Effect of rosuvastatin on outcomes in chronic haemodialysis patients - Design and rationale of the AURORA study

Bengt Fellström, Faiez Zannad, Roland Schmieder, Hallvard Holdaas, Alan Jardine, Helen Rose, Wim Wilpshaar, K. Bannister, J. Beutler, D. Chae, S. M. Cobbe, B. Espinoza Vazquez, C. Gronhagen-Riska, J. Lima, R. Lins, A. McMahon, G. Mayer, H. Parving, G. Remuzzi, O. SamuelssonS. Sonkodi, G. Suleymanlar, V. Tesar, D. Tsakiris, V. Todorov, A. Wiecek, R. Wûthrich, H. Dargie, E. Ritz, H. Wedel, A. H. Zwinderman, A. Brady, C. Deighan, A. Gaw, P. Macfarlane, D. Stott

Research output: Contribution to journalArticle

Abstract

Background: Patients with end-stage renal disease (ESRD) are at high risk of cardiovascular events. Multiple risk factors for atherosclerosis are present in ESRD and may contribute to the increased risk of cardiovascular mortality in this population. In contrast to patients with normal trend function the benefits of modifying lipid levels on cardiovascular outcomes in patients with ESRD on haemodialysis have yet to be confirmed in large prospective randomised trials. A study to evaluate the Use of Rosuvastatin in subjects On Regular haemodialysis: an Assessment of survival and cardiovascular events (AURORA) will be the first large-scale international trial to assess the effects of statin therapy on cardiovascular morbidity and mortality in ESRD patients on chronic haemodialysis. Methods: More than 2,750 ESRD patients who have been receiving chronic haemodialysis treatment for at least 3 months have been randomised (1:1), irrespective of baseline lipid levels, to treatment with rosuvastatin 10 mg or placebo. The primary study endpoint is the time to a major cardiovascular event (first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke). Secondary endpoints include all-cause mortality, major cardiovascular event-free survival time, time to cardiovascular death, time to non-cardiovascular death, cardiovascular interventions, tolerability of treatment and health economic costs per life-year saved. Study medication will be given until 620 subjects have experienced a major cardiovascular event. Conclusion: Our hypothesis is that results from AURORA will establish the clinical efficacy and tolerability of rosuvastatin in patients with ESRD receiving chronic haemodialysis and guide the optimal management of this expanding population.

Original languageEnglish
Article number9
JournalCurrent Controlled Trials in Cardiovascular Medicine
Volume6
DOIs
Publication statusPublished - May 23 2005

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Chronic Kidney Failure
Renal Dialysis
Mortality
Lipids
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Therapeutics
Health Care Costs
Population
Disease-Free Survival
Rosuvastatin Calcium
Atherosclerosis
Stroke
Myocardial Infarction
Placebos
Economics
Morbidity
Survival

Keywords

  • Atherosclerosis
  • Cardiovascular disease
  • End-stage renal disease
  • Haemodialysis
  • Lipids
  • Statin

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Effect of rosuvastatin on outcomes in chronic haemodialysis patients - Design and rationale of the AURORA study. / Fellström, Bengt; Zannad, Faiez; Schmieder, Roland; Holdaas, Hallvard; Jardine, Alan; Rose, Helen; Wilpshaar, Wim; Bannister, K.; Beutler, J.; Chae, D.; Cobbe, S. M.; Vazquez, B. Espinoza; Gronhagen-Riska, C.; Lima, J.; Lins, R.; McMahon, A.; Mayer, G.; Parving, H.; Remuzzi, G.; Samuelsson, O.; Sonkodi, S.; Suleymanlar, G.; Tesar, V.; Tsakiris, D.; Todorov, V.; Wiecek, A.; Wûthrich, R.; Dargie, H.; Ritz, E.; Wedel, H.; Zwinderman, A. H.; Brady, A.; Deighan, C.; Gaw, A.; Macfarlane, P.; Stott, D.

In: Current Controlled Trials in Cardiovascular Medicine, Vol. 6, 9, 23.05.2005.

Research output: Contribution to journalArticle

Fellström, B, Zannad, F, Schmieder, R, Holdaas, H, Jardine, A, Rose, H, Wilpshaar, W, Bannister, K, Beutler, J, Chae, D, Cobbe, SM, Vazquez, BE, Gronhagen-Riska, C, Lima, J, Lins, R, McMahon, A, Mayer, G, Parving, H, Remuzzi, G, Samuelsson, O, Sonkodi, S, Suleymanlar, G, Tesar, V, Tsakiris, D, Todorov, V, Wiecek, A, Wûthrich, R, Dargie, H, Ritz, E, Wedel, H, Zwinderman, AH, Brady, A, Deighan, C, Gaw, A, Macfarlane, P & Stott, D 2005, 'Effect of rosuvastatin on outcomes in chronic haemodialysis patients - Design and rationale of the AURORA study', Current Controlled Trials in Cardiovascular Medicine, vol. 6, 9. https://doi.org/10.1186/1468-6708-6-9
Fellström, Bengt ; Zannad, Faiez ; Schmieder, Roland ; Holdaas, Hallvard ; Jardine, Alan ; Rose, Helen ; Wilpshaar, Wim ; Bannister, K. ; Beutler, J. ; Chae, D. ; Cobbe, S. M. ; Vazquez, B. Espinoza ; Gronhagen-Riska, C. ; Lima, J. ; Lins, R. ; McMahon, A. ; Mayer, G. ; Parving, H. ; Remuzzi, G. ; Samuelsson, O. ; Sonkodi, S. ; Suleymanlar, G. ; Tesar, V. ; Tsakiris, D. ; Todorov, V. ; Wiecek, A. ; Wûthrich, R. ; Dargie, H. ; Ritz, E. ; Wedel, H. ; Zwinderman, A. H. ; Brady, A. ; Deighan, C. ; Gaw, A. ; Macfarlane, P. ; Stott, D. / Effect of rosuvastatin on outcomes in chronic haemodialysis patients - Design and rationale of the AURORA study. In: Current Controlled Trials in Cardiovascular Medicine. 2005 ; Vol. 6.
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T1 - Effect of rosuvastatin on outcomes in chronic haemodialysis patients - Design and rationale of the AURORA study

AU - Fellström, Bengt

AU - Zannad, Faiez

AU - Schmieder, Roland

AU - Holdaas, Hallvard

AU - Jardine, Alan

AU - Rose, Helen

AU - Wilpshaar, Wim

AU - Bannister, K.

AU - Beutler, J.

AU - Chae, D.

AU - Cobbe, S. M.

AU - Vazquez, B. Espinoza

AU - Gronhagen-Riska, C.

AU - Lima, J.

AU - Lins, R.

AU - McMahon, A.

AU - Mayer, G.

AU - Parving, H.

AU - Remuzzi, G.

AU - Samuelsson, O.

AU - Sonkodi, S.

AU - Suleymanlar, G.

AU - Tesar, V.

AU - Tsakiris, D.

AU - Todorov, V.

AU - Wiecek, A.

AU - Wûthrich, R.

AU - Dargie, H.

AU - Ritz, E.

AU - Wedel, H.

AU - Zwinderman, A. H.

AU - Brady, A.

AU - Deighan, C.

AU - Gaw, A.

AU - Macfarlane, P.

AU - Stott, D.

PY - 2005/5/23

Y1 - 2005/5/23

N2 - Background: Patients with end-stage renal disease (ESRD) are at high risk of cardiovascular events. Multiple risk factors for atherosclerosis are present in ESRD and may contribute to the increased risk of cardiovascular mortality in this population. In contrast to patients with normal trend function the benefits of modifying lipid levels on cardiovascular outcomes in patients with ESRD on haemodialysis have yet to be confirmed in large prospective randomised trials. A study to evaluate the Use of Rosuvastatin in subjects On Regular haemodialysis: an Assessment of survival and cardiovascular events (AURORA) will be the first large-scale international trial to assess the effects of statin therapy on cardiovascular morbidity and mortality in ESRD patients on chronic haemodialysis. Methods: More than 2,750 ESRD patients who have been receiving chronic haemodialysis treatment for at least 3 months have been randomised (1:1), irrespective of baseline lipid levels, to treatment with rosuvastatin 10 mg or placebo. The primary study endpoint is the time to a major cardiovascular event (first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke). Secondary endpoints include all-cause mortality, major cardiovascular event-free survival time, time to cardiovascular death, time to non-cardiovascular death, cardiovascular interventions, tolerability of treatment and health economic costs per life-year saved. Study medication will be given until 620 subjects have experienced a major cardiovascular event. Conclusion: Our hypothesis is that results from AURORA will establish the clinical efficacy and tolerability of rosuvastatin in patients with ESRD receiving chronic haemodialysis and guide the optimal management of this expanding population.

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KW - Cardiovascular disease

KW - End-stage renal disease

KW - Haemodialysis

KW - Lipids

KW - Statin

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