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LIPITOR Atorvastatin Calcium Tablets Indications And Clinical Use

Indications And Clinical Use

LIPITOR (atorvastatin calcium) is indicated 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.

 

  • 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 still present:
    a. LDL-C remains >4.9 mmol/L (190 mg/dL) or
    b. LDL-C remains >4.1 mmol/L (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

Prior to initiating therapy with LIPITOR, secondary causes should be excluded for elevations in plasma lipid levels (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, and alcoholism), and a lipid profile performed to measure total cholesterol, LDL-C, HDL-C, and TG. For patients with TG <4.52 mmol/L (<400 mg/dL), LDL-C can be estimated using the following equation:

LDL-C (mmol/L) = total-C - [(0.37 x (TG) + HDL-C)]
LDL-C (mg/dL) = total-C - [(0.2 x (TG) + HDL-C)]

For patients with TG levels >4.52 mmol/L (>400 mg/dL), this equation is less accurate and LDL-C concentrations should be measured directly or by ultracentrifugation.

Patients with high or very high triglyceride levels, i.e. > 2.2 mmol/L (200 mg/dL) or > 5.6 mmol/L (500 mg/dL), respectively, may require triglyceride-lowering therapy (fenofibrate, bezafibrate or nicotinic acid) alone or in combination with LIPITOR.

In general, combination therapy with fibrates must be undertaken cautiously and only after risk-benefit analysis (see WARNINGS AND PRECAUTIONS, Muscle Effects, Pharmacokinetic Interactions and DRUG INTERACTIONS).

Elevated serum triglycerides are most often observed in patients with the metabolic syndrome (abdominal obesity, atherogenic dyslipidemia {elevated triglycerides, small dense LDL particles and low HDL-cholesterol}, insulin resistance with or without glucose intolerance, raised blood pressure and prothrombic and proinflammatory states).

When drugs are prescribed attention to therapeutic lifestyle changes (reduced intake of saturated fats and cholesterol, weight reduction, increased physical activity, ingestion of soluble fibers) should always be maintained and reinforced.

Prevention of Cardiovascular Disease
LIPITOR is indicated to reduce the risk of myocardial infarction in adult 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.

LIPITOR is also indicated to reduce the risk of myocardial infarction and stroke in adult patients with type 2 diabetes mellitus and hypertension without clinically evident coronary heart disease, but with other risk factors such as age ≥55 years, retinopathy, albuminuria or smoking.

LIPITOR is indicated to reduce the risk of myocardial infarction in patients with clinically evident coronary heart disease.

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