Lovastatin (Page 2 of 11)

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.

TABLE II Lovastatin vs Placebo (Mean Percent Change from Baseline After 6 Weeks)
DOSAGENTOTAL-CLDL-CHDL-CLDL-C/ HDL-CTOTAL-C/ HDL/CTRIG.
Placebo33-2-1-10+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.

TABLE III Lovastatin vs. Cholestyramine (Percent Change from Baseline After 12 Weeks)
TREATMENTNTOTAL-C (mean) LDL-C (mean) HDL-C (mean) LDL-C/ HDL-C (mean) TOTAL-C/ HDL-C (mean) VLDL-C (median) TRIG. (median)
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.

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