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In STELLAR, a separate comparative trial, CRESTOR showed

HDL-C increases at each dose in patients with hyperlipidemia or mixed dyslipidema8

HDL Graph

#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

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

At 6 weeks, CRESTOR demonstrated significant HDL-C increases8

+7.7% with CRESTOR 10 mg (P<.002 vs pravastatin 10 mg)8

+9.5% with CRESTOR 20 mg (P<.002 vs atorvastatin 20 mg, 40 mg, 80 mg; simvastatin 40 mg; and pravastatin 20 mg, 40 mg)8

Close

In STELLAR, a separate comparative trial, CRESTOR showed

LDL-C reductions at each dose in patients with hyperlipidemia or mixed dyslipidema8

LDL Graph

‡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

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

At 6 weeks, CRESTOR demonstrated significant LDL-C reductions8

-46% with CRESTOR 10 mg (P<.002 vs atorvastatin 10 mg; simvastatin 10 mg, 20 mg, 40 mg; pravastatin 10 mg, 20 mg, 40 mg)8

-52% with CRESTOR 20 mg (P<.002 vs atorvastatin 20 mg, 40 mg; simvastatin 20 mg, 40 mg, 80 mg; and pravastatin 20 mg, 40 mg)8

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In the METEOR trial, in patients with hyperlipidemia,1,31

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.

In the METEOR trial, carotid intima-media thickness (CIMT) increased in the placebo group but did not change in the CRESTOR group (Figure 1). The rates of change shown in Figure 1 are plotted over time in Figure 2.

In the METEOR trial, compared to baseline, Overall, no significant progression of
atherosclerosis was observed with CRESTOR* while significant disease progression was observed with placebo† 1,31 *P=.32 with CRESTOR. †P<.0001 with placebo.

In the METEOR trial, CRESTOR was well tolerated over the 2-year study period31 —
further supporting its proven safety profile as demonstrated in other clinical studies5

In the METEOR trial, The most common adverse reactions (%) 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), ALT>3x ULN (2.2 vs 0.7)1


 

Journal Resources

This website and reprint link is 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

Journal reprints

Major studies have evaluated the safety and efficacy of CRESTOR in a clinical setting. Here are a few clinical studies that may be of interest to you. If you would like to review the complete study findings, you can print out the full journal article.

 
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The American Journal of Cardiology

MERCURY II* trial

Achieving LDL cholesterol, non-HDL cholesterol, and apolipoprotein B target levels in high-risk patients (MERCURY II trial)

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

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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The American Journal of Cardiology

STELLAR† Trial

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 Type IIa/IIb dyslipidemia.

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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The Journal of the American Medical Association

METEOR‡ Trial

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 carotid intima-media thickness (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.

Download the PDF of the full journal article reporting the results of the METEOR trial, excerpted from a 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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Important Safety Information about CRESTOR

1

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 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.

It is recommended that liver function 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 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.

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%).1,13

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



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Please see full Prescribing Information for CRESTOR.

CRESTOR was licensed from SHIONOGI & CO. LTD, Osaka, Japan.

CRESTOR is a registered trademark of the AstraZeneca group of companies.
263704  6/08 ©2008 AstraZeneca Pharmaceuticals LP. All rights reserved.
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