EFFECT OF ATORVASTATIN VERSUS SIMVASTATIN ON LIPID PROFILE AND PLASMA-FIBRINOGEN IN PATIENTS WITH HYPERCHOLESTEROLEMIA - A PILOT, RANDOMIZED, DOUBLE-BLIND, DOSE-TITRATING STUDY

Objective: To investigate the effect of atorvastatin vs simvastatin on lipid profile and plasma fibrinogen in patients with hypercholesterol aemia. Patients: 30 outpatients (25 men), with a median age of 51 year s were studied. Eight patients had established coronary artery disease (CAD) and four had diabetes mellitus at baseline. 11 patients present ed a Frederickson's IIb phenotype and 19 a IIa phenotype at baseline. Study Design: After a 6-week placebo period, patients were randomly as signed to simvastatin (10 mg/day, n = 15) or atorvastatin (10 mg/day, n = 15). Lipid profile, apolipoproteins B and A-I and plasma fibrinoge n were measured for a 16-week period, at 4-week intervals. Thereafter, the dose of each drug was doubled only in patients with low density l ipoprotein cholesterol (LDL-C) levels above 130 mg/dl for a further 16 -week period. Results: Ten of 15 patients on atorvastatin 10mg (66%) a nd four of 15 on simvastatin 10mg (27%) achieved the LDL-C <130 mg/dl goal. Apolipoprotein B was reduced by both drugs (-33%, p < 0.001 for atorvastatin and -18%, p < 0.05 for simvastatin), but plasma fibrinoge n and triglyceride were reduced only by atorvastatin (-20%, p < 0.01; -36%, p < 0.001, respectively). During the second 16-week period seven of ii patients receiving the simvastatin 20mg dose (64%) achieved the LDL-C <130 mg/dl goal. The comparison of atorvastatin 10mg with simva statin 20mg showed that the drugs appear to be equipotent in terms of LDL-C lowering. Conclusions: Atorvastatin in equipotent doses to simva statin appeared to be more effective than the latter in reducing trigl yceride and plasma fibrinogen in patients with hypercholesterolaemia, mainly in those with Frederickson's phenotype IIb.