CRESTOR

Getting to goal


CRESTOR helps get your patients to goal without titration*



In patients with type 2 diabetes

Up to 94% achieved LDL-C <100 mg/dL with CRESTOR 10 mg


*
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 High-Risk patients, <100 mg/dL for High-Risk patients, and an optional goal of <70 mg/dL for Very High-Risk patients 2, 3.
†
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.
  • 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/ApoA-1 ratio after 6 weeks, was not significantly different between CRESTOR and atorvastatin. LDL-C goal achievement was another end point.
  • 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.



CRESTOR is indicated

1
As an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in patients with primary hyperlipidemia and 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 contraindicated

1
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 CRESTOR

1
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%).13



Please see full Prescribing Information for CRESTOR.

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

CRESTOR is a registered trademark of the AstraZeneca group of companies.
259343  3/08 ©2008 AstraZeneca Pharmaceuticals LP. All rights reserved.
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