Raising HDL-C

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In this section, you can review HDL cholesterol increase results from comparative clinical trials in which CRESTOR® (rosuvastatin calcium) was used as an adjunct to diet in patients who started statin therapy and in patients who switched statin therapy.

See how CRESTOR compares to other statins in raising HDL-cholesterol.

Click on the "+" and "-" signs to expand and collapse the clinical information.

Next: Use in Patients with Diabetes

TRIAL: ECLIPSE

HDL-C increases vs atorvastatin in hypercholesterolemic patients with CHD, 10-year CHD risk score >20% (CHD risk equivalent), or clinical evidence of atherosclerosis1

HDL-C increases vs atorvastatin in hypercholesterolemic patients with CHD, 10-year CHD risk score >20% (CHD risk equivalent), or clinical evidence of atherosclerosis

*P<.01 CRESTOR 10 mg vs atorvastatin 10 mg.
P<.001 CRESTOR 20 mg vs atorvastatin 20 mg; CRESTOR 40 mg vs atorvastatin 40 mg; CRESTOR 40 mg vs atorvastatin 80 mg.

Mean baseline HDL-C: 51 mg/dL to 52 mg/dL.

Week 6:
CRESTOR 10 mg n=498
atorvastatin 10 mg n=510

Week 12:
CRESTOR 20 mg n=492
atorvastatin 20 mg n=494

Week 18:
CRESTOR 40 mg n=480
atorvastatin 40 mg n=483

Week 24:
CRESTOR 40 mg n=464
atorvastatin 80 mg n=476

TRIAL DESCRIPTION:

Adapted from the ECLIPSE trial.1 ECLIPSE was a 24-week, open-label, randomized, multicenter, forced-titration, parallel-group trial comparing the efficacy and safety of CRESTOR and atorvastatin in 1036 patients with hypercholesterolemia and CHD, 10-year CHD risk score >20% (CHD risk equivalent), or clinical evidence of atherosclerosis. Following a 6-week dietary lead-in period, patients were randomized to receive CRESTOR 10 mg or atorvastatin 10 mg for 6 weeks. Doses were force-titrated at 6-week intervals until maximum doses were achieved. Statistical comparisons were not made across the dose range, only across the same time period. The primary end point was percentage of patients achieving NCEP ATP III LDL-C goal of <100 mg/dL at week 24. Percentage change from baseline in HDL-C was a secondary end point.

TRIAL: MERCURY I

Changes in HDL-C in patients who switched to CRESTOR vs remaining on simvastatin or atorvastatin2

Changes in HDL-C in patients who switched to CRESTOR vs remaining on simvastatin or atorvastatin

*P<.05 atorvastatin 10 mg switched to CRESTOR 10 mg vs atorvastatin 10 mg.
P<.025 atorvastatin 20 mg switched to CRESTOR 10 mg vs atorvastatin 20 mg.

Mean baseline HDL-C: 48 mg/dL to 50 mg/dL.

Arm 1 (Weeks 1-16):
CRESTOR 10 mg n=521

Arm 2 (Week 16):
CRESTOR 10 mg n=276
atorvastatin 10 mg n=240

Arm 3 (Week 16):
CRESTOR 10 mg n=293
CRESTOR 20 mg n=305
atorvastatin 20 mg n=299

Arm 4 (Week 16):
CRESTOR 10 mg n=277
simvastatin 20 mg n=250

TRIAL DESCRIPTION:

Adapted from the MERCURY I trial.2 MERCURY I was a 16-week, randomized, open-label, 2-period, multicenter, parallel-group study. Following a 6-week dietary lead-in period, hypercholesterolemic patients with CHD, established atherosclerotic disease, type 2 diabetes or a 10-year CHD risk score >20% (as defined by the Joint European Society, 1998) 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 HDL-C was a secondary end point.

TRIAL: STELLAR

HDL-C increases by dose in patients with hyperlipidemia or mixed dyslipidemia treated with CRESTOR vs other statins3,4

HDL-C increases by dose in patients with hyperlipidemia or mixed dyslipidemia treated with CRESTOR vs other statins

In the STELLAR trial, CRESTOR increased HDL-C at each dose.
At 6 weeks, CRESTOR demonstrated significant HDL-C increases.
+7.7% with CRESTOR 10 mg (P<.002 vs pravastatin 10 mg).
+9.5% with CRESTOR 20 mg (P<.002 vs atorvastatin 20 mg, 40 mg, 80 mg; simvastatin 40 mg; and pravastatin 20 mg, 40 mg).

*P<.002 CRESTOR 10 mg vs pravastatin 10 mg.
P=NS CRESTOR 10 mg vs atorvastatin 10 mg, 20 mg, 40 mg; simvastatin 10 mg, 20 mg, 40 mg; pravastatin 20 mg, 40 mg.
P<.002 CRESTOR 20 mg vs atorvastatin 20 mg, 40 mg, 80 mg; simvastatin 40 mg; pravastatin 20 mg, 40 mg.
P=NS CRESTOR 20 mg vs simvastatin 20 mg, 80 mg.
P<.002 CRESTOR 40 mg vs atorvastatin 40 mg, 80 mg; simvastatin 40 mg; pravastatin 40 mg.
P=NS CRESTOR 40 mg vs simvastatin 80 mg.

Mean baseline HDL-C: 50 mg/dL to 51 mg/dL.

CRESTOR n=473
atorvastatin n=634
simvastatin n=648
pravastatin n=485

TRIAL DESCRIPTION:

Adapted from the STELLAR trial.3,4 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 hyperlipidemia or mixed dyslipidemia. The primary end point was percentage change from baseline in LDL-C at week 6. Percentage change from baseline in HDL-C was a secondary end point. 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.

Read full Prescribing Information
TRIAL: MERCURY II

HDL-C increases after switching to CRESTOR vs remaining on simvastatin in hypercholesterolemic patients with CHD, established atherosclerotic disease, diabetes, or a 10-year CHD risk >20%5

HDL-C increases after switching to CRESTOR vs remaining on simvastatin in hypercholesterolemic patients with CHD, established atherosclerotic disease, diabetes, or a 10-year CHD risk >20%

P=NS 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 HDL-C: 47 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

TRIAL DESCRIPTION:

Adapted from the MERCURY II trial.5 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. Percentage change in HDL-C was a secondary end point.

Read full Prescribing Information

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 statins, 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. There have been rare reports of immune-mediated necrotizing myopathy associated with statin use. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and if muscle signs and symptoms persist after discontinuing CRESTOR
  • It is recommended that liver enzyme tests be performed before the initiation of CRESTOR and if signs or symptoms of liver injury occur. All patients treated with CRESTOR should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including CRESTOR. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with CRESTOR, promptly interrupt therapy. If an alternate etiology is not found, do not restart CRESTOR
  • 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 statins, including CRESTOR. Based on clinical trial data with CRESTOR, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus
  • 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%)#‡‡
  • Rare postmarketing reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) have been associated with statin use, including CRESTOR. These reports are generally nonserious and reversible upon statin discontinuation
  • 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 (PDF - 152k)

Please see the full Prescribing Information available at CrestorTouchPoints.com

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

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

CRESTOR is a registered trademark, and AZ&Me is a trademark of the AstraZeneca group of companies.

LIPITOR (atorvastatin calcium) is a registered trademark of Pfizer Inc.

©2013 AstraZeneca. All rights reserved. 829806-2848509 Last Updated 8/13


US Flag  This product information is intended for US Health Care Professionals only.

Footnote
*Percentage of patients on CRESTOR 20 mg (n=160) achieving NCEP ATP III LDL-C goal by risk category5: High-risk–77.3%; Medium-risk–93.8%; Low-risk–94.0%. Mean baseline LDL-C: 187 mg/dL.
Footnote
LDL-C Goals: <100 mg/dL for patients with coronary heart disease (CHD), CHD risk equivalents, or multiple risk factors that conferred a 10-year CHD risk of >20%; <130 mg/dL for medium-risk patients (multiple [2+] risk factors with 10-year risk for CHD <20%); and <160 mg/dL for low-risk patients (0-1 risk factor).
^

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