Clinical trial of lovastatin versus gemfibrozil in the treatment of primary hypercholesterolemia
Catalán M, López de Ocáriz A, Alvarez MP, Ariño M, Azanza JR, Honorato J.
Servicio de Farmacología Clínica, Clínica Universitaria, Facultad de Medicina, Universidad de Navarra.
Magazine: Revista de Medicina de la Universidad de Navarra
Date: Aug 1, 1992Clinical Pharmacology [SP]
A randomized, double-blind, 12 weeks comparison of Lovastatin and Gemfibrozil in the treatment of patients with primary hypercholesterolemia was performed in 31 patients. After a placebo and diet period (4 weeks), they were assigned to either Lovastatin 20 mg nightly or Gemfibrozil 600 mg twice daily, if their total serum cholesterol was < 300 mg/dl, and to either Lovastatin 40 mg nightly or Gemfibrozil 600 mg/12 if it was > 300 mg/dl. In both cases, the Lovastatin dose was doubled after 6 weeks, if serum cholesterol remained > 200 mg/dl. The dose of Gemfibrozil kept constant.
Lovastatin reduced serum cholesterol from 354 +/- 91 mg/dl to 253 +/- 62 mg/dl (p < 0.001), LDL-cholesterol from 277 +/- 104 to 192 +/- 71 mg/dl (p < 0.001) and serum triglyceride level from 125 +/- 66 a 84 +/- 41 mg/dl. The corresponding reductions achieved by Gemfibrozil were: 343 +/- 86 to 290 +/- 72 mg/dl (p < 0.01), 264 +/- 89 to 217 +/- 67 mg/dl (p < 0.05) and 152 +/- 84 to 89 +/- 41 mg/dl (p < 0.001), respectively. Lovastatin therapy caused a 30.6% reduction in total cholesterol level, while Gemfibrozil achieved a 19.47%. There were no significant changes in HDL-cholesterol.
Patients had no serious or clinically significant adverse effects. The current data suggest that Lovastatin (an inhibitor of HMG-Coa reductase) may provide one important means for lipid-lowering therapy in patients with primary hypercholesterolemia.
CITATION Rev Med Univ Navarra. 1992 Jul-Sep;37(3):127-33
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