*According to the third report of the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) Guidelines, the LDL-C goal is <160 mg/dL for low-risk patients, <130 mg/dL for medium-risk patients, and <100 mg/dL for high-risk patients.^4
†According to the third report of the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) update, the optional LDL-C goal is <70 mg/dL for very high-risk patients.⁵

Adapted from the ECLIPSE Trial.^1,2 ECLIPSE was a 24-week, open-label, randomized, multicenter, forced-titration, parallel-group trial comparing the efficacy and safety of CRESTOR and atorvastatin in 1036 patients with hypercholesterolemia and CHD, 10-year CHD risk score >20% (CHD risk equivalent), or clinical evidence of atherosclerosis. Following a 6-week dietary lead-in period, patients were randomized to receive CRESTOR 10 mg or atorvastatin 10 mg for 6 weeks. Doses were force-titrated at 6-week intervals until maximum doses were achieved. Statistical comparisons were not made across the dose range, only across the same time period. The primary end point was percentage of patients achieving NCEP ATP III LDL-C goal of <100 mg/dL at Week 24. During the course of this study, the NCEP ATP III guidelines were updated to include an optional LDL-C goal of <70 mg/dL for very high-risk patients. Analysis of this goal was added to the statistical analysis plan before unblinding of the study data.

Important Safety Information for CRESTOR Tablets

• CRESTOR is contraindicated in patients with a known hypersensitivity to any component of this product, in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are pregnant or may become pregnant, and in nursing mothers
• Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with statins, including CRESTOR. These risks can occur at any dose level but are increased at the highest dose (40 mg)
• CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy (eg, age ≥65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy during treatment with CRESTOR may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, lopinavir/ritonavir, or atazanavir/ritonavir
• Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever
• It is recommended that liver enzyme tests be performed before the initiation of CRESTOR and if signs or symptoms of liver injury occur. All patients treated with CRESTOR should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including CRESTOR. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with CRESTOR, promptly interrupt therapy. If an alternate etiology is not found, do not restart CRESTOR
• CRESTOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease
• CRESTOR significantly increased INR in patients receiving coumarin anticoagulants. In patients taking coumarin anticoagulants and CRESTOR concomitantly, INR should be determined before starting CRESTOR and frequently enough during early therapy to ensure that no significant alteration of INR occurs
• Dipstick-positive proteinuria and microscopic hematuria were observed among patients treated with CRESTOR. These findings were more frequent in patients taking CRESTOR 40 mg, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, dose reduction should be considered for patients on CRESTOR therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing
• Increases in HbA1c and fasting serum glucose levels have been reported with statins, including CRESTOR
• In the controlled clinical trials database, the most common adverse reactions were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%)^3,6
• Rare postmarketing reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) have been associated with statin use, including CRESTOR. These reports are generally nonserious and reversible upon statin discontinuation
• The dose range for CRESTOR is 5 mg to 40 mg orally once daily. The usual starting dose is 10 mg to 20 mg. Patients initiating CRESTOR therapy or switching from another statin should begin treatment with CRESTOR at the appropriate starting dose. After initiation or upon titration of CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly. CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg

Indications

• CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non HDL-C, and triglycerides, and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia and to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels

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