[Treatment of primary hypercholesterolemia with pravastatin. A placebo-controlled trial]

Abstract

We present the results of a multicentre, placebo-controlled, randomized double-blind comparison of the treatment of primary hypercholesterolaemia with pravastatin (Pravachol), an HMG-CoA-reductase inhibitor. The study was conducted in both general practice and hospital settings. Two hundred and eighty-six patients who despite oral and written dietary instructions and advice on healthy living had elevated total serum cholesterol levels of between six and eight mmol/l were randomized to treatment with either parvastatin (Pravachol) or placebo. The study showed a significant reduction in both total serum cholesterol (of 16%) and serum LDL-cholesterol among those treated with pravastatin (Pravachol), as well as a small increase tin serum HDL-cholesterol of six percent. Advice on diet and healthy living resulted in a reduction of serum cholesterol of only 1.5%. There were no important differences between those treated from the hospital and those treated in general practice. The incidence of side-effects was low and comparable to placebo levels, and only two percent of the pravastatin (Pravachol) treated patients had to have the treatment stopped. All side-effects were reversible. No side-effects relating to the central nervous system were registered, and no elevations of serum creatinine phosphokinase were observed amongst the pravastatin treated patients, presumably because of the drug's selective inhibitory effect on cholesterol synthesis in the liver.