OPEN-LABEL STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF FLUVASTATIN VERSUS BEZAFIBRATE FOR HYPERCHOLESTEROLEMIA

Increased levels of total cholesterol and low density lipoprotein chol esterol (LDL-C) are associated with the development of coronary artery disease, which has become a worldwide public health problem. Clinical trials show that, in the long term, effective lowering of total chole sterol and raising of high density lipoprotein cholesterol (HDL-C) can slow atherosclerosis progression and reduce coronary artery disease r isk. This study evaluated the efficacy, safety, and tolerability of fl uvastatin versus bezafibrate (slow release) in patients with cholester ol >241 mg/dL (6.2 mmol/liter) not responding to dietary treatment alo ne (cholesterol <300 mg/day for 8 weeks). Patients were divided into 2 groups: group A (13 women, 7 men; mean age, 47.8 +/- 9.7 years; range , 30-70) received 40 mg fluvastatin once daily with their evening meal ; group B (14 women, 6 men; mean age, 45 +/- 11 years, range, 25-68) r eceived 400 mg bezafibrate once daily with either breakfast or their e vening meal. After 12 weeks of treatment, the mean cholesterol decreas e in group A was 27% (from 271 +/- 51.4 to 197.4 +/- 24.3 mg/dL; p <0. 001) versus 8% (from 278.6 +/- 33.2 to 255.8 +/- 20.3 mg/dL; p <0.005) in group B. At the same time point, LDL-C was significantly decreased in group A (from 197.9 +/- 49 to 107.5 +/- 27.6 mg/dL; p <0.001) but not in group B (from 181.6 +/- 39.6 to 173.3 +/- 24.3 mg/dL). However, group B achieved a significant reduction in triglycerides (p <0.001), whereas triglycerides were increased in group A, although in 11 of 20 patients these elevations remained within the upper limits of normal. HDL-C did not change significantly in group A (from 57.2 +/- 17.8 to 56.1 +/- 11.7 mg/dL), whereas group B showed a significant reduction ( 57.5 +/- 18 to 52.7 +/- 12.8 mg/dL; p <0.005). There were significant reductions in LDL-C and total cholesterol with fluvastatin (p <0.001) compared with bezafibrate. Overall tolerability was good. In conclusio n, fluvastatin appears to have a good safety, tolerability, and effica cy profile in hypercholesterolemic patients. Fluvastatin can reduce to tal cholesterol and LDL-C levels significantly without modifying HDL-C levels, making it a valuable treatment in such patients.