RESUMO
This study was carried out to assess the efficacy, safety and tolerability of fluvastatin as monotherapy in the treatment of primary hypercholesterolemia. This multicenter study started with 467 patients but only 315 subjects completed 12 weeks treatment. Patients followed a standard lipid-lowering diet for 3 weeks before entering and throughout the study. Every patient received fluvastatin 20 mg once daily with the evening meal for the first 6 weeks, from week 7 to week 12 the daily dose was changed to one capsule 40 mg daily in the evening. Results showed that the mean percent changes in lipid parameters between baseline and endpoint was as follows: LDL-C [-32.7%]; total cholesterol [-29.42%], triglycerides [-19.7%] and HDL-C [16.6%]. Meanwhile, the mean percent increase in liver enzymes between baseline and endpoint was 17.2% for ASAT and 20.3% for ALAT, respectively, but the mean values of both enzymes at the endpoint were within normal range. The most frequent side effects being gastrointestinal [4.3%] including dyspepsia, nausea, flatulence and diarrhea. In conclusion, fluvastatin as monotherapy in the treatment of hypercholesterolemia among Saudis was found to be safe, well tolerated and produced a significant improvement in the overall lipid parameters