CLINICAL EFFICACY OF FLUVASTATIN FOR HYPERLIPIDEMIA IN JAPANESE PATIENTS

The objective of the study was to evaluate the efficacy and safety of fluvastatin in patients with hypercholesterolemia, including heterozyg ous familial hypercholesterolemia, in a 1-year study (a 12-week open a ssessment, followed by 40 weeks of active treatment). Of the 337 patie nts enrolled in the study, the effects of fluvastatin were analyzed in 296 patients at baseline and at 12 weeks. Of these, 265 were receivin g 20 mg/day fluvastatin at week 12 and in 20 patients the dose held be en increased to 30 mg/day; 11 patients violated the dosing protocol. A total of 229 patients continued into the 40-week, long-term phase, an d 212 patients were analyzed at baseline and after 24 and 52 weeks. At the end of treatment, 153 evaluable patients were still taking 20 mg/ day fluvastatin, 1 was taking 10 mg/day, and 48 patients were taking 3 0 mg/day, and 10 were taking 40 mg/day. In the 20 mg/day fluvastatin g roup, low density lipoprotein cholesterol (LDL-C) levels decreased by 24.1% at week 12 and by 29.3% at week 52. In those patients requiring the higher doses, the corresponding reductions in LDL-C were 20.2% (we ek 12) and 26.7% (week 52). Total cholesterol was also reduced at week 12 by 17.0% (20 mg/day) and 15.7% (20-30 mg/day), and at week 52 by 2 0.4% (less than or equal to 20 mg/day) and 19.2% (greater than or equa l to 30 mg/day). Throughout the study, fluvastatin was generally well tolerated and no serious clinical adverse events were observed. In con clusion, long-term treatment of hypercholesterolemia with fluvastatin at dosages of 20-40 mg daily can be considered both safe and effective .