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Raising HDL-C: Comparative Data

In this section, you can review HDL cholesterol increase results from comparative clinical trials in which CRESTOR^® (rosuvastatin calcium) was used as an adjunct to diet in patients who started statin therapy and in patients who switched statin therapy. You can also download the MERCURY II and STELLAR publications.

TRIAL: ECLIPSE

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HDL-C increases vs atorvastatin in hypercholesterolemic patients with CHD, 10-year CHD risk score >20% (CHD risk equivalent), or clinical evidence of atherosclerosis¹

*P<.01 CRESTOR 10 mg vs atorvastatin 10 mg.
^†P<.001 CRESTOR 20 mg vs atorvastatin 20 mg; CRESTOR 40 mg vs atorvastatin 40 mg; CRESTOR 40 mg vs atorvastatin 80 mg.

Mean baseline HDL-C: 51 mg/dL to 52 mg/dL.

Week 6:
CRESTOR 10 mg n=498
atorvastatin 10 mg n=510

Week 12:
CRESTOR 20 mg n=492
atorvastatin 20 mg n=494

Week 18:
CRESTOR 40 mg n=480
atorvastatin 40 mg n=483

Week 24:
CRESTOR 40 mg n=464
atorvastatin 80 mg n=476

Adapted from the ECLIPSE trial.¹ 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, clinical evidence of atherosclerosis, or a 10-year CHD risk score >20% (CHD risk equivalent). 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. Percentage change from baseline in HDL-C was a secondary end point.

TRIAL: MERCURY I

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Changes in HDL-C in patients who switched to CRESTOR vs remaining on simvastatin or atorvastatin²

*P<.05 atorvastatin 10 mg switched to CRESTOR 10 mg vs atorvastatin 10 mg.
^†P<.025 atorvastatin 20 mg switched to CRESTOR 10 mg vs atorvastatin 20 mg.

Mean baseline HDL-C: 48 mg/dL to 50 mg/dL.

Arm 1 (Weeks 1-16):
CRESTOR 10 mg n=521

Arm 2 (Week 16):
CRESTOR 10 mg n=276
atorvastatin 10 mg n=240

Arm 3 (Week 16):
CRESTOR 10 mg n=293
CRESTOR 20 mg n=305
atorvastatin 20 mg n=299

Arm 4 (Week 16):
CRESTOR 10 mg n=277
simvastatin 20 mg n=250

Adapted from the MERCURY I trial.² MERCURY I was a 16-week, randomized, open-label, 2-period, multicenter, parallel-group study. Following a 6-week dietary lead-in period, hypercholesterolemic patients with CHD, established atherosclerotic disease, type 2 diabetes or a 10-year CHD risk score >20% (as defined by the Joint European Society, 1998) were randomized to 1 of 5 treatment arms: CRESTOR 10 mg, atorvastatin 10 mg, atorvastatin 20 mg, simvastatin 20 mg, or pravastatin 40 mg once daily (period 1: 8 weeks). Patients then remained on these treatments or were switched as follows: half from atorvastatin 10 mg, simvastatin 20 mg, and pravastatin 40 mg to CRESTOR 10 mg once daily; one third of each from atorvastatin 20 mg to CRESTOR 10 mg and 20 mg once daily (period 2: 8 weeks). Primary end point was percentage of patients reaching Joint European Societies' LDL-C goal <116 mg/dL at week 16. Percentage change in HDL-C was a secondary end point.

TRIAL: STELLAR

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HDL-C increases by dose in patients with hyperlipidemia or mixed dyslipidemia treated with CRESTOR vs other statins^3,4

In the STELLAR trial, CRESTOR increased HDL-C at each dose
At 6 weeks, CRESTOR demonstrated significant HDL-C increases. +7.7% with CRESTOR 10 mg (P<.002 vs pravastatin 10 mg).
+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).

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

Mean baseline HDL-C: 50 mg/dL to 51 mg/dL.

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

Adapted from the STELLAR trial.^3,4 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. Percentage change from baseline in HDL-C was a secondary end point. 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.

TRIAL: STELLAR

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HDL-C increases by dose in patients ≥65 years of age treated with CRESTOR vs other statins⁵

*P<.002 CRESTOR 20 mg vs atorvastatin 80 mg.
^†P<.002 CRESTOR 40 mg vs atorvastatin 40 mg and 80 mg.

Mean baseline HDL-C: 50 mg/dL to 55 mg/dL.

CRESTOR n=137
atorvastatin n=195
simvastatin n=191
pravastatin n=130

Adapted from a post-hoc analysis of the STELLAR trial.^3,4,5 The post-hoc analysis was performed on patients ≥65 years of age (n=653). 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.

TRIAL: MERCURY II

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HDL-C increases after switching to CRESTOR vs remaining on simvastatin in hypercholesterolemic patients with CHD, established atherosclerotic disease, diabetes, or a 10-year CHD risk >20%⁶

P=NS simvastatin 20 mg switched to CRESTOR 10 mg vs simvastatin 20 mg, simvastatin 40 mg switched to CRESTOR 20 mg vs simvastatin 40 mg.

Mean baseline HDL-C: 47 mg/dL.

Arm 1 (Weeks 1-16)
CRESTOR 20 mg=362

Arm 4 (Week 16)
CRESTOR 10 mg n=179
simvastatin 20 mg n=185

Arm 5 (Week 16)
CRESTOR 20 mg n=183
simvastatin 40 mg n=183

Adapted from the MERCURY II trial.⁶ MERCURY II was a 16-week, randomized, open-label, 2-period, parallel-group, multicenter study. Following a 6-week dietary lead-in period, hypercholesterolemic patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20% were randomized to 1 of 5 arms: CRESTOR 20 mg, atorvastatin 10 mg, atorvastatin 20 mg, simvastatin 20 mg, or simvastatin 40 mg once daily (period 1: 8 weeks). Patients then remained on these treatments or were switched as follows: half from atorvastatin 10 mg and simvastatin 20 mg to CRESTOR 10 mg once daily; half from atorvastatin 20 mg and simvastatin 40 mg to CRESTOR 20 mg once daily (period 2: 8 weeks). Patients had either been treated with CRESTOR, atorvastatin, or simvastatin for 16 weeks or with CRESTOR for 8 weeks following 8 weeks of comparator treatment. The primary end point was percentage of patients achieving NCEP ATP III LDL-C goal <100 mg/dL at week 16. Percentage change in HDL-C was a secondary end point.

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 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, 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 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 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 HMG-CoA reductase inhibitors, 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%)^#‡‡
• 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
• 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)

Please see the full Prescribing Information available at CrestorTouchPoints.com
CRESTOR is licensed from SHIONOGI & CO, LTD, Osaka, Japan.

CRESTOR is a registered trademark of the AstraZeneca group of companies.

©2011 AstraZeneca. All rights reserved. 1482202 12/11

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