Effect of rosuvastatin on outcomes in chronic haemodialysis patients – design and rationale of the AURORA study

Bengt Fellström¹ , Faiez Zannad² , Roland Schmieder³ , Hallvard Holdaas⁴ , Alan Jardine⁵ , Helen Rose⁶ and Wim Wilpshaar⁷ for the AURORA Study Group

¹Department of Medical Science, Renal Unit, University Hospital, Uppsala, Sweden

²Clinical Investigation Center INSERM (CIC), Hôpital Jeanne d'Arc, Toul, France

³Med Klinik IV, Univ.-Klinik Erlangen-Nürnberg, Germany

⁴Department of Nephrology, Rikshospitalet, Oslo, Norway

⁵Department of Medicine and Therapeutics, Western Infirmary Hospital, Glasgow, United Kingdom

⁶AstraZeneca, Macclesfield, United Kingdom

⁷AstraZeneca, Macclesfield, United Kingdom

author email corresponding author email

Current Controlled Trials in Cardiovascular Medicine 2005, 6:9doi:10.1186/1468-6708-6-9


Published:	23 May 2005

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 renal 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.