Effect of rosuvastatin on outcomes in chronic haemodialysis patients: baseline data from the AURORA study

Kidney Blood Press Res. 2007;30(5):314-22. doi: 10.1159/000106803. Epub 2007 Jul 11.

Abstract

Background: Cardiovascular disease (CVD) is the leading cause of death in patients with end-stage renal disease (ESRD).

Aims: AURORA (A study to evaluate the Use of Rosuvastatin in subjects On Regular haemodialysis: an Assessment of survival and cardiovascular events) is the first large-scale international trial to assess the effects of statins on cardiovascular outcomes in patients with ESRD on chronic haemodialysis. Preliminary baseline data from the randomised population are presented.

Methods: A total of 2,775 patients from 280 centres in 25 countries were randomised into the study. Patients aged 50-80 years on regular chronic haemodialysis for at least 3 months before screening were eligible for inclusion. They were randomised 1:1 to receive either rosuvastatin 10 mg or placebo daily and assessed throughout the study.

Results: The mean age at baseline was 64 years. Most patients were male (62%) and 85% were white. The median time since commencing renal replacement was 32 months. Mean total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels were 4.53 mmol/l (175 mg/dl) and 2.57 mmol/l (99 mg/dl), respectively.

Conclusion: Results from the AURORA trial will impact on the current guidelines and use of statins in this patient population.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Double-Blind Method
  • Female
  • Fluorobenzenes / therapeutic use*
  • Humans
  • Internationality
  • Kidney Failure, Chronic / drug therapy*
  • Kidney Failure, Chronic / epidemiology
  • Male
  • Middle Aged
  • Pyrimidines / therapeutic use*
  • Renal Dialysis* / trends
  • Rosuvastatin Calcium
  • Sulfonamides / therapeutic use*
  • Treatment Outcome

Substances

  • Fluorobenzenes
  • Pyrimidines
  • Sulfonamides
  • Rosuvastatin Calcium