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Mevacor
Clinical Pharmacology
Mevacor
MEVACOR has been shown to be highly effective in reducing 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 4-6 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, MEVACOR, administered in doses ranging from 10 mg q.p.m. to 40 mg b.i.d., was compared to placebo. MEVACOR consistently and significantly decreased plasma total-C, LDL-C, total-C/HDL-C ratio and LDL-C/HDL-C ratio. In addition, MEVACOR produced increases of variable magnitude in HDL-C, and modestly decreased VLDL-C and plasma TG (see Tables I through III for dose response results).
The results of a study in patients with primary hypercholesterolemia are presented in Table I.
TABLE I : MEVACOR vs. Placebo (Mean Percent Change from Baseline After 6 Weeks)
| 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 |
| MEVACOR | |||||||
| 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 |
MEVACOR 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 II.
TABLE II : MEVACOR vs. Cholestyramine (Percent Change from Baseline After 12 Weeks)
| 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) |
| MEVACOR | ||||||||
| 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 |
Generic Name: Lovastatin
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