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Lipitor
Clinical Pharmacology
Lipitor
In patients with Fredrickson Types IIa and IIb hyperlipoproteinemia pooled from 24 controlled trials, the median (25th and 75th percentile) percent changes from baseline in HDL-C for atorvastatin 10, 20, 40, and 80 mg were 6.4 (-1.4, 14), 8.7(0, 17), 7.8(0, 16), and 5.1 (-2.7, 15), respectively. Additionally, analysis of the pooled data demonstrated consistent and significant decreases in total-C, LDL-C, TG, total-C/HDL-C, and LDL-C/HDL-C.
In three multicenter, double-blind studies in patients with hypercholesterolemia, LIPITOR was compared to other HMG-CoA reductase inhibitors. After randomization, patients were treated for 16 weeks with either LIPITOR 10 mg per day or a fixed dose of the comparative agent (Table 3).
TABLE 3. Mean Percent Change From Baseline at Endpoint
(Double-Blind, Randomized, Active-Controlled Trials)
| Treatment (Daily Dose) |
N | Total-C | LDL-C | Apo B | TG | HDL-C | Non-HDL-C/HDL-C |
| Study 1 | |||||||
| Atorvastatin 10 mg | 707 | -27a | -36a | -28a | -17a | +7 | -37a |
| Lovastatin 20 mg | 191 | -19 | -27 | -20 | - 6 | +7 | -28 |
| 95% CI for Diff1 | -9.2, -6.5 | -10.7, -7.1 | -10.0, -6.5 | -15.2, -7.1 | -1.7, 2.0 | -11.1, -7.1 | |
| Study 2 | |||||||
| Atorvastatin 10 mg | 222 | -25b | -35b | -27b | -17b | +6 | -36b |
| Pravastatin 20 mg | 77 | -17 | -23 | -17 | - 9 | +8 | -28 |
| 95% CI for Diff1 | -10.8, -6.1 | -14.5, -8.2 | -13.4, -7.4 | -14.1, -0.7 | -4.9, 1.6 | -11.5, -4.1 | |
| Study 3 | |||||||
| Atorvastatin 10 mg | 132 | -29c | -37c | -34c | -23c | +7 | -39c |
| Simvastatin 10 mg | 45 | -24 | -30 | -30 | -15 | +7 | -33 |
| 95% CI for Diff1 | -8.7, -2.7 | -10.1, -2.6 | -8.0, -1.1 | -15.1, -0.7 | -4.3, 3.9 | -9.6, -1.9 | |
| 1 A negative value for the 95%
CI for the difference between treatments favors atorvastatin for all except
HDL-C, for which a positive value favors atorvastatin. If the range does
not include 0, this indicates a statistically significant difference.
a Significantly different from lovastatin, ANCOVA, p≤0.05 b Significantly different from pravastatin, ANCOVA, p≤0.05 c Significantly different from simvastatin, ANCOVA, p≤0.05 |
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Generic Name: Atorvastatin Calcium
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