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GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR(R) (lovastatin) from Merck & Co., Inc.
Date:11/26/2007

lacebo 61 -1.1 -1.4 -2.2 -1.4 -4.4

MEVACOR 64 -19.3 -24.2 +1.1 -1.9 -21

*data presented as median percent changes

The mean achieved LDL-C value was 190.9 mg/dL (range: 108-336 mg/dL) in the MEVACOR group compared to 244.8 mg/dL (range: 135-404 mg/dL) in the placebo group.

Efficacy of Lovastatin in Post-menarchal Girls with Heterozygous Familial Hypercholesterolemia

In a double-blind, placebo-controlled study, 54 girls 10-17 years of age who were at least 1 year post-menarche with heFH were randomized to lovastatin (n=35) or placebo (n=19) for 24 weeks. Inclusion in the study required a baseline LDL-C level of 160-400 mg/dL and a parental history of familial hypercholesterolemia. The mean baseline LDL-C value was 218.3 mg/dL (range: 136.3-363.7 mg/dL) in the MEVACOR group compared to 198.8 mg/dL (range: 151.1-283.1 mg/dL) in the placebo group. The dosage of lovastatin (once daily in the evening) was 20 mg for the first 4 weeks, and 40 mg thereafter.

MEVACOR significantly decreased plasma levels of total-C, LDL-C, and apolipoprotein B (see Table V).

TABLE V

Lipid-lowering Effects of Lovastatin in Post-menarchal Girls with

Heterozygous Familial Hypercholesterolemia

(Mean Percent Change from Baseline at Week 24 in Intention-to-Treat

Population)

DOSAGE N TOTAL-C LDL-C HDL-C TG.* Apolipoprotein B

Placebo 18 +3.6 +2.5 +4.8 -3.0 +6.4

MEVACOR 35 -22.4 -29.2 +2.4 -22.7 -24.4

*data presented as median percent changes

The mean achieved LDL-C value was 154.5 mg/dL (range: 82-286 mg/dL) in the MEVACOR group compared to 203.5 mg/dL (range: 135-304 mg/dL) in the placebo group.

The safety and efficacy of doses above 40 mg daily have not been
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SOURCE GlaxoSmithKline
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