Lowering LDL-C: Switching Therapy Comparative Data

In this section, you can review LDL cholesterol reduction results and LDL cholesterol goal attainment results from comparative clinical trials in which CRESTOR® (rosuvastatin calcium) was used as an adjunct to diet in patients who switched statin therapy. You can also download the MERCURY II publication.

LDL Cholesterol Reductions vs Other Statins

LDL Cholesterol Goal Attainment vs Other Statins

LDL Cholesterol Reductions, Additional Results vs Other Statins

TRIAL: MERCURY II
^ Back to top

LDL-C reductions in patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20% switching to CRESTOR vs remaining on atorvastatin1

LDL-C reductions in patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20% switching to CRESTOR vs remaining on atorvastatin

*P<.001 atorvastatin 10 mg switched to CRESTOR 10 mg vs atorvastatin 10 mg; atorvastatin 20 mg switched to CRESTOR 20 mg vs atorvastatin 20 mg.

Mean baseline LDL-C: 167 mg/dL to 169 mg/dL.

Arm 1 (Weeks 1-16):
CRESTOR 20 mg n=362

Arm 2 (Week 16):
CRESTOR 10 mg n=189
atorvastatin 10 mg n=180

Arm 3 (Week 16):
CRESTOR 20 mg n=184
atorvastatin 20 mg n=182

Enlarge Chart
Download Publication
Read full Prescribing Information

Adapted from the MERCURY II trial.1 MERCURY II was a 16-week, randomized, open-label, 2-period, parallel-group, multicenter study. Following a 6-week dietary lead-in period, hypercholesterolemic patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20% 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). Patients had either been treated with CRESTOR, atorvastatin, or simvastatin for 16 weeks or with CRESTOR for 8 weeks following 8 weeks of comparator treatment. The primary end point was percentage of patients achieving NCEP ATP III LDL-C goal <100 mg/dL at week 16. Changes in LDL-C at weeks 8 and 16 were secondary end points.

TRIAL: MERCURY II
^ Back to top

LDL-C reductions in patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20%, switching to CRESTOR vs remaining on simvastatin1

LDL-C reductions in patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20%, switching to CRESTOR vs remaining on simvastatin

*P<.001 simvastatin 20 mg switched to CRESTOR 10 mg vs simvastatin 20 mg; simvastatin 40 mg switched to CRESTOR 20 mg vs simvastatin 40 mg.

Mean baseline LDL-C: 167 mg/dL to 169 mg/dL

Arm 1 (Weeks 1-16):
CRESTOR 20 mg n=362

Arm 4 (Week 16):
CRESTOR 10 mg n=179
simvastatin 20 mg n=185

Arm 5 (Week 16):
CRESTOR 20 mg n=183
simvastatin 40 mg n=183

Enlarge Chart
Download Publication
Read full Prescribing Information

Adapted from the MERCURY II trial.1 MERCURY II was a 16-week, randomized, open-label, 2-period, parallel-group, multicenter study. Following a 6-week dietary lead-in period, hypercholesterolemic patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20% 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). Patients had either been treated with CRESTOR, atorvastatin, or simvastatin for 16 weeks or with CRESTOR for 8 weeks following 8 weeks of comparator treatment. The primary end point was percentage of patients achieving NCEP ATP III LDL-C goal <100 mg/dL at week 16.

TRIAL: MERCURY II
^ Back to top

LDL-C reductions after switching to CRESTOR 10 mg from simvastatin 20 mg in patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20%1

LDL-C reductions after switching to CRESTOR 10 mg from simvastatin 20 mg in patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20%

*P<.001 for difference between mean percentage change in LDL-C for CRESTOR 10 mg (-15%) and simvastatin 20 mg (+3%) from week 8 to week 16.

Mean baseline LDL-C: 169 mg/dL.

Week 8:
simvastatin 20 mg n=387

Week 16:
CRESTOR 10 mg n=179
simvastatin 20 mg n=185

Enlarge Chart
Download Publication
Read full Prescribing Information

Adapted from the MERCURY II trial.1 MERCURY II was a 16-week, randomized, open-label, 2-period, parallel-group, multicenter study. Following a 6-week dietary lead-in period, hypercholesterolemic patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20% 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). Patients had either been treated with CRESTOR, atorvastatin, or simvastatin for 16 weeks or with CRESTOR for 8 weeks following 8 weeks of comparator treatment. The primary end point was percentage of patients achieving NCEP ATP III LDL-C goal <100 mg/dL at week 16. Changes in LDL-C at weeks 8 and 16 were secondary end points.

TRIAL: MERCURY II
^ Back to top

Goal attainment (LDL-C <100 mg/dL) in patients at high risk* of CHD, switching to CRESTOR vs remaining on atorvastatin1

Goal attainment (LDL-C <100 mg/dL) in patients at high risk of CHD, switching to CRESTOR vs remaining on atorvastatin

*CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk
score >20%

†P<.001 atorvastatin 10 mg switched to CRESTOR 10 mg vs atorvastatin 10 mg; atorvastatin 20 mg switched to CRESTOR 20 mg vs atorvastatin 20 mg.

Mean baseline LDL-C: 167 mg/dL to 169 mg/dL.

Arm 1 (Weeks 1-16):
CRESTOR 20 mg n=362

Arm 2 (Week 16):
CRESTOR 10 mg n=189
atorvastatin 10 mg n=180

Arm 3 (Week 16):
CRESTOR 20 mg n=184
atorvastatin 20 mg n=182

Enlarge Chart
Download Publication
Read full Prescribing Information

Adapted from the MERCURY II trial.1 MERCURY II was a 16-week, randomized, open-label, 2-period, parallel-group, multicenter study. Following a 6-week dietary lead-in period, hypercholesterolemic patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20% 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). Patients had either been treated with CRESTOR, atorvastatin, or simvastatin for 16 weeks or with CRESTOR for 8 weeks following 8 weeks of comparator treatment. The primary end point was percentage of patients achieving NCEP ATP III LDL-C goal <100 mg/dL at week 16.

TRIAL: MERCURY II
^ Back to top

Goal attainment (LDL-C <100 mg/dL) in patients at high risk of CHD switching to CRESTOR vs remaining on simvastatin1

Goal attainment (LDL-C <100 mg/dL) in patients at high risk of CHD switching to CRESTOR vs remaining on simvastatin

*P<.001 simvastatin 20 mg switched to CRESTOR 10 mg vs simvastatin 20 mg; simvastatin 40 mg switched to CRESTOR 20 mg vs simvastatin 40 mg.

Mean baseline LDL-C: 167 mg/dL to 169 mg/dL.

Arm 1 (Weeks 1-16):
CRESTOR 20 mg n=362

Arm 4 (Week 16):
CRESTOR 10 mg n=179
simvastatin 20 mg n=185

Arm 5 (Week 16):
CRESTOR 20 mg n=183
simvastatin 40 mg n=183

Enlarge Chart
Download Publication
Read full Prescribing Information

Adapted from the MERCURY II trial.1 MERCURY II was a 16-week, randomized, open-label, 2-period, parallel-group, multicenter study. Following a 6-week dietary lead-in period, hypercholesterolemic patients with CHD, established atherosclerotic disease, diabetes, or 10-year CHD risk score >20% 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). Patients had either been treated with CRESTOR, atorvastatin, or simvastatin for 16 weeks or with CRESTOR for 8 weeks following 8 weeks of comparator treatment. The primary end point was percentage of patients achieving NCEP ATP III LDL-C goal <100 mg/dL at week 16.

TRIAL: MERCURY I
^ Back to top

Percentage change from baseline LDL-C at 16 weeks in patients switching to CRESTOR vs remaining on atorvastatin2

Percentage change from baseline LDL-C at 16 weeks in patients switching to CRESTOR vs remaining on atorvastatin

Enlarge Chart

Adapted from the MERCURY I trial.2 MERCURY I was a 16-week, randomized, open-label, 5-arm, 2-period, multicenter, parallel-group study in patients with hypercholesterolemia. Patients had a history of CHD or established atherosclerotic disease, type 2 diabetes, or a CHD risk >20% over 10 years (as defined by the Joint European Societies, 1998). Following a 6-week dietary lead-in period, patients were randomized to 1 of 5 treatment arms: CRESTOR 10 mg, atorvastatin 10 mg, atorvastatin 20 mg, simvastatin 20 mg, or pravastatin 40 mg once daily (period 1: 8 weeks). Patients then remained on these treatments or were switched as follows: half from atorvastatin 10 mg, simvastatin 20 mg, and pravastatin 40 mg to CRESTOR 10 mg once daily; one third of each from atorvastatin 20 mg to CRESTOR 10 mg and 20 mg once daily (period 2: 8 weeks). Primary end point was percentage of patients reaching Joint European Societies' LDL-C goal <116 mg/dL at week 16. Percentage change in LDL-C was a secondary end point.

TRIAL: MERCURY I
^ Back to top

Percentage change from baseline LDL-C at 16 weeks in patients switching to CRESTOR vs remaining on simvastatin or pravastatin2

MERCURY I LDL-C results - Percentage change from baseline LDL-C at 16 weeks in patients switching to CRESTOR vs remaining on simvastatin or pravastatin

 

Enlarge Chart

Adapted from the MERCURY I trial.2 MERCURY I was a 16-week, randomized, open-label, 2-period, parallel-group, multicenter study. Following a 6-week dietary lead-in period, hypercholesterolemic patients with a history of CHD or established atherosclerotic disease, type 2 diabetes, or a CHD risk >20% over 10 years (as defined by the Joint European Society, 1998) were randomized to 1 of 5 arms: CRESTOR 10 mg, atorvastatin 10 mg, atorvastatin 20 mg, simvastatin 20 mg, or pravastatin 40 mg once daily (period 1: 8 weeks). Patients then remained on these treatments or were switched as follows: half from atorvastatin 10 mg, simvastatin 20 mg, and pravastatin 40 mg to CRESTOR 10 mg once daily; one third of each from atorvastatin 20 mg to CRESTOR 10 mg and 20 mg once daily (period 2: 8 weeks). The primary end point was percentage of patients reaching Joint European Societies' LDL-C goal <116 mg/dL at week 16. Percentage change in LDL-C was a secondary end point.

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 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, lopinavir/ritonavir, or atazanavir/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
  • 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 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 HMG-CoA reductase inhibitors, including CRESTOR
  • 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%)#‡‡
  • The dose range for CRESTOR is 5 mg to 40 mg orally once daily. The usual starting dose is 10 mg to 20 mg. Patients initiating CRESTOR therapy or switching from another statin should begin treatment with CRESTOR at the appropriate starting dose. After initiation or upon titration of CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly. CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg

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 Adobe pdf (PDF - 152k) Opens in a new window

Please see the full Prescribing Information available at CrestorTouchPoints.com

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

CRESTOR is a registered trademark of the AstraZeneca group of companies.

©2011 AstraZeneca. All rights reserved. 1482202 12/11


US Flag  This product information is intended for US health care professionals only.

Footnote

Defined as covered without prior authorization on Commercial, Medicare Part D, and Medicaid formularies. Patients without prior authorization means covered lives at Tiers 1 to 7 calculated by Fingertip Formulary as of October 12, 2011 that do not require additional information to the health plan in order for CRESTOR to be covered. Data include covered lives whose prescriptions may be subject to step-therapy requirements.

Footnote

†Based on the ’average Tier 1 copay for Commercial covered lives’ for generic statins from Fingertip Formulary as of July 26, 2011. Certain restrictions may apply.

Patients may visit www.crestor.com for these eligibility requirements and to sign up for the CRESTOR Savings Card.

If patients can’t afford their medication, AstraZeneca may be able to help. For more information, please visit www.AstraZeneca-us.com.

Physicians and patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

^

Here is your Personal Account Specialist for CRESTOR in Zip code :

Personal Account Specialist

[1-XXX-XXX-XXXX]

Available Monday through Friday,
8 am to 6 pm EST

Your Personal Account Specialist is a TMS employee, a service provider for AstraZeneca.

Register for AZ TouchPoints

Close

AstraZeneca is committed to helping Health Care Professionals provide appropriate care for their patients. Please provide us with the following information so that we can keep your records up to date and can send you any information that you request. If in the future you no longer want to receive health-related materials from AstraZeneca, please call 1-800-236-9933. Please visit www.azprivacystatement.com to review our Privacy Statement.

Enter Your InformationAll fields required

 
 
 

Create Your Account

   
 
 
 

After registering, a confirmation will be sent to <e-mail address>.

Register
Cancel

Your e-mail address and password will enable
you to log in and securely manage your account.

Your password must contain BOTH letters
and numbers and be between 6-12 characters.

The National Provider Identifier (NPI) is a unique 10-digit number used to confirm you are a licensed health care provider. Covered health care providers must use their NPI in the administrative and financial transactions adopted under the Health Insurance Portability and Accountability Act (HIPAA).

1488804 11/11

Register for AZ TouchPoints

Close

AstraZeneca is committed to helping Health Care Professionals provide appropriate care for their patients. Please provide us with the following information so that we can keep your records up to date and can send you any information that you request. If in the future you no longer want to receive health-related materials from AstraZeneca, please call 1-800-236-9933. Please visit www.azprivacystatement.com to review our Privacy Statement.

Enter Your InformationAll fields required

 
 
 

Create Your Account

   
 
 
 

After registering, a confirmation will be sent to .

Register
Cancel

Your e-mail address and password will enable
you to log in and securely manage your account.

Your password must contain BOTH letters
and numbers and be between 6-12 characters.

The National Provider Identifier (NPI) is a unique 10-digit number used to confirm you are a licensed health care provider. Covered health care providers must use their NPI in the administrative and financial transactions adopted under the Health Insurance Portability and Accountability Act (HIPAA).

1488804 11/11

Log In

Close
 
 
 
Remember my e-mail address Forgot Password?

Not Registered?

1488804 11/11

Forgot Your Password?

Close

To receive an e-mail with your password, please enter the e-mail address you provided for this account.

 
Submit

Return to Login
 
1488804 11/11

Password Sent

Close

You will receive a temporary password shortly. Please check your e-mail and log in again.


Return to Login

1488804 11/11

Log In

Close

You have unsuccessfully attempted to log in 3 times. If you forgot your password, click here. If you forgot the e-mail address used to create your account, call 1-800-236-9933, Monday through Friday, 8 am to 6 pm ET, excluding holidays.


Return to Login
1488804 11/11

Please Log In to Access This Content

Close

Not Registered?

Some content on AZ TouchPoints is available to registered users only. Once registered, you can use your e-mail address and password to log into any Web site powered by AZ TouchPoints.


Register Now

Log In

 
Remember me Forgot Password?

1488804 11/11

Forgot Your Password?

To receive an e-mail with your password, please enter the e-mail address you provided for this account.

 
Submit

Return to Login

1488804 11/11

AZ TouchPoints Web Sites

Close
1488804 11/11

How Can We Help You?

Close

If you would like information regarding products from
AstraZeneca, please call

1-800-236-9933

Monday through Friday, 8:00 am to 6:00 pm ET,
excluding holidays.

1488805 11/11

Visit the Suite of AZ TouchPoints Web Sites

Close

AZ Medical Information Support

Visit the AstraZeneca Medical Information Support site to find answers to questions about AZ medicines.


Access AZ Medical Information Support
1486307 11/11