Atorvastatin Calcium (Page 8 of 10)

14.2 Hyperlipidemia and Mixed Dyslipidemia

Atorvastatin 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.

Atorvastatin 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 given as a single dose over 6 weeks, significantly reduced total-C, LDL-C, apo B, and TG. (Pooled results are provided in Table 9.)

TABLE 9: Dose Response in Patients With Primary Hyperlipidemia (Adjusted Mean % Change From Baseline) *
*
Results are pooled from 2 dose-response studies.
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

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 atorvastatin 10 mg, 20 mg, 40 mg, 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, atorvastatin was compared to other statins. After randomization, patients were treated for 16 weeks with either atorvastatin 10 mg per day or a fixed dose of the comparative agent (Table 10).

TABLE 10: Mean Percentage Change from Baseline at Endpoint (Double-Blind, Randomized, Active-Controlled Trials)
*
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.
Significantly different from lovastatin, ANCOVA, p ≤0.05
Significantly different from pravastatin, ANCOVA, p ≤0.05
§
Significantly different from simvastatin, ANCOVA, p ≤0.05
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 * -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
Atorvastatin 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
Atorvastatin 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 10 is not known. Table 10 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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.