein B (apo B), the Total-C/HDL-C ratio and for increasing HDL-C in hyperlipidemic and dyslipidemic conditions, including: • Primary hypercholesterolemia (Type IIa); • Combined (mixed) hyperlipidemia (Type IIb), including familial combined hyperlipidemia, regardless of whether cholesterol or triglycerides are the lipid abnormality of concern; • Dysbetalipoproteinemia (Type III); • Hypertriglyceridemia (Type IV); • Familial hypercholesterolemia (homozygous and heterozygous).

For homozygous familial hypercholesterolemia, LIPITOR should be used as an adjunct to treatments such as LDL apheresis, or as monotherapy if such treatments are not available. • the prevention of Cardiovascular Disease, to reduce the risk of myocardial infarction in the following conditions: • hypertensive patients without clinically evident coronary heart disease, but with at least three additional risk factors for coronary heart disease such as age ≥55 years, male sex, smoking, type 2 diabetes, left ventricular hypertrophy, other specified abnormalities on ECG, microalbuminuria or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥6, or premature family history of coronary heart disease.

1 INDICATIONS AND USAGE Atorvastatin calcium tablets are indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.

Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).