Safety and efficacy of fluvastatin in hyperlipidemic patients with chronic renal disease.
BACKGROUND
There are few reports on the safety and efficacy of long-term treatment with statins in patients with chronic renal disease and hyperlipidemia. We evaluated these subjects treated with fluvastatin.


METHODS
After a 4-week run-in period, a total of 80 patients with diabetic nephropathy or chronic glomerulonephritis were randomly allocated to receive dietary therapy and fluvastatin 20 mg/day (n=39), or dietary therapy alone (n=41) for a period of 48 weeks. Lipid parameters, rhabdomyolysis-related indicators, 24-hour urinary albumin excretion and creatinine clearance were measured. The pharmacokinetics of fluvastatin was examined in 8 patients.


RESULTS
Creatinine clearance and 24-hour urinary albumin excretion did not differ between the two groups. The peak serum fluvastatin concentration (Cmax) was 141+/-67 microg/L and the mean AUC0-6 h was 341+/-149 microgh/L. Fluvastatin treatment significantly lowered serum total cholesterol, low-density lipoprotein (LDL) cholesterol and apo-lipoprotein B concentrations by 16%, 25%, and 22%, respectively, compared with patients receiving dietary therapy alone. There were no significant differences in serum triglyceride and high-density lipoprotein (HDL) cholesterol concentrations between the two treatment groups. Serum creatine kinase and aldolase concentrations did not change throughout treatment in both groups.


CONCLUSIONS
Fluvastatin treatment significantly improved lipid parameters in patients with chronic renal disease. Fluvastatin was well tolerated, with no adverse effects on renal function and no muscular toxicity. However, the drug showed no direct renoprotective effects.
Yasuda
Gen
G
Center Hospital, Yokohama City University School of Medicine, Yokohama, Japan. y911429@urahp.yokohama-cu.ac.jp
Kuji
Tadashi
T
Hasegawa
Kyoko
K
Ogawa
Nariaki
N
Shimura
Gaku
G
Ando
Daisaku
D
Umemura
Satoshi
S
D000328:Adult; D000368:Aged; D000419:Albuminuria / Q000517:prevention & control; D002908:Chronic Disease; D003404:Creatinine / Q000097:blood / Q000652:urine; D003928:Diabetic Nephropathies / Q000150:complications* / Q000378:metabolism; D005229:Fatty Acids, Monounsaturated / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D005919:Glomerular Filtration Rate; D005921:Glomerulonephritis / Q000150:complications* / Q000378:metabolism; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006949:Hyperlipidemias / Q000150:complications* / Q000188:drug therapy* / Q000378:metabolism; D007211:Indoles / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009211:Myoglobin / Q000097:blood; D011446:Prospective Studies
D005229:Fatty Acids, Monounsaturated; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D009211:Myoglobin; D000077340:Fluvastatin; D003404:Creatinine