PMID- 17100723
OWN - NLM
STAT- MEDLINE
DCOM- 20070201
LR  - 20181201
IS  - 0902-0063 (Print)
IS  - 0902-0063 (Linking)
VI  - 20
IP  - 6
DP  - 2006 Nov-Dec
TI  - No detrimental effect on renal function during long-term use of fluvastatin in 
      renal transplant recipients in the Assessment of Lescol in Renal Transplantation 
      (ALERT) study.
PG  - 732-9
AB  - BACKGROUND: Concerns have recently been raised regarding a potential harmful 
      effect of statins on renal function. This study investigated the effect of 
      fluvastatin treatment on renal function in renal transplant recipients enrolled 
      in the Assessment of Lescol in Renal Transplantation (ALERT) trial. METHODS: 
      ALERT was a randomized, double-blind, placebo-controlled study of the effect of 
      fluvastatin, 40-80 mg daily (n = 1050) or placebo (n = 1052) on cardiac and renal 
      outcomes in renal transplant recipients over a follow-up period of five to six 
      years. The incidence of graft loss, changes in serum creatinine, calculated 
      creatinine clearance and proteinuria, and the incidence of renal adverse events 
      (AEs) were assessed in both treatment groups. RESULTS: Fluvastatin treatment in 
      ALERT had no significant effect compared with placebo on renal function, assessed 
      by serum creatinine (overall adjusted mean +/- SEM: fluvastatin, 175.4 +/- 2.20 
      micromol/L; placebo, 172.7 +/- 2.20 micromol/L; p = 0.39), creatinine clearance 
      (fluvastatin, 55.3 +/- 0.30 mL/min; placebo, 55.8 +/- 0.30 mL/min; p = 0.26) or 
      proteinuria (fluvastatin, 0.58 +/- 0.03 g/24 h; placebo, 0.53 +/- 0.03 g/24 h; p 
      = 0.31). There were no significant differences between treatment groups when the 
      283 patients suffering graft loss were excluded from the analysis. Fluvastatin 
      also had no detrimental effect on creatinine clearance or proteinuria in the 
      subgroup of 340 diabetic patients without graft loss in ALERT. No notable 
      differences in the rate of renal or musculoskeletal AEs were observed between 
      fluvastatin and placebo groups. CONCLUSIONS: Fluvastatin had no detrimental 
      effect on renal function, or the risk of renal AEs, in renal transplant 
      recipients with or without diabetes enrolled in ALERT. Fluvastatin treatment for 
      the prevention of cardiac events may therefore be used without fear of 
      jeopardizing renal function.
FAU - Fellstrom, Bengt
AU  - Fellstrom B
AD  - Department of Medical Science, Renal Unit, University Hospital, Uppsala, Sweden. 
      bengt.fellstrom@medsci.uu.se
FAU - Abedini, Sadollah
AU  - Abedini S
FAU - Holdaas, Hallvard
AU  - Holdaas H
FAU - Jardine, Alan G
AU  - Jardine AG
FAU - Staffler, Beatrix
AU  - Staffler B
FAU - Gimpelewicz, Claudio
AU  - Gimpelewicz C
CN  - Assessment of Lescol in Renal Transplantation (ALERT) study group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Denmark
TA  - Clin Transplant
JT  - Clinical transplantation
JID - 8710240
RN  - 0 (Antioxidants)
RN  - 0 (Fatty Acids, Monounsaturated)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Indoles)
RN  - 4L066368AS (Fluvastatin)
RN  - MU72812GK0 (Creatine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antioxidants/*therapeutic use
MH  - Creatine/*blood
MH  - Double-Blind Method
MH  - Europe/epidemiology
MH  - Fatty Acids, Monounsaturated/*therapeutic use
MH  - Female
MH  - Fluvastatin
MH  - Follow-Up Studies
MH  - *Graft Rejection/epidemiology/metabolism/prevention & control
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*therapeutic use
MH  - Incidence
MH  - Indoles/*therapeutic use
MH  - Kidney Transplantation/*methods
MH  - Male
MH  - Middle Aged
MH  - Proteinuria/epidemiology/*urine
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2006/11/15 09:00
MHDA- 2007/02/03 09:00
CRDT- 2006/11/15 09:00
PHST- 2006/11/15 09:00 [pubmed]
PHST- 2007/02/03 09:00 [medline]
PHST- 2006/11/15 09:00 [entrez]
AID - CTR555 [pii]
AID - 10.1111/j.1399-0012.2006.00555.x [doi]
PST - ppublish
SO  - Clin Transplant. 2006 Nov-Dec;20(6):732-9. doi: 10.1111/j.1399-0012.2006.00555.x.