TRIAL: STELLAR
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As an adjunct to diet

HDL-C increases by dose in patients with hyperlipidemia or mixed dyslipidema5

HDL Graph
Adapted from the STELLAR trial. 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. The study performed the following dose comparisons: CRESTOR 10 mg vs atorvastatin 10 mg, 20 mg, and 40 mg, simvastatin 10 mg, 20 mg, and 40 mg, and pravastatin 10 mg, 20 mg, and 40 mg; CRESTOR 20 mg vs atorvastatin 20 mg, 40 mg, and 80 mg, simvastatin 20 mg, 40 mg and 80 mg, and pravastatin 20 mg and 40 mg; and CRESTOR 40 mg vs atorvastatin 40 mg and 80 mg, simvastatin 40 mg and 80 mg, and pravastatin 40 mg.5

TRIAL: STELLAR
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In STELLAR, a separate comparative trial, CRESTOR showed

LDL-C reductions at each dose in patients with hyperlipidemia or mixed dyslipidema1,5,6

LDL Graph
Adapted from the STELLAR trial. 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. The study performed the following dose comparisons: CRESTOR 10 mg vs atorvastatin 10 mg, 20 mg, and 40 mg, simvastatin 10 mg, 20 mg, and 40 mg, and pravastatin 10 mg, 20 mg, and 40 mg; CRESTOR 20 mg vs atorvastatin 20 mg, 40 mg, and 80 mg, simvastatin 20 mg, 40 mg and 80 mg, and pravastatin 20 mg and 40 mg; and CRESTOR 40 mg vs atorvastatin 40 mg and 80 mg, simvastatin 40 mg and 80 mg, and pravastatin 40 mg.5

TRIAL: METEOR
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In the METEOR trial, as an adjunct to diet in at-risk patients with hyperlipidemia,

Annualized rate of change in maximum CIMT1,7

Athero Graph

Adapted from the METEOR trial, a randomized, double-blind, placebo-controlled trial comparing the effect of CRESTOR 40 mg with placebo on the progression of atherosclerosis over 2 years in 984 low-risk patients (defined as Framingham risk score of <10% over 10 years) with hypercholesterolemia (mean LDL-C of 155 mg/dL) and subclinical atherosclerosis as detected by CIMT for 12 carotid artery sites and assessed via B-mode ultrasound. The primary end point was the annualized rate of change in maximum CIMT for 12 carotid artery sites.7

Journal Resources

This Web site and reprint link are provided as a service by AstraZeneca.

This link will take you to the following:

Effect of Rosuvastatin on Progression of Carotid Intima-Media Thickness in Low-Risk Individuals With Subclinical Atherosclerosis: The METEOR Trial

John R. Crouse III; Joel S. Raichlen; Ward A. Riley; Gregory W. Evans; Mike K. Palmer; Daniel H. O'Leary; Diederick E. Grobbee; Michiel L. Bots; for the METEOR Study Group. JAMA. 2007;297:1344-1353. Published online March 25, 2007 (doi:10.1001/jama.297.12.1344).

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CRESTOR® (rosuvastatin calcium)



 

Journal Reprints

Several major studies have evaluated the safety and efficacy of CRESTOR® (rosuvastatin calcium) in a clinical setting. If you would like to review study findings, print out the full journal articles below. You may also sign up to be notified when new reprints become available.

  • STELLAR Trial: comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses5
  • MERCURY II Trial: measurement of LDL-C reductions and LDL-C goal attainments in patients who switched statin therapy from simvastatin or atorvastatin to CRESTOR33
  • METEOR Trial: effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis7
STELLAR

STELLAR* Trial5
Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses

STELLAR is a 6-week, multicenter, open-label, randomized, 15-arm trial comparing the efficacy and safety of CRESTOR with that of atorvastatin, simvastatin, and pravastatin in more than 2000 patients with hyperlipidemia or mixed dyslipidemia.5

Download the PDF of the full journal article reporting the results of the STELLAR trial, excerpted from the July 15, 2003 issue of The American Journal of Cardiology.

*STELLAR = Statin Therapies for Elevated Lipid Levels Compared Across Doses to Rosuvastatin

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MERCURY II

MERCURY II† Trial33
Achieving LDL-C, non-HDL-C, and apolipoprotein B target levels in at-risk patients

MERCURY II is a 16-week, multinational, randomized, open-label trial comparing the effectiveness of rosuvastatin 20 mg, atorvastatin 10 mg, atorvastatin 20 mg, simvastatin 20 mg, and simvastatin 40 mg in helping 1993 at-risk patients achieve LDL-C goal.33

Download the PDF of the full journal article reporting the results of the MERCURY II trial, excerpted from the May 2006 issue of The American Heart Journal.

†MERCURY II = Measuring Effective Reductions in Cholesterol Using Rosuvastatin TherapY

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METEOR Trial Journal Reprint

METEOR‡ Trial7
Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis

The METEOR trial is a randomized, double-blind, placebo-controlled trial comparing the effect of CRESTOR 40 mg with placebo on the progression of atherosclerosis over 2 years in 984 low-risk patients (defined as Framingham risk score of <10% over 10 years) with hypercholesterolemia (mean LDL-C of 155 mg/dL) and subclinical atherosclerosis as detected by CIMT for 12 carotid artery sites and assessed via B-mode ultrasound. The primary end point was the annualized rate of change in maximum CIMT for 12 carotid artery sites.7

Download the PDF of the full journal article reporting the results of the METEOR trial, excerpted from the 2007 issue of The Journal of the American Medical Association.

‡METEOR = Measuring Effects on Intima-Media Thickness: an Evaluation Of Rosuvastatin

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CRESTOR is indicated1

  • 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.

  • 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.

  • The effect of CRESTOR on cardiovascular morbidity and mortality has not been determined; long-term outcomes studies are currently under way.

CRESTOR is contraindicated1

  • 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.

Important safety information about CRESTOR1

  • Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, 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, or lopinavir/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.

  • CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg. Patients initiating CRESTOR therapy or switching from another statin should begin treatment with CRESTOR at the appropriate starting dose.

  • It is recommended that liver enzyme tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (eg, semiannually) thereafter. Should an increase in ALT or AST of >3 times ULN persist, reduction of dose or withdrawal of CRESTOR is recommended. CRESTOR should be used with caution in patients who consume substantial quantities of alcohol.

  • 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%).4

Please see full Prescribing Information for CRESTOR.

 
 

CRESTOR is licensed by AstraZeneca from Shionogi & Co LTD, Osaka, Japan.

CRESTOR is a registered trademark of the AstraZeneca group of companies.
©2008 AstraZeneca Pharmaceuticals LP. All rights reserved. 261269 10/08

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This product information is intended for
US health care professionals only.

AstraZeneca



The information on this Web site should not take the place of talking with your doctor or health care professional about how to manage and treat your cholesterol. If you have any questions about your condition, or if you would like more information about CRESTOR or cholesterol, talk to your doctor or pharmacist. Only you and your doctor can decide if CRESTOR is right for you.

AstraZeneca

Please see full Prescribing Information for CRESTOR
http://switch.atdmt.com/action/nyccre_CRE20070316crestorcomPI_1

CRESTOR is licensed by AstraZeneca from Shionogi & Co LTD, Osaka, Japan.

CRESTOR is a registered trademark of the AstraZeneca group of companies.
©2008 AstraZeneca Pharmaceuticals LP. All rights reserved. 261269 10/08