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Crestor
Clinical Pharmacology
Crestor
Active-Controlled Study: CRESTOR was compared with the HMG-CoA reductase inhibitors atorvastatin, simvastatin, and pravastatin in a multicenter, open-label, dose-ranging study of 2,240 patients with hyperlipidemia or mixed dyslipidemia. After randomization, patients were treated for 6 weeks with a single daily dose of either CRESTOR, atorvastatin, simvastatin, or pravastatin (Figure 1 and Table 6).
Figure 1. Percent LDL-C Change by Dose of CRESTOR, Atorvastatin, Simvastatin, and Pravastatin at Week 6 in Patients with Hyperlipidemia or Mixed Dyslipidemia
 |
Box plots are a representation of the 25th, 50th, and 75th percentile
values, with whiskers representing the 10th and 90th percentile values.
Mean baseline LDL-C: 189 mg/dL
Table 6. Percent Change in LDL-C From Baseline to Week 6 (LS Mean*) by Treatment Group (sample sizes ranging from 156–157 patients per group)
| Treatment Daily Dose | ||||
| Treatment | 10 mg | 20 mg | 40 mg | 80 mg |
| CRESTOR | -46† | -52‡ | -55§ | --- |
| Atorvastatin | -37 | -43 | -48 | -51 |
| Simvastatin | -28 | -35 | -39 | -46 |
| Pravastatin | -20 | -24 | -30 | --- |
| * Corresponding standard errors are approximately 1.00 &dagger CRESTOR 10 mg reduced LDL-C significantly more than atorvastatin 10 mg; pravastatin 10 mg, 20 mg, and40 mg; simvastatin 10 mg, 20 mg, and 40 mg. (p < 0.002) &Dagger CRESTOR 20 mg reduced LDL-C significantly more than atorvastatin 20 mg and 40 mg; pravastatin 20 mgand 40 mg; simvastatin 20 mg, 40 mg, and 80 mg. (p < 0.002) § CRESTOR 40 mg reduced LDL-C significantly more than atorvastatin 40 mg; pravastatin 40 mg; simvastatin40 mg, and 80 mg (p < 0.002) |
||||
Heterozygous Familial Hypercholesterolemia
Active-Controlled Study: In a study of patients with heterozygous FH (baseline mean LDL of 291), patients were randomized to CRESTOR 20 mg or atorvastatin 20 mg. The dose was increased by 6-week intervals. Significant LDL-C reductions from baseline were seen at each dose in both treatment groups (Table 7).
Table 7. Mean LDL-C Percentage Change from Baseline
| CRESTOR (n = 435) *LS Mean 95% CI |
Atorvastatin (n = 187) LS Mean 95% CI |
|
| Week 20 6 mg | -47% (-49%, -46%) | -38% (-40%, -36%) |
| Week 40 12 mg | -55% (-57%, -54%) | -47% (-49%, -45%) |
| Week 80 18 mg | NA | -52% (-54%, -50%) |
| *LS Means are least square means adjusted for baseline LDL | ||
Hypertriglyceridemia
Generic Name: Rosuvastatin Calcium
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