Prescription Drug Information: Lovastatin (Page 2 of 9)
Clinical Studies in Adults
Lovastatin has been shown to reduce total-C and LDL-C in heterozygous familial and non-familial forms of primary hypercholesterolemia and in mixed hyperlipidemia. A marked response was seen within 2 weeks, and the maximum therapeutic response occurred within 4 to 6 weeks. The response was maintained during continuation of therapy. Single daily doses given in the evening were more effective than the same dose given in the morning, perhaps because cholesterol is synthesized mainly at night.
In multicenter, double-blind studies in patients with familial or non-familial hypercholesterolemia, lovastatin, administered in doses ranging from 10 mg q.p.m. to 40 mg b.i.d., was compared to placebo. Lovastatin significantly decreased plasma total-C, LDL-C, total-C/HDL-C ratio and LDL-C/HDL-C ratio. In addition, lovastatin produced increases of variable magnitude in HDL-C, and modestly decreased VLDL-C and plasma TG (see TABLES II through IV for dose response results).
The results of a study in patients with primary hypercholesterolemia are presented in TABLE II.
DOSAGE | N | TOTAL-C | LDL-C | HDL-C | LDL-C/HDL-C | TOTAL-C/HDL-C | TG. |
Placebo | 33 | -2 | -1 | -1 | 0 | +1 | +9 |
Lovastatin | |||||||
10 mg q.p.m. | 33 | -16 | -21 | +5 | -24 | -19 | -10 |
20 mg q.p.m. | 33 | -19 | -27 | +6 | -30 | -23 | +9 |
10 mg b.i.d. | 32 | -19 | -28 | +8 | -33 | -25 | -7 |
40 mg q.p.m. | 33 | -22 | -31 | +5 | -33 | -25 | -8 |
20 mg b.i.d. | 36 | -24 | -32 | +2 | -32 | -24 | -6 |
Lovastatin was compared to cholestyramine in a randomized open parallel study. The study was performed with patients with hypercholesterolemia who were at high risk of myocardial infarction. Summary results are presented in TABLE III.
TREATMENT | N | TOTAL-C (mean) | LDL-C (mean) | HDL-C (mean) | LDL-C/HDL-C (mean) | TOTAL-C/HDL-C (mean) | VLDL-C (median) | TG. (mean) |
Lovastatin | ||||||||
20 mg b.i.d. | 85 | -27 | -32 | +9 | -36 | -31 | -34 | -21 |
40 mg b.i.d. | 88 | -34 | -42 | +8 | -44 | -37 | -31 | -27 |
Cholestyramine | ||||||||
12 g b.i.d. | 88 | -17 | -23 | +8 | -27 | -21 | +2 | +11 |
Lovastatin was studied in controlled trials in hypercholesterolemic patients with well-controlled non-insulin dependent diabetes mellitus with normal renal function. The effect of lovastatin on lipids and lipoproteins and the safety profile of lovastatin were similar to that demonstrated in studies in nondiabetics. Lovastatin had no clinically important effect on glycemic control or on the dose requirement of oral hypoglycemic agents.
Expanded Clinical Evaluation of Lovastatin (EXCEL) Study
Lovastatin was compared to placebo in 8,245 patients with hypercholesterolemia (total-C 240 to 300 mg/dL [6.2 mmol/L to 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.
DOSAGE | N 1 | TOTAL-C (mean) | LDL-C (mean) | HDL-C (mean) | LDL-C/HDL-C (mean) | TOTAL-C/HDL-C (mean) | TG. (median) |
Placebo | 1663 | +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 |
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