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CRESTOR® (rosuvastatin calcium)



 

Indications

As an adjunct to diet, CRESTOR® (rosuvastatin calcium) is indicated to lower LDL-C, raise HDL-C, and is approved to slow the progression of atherosclerosis in adult patients as part of a treatment plan to lower cholesterol to goal.1

Reduce LDL-C and raise HDL-C

CRESTOR is indicated along with 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.1

Lowering LDL Cholesterol and Raising HDL Cholesterol with CRESTOR

  • Lower LDL-C and raise HDL-C with a low 10-mg dose of CRESTOR 1
  • In patients with type 2 diabetes, up to 94%± achieved LDL-C goal of <100 mg/dL§ with a starting dose of CRESTOR 10 mg11,12,13
  • Safety profile in line with other leading statins1, 9, 10

±In 3 titration trials of patients with type 2 diabetes treated with a starting dose of CRESTOR 10 mg.

In the ANDROMEDA trial (n=240), 94% reached LDL-C goal of <96.5 mg/dL at 8 weeks. There was a mean LDL-C reduction of 51% from baseline of 131 mg/dL. The primary end point was the percentage change from baseline in LDL-C after 16 weeks.11

In the CORALL trial (n=130), 82% reached LDL-C goal of <100 mg/dL at 6 weeks. There was a mean LDL-C reduction of 46% from baseline of 163 mg/dL. The primary end point, the percentage change from baseline in ApoB/ApoA1 ratio after 6 weeks, was not significantly different between CRESTOR and atorvastatin. LDL-C goal achievement was another end point.12

In the URANUS trial (n=232), 65% reached LDL-C goal of <100 mg/dL at 4 weeks. There was a mean LDL-C reduction of 48% from baseline of 178 mg/dL. The primary end point was the percentage change from baseline in LDL-C after 16 weeks.13

§According to the third report of the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) update, the LDL-C goal is <160 mg/dL for lower-risk patients, <130 mg/dL for moderate-risk patients, <130 mg/dL (optional goal of <100 mg/dL) for moderately at-risk patients, <100 mg/dL for at-risk patients, and an optional goal of <70 mg/dL for very at-risk patients.14,15

Slow the progression of atherosclerosis

As an adjunct to diet, CRESTOR is approved to slow the progression of atherosclerosis in at-risk patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.1

The effect of CRESTOR on cardiovascular morbidity and mortality has not been determined. Long-term outcomes studies are currently under way.1


Atherosclerosis is a common, progressive vascular disease.15,16

Atherosclerotic plaques can progress significantly before they are detected.15,16

Plaque build-up in the artery

Is your statin of choice indicated to slow the progression of atherosclerosis?

CRESTOR is Indicated to Slow the Progression of Atherosclerosis

Statin combination = a fixed-dose combination of 2 agents.
Multiple generic formulations are widely available.

Unlike Lipitor and simvastatin, CRESTOR has not been shown to reduce cardiovascular morbidity and mortalitiy; long-term outcome studies are currently under way.

Lescol and Lescol XL are registered trademarks of Novartis Pharmaceuticals Corporation.
Mevacor is a registered trademark of Merck & Co., Inc.
Pravachol is a registered trademark of Bristol-Myers Squibb Company.
Lipitor is a registered trademark of Pfizer Inc.
Zocor is a registered trademark of Merck & Co., Inc.
Vytorin is a registered trademark of MSP Singapore Company, LLC.

Help your at-risk patients understand atherosclerosis

There is an opportunity to raise awareness about atherosclerosis. The ongoing dialogue you have with your at-risk patients builds greater understanding about this prevalent health condition. By educating your patients about atherosclerosis, we can

  • Raise awareness about the disease
  • Communicate the importance of cholesterol management
  • Call attention to the link between cholesterol and arterial plaque buildup
  • Motivate at-risk patients to take better care of their arteries

See how AstraZeneca is helping educate at-risk patients about atherosclerosis.

CRESTOR is indicated1

  • 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.

  • As an adjunct to diet 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.

  • The effect of CRESTOR on cardiovascular morbidity and mortality has not been determined; long-term outcomes studies are currently under way.

CRESTOR is contraindicated1

  • 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.

Important safety information about CRESTOR1

  • Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, 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, or lopinavir/ritonavir.

  • Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

  • CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg. Patients initiating CRESTOR therapy or switching from another statin should begin treatment with CRESTOR at the appropriate starting dose.

  • It is recommended that liver enzyme tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (eg, semiannually) thereafter. Should an increase in ALT or AST of >3 times ULN persist, reduction of dose or withdrawal of CRESTOR is recommended. CRESTOR should be used with caution in patients who consume substantial quantities of alcohol.

  • 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%).4

Please see full Prescribing Information for CRESTOR.



Please see full Prescribing Information for CRESTOR
http://switch.atdmt.com/action/nyccre_CRE20070316crestorcomPI_1

CRESTOR is licensed by AstraZeneca from Shionogi & Co LTD, Osaka, Japan.