A controlled trial of pravastatin vs probucol in the treatment of primary hypercholesterolemia.
We compared the safety, tolerability and efficacy of the HMGCoA reductase inhibitor pravastatin and probucol in the treatment of patients with primary hypercholesterolemia using an active, drug controlled, double blind, randomized, double placebo design. Patients were included if LDL-C levels after a minimum of six weeks on an AHA phase I diet were greater than 150 mg/dL and triglycerides were less than 350 mg/dL. Included patients were randomly assigned to either pravastatin 40 mg pm or probucol 500 mg bi. They also received matching placebos for each drug. The active drug period lasted 16 weeks, during which the patients were seen at 4, 8, 12 and 16 weeks after baseline. There were no significant differences in baseline values between both treatment groups. Significantly lower values of total cholesterol and LDL-C were observed with pravastatin as compared to probucol. While a non significant increase of HDL-C was observed with pravastatin, a remarkable and statistically significant decrease was observed with probucol. A large dispersion of triglycerides levels was observed with both drugs and no statistically significant changes were demonstrated. Both pravastatin and probucol were well tolerated: only minimal clinical and laboratory changes, not considered to have been drug-related, were observed. No changes, considered drug-related, were observed in the cristalline lens. This study shows an overall superiority of pravastatin over probucol with significant larger decreases of total cholesterol and LDL-C and a better effect on HDL-C.
Gómez-Pérez
F J
FJ
Department of Diabetes and Lipid Metabolism, Instituto Nacional de la Nutrición Salvador Zubirán, México, D.F.
Bustamante
F
F
Vergara
A
A
Villaseñor
J
J
Wong
B
B
Rull
J A
JA
D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017035:Pravastatin / Q000009:adverse effects / Q000627:therapeutic use*; D011341:Probucol / Q000009:adverse effects / Q000627:therapeutic use*
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D017035:Pravastatin; D011341:Probucol