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Prescribing CRESTOR
Primary Prevention of CVD Indication
Based on the impressive results of the JUPITER trial, CRESTOR® (rosuvastatin calcium) has a primary prevention of cardiovascular disease (CVD) indication.
CRESTOR is indicated in patients without clinically evident coronary heart disease (CHD), to reduce the risk of myocardial infarction, stroke, and arterial revascularization in men ≥50 years and women ≥60 years with hsCRP ≥2 mg/L and at least one additional cardiovascular disease risk factor.1,2
In the JUPITER trial, CRESTOR 20 mg vs placebo demonstrated1,2
54% relative risk reduction in myocardial infarction (P<.001)
0.4% absolute risk reduction
48% relative risk reduction in stroke (P=.002)
0.3% absolute risk reduction
46% relative risk reduction in arterial revascularization (P<.001)
0.7% absolute risk reduction
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.
Risk reduction of myocardial infarction with CRESTOR vs placebo1,2
Adapted from the JUPITER Trial
Risk reduction of myocardial infarction with CRESTOR vs placebo1,2
Adapted from the JUPITER Trial
Risk reduction of myocardial infarction with CRESTOR vs placebo1,2
*Absolute risk reduction %=(events in placebo arm/total number of subjects in placebo arm - events in CRESTOR arm/total number of subjects in CRESTOR arm) x 100.
HR=hazard ratio.
CI=confidence interval.
TRIAL DESCRIPTION:
Adapted from the JUPITER trial.1,2 JUPITER was a long-term, randomized, double-blind, placebo-controlled study in 17,802 patients (CRESTOR=8901, placebo=8901) designed to assess the effects of CRESTOR 20 mg in the primary prevention of CVD events in men (≥50 years) and women (≥60 years) who had no clinically evident CVD, LDL-C levels <130 mg/dL, and hsCRP levels ≥2 mg/L. Patients were followed for a mean duration of 2 years. The primary end point was a composite end point consisting of the time-to-first occurrence of any of the following major cardiovascular (CV) events: CV death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or an arterial revascularization procedure.
The study population had an estimated baseline CHD risk of 11.6% over 10 years based on the Framingham risk criteria and included a high percentage of patients with additional risk factors such as hypertension (58%), low HDL-C levels (23%), cigarette smoking (16%), or a family history of premature CHD (12%). Study participants had a median baseline LDL-C of 108 mg/dL and hsCRP of 4.3 mg/L.
In a post-hoc subgroup analysis of JUPITER subjects (n=1405; CRESTOR=725, placebo=680) with an hsCRP ≥2 mg/L and no other traditional risk factors (smoking, BP ≥140/90 mm Hg or taking antihypertensives, low HDL-C) other than age, after adjustment for high HDL-C, there was no significant treatment benefit with CRESTOR treatment.
Risk reduction of stroke with CRESTOR vs placebo1,2
Adapted from the JUPITER Trial
Risk reduction of stroke with CRESTOR vs placebo1,2
Adapted from the JUPITER Trial
Risk reduction of stroke with CRESTOR vs placebo1,2
*Absolute risk reduction %=(events in placebo arm/total number of subjects in placebo arm - events in CRESTOR arm/total number of subjects in CRESTOR arm) x 100.
HR=hazard ratio.
CI=confidence interval.
TRIAL DESCRIPTION:
Adapted from the JUPITER trial.1,2 JUPITER was a long-term, randomized, double-blind, placebo-controlled study in 17,802 patients (CRESTOR=8901, placebo=8901) designed to assess the effects of CRESTOR 20 mg in the primary prevention of CVD events in men (≥50 years) and women (≥60 years) who had no clinically evident CVD, LDL-C levels <130 mg/dL, and hsCRP levels ≥2 mg/L. Patients were followed for a mean duration of 2 years. The primary end point was a composite end point consisting of the time-to-first occurrence of any of the following major cardiovascular (CV) events: CV death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or an arterial revascularization procedure.
The study population had an estimated baseline CHD risk of 11.6% over 10 years based on the Framingham risk criteria and included a high percentage of patients with additional risk factors such as hypertension (58%), low HDL-C levels (23%), cigarette smoking (16%), or a family history of premature CHD (12%). Study participants had a median baseline LDL-C of 108 mg/dL and hsCRP of 4.3 mg/L.
In a post-hoc subgroup analysis of JUPITER subjects (n=1405; CRESTOR=725, placebo=680) with an hsCRP ≥2 mg/L and no other traditional risk factors (smoking, BP ≥140/90 mm Hg or taking antihypertensives, low HDL-C) other than age, after adjustment for high HDL-C, there was no significant treatment benefit with CRESTOR treatment.
Risk reduction of arterial revascularization* with CRESTOR vs placebo1,2
Adapted from the JUPITER Trial
Risk reduction of arterial revascularization* with CRESTOR vs placebo1,2
Adapted from the JUPITER Trial
Risk reduction of arterial revascularization* with CRESTOR vs placebo1,2
*Including coronary artery bypass graft, or bypass grafting of a peripheral artery or carotid artery, or angioplasty or stent placement.
†Absolute risk reduction %=(events in placebo arm/total number of subjects in placebo arm - events in CRESTOR arm/total number of subjects in CRESTOR arm) x 100.
HR=hazard ratio.
CI=confidence interval.
TRIAL DESCRIPTION:
Adapted from the JUPITER trial.1,2 JUPITER was a long-term, randomized, double-blind, placebo-controlled study in 17,802 patients (CRESTOR=8901, placebo=8901) designed to assess the effects of CRESTOR 20 mg in the primary prevention of CVD events in men (≥50 years) and women (≥60 years) who had no clinically evident CVD, LDL-C levels <130 mg/dL, and hsCRP levels ≥2 mg/L. Patients were followed for a mean duration of 2 years. The primary end point was a composite end point consisting of the time-to-first occurrence of any of the following major cardiovascular (CV) events: CV death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or an arterial revascularization procedure.
The study population had an estimated baseline CHD risk of 11.6% over 10 years based on the Framingham risk criteria and included a high percentage of patients with additional risk factors such as hypertension (58%), low HDL-C levels (23%), cigarette smoking (16%), or a family history of premature CHD (12%). Study participants had a median baseline LDL-C of 108 mg/dL and hsCRP of 4.3 mg/L.
In a post-hoc subgroup analysis of JUPITER subjects (n=1405; CRESTOR=725, placebo=680) with an hsCRP ≥2 mg/L and no other traditional risk factors (smoking, BP ≥140/90 mm Hg or taking antihypertensives, low HDL-C) other than age, after adjustment for high HDL-C, there was no significant treatment benefit with CRESTOR treatment.
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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.
- Data on File, 295753, AstraZeneca Pharmaceuticals LP.
- Jones PH, Davidson MH, Stein EA, et al; STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;93(2):152-160.
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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