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Pediatric Use of Mevacor
JAMA. 2002;287:1640.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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The FDA has approved a new indication for lovastatin (Mevacor, Merck & Co Inc, Whitehouse Station, NJ), an approved cholesterol-lowering agent, as an adjunct to diet to reduce total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B levels in adolescent boys and in girls who are at least 1 year postmenarche who have heterozygous familial hypercholesterolemia (heFH).
The pediatric use is approved if (1) despite an adequate trial of diet therapy, LDL-C remains higher than 189 mg/dL; (2) LDL-C remains higher than 160 mg/dL and the patient has a family history of premature cardiovascular disease; or (3) two or more other risk factors for cardiovascular disease are present.
The approval is based on two double-blind, placebo-controlled studies in 10- to 17-year-olds with heFH. In one of the trials, 132 boys were randomized to receive lovastatin or placebo for 48 weeks. Inclusion in the study required a baseline LDL-C level of . . . [Full Text of this Article]
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JNM 2003;44:1148-1155.
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