Lipitor (Page 8 of 10)

14.2 Hyperlipidemia and Mixed Dyslipidemia

LIPITOR reduces total-C, LDL-C, VLDL-C, apo B, and TG, and increases HDL-C in patients with hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( Fredrickson Types IIa and IIb). Therapeutic response is seen within 2 weeks, and maximum response is usually achieved within 4 weeks and maintained during chronic therapy.

LIPITOR 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, LIPITOR given as a single dose over 6 weeks, significantly reduced total-C, LDL-C, apo B, and TG. (Pooled results are provided in Table 7.)

TABLE 7. Dose Response in Patients With Primary Hyperlipidemia (Adjusted Mean % Change From Baseline) *
Dose N TC LDL-C Apo B TG HDL-C Non-HDL-C/ HDL-C
*
Results are pooled from 2 dose-response studies.
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

In patients with Fredrickson Types IIa and IIb hyperlipoproteinemia pooled from 24 controlled trials, the median (25 th and 75 th percentile) percent changes from baseline in HDL-C for LIPITOR 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 hyperlipidemia, LIPITOR was compared to other statins. After randomization, patients were treated for 16 weeks with either LIPITOR 10 mg per day or a fixed dose of the comparative agent (Table 8).

TABLE 8. 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
*
Significantly different from lovastatin, ANCOVA, p ≤0.05
A negative value for the 95% CI for the difference between treatments favors LIPITOR for all except HDL-C, for which a positive value favors LIPITOR. If the range does not include 0, this indicates a statistically significant difference.
Significantly different from pravastatin, ANCOVA, p ≤0.05
§
Significantly different from simvastatin, ANCOVA, p ≤0.05
Study 1
LIPITOR 10 mg 707 -27 * -36 * -28 * -17 * +7 -37 *
Lovastatin 20 mg 191 -19 -27 -20 -6 +7 -28
95% CI for Diff -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
LIPITOR 10 mg 222 -25 -35 -27 -17 +6 -36
Pravastatin 20 mg 77 -17 -23 -17 -9 +8 -28
95% CI for Diff -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
LIPITOR 10 mg 132 -29 § -37 § -34 § -23 § +7 -39 §
Simvastatin 10 mg 45 -24 -30 -30 -15 +7 -33
95% CI for Diff -8.7, -2.7 -10.1, -2.6 -8.0, -1.1 -15.1, -0.7 -4.3, 3.9 -9.6, -1.9

The impact on clinical outcomes of the differences in lipid-altering effects between treatments shown in Table 8 is not known. Table 8 does not contain data comparing the effects of LIPITOR 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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