文摘
We have investigated the efficacy, safety and tolerability of fluvastatin, a synthetic 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor, in an open, multicenter study in patients with hypercholesterolemia. 231 patients (102 Men and 129 Women) with ages between 40-70 years (mean age 52 ± 10 years) enrolled to the study. Those with total cholesterol levels > 250 mg/dl were given fluvastatin 40 mg/day for 12 weeks. Before and at the end of the 4th, 8th and 12th weeks of treatment, total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride levels were evaluated. The safety and tolerability of fluvastatin were determined by evaluating the laboratory parameters and recording adverse events. Before the treatment, total-C, LDL-C, HDL-C and triglyceride levels were measured (284 ± 47 mg/dl, 196 ± 43 mg/dl, 41 ± 15 mg/dl and 234 ± 202 mg/dl, respectively). At the end of the 12th week, the levels of total-C, LDL-C, HDL-C and triglyceride were measured (216 ± 44 mg/dl, 139 ± 36 mg/dl, 45 ± 12 mg/dl and 181 ± 135 mg/dl, respectively) (p < 0.001). At the end of 4th week of treatment, total-C, LDL-C and triglyceride levels decreased by 14 % , 16 % and 10 % , respectively. During the treatment, the decrease continued. At the end of 8th week, the decrease of total-C, LDL-C and triglyceride levels were 23 % , 22 % and 20 % , respectively and at the end of 12th week, the decrease of these parameters was 24 % , 29 % , and 22 % respectively. Furthermore at the end of the 12th week, the increase of HDL-C levels was 8 % . At the baseline visit Total-C/HDL-C ratio was 5.6, at the end of the 4th week this ratio began to decrease and at the end of 12th week this ratio was 4.8 (29 % ). The adverse events observed, were mild gastrointestinal symptoms in 3 patients and mild CPK elevation in 1 patient which did not have patient, any influence in the conduct of the study.
