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Effect of rosuvastatin on outcomes in chronic haemodialysis patients: baseline data from the AURORA study
Bengt Fellström1, Hallvard Holdaas, Alan G Jardine
1Department of Medical Science, Renal Unit, University Hospital, Uppsala, Sweden. bengt.fellstrom@medsci.uu.se
Insights
Cardiovascular disease is a major risk for patients with end-stage renal disease (ESRD). The AURORA trial investigates statin use in ESRD patients on chronic hemodialysis to assess cardiovascular outcomes.
Area of Science:
- Nephrology
- Cardiology
- Clinical Trials
Background:
- Cardiovascular disease (CVD) is the primary cause of mortality in end-stage renal disease (ESRD) patients.
- Patients undergoing chronic hemodialysis represent a high-risk population for cardiovascular events.
Purpose of the Study:
- The AURORA trial is the first large-scale international study evaluating statin efficacy on cardiovascular outcomes in ESRD patients on chronic hemodialysis.
- This study aims to assess the impact of rosuvastatin on survival and cardiovascular events in this specific patient group.
Main Methods:
- 2,775 patients aged 50-80 years on chronic hemodialysis were randomized 1:1 to receive rosuvastatin 10 mg daily or placebo.
- The study involved 280 centers across 25 countries, with patients requiring at least 3 months of hemodialysis prior to screening.
Main Results:
- Baseline characteristics included a mean age of 64 years, 62% male, and 85% white patients.
- The median time on renal replacement therapy was 32 months.
- Mean total cholesterol was 4.53 mmol/l and mean LDL-C was 2.57 mmol/l at baseline.
Conclusions:
- The AURORA trial results are anticipated to influence current clinical guidelines regarding statin use in ESRD patients.
- Findings will provide critical insights into managing cardiovascular risk in patients with end-stage renal disease on hemodialysis.
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.
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