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Clinical Experience

Lowering LDL-C: Starting Therapy Comparative Data
Lowering LDL-C: Switching Therapy Comparative Data
Raising HDL-C: Comparative Data
Slowing Atherosclerosis Progression
Use in Patients With Diabetes
Use in Specific Populations: Comparative Data
Safety

Patient Support

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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.

HDL Cholesterol Increases vs Other Statins

HDL-C increases vs atorvastatin in patients with CHD, CHD risk equivalents, or clinical evidence of atherosclerosis¹ Adapted from the ECLIPSE Trial
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Changes in HDL-C in patients who switched to CRESTOR vs remaining on other statins² Adapted from the MERCURY I Trial
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HDL-C increases by dose in patients with hyperlipidemia or mixed dyslipidemia treated with CRESTOR vs other statins³ Adapted from the STELLAR Trial
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HDL-C increases by dose in patients ≥65 years of age treated with CRESTOR vs other statins⁴ Adapted from the STELLAR Trial
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HDL-C increases vs simvastatin in patients at high risk of CHD⁵ Adapted from the MERCURY II Trial
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TRIAL: ECLIPSE

HDL-C increases vs atorvastatin in patients with CHD, CHD risk equivalents, or clinical evidence of atherosclerosis¹

Raising HDL Cholesterol with CRESTOR vs. atorvastatin

*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

ECLIPSE was a 24-week, open-label, randomized, multicenter, forced-titration, parallel-group trial comparing the efficacy and safety of CRESTOR and atorvastatin in patients with hypercholesterolemia and CHD, CHD risk equivalents (10-year risk >20%), 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 at week 24. Percentage change from baseline in HDL-C was a secondary end point.¹

TRIAL: MERCURY I

Changes in HDL-C in patients who switched to CRESTOR vs remaining on other statins²

HDL Cholesterol changes in patients after switching to CRESTOR

*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:
CRESTOR 10 mg/
CRESTOR 10 mg n=521

Arm 2:
atorvastatin 10 mg/
CRESTOR 10 mg n=276
atorvastatin 10 mg/
atorvastatin 10 mg n=240

Arm 3:
atorvastatin 20 mg/
CRESTOR 10 mg n=293
atorvastatin 20 mg/
CRESTOR 20 mg n=305
atorvastatin 20 mg/
atorvastatin 20 mg n=299

Arm 4:
simvastatin 20 mg/
CRESTOR 10 mg n=277
simvastatin 20 mg/
simvastatin 20 mg n=250

Arm 5 (not shown):
pravastatin 40 mg/
CRESTOR 10 mg n=253
pravastatin 40 mg/
pravastatin 40 mg n=253

MERCURY I was a 16-week, randomized, open-label, 5-arm, 2-period, multicenter, parallel-group study in patients with hyperlipidemia or mixed dyslipidemia. Patients had a history of CHD or established atherosclerotic disease, type 2 diabetes, or a CHD risk >20% over 10 years. Following a 6-week dietary lead-in period, patients 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 16.²

TRIAL: STELLAR

HDL-C increases by dose in patients with hyperlipidemia or mixed dyslipidemia treated with CRESTOR vs other statins³

HDL Cholesterol increases by dose with CRESTOR vs. other statins

Mean percentage change from baseline in HDL-C.

*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

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.³

TRIAL: STELLAR

HDL-C increases by dose in patients ≥65 years of age treated with CRESTOR vs other statins⁴

HDL Cholesterol increases in patients over 65 with CRESTOR vs. other statins

*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, 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 the percentage change in LDL-C from baseline to 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.⁴

TRIAL: MERCURY II

HDL-C increases vs simvastatin in patients at high risk of CHD⁵

HDL Cholesterol increase in patients at risk of CHD with CRESTOR vs. atorvastatin or simvastatin

*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.

CRESTOR 10 mg (Week 16) n=179
simvastatin 20 mg (Week 16) n=185
CRESTOR 20 mg (Week 16) n=183
simvastatin 40 mg (Week 16) n=183
CRESTOR 20 mg (Weeks 1–16) n=362

MERCURY II was a 16-week, randomized, open-label, 2-period, parallel-group, multicenter study. Following a 6-week dietary lead-in period, patients at high risk of CHD 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 at week 16.⁵

AZOnDemand™

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Patient Stories

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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

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

Read full Prescribing Information (PDF - 152k)

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CRESTOR is a registered trademark, and AZOnDemand is a trademark of the AstraZeneca group of companies.

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

Raising HDL-C: Comparative Data

HDL Cholesterol Increases vs Other Statins

HDL-C increases vs atorvastatin in patients with CHD, CHD risk equivalents, or clinical evidence of atherosclerosis1

Changes in HDL-C in patients who switched to CRESTOR vs remaining on other statins2

HDL-C increases by dose in patients with hyperlipidemia or mixed dyslipidemia treated with CRESTOR vs other statins3