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ALERT
Assessment of Lescol in Renal Transplantation
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Author(s) |
Holdaas H, Fellström B, Jardine AG, Holme I, Nyberg G, Fauchald P, Grönhagen-Riska C, Madsen S, Neumayer HH, Cole E, Maes B, Ambühl P, Olsson AG, Hartmann A, Solbu DO, Pedersen TR
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Title(s) |
Effect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial
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Reference(s) |
Lancet 2003;361:2024–31 |
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Disease |
Renal transplantation
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Purpose |
To investigate the effects of fluvastatin on the incidence of major adverse cardiac and renal events in renal transplant recipients
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Study design |
Randomised, double-blind, placebo-controlled
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Follow-up |
Median 5.4 years
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Patients |
2102 patients (1050 fluvastatin, 1052 placebo), mean age 50 years, who had received renal or combined renal and pancreas transplants > 6 months previously, with stable graft function, receiving cyclosporine, with total serum cholesterol 4.0–9.0 mmol/l (or 4.0–7.0 mmol/l in patients with MI > 6 months previously)
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Treatment regimen |
Fluvastatin, 40 mg/day, or placebo. After about 2 years, the dose was doubled in both groups
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Results |
The incidence of major adverse cardiac events was slightly lower in the fluvastatin group than in the placebo group (risk ratio 0.83; p = 0.139). Compared to placebo, fluvastatin significantly reduced the risk of cardiac death (p = 0.031), definite nonfatal MI (p = 0.05) and the combined endpoint of cardiac death or definite nonfatal MI (p = 0.005). The renal composite endpoint of graft loss or doubling of serum creatinine was similar in the two groups (p = 0.369)
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Comments |
The results of a 2-year ALERT extension study have been published in Am J Transplant 2005;5:2929–36
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