Clinical Studies Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb) Lipitor reduces total-C, LDL-C, VLDL-C, apo B, and TG, and increases HDL-C in patients with hypercholesterolemia and mixed dyslipidemia. 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 hypercholesterolemia, with and without hypertriglyceridemia, in men and women, and in the elderly. Experience in pediatric patients has been limited to patients with homozygous FH. In two multicenter, placebo-controlled, dose-response studies in patients with hypercholesterolemia, 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 1). TABLE 1. Dose Response in Patients with Primary Hypercholesterolemia (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 -------------------------------------------------------------------------------- aResults are pooled from 2 dose-response studies. 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 decrease in total-C, LDL-C, TG, total-C/HDL-C, and LDL-C/HDL-C. | ||||
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