LIPITOR (atorvastatin calcium) Indication Statement
LIPITOR is indicated as an adjunct to diet to reduce the risk of myocardial infarction (MI),
stroke, revascularization procedures, and angina in adult patients with multiple risk factors
but without clinically evident coronary heart disease (CHD); to reduce the risk of MI and
stroke in patients with type 2 diabetes and without clinically evident CHD, but with
multiple risk factors; to reduce the risk of nonfatal MI, fatal and nonfatal stroke,
revascularization procedures, hospitalization for congestive heart failure, and
angina in adult patients with clinically evident CHD.
LIPITOR, as an adjunct to diet, is also indicated 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.
Important Safety Information
LIPITOR is contraindicated in patients with active liver disease or unexplained persistent elevations
of hepatic transaminases; in women who are or may become pregnant or who are nursing; in patients
with hypersensitivity to any component of this medication.
Rare cases of rhabdomyolysis have been reported with LIPITOR and other statins. Tell patients to
promptly report muscle pain, tenderness, or weakness. Predisposing factors include advanced age (≥65),
uncontrolled hypothyroidism, and renal impairment. Patients with a history of renal impairment merit
closer monitoring. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or
discontinued.
The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and
strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, and HIV protease inhibitors) increases
the risk of myopathy/rhabdomyolysis. Lower doses of LIPITOR should be considered. Physicians
should carefully monitor patients for signs or symptoms of myopathy early during therapy and
when titrating the dose of either drug.
It is recommended that liver function tests be performed prior to and 12 weeks following both the initiation
of therapy and any elevation of dose, and periodically thereafter. If ALT or AST values >3 x ULN persist,
dose reduction or withdrawal is recommended.
In a post hoc analysis of the SPARCL study in patients without CHD who had a stroke or TIA within the
preceding 6 months, a higher incidence of hemorrhagic stroke was seen in the LIPITOR 80-mg group
compared with placebo (2.3% vs 1.4%). Some baseline characteristics, including hemorrhagic and
lacunar stroke on study entry, were associated with a higher incidence of hemorrhagic stroke
in the atorvastatin group.
The most commonly reported adverse reactions with LIPITOR in placebo-controlled trials were: nasopharyngitis,
arthralgia, diarrhea, pain in extremity, and urinary tract infection.