CRESTOR

Treatment options for at-risk patients like María

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 appropriate for your at-risk patients by exploring María’s hypothetical profile. Then see how the statin you choose can make a difference.

Your Patient — Not at Goal

María has not achieved her LDL-C goal of <100 mg/dL on her current therapy.

Background

Gender: Female

Age: 66

LDL-C: 180 mg/dL

HDL-C: 40 mg/dL

TG: 190 mg/dL

Total-C: 258 mg/dL

Treatment Options

View treatment options for María by clicking on the icons.

Option 1
Option 2
Option 3

Switching to CRESTOR

See María’s anticipated results if you switched her to CRESTOR 10 mg from simvastatin 20 mg.*

Lipid Assessment
Baseline levels
(before ANY statin treatment)		 Post-simvastatin 20 mg
at Week 8		 Post-CRESTOR 10 mg at Week 16
(after 8 weeks of CRESTOR therapy)
LDL-C: 180 mg/dL LDL-C: 118 mg/dL LDL-C: 98 mg/dL
HDL-C: 40 mg/dL HDL-C: 42 mg/dL HDL-C: 43 mg/dL
TG: 190 mg/dL TG: 165 mg/dL TG: 155 mg/dL
Non-HDL-C: 218 mg/dL Non-HDL-C: 151 mg/dL Non-HDL-C: 129 mg/dL
Total-C: 258 mg/dL Total-C: 193 mg/dL Total-C: 172 mg/dL

*Expected results based on adaptation of MERCURY II 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: Female Marital status: Married
Age: 66 Ethnicity: Hispanic
LDL-C: 180 mg/dL Occupation: Homemaker; cares for grandchildren
HDL-C: 40 mg/dL Family history: Father died due to a stroke at age 68;
TG: 190 mg/dL mother was a diabetic, died at age 72
Total-C: 258 mg/dL Social considerations: Only exercise is housecleaning
and short walks; watching her diet
Insurance coverage: Pharmacy benefits through
Medicare Part D
Past Medical History
Hypercholesterolemia
Hypertension
Mild osteoarthritis
Peripheral artery disease
Obesity
Medications
Simvastatin 20 mg qhs
Propranolol 40 mg bid, hydrochlorothiazide 25 mg qd
Acetaminophen 1300 mg bid
Lipid Assessment
Baseline levels
(before ANY statin treatment)		 Post-simvastatin 20 mg
at Week 8
LDL-C: 180 mg/dL LDL-C: 118 mg/dL
HDL-C: 40 mg/dL HDL-C: 42 mg/dL
TG: 190 mg/dL TG: 165 mg/dL
Non-HDL-C: 218 mg/dL Non-HDL-C: 151 mg/dL
Total-C: 258 mg/dL Total-C: 193 mg/dL
                      

Option 1:

Double the dose of current statin treatment



CRESTOR 10 mg reduced LDL-C significantly more than simvastatin 10 mg, 20 mg, and 40 mg at Week 67

  • In the total population of the STELLAR trial, LDL-C reductions were†1,8
    • -46% with CRESTOR 10 mg (n=156)
    • -28% with simvastatin 10 mg (n=165)
    • -35% with simvastatin 20 mg (n=162)
    • -39% with simvastatin 40 mg (n=158)

†P>.002 CRESTOR 10 mg vs simvastatin 10 mg, 20 mg, and 40 mg.
Mean baseline LDL-C: 184 mg/dL to 194 mg/dL.

CRESTOR 10 mg n=45 simvastatin 10 mg n=54
simvastatin 20 mg n=55 simvastatin 40 mg n=44

Graph adapted from a post-hoc analysis of the STELLAR trial, performed on patients ≥65 years of age (n=653). 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 patients with hypercholesterolemia (n=2240). The primary end point was the percentage change in LDL-C from baseline to Week 6. The study performed the following dose comparisons: CRESTOR 10 mg vs atorvastatin 10 mg, 20 mg, and 40 mg, simvastatin 10 mg, 20 mg, and 40 mg, and pravastatin 10 mg, 20 mg, and 40 mg; CRESTOR 20 mg vs atorvastatin 20 mg, 40 mg, and 80 mg, simvastatin 20 mg, 40 mg, and 80 mg, and pravastatin 20 mg and 40 mg; and CRESTOR 40 mg vs atorvastatin 40 mg and 80 mg, simvastatin 40 mg and 80 mg, and pravastatin 40 mg. STELLAR was not a forced-titration trial.1,8

                      

Option 2:

Consider switching to 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
                      

Option 3:

Switch to a low 10-mg dose of CRESTOR



Greater LDL-C reduction after switching to CRESTOR 10 mg from simvastatin 20 mg11

  • LDL-C reductions in the MERCURY II trial at Week 16 were*
    • -45.5% with CRESTOR 10 mg (n=179)
    • -32.1% with simvastatin 20 mg (n=185)

*P<.001 CRESTOR 10 mg vs simvastatin 20 mg.
Mean baseline LDL-C: 167 mg/dL to 172 mg/dL.

Graph shows expected LDL-C reductions based on results adapted from the MERCURY II trial. MERCURY II was a 16-week, randomized, open-label, 2-period, parallel-group, multicenter study. Following a 6-week dietary lead-in period, patients 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). Subjects had either been treated with CRESTOR, atorvastatin, or simvastatin for 16 weeks, or with CRESTOR for 8 weeks following 8 weeks of comparator treatment. Primary end point was percentage of subjects achieving NCEP ATP III LDL-C goal at Week 16.11