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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.
In high-risk patients in the ECLIPSE trial,
CRESTOR helped more patients achieve LDL-C goal than Lipitor®
(atorvastatin calcium)2
Adapted from the ECLIPSE Trial
In high-risk patients in the ECLIPSE trial,
CRESTOR helped more patients achieve LDL-C goal than Lipitor®
(atorvastatin calcium)2
Adapted from the ECLIPSE Trial
High-risk patients (%) achieving NCEP ATP III LDL-C goal <100 mg/dL2
*P<.001 vs atorvastatin during same time point (eg, Week 6).
Mean baseline LDL-C: 188 mg/dL to 189 mg/dL.
Adapted from Faergeman et al.
CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg.
Very high-risk patients (%) achieving updated NCEP ATP III LDL-C optional goal <70 mg/dL†2,3
†According to the third report of the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) update, the optional LDL-C goal is <70 mg/dL for very high-risk patients.4
‡P<.001 vs atorvastatin during same time point (eg, Week 6).
Adapted from Faergeman et al.
CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg.
TRIAL DESCRIPTION:
Adapted from the ECLIPSE trial.2,3 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. During the course of this study, the NCEP ATP III guidelines were updated to include an optional LDL-C goal of <70 mg/dL for very high-risk patients. Analysis of this goal was added to the statistical analysis plan before unblinding of the study data.
In the STELLAR trial in patients with hyperlipidemia or mixed dyslipidemia nearly 9 out of 10 met their LDL-C goal with CRESTOR 20 mg*5
Adapted from the STELLAR Trial
In the STELLAR trial in patients with hyperlipidemia or mixed dyslipidemia nearly 9 out of 10 met their LDL-C goal with CRESTOR 20 mg*5
Adapted from the STELLAR Trial
ATP III LDL-C goal attainment by dose at 6 weeks in patients with hyperlipidemia or mixed dyslipidemia treated with CRESTOR vs other statins5
*LDL-C goals: <100 mg/dL for patients with coronary heart disease (CHD), CHD risk equivalents, or multiple risk factors that conferred a 10-year CHD risk of >20%; <130 mg/dL or <160 mg/dL for patients at lower risk. Mean baseline LDL-C: 187 mg/dL.
†P<.002 vs simvastatin 10 mg, 20 mg; pravastatin 10 mg, 20 mg, 40 mg.
‡P<.002 vs atorvastatin 20 mg; simvastatin 20 mg, 40 mg; pravastatin 20 mg, 40 mg.
§P<.002 vs simvastatin 40 mg; pravastatin 40 mg.
P=NS CRESTOR 10 mg vs atorvastatin 10 mg, 20 mg, 40 mg; simvastatin 40 mg.
P=NS CRESTOR 20 mg vs atorvastatin 40 mg, 80 mg; simvastatin 80 mg.
P=NS CRESTOR 40 mg vs atorvastatin 40 mg, 80 mg; simvastatin 80 mg.
TRIAL DESCRIPTION:
Adapted from the STELLAR trial.1,5 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 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. Secondary end points included achievement of NCEP ATP III goal.
Achievement of LDL-C <100 mg/dL vs atorvastatin in patients with hyperlipidemia or mixed dyslipidemia6
Adapted from the STELLAR Trial
Achievement of LDL-C <100 mg/dL vs atorvastatin in patients with hyperlipidemia or mixed dyslipidemia6
Adapted from the STELLAR Trial
Achievement of LDL-C <100 mg/dL* vs atorvastatin in patients with hyperlipidemia or mixed dyslipidemia6
*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
TRIAL DESCRIPTION:
Adapted from the STELLAR trial.1,5,6 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.
Achievement of LDL-C <100 mg/dL vs simvastatin in patients with hyperlipidemia or mixed dyslipidemia6
Adapted from the STELLAR Trial
Achievement of LDL-C <100 mg/dL vs simvastatin in patients with hyperlipidemia or mixed dyslipidemia6
Adapted from the STELLAR Trial
Achievement of LDL-C <100 mg/dL* vs simvastatin in patients with hyperlipidemia or mixed dyslipidemia6
*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
TRIAL DESCRIPTION:
Adapted from the STELLAR trial.1,5,6 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.
Achievement of LDL-C <100 mg/dL vs pravastatin in patients with hyperlipidemia or mixed dyslipidemia6
Adapted from the STELLAR Trial
Achievement of LDL-C <100 mg/dL vs pravastatin in patients with hyperlipidemia or mixed dyslipidemia6
Adapted from the STELLAR Trial
Achievement of LDL-C <100 mg/dL* vs pravastatin in patients with hyperlipidemia or mixed dyslipidemia6
*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
TRIAL DESCRIPTION:
Adapted from the STELLAR trial.1,5,6 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.
Next: LDL-C Reductions
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.
- 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.
- Faergeman O, Sosef F, Duffield E; on behalf of the ECLIPSE study investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force titrated in high-risk patients: results from the ECLIPSE study. Poster presented at: 14th International Symposium on Atherosclerosis; June 18-22, 2006; Rome, Italy.
- Grundy SM, Cleeman JI, Merz CNB, et al; for the Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110:227-239.
- 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.
- McKenney JM, Jones PH, Adamczyk MA, Cain VA, Bryzinski BS, Blasetto JW; STELLAR Study Group. Comparison of the efficacy of rosuvastatin versus atorvastatin, simvastatin, and pravastatin in achieving lipid goals: results from the STELLAR trial. Curr Med Res Opin. 2003;19(8):689-698.
Lipitor is a registered trademark of Pfizer Inc.
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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