Lowering LDL-C: Starting Therapy Comparative Data

In this section, you can review LDL cholesterol reduction results and LDL cholesterol goal attainment results from comparative clinical trials in which CRESTOR® (rosuvastatin calcium) was used as an adjunct to diet in adult patients starting statin therapy. You can also download the STELLAR publication.  The usual starting dose of CRESTOR is 10 mg to 20 mg. CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg.1

LDL Cholesterol Reductions vs Atorvastatin

LDL Cholesterol Reductions vs Other Statins

LDL Cholesterol Goal Attainment vs. Other Statins

Achievement of LDL Cholesterol <100 mg/dL vs Other Statins

TRIAL: ECLIPSE
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LDL-C reductions vs atorvastatin in hypercholesterolemic patients with coronary heart disease (CHD), 10-year CHD risk score >20% (CHD risk equivalent), or clinical evidence of atherosclerosis2

LDL-C reductions vs atorvastatin in hypercholesterolemic patients with coronary heart disease (CHD), 10-year CHD risk score >20% (CHD risk equivalent), or clinical evidence of atherosclerosis

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

Mean baseline LDL-C: 188 mg/dL to 189 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

Enlarge Chart

Adapted from the ECLIPSE trial.2 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, 10-year CHD risk score >20% (CHD risk equivalent), 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 of <100 mg/dL at Week 24. Percentage change from baseline in HDL-C was a secondary end point.

TRIAL: RADAR
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LDL-C reductions vs atorvastatin in hypercholesterolemic patients with cardiovascular disease (CVD) and low HDL-C3

LDL-C reduction vs atorvastatin in hypercholesterolemic patients with cardiovascular disease (CVD) and low HDL-C

*P<.05 CRESTOR 10 mg vs atorvastatin 20 mg.

†P<.01 CRESTOR 20 mg vs atorvastatin 40 mg.
‡P<.0001 CRESTOR 40 mg vs atorvastatin 80 mg.

Mean baseline LDL-C: 139 mg/dL to 143 mg/dL.

CRESTOR n=230
atorvastatin n=231

 
Enlarge Chart

Adapted from the RADAR Trial.3 RADAR was a randomized, multicenter, open-label, parallel-group, forced-titration trial comparing the efficacy and safety of CRESTOR with atorvastatin in 461 hypercholesterolemic patients with CVD and low HDL-C levels (<40 mg/dL).  Patients were randomized to receive CRESTOR 10 mg or atorvastatin 20 mg for 6 weeks. At week 6, doses were increased to CRESTOR 20 mg or atorvastatin 40 mg, and at week 12, doses were increased to CRESTOR 40 mg or atorvastatin 80 mg for an additional 6 weeks. Statistical comparisons were not made across the dose range, only across the same time period (6 weeks vs 6 weeks, 12 weeks vs 12 weeks, 18 weeks vs 18 weeks). The primary end point of RADAR was the percentage change from baseline in LDL-C/HDL-C ratio at 6 weeks. Percentage change from baseline in LDL-C was a tertiary end point.

TRIAL: STELLAR
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LDL-C reductions vs atorvastatin in patients with hyperlipidemia or mixed dyslipidemia1,4,5

LDL-C reductions vs atorvastatin in patients with hyperlipidemia or mixed dyslipidemia

*P<.002 CRESTOR 10 mg vs atorvastatin 10 mg.
†P<.002 CRESTOR 20 mg vs atorvastatin 20 mg, 40 mg.
‡P<.002 CRESTOR 40 mg vs atorvastatin 40 mg.

P=NS CRESTOR 10 mg vs atorvastatin 20, 40 mg
CRESTOR 20 mg vs atorvastatin 80 mg
CRESTOR 40 mg vs atorvastatin 80 mg

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

CRESTOR n=473
atorvastatin n=634

 
Enlarge Chart
Download Publication
Read full Prescribing Information

Adapted from the STELLAR trial.1,4,5STELLAR 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; CRESTOR 20 mg vs atorvastatin 20 mg, 40 mg, and 80 mg; and CRESTOR 40 mg vs atorvastatin 40 mg and 80 mg.

TRIAL: STELLAR
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LDL-C reductions vs simvastatin in patients with hyperlipidemia or mixed dyslipidemia1,4,5

LDL-C reductions vs simvastatin in patients with hyperlipidemia or mixed dyslipidemia

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

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

CRESTOR n=473
simvastatin n=648

 
Enlarge Chart
Download Publication
Read full Prescribing Information

Adapted from the STELLAR trial.1,4,5 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 simvastatin 10 mg, 20 mg, and 40 mg; CRESTOR 20 mg vs simvastatin 20 mg, 40 mg, and 80 mg; and CRESTOR 40 mg vs simvastatin 40 mg and 80 mg.

TRIAL: STELLAR
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LDL-C reductions vs pravastatin in patients with hyperlipidemia or mixed dyslipidemia1,4,5

LDL-C reductions vs pravastatin in patients with hyperlipidemia or mixed dyslipidemia

*P<.002 CRESTOR 10 mg vs pravastatin 10 mg, 20 mg, 40 mg.1
†P<.002 CRESTOR 20 mg vs pravastatin 20 mg, 40 mg.
‡P<.002 CRESTOR 40 mg vs pravastatin 40 mg.

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

CRESTOR n=473
pravastatin n=485

Enlarge Chart
Download Publication
Read full Prescribing Information

Adapted from the STELLAR trial.1,4,5 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 pravastatin 10 mg, 20 mg, and 40 mg; CRESTOR 20 mg vs pravastatin 20 mg and 40 mg; and CRESTOR 40 mg pravastatin 40 mg.

TRIAL: ECLIPSE
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NCEP ATP III LDL-C Goal Attainment <100 mg/dL vs atorvastatin in hypercholesterolemic patients with CHD, 10-year CHD risk score >20% (CHD risk equivalent), or clinical evidence of atherosclerosis2

NCEP ATP III LDL-C Goal Attainment <100 mg/dL vs atorvastatin in hypercholesterolemic patients with CHD, 10-year CHD risk score >20% (CHD risk equivalent), or clinical evidence of atherosclerosis
 

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

Mean baseline LDL-C: 188 mg/dL to 189 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

Enlarge Chart

Adapted from the ECLIPSE trial.2 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, 10-year CHD risk score >20% (CHD risk equivalent), 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 of <100 mg/dL at Week 24. Percentage change from baseline in HDL-C was a secondary end point.

TRIAL: STELLAR
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Achievement of LDL-C <100 mg/dL* vs atorvastatin in patients with hyperlipidemia or mixed dyslipidemia6

Achievement of LDL-C <100 mg/dL vs atorvastatin in patients with hyperlipidemia or mixed dyslipidemia

*Regardless of risk category
†P<.002 CRESTOR 10 mg vs atorvastatin 10 mg.
‡P<.002 CRESTOR 20 mg vs atorvastatin 20 mg.
§P<.002 CRESTOR 40 mg vs atorvastatin 40 mg.

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

CRESTOR 10 mg n=156
CRESTOR 20 mg n=160
CRESTOR 40 mg n=157

atorvastatin 10 mg n=158
atorvastatin 20 mg n=154
atorvastatin 40 mg n=156
atorvastatin 80 mg n=165

Enlarge Chart

Adapted from the STELLAR trial.1,4,6 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; CRESTOR 20 mg vs atorvastatin 20 mg, 40 mg, and 80 mg; and CRESTOR 40 mg vs atorvastatin 40 mg and 80 mg. Percentage of patients achieving LDL-C <100 mg/dL was not a prospectively planned analysis.

TRIAL: STELLAR
^ Back to top

Achievement of LDL-C <100 mg/dL* vs simvastatin in patients with hyperlipidemia or mixed dyslipidemia6

Achievement of LDL-C <100 mg/dL vs simvastatin in patients with hyperlipidemia or mixed dyslipidemia

*Regardless of risk category
†P<.002 CRESTOR 10 mg vs simvastatin 10 mg, 20 mg, 40 mg
‡P<.002 CRESTOR 20 mg vs simvastatin 20 mg, 40 mg, 80 mg
§P<.002 CRESTOR 40 mg vs simvastatin 40 mg, 80 mg

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

CRESTOR 10 mg n=156
CRESTOR 20 mg n=160
CRESTOR 40 mg n=157

simvastatin 10 mg n=165
simvastatin 20 mg n=162
simvastatin 40 mg n=158
simvastatin 80 mg n=163

Enlarge Chart

Adapted from the STELLAR trial.1,4,6 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 simvastatin 10 mg, 20 mg, and 40 mg; CRESTOR 20 mg vs simvastatin 20 mg, 40 mg, and 80 mg; and CRESTOR 40 mg vs simvastatin 40 mg and 80 mg. Percentage of patients achieving LDL-C <100 mg/dL was not a prospectively planned analysis.

TRIAL: STELLAR
^ Back to top

Achievement of LDL-C <100 mg/dL* vs pravastatin in patients with hyperlipidemia or mixed dyslipidemia6

Achievement of LDL-C <100 mg/dL vs pravastatin in patients with hyperlipidemia or mixed dyslipidemia

*Regardless of risk category
†P<.002 CRESTOR 10 mg vs pravastatin 10 mg, 20 mg, 40 mg.
‡P<.002 CRESTOR 20 mg vs pravastatin 20 mg, 40 mg.
§P<.002 CRESTOR 40 mg vs pravastatin 40 mg.

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

CRESTOR 10 mg n=156
CRESTOR 20 mg n=160
CRESTOR 40 mg n=157

pravastatin 10 mg n=160
pravastatin 20 mg n=164
pravastatin 40 mg n=161

Enlarge Chart

Adapted from the STELLAR trial.1,4,6 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 pravastatin 10 mg, 20 mg, and 40 mg; CRESTOR 20 mg vs pravastatin 20 mg and 40 mg; and CRESTOR 40 mg vs pravastatin 40 mg. Percentage of patients achieving LDL-C <100 mg/dL was not a prospectively planned analysis.

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 statins, 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 the initiation of CRESTOR and if signs or symptoms of liver injury occur. All patients treated with CRESTOR should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including CRESTOR. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with CRESTOR, promptly interrupt therapy. If an alternate etiology is not found, do not restart CRESTOR
  • 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 statins, 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%)#‡‡
  • Rare postmarketing reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) have been associated with statin use, including CRESTOR. These reports are generally nonserious and reversible upon statin discontinuation
  • 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 Adobe pdf (PDF - 152k) Opens in a new window

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.

©2012 AstraZeneca. All rights reserved. 1569505 3/12


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

Footnote

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 October 12, 2011 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.

Footnote

†Based on the ’average Tier 1 copay for Commercial covered lives’ for generic statins from Fingertip Formulary as of July 26, 2011. Certain restrictions may apply.

Patients may visit www.crestor.com for these eligibility requirements and to sign up for the CRESTOR Savings Card.

If patients can’t afford their medication, AstraZeneca may be able to help. For more information, please visit www.AstraZeneca-us.com.

Physicians and patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

^

Here is your Personal Account Specialist for CRESTOR in Zip code :

Personal Account Specialist

[1-XXX-XXX-XXXX]

Available Monday through Friday,
8 am to 6 pm EST

Your Personal Account Specialist is a TMS employee, a service provider for AstraZeneca.

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