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.

Next: LDL-C Reductions

TRIAL: ECLIPSE

High-risk patients (%) achieving NCEP ATP III LDL-C goal < 100 mg/dL2

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 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/dL2,3

chart shows patients who achieved LDL-C Goals of <70 mg/dl

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.

Read full Prescribing Information
TRIAL: STELLAR

ATP III LDL-C goal attainment by dose at 6 weeks in patients with hyperlipidemia or mixed dyslipidemia treated with CRESTOR vs other statins5

ATP III LDL-C goal attainment by dose at 6 weeks in patients with hyperlipidemia or mixed dyslipidemia treated with CRESTOR vs other statins

*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.

Read full Prescribing Information
TRIAL: STELLAR

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

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.

TRIAL: STELLAR

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

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.

TRIAL: STELLAR

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

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.

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. 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

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

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

CRESTOR is licensed from SHIONOGI & CO, LTD, Osaka, Japan.

CRESTOR is a registered trademark, and AZ&Me is a trademark of the AstraZeneca group of companies.

LIPITOR (atorvastatin calcium) is a registered trademark of Pfizer Inc.

©2013 AstraZeneca. All rights reserved. 829806-2848509 Last Updated 8/13


US Flag  This product information is intended for US Health Care Professionals only.

Footnote
*Percentage of patients on CRESTOR 20 mg (n=160) achieving NCEP ATP III LDL-C goal by risk category5: High-risk–77.3%; Medium-risk–93.8%; Low-risk–94.0%. Mean baseline LDL-C: 187 mg/dL.
Footnote
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 for medium-risk patients (multiple [2+] risk factors with 10-year risk for CHD <20%); and <160 mg/dL for low-risk patients (0-1 risk factor).
^

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

Personal Account Specialist

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Available Monday through Friday,
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Your Personal Account Specialist is a TMS employee, a service provider for AstraZeneca.

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