Meeting national cholesterol education goals in clinical practice--a comparison of lovastatin and fluvastatin in primary prevention.

The available clinical data for 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors demonstrate their efficacy and safety in treating hypercholesterolemia and improving long-term morbidity and mortality related to coronary artery disease. Comparative studies among agents in this class support the general perception that, at the most commonly prescribed doses, all these drugs reduce low-density lipoprotein (LDL) cholesterol levels by about 20-30%. The primary measure of efficacy in the current study was the percentage of patients achieving goal levels for LDL cholesterol of < 160 mg/dL, as proposed by the National Cholesterol Education Program (NCEP). This study compares the most widely prescribed agent in this class, lovastatin, with the newest agent, fluvastatin. Patients enrolled had previously been satisfactorily treated with lovastatin 20 mg every evening. Following a placebo washout period, patients were randomized to receive lovastatin 20 mg with the evening meal (69 patients) or fluvastatin 20 mg at bedtime (68 patients) for 4 weeks of open-label therapy. In a second 4-week period, patients on lovastatin continued on the initial dosage while patients receiving fluvastatin had their daily dosage increased to 40 mg at bedtime to evaluate the range of efficacy from 20-40 mg/day. In both treatment arms, the majority of patients achieved the goal lipid level. Approximately 85% of patients on fluvastatin 20 mg and 90% of patients on lovastatin 20 mg achieved the goal within 4 weeks. This small difference was not statistically significant. Increasing the dosage to 40 mg at bedtime in the fluvastatin arm produced goal LDL cholesterol levels in about 90% of patients. Both agents were well tolerated; no patients discontinued therapy because of adverse events.

RCT Entities:   Population Interventions Outcomes