[Effectiveness and tolerability of simvastatin in patients with moderate-to-severe hypercholesterolemia. Results of a 12-month study].

Several epidemiological and clinical studies have underlined the close relationship between hypercholesterolemia and risk of coronary heart disease suggesting the opportunity of treating hypercholesterolemic patients according to their associated risk factors. Simvastatin, a drug for the treatment of hypercholesterolemia, is a competitive inhibitor of 3-Hydroxy-Methyl-Glutaryl-CoA reductase, the rate limiting enzyme in cholesterol biosynthesis. In the present study we have assessed the efficacy, safety and tolerability of simvastatin (10-20 mg) administered once daily for a period of 12 months to 50 patients with coronary heart disease (CHD) or at high risk for CHD according to the National Cholesterol Education Program. All patients underwent complete physical examination and laboratory safety tests (including blood cell count, liver function tests, creatine kinase and lipid profile) at baseline and every 6 weeks during treatment. Simvastatin was highly effective in reducing total and LDL cholesterol (-25% and -35% respectively). No significant effect on HDL cholesterol or triglycerides was obtained. Two patients were excluded after 6 weeks of treatment because of a serum creatine kinase increase (more than twice normal values). This was the only drug related side effect. In conclusion our data show that: a) simvastatin treatment is well accepted and compliance is good; b) the effect of simvastatin is evident after the first 6 weeks of treatment and is maintained during the whole treatment time; c) simvastatin is highly effective in lowering total and LDL cholesterol. When considering a patient who has had an atherosclerotic event the best deterrent to the occurrence of a subsequent event (secondary prevention) could be reduction of serum total and LDL cholesterol.(ABSTRACT TRUNCATED AT 250 WORDS)