Lipitor Clinical Pharmacology

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Lipitor - Clinical Pharmacology [Atorvastatin]

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 2).

TABLE 2. Mean Percent Change from Baseline at End Point
(Double-Blind, Randomized, Active-Controlled Trials)
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Treatment (Daily Dose) N Total C LDL-C Apo B TG HDL-C Non-HDL-C/HDL-C
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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
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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
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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
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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

The impact on clinical outcomes of the differences in lipid-altering effects between treatments shown in Table 2 is not known. Table 2 does not contain data comparing the effects of atorvastatin 10 mg and higher doses of lovastatin, pravastatin, and simvastatin. The drugs compared in the studies summarized in the table are not necessarily interchangeable.