ATORVASTATIN CALCIUM (Page 8 of 11)

14.2 Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)

Atorvastatin calcium reduces total-C, LDL-C, VLDL-C, apo B, and TG, and increases HDL-C in patients with hyperlipidemia and mixed dyslipidemia. Therapeutic response is seen within 2 weeks, and maximum response is usually achieved within 4 weeks and maintained during chronic therapy.

Atorvastatin calcium is effective in a wide variety of patient populations with hyperlipidemia, with and without hypertriglyceridemia, in men and women, and in the elderly.

In two multicenter, placebo-controlled, dose-response studies in patients with hyperlipidemia, atorvastatin calcium given as a single dose over 6 weeks, significantly reduced total-C, LDL-C, apo B, and TG. (Pooled results are provided in Table 6.)

TABLE 6. Dose-Response in Patients With Primary Hyperlipidemia (Adjusted Mean % Change From Baseline) a
Dose N TC LDL-C Apo B TG HDL-C Non-HDL-C/HDL-C
Placebo 21 4 4 3 10 -3 7
10 22 -29 -39 -32 -19 6 -34
20 20 -33 -43 -35 -26 9 -41
40 21 -37 -50 -42 -29 6 -45
80 23 -45 -60 -50 -37 5 -53

Results are pooled from 2 dose-response studies. a

In patients with Fredrickson Types IIa and IIb hyperlipoproteinemia pooled from 24 controlled trials, the median (25 and 75 percentile) percent changes from baseline in HDL-C for atorvastatin calcium 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. th th

In three multicenter, double-blind studies in patients with hyperlipidemia, atorvastatin calcium was compared to other statins. After randomization, patients were treated for 16 weeks with either atorvastatin calcium 10 mg per day or a fixed dose of the comparative agent (Table 7).

TABLE 7. Mean Percentage 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 -27 a -36 a -28 a -17 a +7 -37 a
Lovastatin 20 mg 191 -19 -27 -20 – 6 +7 -28
95% CI for Diff 1 -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 -25 b -35 b -27 b -17 b +6 -36 b
Pravastatin 20 mg 77 -17 -23 -17 – 9 +8 -28
95% CI for Diff 1 -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 -29 c -37 c -34 c -23 c +7 -39 c
Simvastatin 10 mg 45 -24 -30 -30 -15 +7 -33
95% CI for Diff 1 -8.7, -2.7 -10.1, -2.6 -8.0, -1.1 -15.1, -0.7 -4.3, 3.9 -9.6, -1.9

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. 1

Significantly different from lovastatin, ANCOVA, p ≤0.05 a

Significantly different from pravastatin, ANCOVA, p ≤0.05 b

Significantly different from simvastatin, ANCOVA, p ≤0.05 c

The impact on clinical outcomes of the differences in lipid-altering effects between treatments shown in Table 7 is not known. Table 7 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.

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