[Pravastatin vs. probucol in the treatment of hypercholesterolemia. A double-blind study]

This 16-week, double-blind study compared the efficacy and safety of pravastatin, a new HMG-CoA reductase inhibitor, with probucol in the treatment of hyperlipidemia in 26 patients at the Instituto Nacional de Cardiología "Ignacio Chávez" in Mexico City. Patients had to have a low-density lipoprotein-cholesterol (LDL-C) level in the 75th (or greater) percentile for age and sex greater than 150 mg/ on 2 occasions, and a triglyceride level less than 350 mg/dl. The patients, aged 21 to 75 years, were randomly assigned to receive either pravastatin, 40 mg once daily at bedtime (n = 15), or probucol, 500 mg twice daily (n = 11). Complete lipid profiles were obtained at 4-week intervals. By the end of the study, mean changes in total cholesterol (CT) and LDL-C in the pravastatin group were -28% and -37%, respectively, p less than 0.001 vs baseline. In the pravastatin group, there was a mean increment in HDL-cholesterol (HDL-C) of 9% and consequently a significant reduction in the LDL-C/HDL-C ratio. However, in the probucol group HDL-C levels dropped -21%, p less than 0.01, and no significant change in the LDL-C/HDL-C ratio was observed, accounting for the significant difference in LDL-C/HDL-C ratios between the 2 groups. Both drugs were well tolerated. One pravastatin patient discontinued because of adverse effects (nausea/vomiting and mild muscle pain). These results suggest that once daily administration of pravastatin is an effective therapy for hypercholesterolemia and that it produces a more favorable response in LDL-C/HDL-C ratio than probucol.