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Clinical Pharmacology
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Clinical Pharmacology

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
Brand Name: Lipitor
Generic Name: Atorvastatin Calcium
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