Cardiovascular AgentsLipitor (atorvastatin)
Manufacturer: Pfizer, Inc.
Drug Approval Classification: Supplemental New Drug Application (Approval Date: 10/18/02)
New Indication: This supplemental new drug application for Lipitor provides for the addition of an indication for the treatment of heterozygous familial hypercholesterolemia in adolescent boys and postmenarchal girls, aged 10 to 17 years, as an adjunct to diet to reduce total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein (apo) B levels, if after an adequate trial of diet therapy the following findings are present:
LDL-C remains ≥ 190mg/dL or
LDL-C remains ≥ 160 mg/dL and:
there is a positive family history of premature cardiovascular disease or
2 or more other cardiovascular disease risk factors are present in the pediatric patient.
Dosing: The recommended starting dose of Lipitor is 10 mg/day; the maximum recommended dose is 20 mg/day. Doses greater than 20 mg have not been studied in this patient population.
Clinical Summary: In a double-blind, placebo-controlled study followed by an open-label phase, 187 boys and postmenarchal girls 10-17 years of age (mean age: 14.1 yrs) with heterozygous familial hypercholesterolemia (FH) or severe hypercholesterolemia were randomized to Lipitor (n = 140) or placebo (n = 47) for 26 weeks and then all received Lipitor for 26 weeks. The dose of Lipitor (once daily) was 10 mg for the first 4 weeks and was uptitrated to 20 mg if the LDL-C level was > 130 mg/dL.
The mean LDL-C value achieved was 130.7 mg/dL (range: 70-242 mg/dL) in the Lipitor group compared with 228.5 mg/dL (range: 152-385 mg/dL) in the placebo group during the 26-week double-blind phase.
Adverse Effects: There were no new adverse events reported in the 6-month study in patients aged 10-17 years.
Medscape Pharmacists. 2002;3(2) © 2002 Medscape
Cite this: December 2002 - Medscape - Dec 30, 2002.