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NDT Advance Access published online on March 22, 2005
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfh735
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© The Author [2005]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oupjournals.org
Received July 10, 2004
Accepted January 19, 2005

Original Articles

Beneficial effect of early initiation of lipid-lowering therapy following renal transplantation

Hallvard Holdaas 1*, Bengt Fellström 2, Alan G. Jardine 3, Gudrun Nyberg 4, Carola Grönhagen-Riska 5, Sören Madsen 6, Hans-Hellmut Neumayer 7, Edward Cole 8, Bart Maes 9, Patrice Ambühl 10, John O. Logan 11, Beatrix Staffler 11, Claudio Gimpelewicz 11, and on behalf of the ALERT Study Group

1 National Hospital, Oslo, Norway, Sweden
2 University Hospital, Uppsala, Sweden
3 Western Infirmary, Glasgow, UK
4 Sahlgrenska University Hospital, Gothenburg, Sweden
5 University Hospital, Helsinki, Finland
6 Skejby Hospital, Aarhus, Denmark
7 Universitätsklinikum Charité, Berlin, Germany
8 University Health Network, Toronto Hospital, Toronto, Canada
9 University Hospital, Leuven, Belgium
10 University Hospital, Zürich, Switzerland
11 Medical Department, Novartis, Basel, Switzerland

* To whom correspondence should be addressed.
Hallvard Holdaas, E-mail: hallvard.holdaas{at}rikshospitalet.no



  Abstract

Background. Renal transplant recipients have a significantly reduced life expectancy, largely due to premature cardiovascular disease. The aim of the current analysis was to investigate the importance of time of initiation of therapy after transplantation, on the benefits of statin therapy.

Methods. 2102 renal transplant recipients with total cholesterol levels of 4.0-9.0 mmol/l were randomly assigned to treatment with fluvastatin (n = 1050) or placebo (n = 1052) and followed for a mean time of 5.1 years. The end-points were major cardiac events. The average median time from transplantation to randomization was 4.5 years (range: 0.5-29 years).

Results. In patients starting treatment with fluvastatin <4.5 years after renal transplantation, the incidence of cardiac events was 4.6% over 5.1 years vs 9.2% in those on placebo (P = 0.007). Fluvastatin significantly reduced the risk of cardiac death and non-fatal myocardial infarction by 56% [risk ratio (RR): 0.44; 95% confidence interval (95% CI): 0.26-0.74; P = 0.002]. In a more detailed analysis patients were grouped into 2-year intervals (since the last transplantation). The frequency of cardiac death and non-fatal myocardial infarction was reduced by 3.2%, 5.1%, 9.6% and 8.2% with fluvastatin treatment as compared to 6%, 10.4%, 13.4% and 9.6% with placebo when treatment was initiated at 0-2, 2-4, 4-6 and >6 years, respectively. The risk reduction for patients initiating therapy with fluvastatin at years 0-2 (compared with >6 years) following transplantation was 59% (RR: 0.41; 95% CI: 0.18-0.92; P = 0.0328). This is also reflected in total time on renal replacement therapy: in patients in the first quartile (<47 months) fluvastatin use was associated with a risk reduction of 64% compared with 19% for patients in the fourth quartile (>120 months) (P = 0.033).

Conclusions. Our data support an early introduction of fluvastatin therapy in a population of transplant recipients at high risk of premature coronary heart disease.

Keywords: cardiac end-points; fluvastatin; renal transplant recipients.
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