As an adjunct to diet for your adult patients with hyperlipidemia

 

Address plaque head-on CRESTOR is indicated to slow the progression of atherosclerosis at any stage of the disease1

Lipitor® is not indicated to slow the progression of atherosclerosis2

CRESTOR is indicated as an adjunct to diet 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.1

For illustration only: Represents potential long-term plaque buildup in the artery.

Plaque buildup in the artery View 2-year study results 1 2 1

Are your hyperlipidemic patients at increased risk at goal?

In high-risk patients in the ECLIPSE trial, CRESTOR helped more patients achieve LDL-C goal than Lipitor®3

Hypothetical patient profiles.

View study description

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.1

View head-to-head data 3 1

In the STELLAR trial in patients with hyperlipidemia nearly 9 out of 10 patients met their LDL-C goal with CRESTOR 20 mg*,,4

*Percentage of patients on CRESTOR 20 mg (n=160) achieving NCEP ATP III LDL-C goal by risk category5: High-risk–77.3%; Medium-risk–93.8%; Low-risk–94.0%. Mean baseline LDL-C: 187 mg/dL.

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.1 1

View study description Explore the data

Based on results from the STELLAR trial, you can have confidence in CRESTOR to provide LDL-C reductions that are important for your patients

And now you have another reason to be confident with the efficacy of CRESTOR

The LDL-C reductions of CRESTOR were further supported in VOYAGER meta-analysis.6

View the data

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.1

6 1 View the data

Study Description X

Adapted from the ECLIPSE trial.3 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.

Study Description X

Adapted from the STELLAR trial.4 STELLAR was a 6-week, multicenter, open-label, randomized, 15-arm trial comparing the efficacy and safety of CRESTOR with atorvastatin, simvastatin, and pravastatin in 2240 patients with hyperlipidemia or mixed dyslipidemia. The primary end point was percentage change from baseline in LDL-C at Week 6. Secondary end points included achievement of NCEP ATP III goal.

Eligible patients can order CRESTOR® online 24/7.

Order samples of CRESTOR online, 24/7 and get direct-to-office delivery

Eighteen dollars

is what eligible patients may pay with the CRESTOR Savings Card

1750004-2949302 Last Updated 5/14

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. There have been rare reports of immune-mediated necrotizing myopathy associated with statin use. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and if muscle signs and symptoms persist after discontinuing CRESTOR
  • 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. Based on clinical trial data with CRESTOR, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus
  • 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%)#,‡‡
  • 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
  • CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg

Important Safety Information from the JUPITER Study

  • A higher percentage of rosuvastatin-treated patients vs placebo-treated patients (6.6% and 6.2%, respectively) discontinued study medication due to an adverse event, irrespective of treatment causality. Myalgia was the most common adverse reaction that led to treatment discontinuation
  • In JUPITER, there was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) vs patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with HbA1c >6.5% at the end of the trial was significantly higher in rosuvastatin-treated patients vs placebo-treated patients
  • The most common adverse reactions reported were myalgia (7.6% vs 6.6%), arthralgia (3.8% vs 3.2%), constipation (3.3% vs 3.0%), and nausea (2.4% vs 2.3%) for CRESTOR vs placebo, respectively

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
  • CRESTOR is indicated to reduce the risk of myocardial infarction, stroke, and arterial revascularization procedures in patients without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men ≥50 and women ≥60), high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease

Read full Prescribing Information (PDF - 152k) 

#Prescribing Information for CRESTOR. AstraZeneca Pharmaceuticals LP, Wilmington, DE.

‡‡Data on File, 268255, AstraZeneca Pharmaceuticals LP.

References

  1. Prescribing Information for CRESTOR. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
  2. Prescribing Information for Lipitor®. Pfizer Inc, New York, NY.
  3. Faergeman O, Hill L, Windler E, et al; on behalf of the ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia. Cardiology. 2008;111(4):219-228.
  4. Jones PH, Davidson MH, Stein EA, et al; for the STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;92(2):152-160.
  5. Data on File, 2280917, AstraZeneca Pharmaceuticals LP.
  6. Nicholls SJ, Brandrup-Wognsen G, Palmer N, et al. Meta-analysis of comparative efficacy of increasing dose of atorvastatin versus rosuvastatin versus simvastatin on lowering levels of atherogenic lipids (from VOYAGER). Am J Cardiol. 2010;105:69-76.

LIPITOR is a registered trademark of Pfizer Inc.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.