Short-Term Efficacy and Safety of Pravastatin in Hypercholesterolemic Women

Abstract

The objective was to assess the short-term efficacy and safety of pravastatin in hypercholesterolemic women. The design was a randomized, double-blind, placebo-controlled trial at 43 outpatient centers in the United States. Subjects were 230 women with low-density lipoprotein (LDL) cholesterol >190 mg/dl or LDL cholesterol between 160–189 mg/dl plus concurrent coronary artery disease or at least 2 other coronary risk factors but no other significant health problems. Interventions included pravastatin 20 mg orally daily (n = 172) or placebo (n = 58) plus a low-fat diet for 12 weeks. Main outcome measures were total, LDL and high density lipoprotein (HDL)—cholesterol and triglyceride levels, adverse symptoms, and biochemical-hematologic changes. Total cholesterol decreased 21.9%; LDL-cholesterol decreased 28.5%; triglycerides were reduced 10.4%; and HDL-cholesterol was increased 2.7% with pravastatin, while no significant changes from baseline were observed with placebo. Fourteen pravastatin-treated (8.1%) and 6 placebo-treated patients (8.6%) withdrew, p = NS. No excess in adverse effects over placebo were noted, and no important changes in either biochemical or hematologic parameters were identified. In this short-term clinical trial with hypercholes-terolemic women, pravastatin was found to be both effective and safe.