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- For US Health Care Professionals
- For Patients
Prescribing CRESTOR
LDL-C Goal Attainment and LDL-C
Reductions
When it comes to lowering LDL cholesterol, your patients at increased risk may need aggressive treatment to achieve their LDL-C goals.
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. 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
For detailed comparative clinical trial data on LDL-C goal attainment or LDL-C reductions, click on the appropriate tab below.
Click on the "+" and "—" signs to expand and collapse the clinical information.
Eligible patients can pay as low as $3‡ for each prescription of CRESTOR‡‡Subject to eligibility. Restrictions apply. Click here for eligibility information.
Changes in LDL-C by dose in patients with hyperlipidemia or mixed dyslipidemia1-4
Adapted from the STELLAR Trial and VOYAGER Meta-analysis
Changes in LDL-C by dose in patients with hyperlipidemia or mixed dyslipidemia1-4
Adapted from the STELLAR Trial and VOYAGER Meta-analysis
Have confidence in CRESTOR to provide LDL-C reductions that are important for your patients
In the STELLAR Trial,
Changes in LDL-C by dose at 6 weeks in patients with hyperlipidemia or mixed dyslipidemia1-3
*P<.002 CRESTOR 10 mg vs atorvastatin 10 mg; simvastatin 10 mg, 20 mg, 40 mg; pravastatin 10 mg, 20 mg, 40 mg;
P=NS CRESTOR 10 mg vs atorvastatin 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=NS CRESTOR 20 mg vs atorvastatin 80 mg.
‡P<.002 CRESTOR 40 mg vs atorvastatin 40 mg; simvastatin 40 mg, 80 mg; pravastatin 40 mg;
P=NS CRESTOR 40 mg vs atorvastatin 80 mg.
In the STELLAR trial, CRESTOR 20 mg reduced LDL-C by 52% at Week 6.1-3
CRESTOR 40 mg should only be used for those patients not achieving their LDL-C goal with 20 mg.
Mean baseline LDL-C: 187 mg/dL to 194 mg/dL.
CRESTOR n=473
atorvastatin n=634
simvastatin n=648
pravastatin n=485
TRIAL DESCRIPTION:
Adapted from the STELLAR trial.1,2 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 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. The primary end point was percentage change from baseline in LDL-C at Week 6.
Now you have another reason to be confident with the efficacy of CRESTOR
LDL-C reductions with CRESTOR were further supported in the VOYAGER meta-analysis (N=32,258)4
Changes in LDL-C by dose in patients with hyperlipidemia or mixed dyslipidemia (total VOYAGER population)4
Mean baseline LDL-C for entire cohort: 171 mg/dL.
§In the VOYAGER meta-analysis, patients were categorized as high-risk if they had either atherogenic dyslipidemia (triglycerides ≥150 mg/dL and HDL-C <40 mg/dL), documented atherosclerotic cardiovascular disease (coronary artery disease, peripheral arterial disease, carotid arterial disease, or abdominal aortic aneurysm), or diabetes.
More than 2/3 of the patients included in the VOYAGER meta-analysis were categorized as high-risk§4
TRIAL DESCRIPTION:
Adapted from the VOYAGER meta-analysis.4 VOYAGER was an individual patient data meta-analysis of 37 randomized studies comparing rosuvastatin with either atorvastatin or simvastatin. The objective of the analysis was to determine the relationship between increasing statin doses and their incremental ability to lower lipid levels and achieve established treatment goals. Studies were identified in the published literature that fulfilled the following criteria: fixed-dose comparisons of rosuvastatin with either atorvastatin or simvastatin, lipid parameters recorded at baseline and on therapy, individual patient data available, and ≥4 weeks in duration. In the 11 studies in which patients were force-titrated to higher doses at predefined intervals, each period was considered an exposure. The total number of exposures was 38,199 to individual doses of statins among 32,258 patients. For each lipid variable, percentage change was calculated from baseline to the end of each fixed-dose period. Differences in percentage change of lipid parameters between each dose of rosuvastatin and each dose of atorvastatin or simvastatin were calculated using only those trials that directly randomized the treatments being compared.
Changes in LDL-C by dose at 6 weeks in patients with hyperlipidemia or mixed dyslipidemia1-3
Adapted from the STELLAR Trial
Changes in LDL-C by dose at 6 weeks in patients with hyperlipidemia or mixed dyslipidemia1-3
Adapted from the STELLAR Trial
In the STELLAR Trial,
Changes in LDL-C by dose at 6 weeks in patients with hyperlipidemia or mixed dyslipidemia1-3
*P<.002 CRESTOR 10 mg vs atorvastatin 10 mg; simvastatin 10 mg, 20 mg, 40 mg; pravastatin 10 mg, 20 mg, 40 mg;
P=NS CRESTOR 10 mg vs atorvastatin 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=NS CRESTOR 20 mg vs atorvastatin 80 mg.
‡P<.002 CRESTOR 40 mg vs atorvastatin 40 mg; simvastatin 40 mg, 80 mg; pravastatin 40 mg;
P=NS CRESTOR 40 mg vs atorvastatin 80 mg.
In the STELLAR trial, CRESTOR 20 mg reduced LDL-C by 52% at Week 6.1-3
CRESTOR 40 mg should only be used for those patients not achieving their LDL-C goal with 20 mg.
Mean baseline LDL-C: 187 mg/dL to 194 mg/dL.
CRESTOR n=473
atorvastatin n=634
simvastatin n=648
pravastatin n=485
TRIAL DESCRIPTION:
Adapted from the STELLAR trial.1,2 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 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. The primary end point was percentage change from baseline in LDL-C at Week 6.
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 atherosclerosis7
Adapted from the ECLIPSE Trial
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 atherosclerosis7
Adapted from the ECLIPSE Trial
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 atherosclerosis7
*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
TRIAL DESCRIPTION:
Adapted from the ECLIPSE trial.7 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.
LDL-C reductions vs atorvastatin in hypercholesterolemic patients with cardiovascular disease (CVD) and low HDL-C8
Adapted from the RADAR Trial
LDL-C reductions vs atorvastatin in hypercholesterolemic patients with cardiovascular disease (CVD) and low HDL-C8
Adapted from the RADAR Trial
LDL-C reductions vs atorvastatin in hypercholesterolemic patients with cardiovascular disease (CVD) and low HDL-C8
*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
TRIAL DESCRIPTION:
Adapted from the RADAR trial.8 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.
3143524-3097604 Last Updated 7/15
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, atazanavir/ritonavir, or simeprevir
- Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. There have been rare reports of immune-mediated necrotizing myopathy associated with statin use. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and if muscle signs and symptoms persist after discontinuing CRESTOR
- 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. Based on clinical trial data with CRESTOR, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus
- 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
- CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg
Important Safety Information from the JUPITER Study
- A higher percentage of rosuvastatin-treated patients vs placebo-treated patients (6.6% and 6.2%, respectively) discontinued study medication due to an adverse event, irrespective of treatment causality. Myalgia was the most common adverse reaction that led to treatment discontinuation
- In JUPITER, there was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) vs patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with HbA1c >6.5% at the end of the trial was significantly higher in rosuvastatin-treated patients vs placebo-treated patients
- The most common adverse reactions reported were myalgia (7.6% vs 6.6%), arthralgia (3.8% vs 3.2%), constipation (3.3% vs 3.0%), and nausea (2.4% vs 2.3%) for CRESTOR vs placebo, respectively
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) 
#Prescribing Information for CRESTOR. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
‡‡Data on File, 268255, AstraZeneca Pharmaceuticals LP.
References:
- Prescribing Information for CRESTOR. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
- Jones PH, Davidson MH, Stein EA, et al; for the STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;92:152-160.
- Data on File, 266987, AstraZeneca Pharmaceuticals LP.
- Nicholls SJ, Brandrup-Wognsen G, Palmer N, et al. Meta-analysis of comparative efficacy of increasing dose of atorvastatin versus rosuvastatin versus simvastatin on lowering levels of atherogenic lipids (from VOYAGER). Am J Cardiol. 2010;105:69-76.
- Data on File, 2250803, AstraZeneca Pharmaceuticals LP.
- Karlson BW, Barter PJ, Palmer MK, Lundman P, Nicholls SJ. Comparison of the effects of different statins and doses on lipid levels in patients with diabetes: results from VOYAGER. Nutr Metab Cardiovasc Dis. 2012;22:697-703.
- Faergeman O, Hill L, Windler E, et al; ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia: results from the ECLIPSE study. Cardiology. 2008;111(4):219-228.
- Jukema JW, Liem A-H, Dunselman PHJM, van der Sloot JAP, Lok DJA, Zwinderman AH. LDL-C/HDL-C ratio in subjects with cardiovascular disease and a low HDL-C: results of the RADAR (Rosuvastatin and Atorvastatin in different Dosages And Reverse cholesterol transport) study. Curr Med Res Opin. 2005;21(11):1865-1874.
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CRESTOR is licensed from SHIONOGI & CO, LTD, Osaka, Japan. CRESTOR is a registered trademark of the AstraZeneca group of companies.
©2018 AstraZeneca. All rights reserved. 3143524-3097604 Last Updated 7/15