TRIAL: STELLAR
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HDL-C increases by dose in patients with hyperlipidemia or mixed dyslipidemia5

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

*P<.002 CRESTOR 10 mg vs pravastatin 10 mg
†P<.002 CRESTOR 20 mg vs atorvastatin 20 mg, 40 mg, 80 mg; simvastatin 40 mg; pravastatin 20 mg, 40 mg
‡P<.002 CRESTOR 40 mg vs atorvastatin 40 mg, 80 mg; simvastatin 40 mg; pravastatin 40 mg

Mean baseline HDL-C: 49 mg/dL to 51 mg/dL

CRESTOR n=473
atorvastatin n=634
simvastatin n=648
pravastatin n=485

At 6 weeks, CRESTOR demonstrated HDL-C increases

  • +7.7% with CRESTOR 10 mg*
  • +9.5% with CRESTOR 20 mg†

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 dyslipidemia1,5,6

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

*P<.002 CRESTOR 10 mg vs atorvastatin 10 mg; simvastatin 10 mg, 20 mg, 40 mg; pravastatin 10 mg, 20 mg, 40 mg
†P<.002 CRESTOR 20 mg vs atorvastatin 20 mg, 40 mg; simvastatin 20 mg, 40 mg, 80 mg; pravastatin 20 mg, 40 mg
‡P<.002 CRESTOR 40 mg vs atorvastatin 40 mg; simvastatin 40 mg, 80 mg; pravastatin 40 mg

Mean baseline LDL-C: 187 mg/dL to 194 mg/dL

CRESTOR n=473
atorvastatin n=634
simvastatin n=648
pravastatin n=485

At 6 weeks, CRESTOR demonstrated LDL-C reductions

  • –46% with CRESTOR 10 mg
  • –52% with CRESTOR 20 mg

TRIAL: METEOR
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In the METEOR trial, in 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

In the METEOR trial, carotid intima-media thickness (CIMT) increased in the placebo group but did not change in the CRESTOR group

  • The most common adverse reactions (%) in the METEOR trial for CRESTOR vs placebo, respectively, were myalgia (12.7 vs 12.1), arthralgia (10.1 vs 7.1), headache (6.4 vs 5.3), dizziness (4.0 vs 2.8), increased CPK (2.6 vs 0.7), abdominal pain (2.4 vs 1.8), and ALT >3x ULN (2.2 vs 0.7)
  • CRESTOR 40 mg should only be used 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

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 doses1
  • MERCURY II Trial: measurement of LDL-C reductions and LDL-C goal attainments in patients who switched statin therapy from simvastatin or atorvastatin to CRESTOR2
  • METEOR Trial: effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis3
STELLAR

STELLAR* Trial1
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.1

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 Trial2
Measurement of LDL-C reductions and LDL-C goal attainments in patients who switched statin therapy from simvastatin or atorvastatin to CRESTOR

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.2

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 = Measuring Effective Reductions in Cholesterol Using Rosuvastatin TherapY

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METEOR Trial Journal Reprint

METEOR‡ Trial3
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 that of 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.3

Download the PDF of the full journal article reporting the results of the METEOR trial, excerpted from the March 28, 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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Defined as covered without prior authorization on commercial, Medicare Part D, and Medicaid formularies. Patients without prior authorization means covered lives at Tiers 1 to 7 calculated by Fingertip Formulary as of June 2009 that do not require additional information to the health plan in order for CRESTOR to be covered. Data include covered lives whose prescriptions may be subject to step-therapy requirements.4

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