A multicenter comparison of lovastatin and probucol for treatment of severe primary hypercholesterolemia. The Lovastatin Study Group IV.

A multicenter study was undertaken to compare the effects of lovastatin (given in 4 different dosage regimens) and probucol in patients with severe primary hypercholesterolemia. The subjects were 290 patients taking lipid-lowering diets who were randomly assigned to 1 of the following treatment regimens for 14 weeks: lovastatin, 40 mg once a day with the morning meal (qam); lovastatin, 40 mg once a day with the evening meal (qpm); lovastatin 80 mg qpm; lovastatin, 40 mg twice daily, or probucol, 500 mg twice daily. One-third of the patients received probucol, and the other two-thirds were equally divided between the 4 lovastatin treatment groups. The mean reductions in total cholesterol in the 5 groups were, respectively, 20, 25, 30, 33 and 10%. The corresponding values for low-density lipoprotein cholesterol were 25, 32, 37, 40 and 8%. High-density lipoprotein cholesterol increased by 9 to 12% in all the lovastatin groups, but decreased by 23% in the probucol group. Triglycerides were reduced by 17 to 25% in all the lovastatin groups, but did not change significantly in the probucol group. Both drugs were well tolerated; no serious adverse events could be attributed to either agent. It is concluded that lovastatin is a considerably more effective lipid-lowering agent than probucol. In addition, lovastatin is almost as effective when given in a single daily dose as when given in a divided dose. When a once-a-day regimen is used, lovastatin is more effective if taken in the evening rather than the morning.