Lovastatin (Page 3 of 11)

Expanded Clinical Evaluation of Lovastatin (EXCEL) Study

Lovastatin was compared to placebo in 8,245 patients with hypercholesterolemia (total-C 240-300 mg/dL [6.2 mmol/L-7.6 mmol/L], LDL-C >160 mg/dL [4.1 mmol/L]) in the randomized, double-blind, parallel, 48-week EXCEL study. All changes in the lipid measurements (Table IV) in lovastatin treated patients were dose-related and significantly different from placebo (p≤0.001). These results were sustained throughout the study.

TABLE IV Lovastatin vs. Placebo (Percent Change from Baseline– Average Values Between Weeks 12 and 48)

**Patients enrolled

DOSAGEN ** TOTAL-C (mean) LDL-C (mean) HDL-C (mean) LDL-C/ HDL-C (mean) TOTAL-C/ HDL-C (mean) TRIG. (median)
Placebo1663 +0.7 +0.4 +2.0 +0.2 +0.6 +4
Lovastatin
20 mg q.p.m. 1642 -17 -24 +6.6 -27 -21 -10
40 mg q.p.m. 1645 -22 -30 +7.2 -34 -26 -14
20 mg b.i.d. 1646 -24 -34 +8.6 -38 -29 -16
40 mg b.i.d. 1649 -29 -40 +9.5 -44 -34 -19
Efficacy of Lovastatin in Adolescent Boys with Heterozygous Familial Hypercholesterolemia

In a double-blind, placebo-controlled study, 132 boys 10 to 17 years of age (mean age 12.7 yrs) with heterozygous familial hypercholesterolemia (heFH) were randomized to lovastatin (n=67) or placebo (n=65) for 48 weeks. Inclusion in the study required a baseline LDL-C level between 189 and 500 mg/dL and at least one parent with an LDL-C level >189 mg/dL. The mean baseline LDL-C value was 253.1 mg/dL (range: 171 to 379 mg/dL) in the lovastatin group compared to 248.2 mg/dL (range 158.5 to 413.5 mg/dL) in the placebo group. The dosage of lovastatin (once daily in the evening) was 10 mg for the first 8 weeks, 20 mg for the second 8 weeks, and 40 mg thereafter.

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

TABLE V Lipid-lowering Effects of Lovastatin in Adolescent Boys with Heterozygous Familial Hypercholesterolemia (Mean Percent Change from Baseline at week 48 in Intention-to-Treat Population)

*data presented as median percent changes

DOSAGE N TOTAL-C LDL-C HDL-C TG. * Apolipoprotein B
Placebo 61 -1.1 -1.4 -2.2 -1.4 -4.4
Lovastatin 64 -19.3 -24.2 +1.1 -1.9 -21

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

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