LIPITOR safety information
IMPORTANT SAFETY INFORMATION

LIPITOR® (atorvastatin calcium) tablets are contraindicated in patients with a known hypersensitivity to any component of this product; in patients with active liver disease or unexplained persistent elevations of hepatic transaminases; in women who are or may become pregnant or who are breastfeeding. Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy.

Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with LIPITOR® (atorvastatin calcium) tablets 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 LIPITOR® (atorvastatin calcium) tablets 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 the initiation of therapy and repeated as clinically indicated thereafter.

Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIPITOR® (atorvastatin calcium) tablets.

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 (atorvastatin calcium) tablets 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 LIPITOR group.

The most commonly reported adverse reactions with LIPITOR® (atorvastatin calcium) tablets in placebo-controlled trials were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.

INDICATIONS

LIPITOR® (atorvastatin calcium) tablets are 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 adult 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

  • 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

  • Reduce elevated TG in adult patients with hypertriglyceridemia and primary dysbetalipoproteinemia

  • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH)

  • Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy

Limitations of Use: LIPITOR has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Please see Full Prescribing Information and Patient Information.

Efficacy

Clinically Proven LDL-C Reductions

LIPITOR® (atorvastatin calcium) tablets provide LDL-C reductions of 39% to 60% across the full dose range1

LIPITOR® (atorvastatin calcium) tablets are contraindicated in patients with a known hypersensitivity to any component of this product; 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.

Do your simvastatin patients need more help reaching their LDL-C goals?

LDL-C reductions comparison chart

As seen in CURVES, LIPITOR showed significantly greater LDL-C reductions than simvastatin across a range of doses.2

The FDA recommends that patients who do not meet their LDL-C goal on simvastatin 40 mg be placed on alternative LDL-C-lowering treatments.3

Study Description

CURVES (N=534) was an 8-week, randomized, open-label, parallel-group study that compared milligram-equivalent doses of LIPITOR® (atorvastatin calcium) tablets with simvastatin, pravastatin, lovastatin, and fluvastatin in patients with LDL-C ≥160 mg/dL and TG ≤400 mg/dL. Baseline LDL-C values were similar and patient demographics evenly distributed across treatment groups. Patients were randomized to LIPITOR 10 mg (n=73), 20 mg (n=51), 40 mg (n=61), or 80 mg (n=10); simvastatin 10 mg (n=70), 20 mg (n=49), or 40 mg (n=61); pravastatin 10 mg (n=14), 20 mg (n=41), or 40 mg (n=25); or lovastatin 20 mg (n=16), 40 mg (n=16), or 80 mg (n=11). LIPITOR 10 mg, 20 mg, and 40 mg produced greater reductions in LDL-C (38%, 46%, and 51%, respectively; P≤.01) compared with equivalent doses of simvastatin, pravastatin, lovastatin, and fluvastatin. LIPITOR 10 mg produced LDL-C reductions comparable with or greater than simvastatin 10 mg, 20 mg, and 40 mg (28%, 35%, and 41%, respectively); pravastatin 10 mg, 20 mg, and 40 mg (19%, 24%, and 34%, respectively); lovastatin 20 mg and 40 mg (29% and 31%, respectively); and fluvastatin 20 mg and 40 mg (17% and 23%, respectively).2

References

1. LIPITOR Product Document [all data referenced to the LPD have to be: a) reviewed and adapted according to the country-specific regulation; b) referenced with and in accordance to the local LIPITOR prescribing information]. 2. Jones P, Kafonek S, Laurora I, Hunninghake D; for CURVES Investigators. Comparative dose efficacy study of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES study). Am J Cardiol. 1998;81(5):582-587. 3. US Food and Drug Administration website. FDA drug safety communication: new restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm204882.htm. Updated February 2, 2012. Accessed October 26, 2015.