CRESTOR

Treatment options for at-risk patients like George

Managing your patient’s lipid profile can be complicated. Choosing an appropriate treatment option to help get your patients to goal doesn’t have to be. Determine which treatment option may be an appropriate choice for your at-risk patients with diabetes like George by exploring his hypothetical profile. Then see how the statin you choose can make a difference.

Your Patient — Diabetic

George requires lipid-lowering therapy to reach his doctor’s desired LDL-C goal.

Background

Gender: Male

Age: 50

LDL-C: 143 mg/dL

HDL-C: 39 mg/dL

TG: 188 mg/dL

Total-C: 220 mg/dL

Treatment Options

View treatment options for George by clicking on the icons.

Option 1
Option 2

With CRESTOR 10 mg

See George’s anticipated results with CRESTOR 10 mg.*

Based on the results of the ANDROMEDA trial,
CRESTOR can be appropriate for lowering LDL-C in diabetic patients like George

CRESTOR provided greater LDL-C reduction vs atorvastatin in patients with diabetes14
  • -51% with CRESTOR 10 mg
  • -39% with atorvastatin 10 mg
||P≤.001 CRESTOR 10 mg vs atorvastatin 10 mg.
Mean baseline LDL-C: 131 mg/dL.

CRESTOR 10 mg n=240 atorvastatin 10 mg n=240

Graph shows expected LDL-C reductions based on results adapted from the ANDROMEDA trial. ANDROMEDA was a randomized, multicenter, parallel-group, forced-titration trial comparing the efficacy and safety of CRESTOR (10 mg and 20 mg) and atorvastatin (10 mg and 20 mg) in patients with type 2 diabetes mellitus. The primary end point was the percentage change from baseline in LDL-C after 16 weeks. Secondary end points included the percentage change from baseline in other lipid and lipoprotein variables.

Lipid Assessment
Baseline levels
(after diet modifications and before ANY statin treatment)		 Post-CRESTOR 10 mg
at Week 8
LDL-C: 143 mg/dL LDL-C: 70 mg/dL
HDL-C: 39 mg/dL HDL-C: 40 mg/dL
TG: 188 mg/dL TG: 147 mg/dL
Non-HDL-C: 181 mg/dL Non-HDL-C: 99 mg/dL
Total-C: 220 mg/dL Total-C: 139 mg/dL


*Expected results based on adaptation of ANDROMEDA trial. Individual results may vary.


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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This product information is intended for
US health care professionals only.
                      
Background
Gender: Male Marital status: Married
Age: 50 Ethnicity: Caucasian
Weight: 232 lb Occupation: Real estate broker
Height: 5 ft 10 in Family history: Father had hypercholesterolemia and died
BMI: 33.3 kg/m2 due to MI at age 52; mother (age 78) has type 2 diabetes
BP: 130/80 mm Hg and CAD
A1c: 7.5% Social considerations: Rarely exercises due to late nights
SCr: 1.1 mg/dL in the office, a smoker for over 30 years, and drinks socially
Insurance coverage: Large national HMO and $15 Tier 2
copay for Rx
Past Medical History
Type 2 diabetes
(diagnosed 4 months ago)
Hypertension
Onychomycosis of toenails
Obesity
Medications
Metformin IR 500 mg bid
Enalapril maleate 20 mg qd
Itraconazole 200 mg qd
Lipid Assessment
Baseline levels
(after diet modifications and before ANY statin treatment)
LDL-C: 143 mg/dL
HDL-C: 39 mg/dL
TG: 188 mg/dL
Non-HDL-C: 181 mg/dL
Total-C: 220 mg/dL
                      

Option 1:

Initiate a single-agent statin therapy



In the STELLAR trial, CRESTOR significantly lowered LDL-C1,8

  • CRESTOR 10 mg provided greater LDL-C reductions
  • vs atorvastatin 10 mg
  • vs simvastatin 10 mg, 20 mg, and 40 mg

†P<.002 vs atorvastatin 10 mg; simvastatin 10 mg, 20 mg, 40 mg.
‡P<.002 vs atorvastatin 20 mg, 40 mg; simvastatin 20 mg, 40 mg.

Mean baseline LDL-C: 187 mg/dL to 190 mg/dL.
CRESTOR 10 mg n=316         atorvastatin n=469         simvastatin n=485

Graph adapted from the STELLAR trial. 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 Type IIa/IIb dyslipidemia. The primary end point was the percentage change from baseline in LDL-C at Week 6. Secondary end points included percentage change from baseline in other lipid levels and percentage of subjects achieving NCEP ATP III goals. At randomization, 7% to 8% of the CRESTOR 10- to 40-mg, atorvastation 10- to 80-mg, simvastatin 10- to 80-mg, and pravastatin 10- to 40-mg groups had diabetes mellitus.

                      

Option 2:

Initiate a fixed-dose combination therapy



Fact 1: Vytorin® (ezetimibe/simvastatin) is a fixed-dose combination of 2 drugs9
  1. Simvastatin (marketed as Zocor® and also available in generic form)
  2. Ezetimibe (marketed as Zetia®)
Fact 2: Simvastatin (a component of Vytorin) is a substrate of CYP450 3A4*9
  1. The use of Vytorin concomitantly with medicines labeled as having a potent inhibitory effect on CYP450 3A4 should be avoided unless the benefits of combined therapy outweigh the increased risk.
  2. If treatment with potent CYP450 3A4 inhibitors itraconazole, ketoconazole, erythromycin, clarithromycin, or telithromycin is unavoidable, therapy with Vytorin should be suspended during the course of treatment.
  3. *There are mechanisms other than CYP450 3A4 inhibition that may result in drug interactions.
Fact 3: The labeling for simvastatin and Vytorin recommends evening administration9,10
Fact 4: In general, more cholesterol is produced by the body than comes from food29,30