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Prescribing CRESTOR
LDL-C Reductions: Switching Therapy
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 patients who switched statin therapy.
See how CRESTOR performed in lowering LDL cholesterol compared to other statins.
For detailed comparative clinical trial data, select 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.
Goal attainment (LDL-C <100 mg/dL) in patients at high risk* of CHD, switching to CRESTOR vs remaining on atorvastatin2
Adapted from the MERCURY II Trial
Goal attainment (LDL-C <100 mg/dL) in patients at high risk* of CHD, switching to CRESTOR vs remaining on atorvastatin2
Adapted from the MERCURY II Trial
Goal attainment (LDL-C <100 mg/dL) in patients at high risk* of CHD, switching to CRESTOR vs remaining on atorvastatin2
*CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20%.
†P<.001 atorvastatin 10 mg switched to CRESTOR 10 mg vs atorvastatin 10 mg; atorvastatin 20 mg switched to CRESTOR 20 mg vs atorvastatin 20 mg.
Mean baseline LDL-C: 167 mg/dL to 169 mg/dL.
Arm 1 (Weeks 1-16):
CRESTOR 20 mg n=362
Arm 2 (Week 16):
CRESTOR 10 mg n=189
atorvastatin 10 mg n=180
Arm 3 (Week 16):
CRESTOR 20 mg n=184
atorvastatin 20 mg n=182
TRIAL DESCRIPTION:
Adapted from the MERCURY II trial.2 MERCURY II was a 16-week, randomized, open-label, 2-period, parallel-group, multicenter study. Following a 6-week dietary lead-in period, hypercholesterolemic patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20% 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 <100 mg/dL at week 16. Changes in LDL-C at weeks 8 and 16 were secondary end points.
Goal attainment (LDL-C <100 mg/dL) in patients at high risk* of CHD switching to CRESTOR vs remaining on simvastatin2
Adapted from the MERCURY II Trial
Goal attainment (LDL-C <100 mg/dL) in patients at high risk* of CHD switching to CRESTOR vs remaining on simvastatin2
Adapted from the MERCURY II Trial
Goal attainment (LDL-C <100 mg/dL) in patients at high risk* of CHD switching to CRESTOR vs remaining on simvastatin2
*CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20%.
†P<.001 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 LDL-C: 167 mg/dL to 169 mg/dL.
Arm 1 (Weeks 1-16):
CRESTOR 20 mg n=362
Arm 4 (Week 16):
CRESTOR 10 mg n=179
simvastatin 20 mg n=185
Arm 5 (Week 16):
CRESTOR 20 mg n=183
simvastatin 40 mg n=183
TRIAL DESCRIPTION:
Adapted from the MERCURY II trial.2 MERCURY II was a 16-week, randomized, open-label, 2-period, parallel-group, multicenter study. Following a 6-week dietary lead-in period, hypercholesterolemic patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20% 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 <100 mg/dL at week 16. Changes in LDL-C at weeks 8 and 16 were secondary end points.
3143524-3097604 Last Updated 7/15
Important Safety Information for CRESTOR® (rosuvastatin calcium) 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, darolutamide, regorafenib, atazanavir/ritonavir, lopinavir/ritonavir, simeprevir or combination of sofosbuvir/velpatasvir/voxilaprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, all combinations with ledipasvir (including ledipasvir/sofosbuvir) or colchicine
- 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 post-marketing 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%)1,2
- Rare post-marketing 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
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References:
- Faergeman O, Hill L, Windler E, et al; on behalf of the ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia. Cardiology. 2008;111(4):219-228.
- Ballantyne CM, Bertolami M, Hernandez Garcia HR, et al. Achieving LDL cholesterol, non-HDL cholesterol, and apolipoprotein B target levels in high-risk patients: Measuring Effective Reductions in Cholesterol Using Rosuvastatin therapY (MERCURY) II. Am Heart J. 2006;151(5):975.e1-975.e9.
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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