The renal safety profile of fluvastatin: results of a pooled analysis.
A pooled analysis was designed to evaluate the effects of fluvastatin on the kidney, in terms of renal adverse events, laboratory abnormalities, and renal function over time. An analysis of adverse events was performed on data from 30 completed clinical trials of fluvastatin in 11,815 patients. An analysis of renal function was also performed on data from patients who participated in long-term studies >6 months in treatment duration. Creatinine clearance was calculated using the Cockcroft-Gault formula. Mean creatinine clearance values were in the normal to near-normal range at baseline. Changes in creatinine clearance and serum creatinine from baseline were similar in fluvastatin-treated patients and placebo-treated patients. In the all-fluvastatin group, mean creatinine clearance (+/-standard deviation) increased from 87.8 (+/-42.8) mL/min at baseline to 89.4 (+/-41.2) mL/min at endpoint. In the placebo group, mean creatinine clearance (+/- standard deviation) increased from 87.7 (+/- 43.9) mL/min at baseline to 88.7 (+/-41.4) mL/min at endpoint. In the all-fluvastatin group, mean serum creatinine (+/- standard deviation) decreased from 1.14 (+/-0.20) mg/dL at baseline to 1.11 (+/-0.20) mg/dL at endpoint. In the placebo group, mean serum creatinine (+/-standard deviation) decreased from 1.15 (+/-0.22) mg/dL at baseline to 1.12 (+/-0.22) mg/dL at endpoint. The incidence of renal adverse events was low and comparable between the fluvastatin and placebo treatment groups. This pooled analysis demonstrates that fluvastatin treatment across the approved daily dose range of 20 mg to 80 mg does not adversely affect creatinine or creatinine clearance over time in dyslipidemic patients.
Holdaas
Hallvard
H
The Medical Department, National Hospital, University of Oslo, Oslo, Norway.
Wanner
Christoph
C
Abletshauser
Claudia
C
Gimpelewicz
Claudio
C
Isaacsohn
Jonathan
J
D000924:Anticholesteremic Agents / Q000009:adverse effects*; D003404:Creatinine / Q000097:blood / Q000652:urine; D004305:Dose-Response Relationship, Drug; D005229:Fatty Acids, Monounsaturated / Q000009:adverse effects*; D005260:Female; D000077340:Fluvastatin; D006801:Humans; D007211:Indoles / Q000009:adverse effects*; D007668:Kidney / Q000187:drug effects* / Q000378:metabolism; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012016:Reference Values
D000924:Anticholesteremic Agents; D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D000077340:Fluvastatin; D003404:Creatinine