Cardiovascular outcome trial · N Engl J Med 2009
AURORA trial
Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.
The bottom line
In patients on hemodialysis, rosuvastatin lowered LDL cholesterol but did not reduce cardiovascular events or all-cause mortality compared with placebo.
No significant benefitUS status: US-approved
At a glance
- Medicine
- Rosuvastatin, 10 mg daily
- Compared with
- Placebo
- People
- 2,776
- Who took part
- Patients 50 to 80 years of age undergoing maintenance hemodialysis
- Design
- randomized, double-blind, prospective trial
- Follow-up
- median follow-up period of 3.8 years
- Main question
- Combined end point of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke
Main result
396 patients in the rosuvastatin group and 408 patients in the placebo group reached the primary end point (9.2 and 9.5 events per 100 patient-years, respectively; hazard ratio for the combined end point in the rosuvastatin group vs. the placebo group, 0.96; 95% confidence interval [CI], 0.84 to 1.11; P=0.59)
Effect on LDL cholesterol
After 3 months, the mean reduction in low-density lipoprotein (LDL) cholesterol levels was 43% in patients receiving rosuvastatin, from a mean baseline level of 100 mg per deciliter (2.6 mmol per liter)
Other results
There was also no significant effect on all-cause mortality (13.5 vs. 14.0 events per 100 patient-years; hazard ratio, 0.96; 95% CI, 0.86 to 1.07; P=0.51)
In the trial's own words
“During a median follow-up period of 3.8 years, 396 patients in the rosuvastatin group and 408 patients in the placebo group reached the primary end point (9.2 and 9.5 events per 100 patient-years, respectively; hazard ratio for the combined end point in the rosuvastatin group vs. the placebo group, 0.96; 95% confidence interval [CI], 0.84 to 1.11; P=0.59).”
Quoted from the abstract of N Engl J Med 2009, checked word for word against PubMed. PubMed 19332456 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the AURORA trial find?
In patients on hemodialysis, rosuvastatin lowered LDL cholesterol but did not reduce cardiovascular events or all-cause mortality compared with placebo.
Who was in AURORA?
2,776 people. Patients 50 to 80 years of age undergoing maintenance hemodialysis.
What was AURORA's main result?
396 patients in the rosuvastatin group and 408 patients in the placebo group reached the primary end point (9.2 and 9.5 events per 100 patient-years, respectively; hazard ratio for the combined end point in the rosuvastatin group vs. the placebo group, 0.96; 95% confidence interval [CI], 0.84 to 1.11; P=0.59)
How much did LDL cholesterol change in AURORA?
After 3 months, the mean reduction in low-density lipoprotein (LDL) cholesterol levels was 43% in patients receiving rosuvastatin, from a mean baseline level of 100 mg per deciliter (2.6 mmol per liter)
Related trials
- JUPITER (2008)In apparently healthy people with normal LDL but elevated CRP, rosuvastatin significantly reduced major cardiovascular events and all-cause death, though with a higher rate of reported diabetes.
- CORONA (2007)In older patients with ischemic systolic heart failure, rosuvastatin lowered LDL cholesterol but did not reduce cardiovascular events or death, though it was safe and reduced cardiovascular hospitalizations.
- SPARCL (2006)In patients with a recent stroke or TIA but no known coronary disease, high-dose atorvastatin modestly reduced recurrent stroke and cardiovascular events, though it slightly increased hemorrhagic stroke risk and did not improve overall mortality.
- IDEAL (2005)High-dose atorvastatin lowered LDL-C more than usual-dose simvastatin and reduced some secondary cardiovascular endpoints and nonfatal MI, but did not significantly reduce the primary composite of major coronary events or all-cause mortality after prior MI.
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