AURORA (rosuvastatin)
Trial question
What is the effect of rosuvastatin on the incidence of cardiovascular events in patients undergoing hemodialysis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 2776
2776 patients (1050 female, 1723 male)
Inclusion criteria: patients, 50 to 80 years of age, who were undergoing maintenance hemodialysis
Key exclusion criteria: statin therapy within the previous 6 months, expected kidney transplantation within 1 year, and serious hematologic, neoplastic, gastrointestinal, infectious, or metabolic disease (excluding diabetes) predicted to limit life expectancy < 1 year, history of a malignant condition, active liver disease, or uncontrolled hypothyroidism
Interventions
N=1391 rosuvastatin (10 mg daily)
N=1385 placebo (matching placebo daily)
Primary outcome
Death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke (events per 100 patient-years)
9.2
9.5
9.5
7.1
4.8
2.4
0.0
Rosuvastatin
Placebo
No significant difference ↔
No significant difference in death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke (events per 100 patient-years) (9.2 vs. 9.5 ; HR 0.96, 96% CI 0.84 to 1.11)
Secondary outcomes
No significant difference in the incidence of death from any cause (13.5/100 py vs. 14/100 py; HR 0.96, 96% CI 0.86 to 1.07)
No significant difference in the incidence of cardiovascular death (7.2 person-years vs. 7.3 person-years; HR 1, 95% CI 0.85 to 1.16)
No significant difference in death due to noncardiovascular causes (events per 100 patient-years) (5.5 vs. 6 ; HR 0.92, 95% CI 0.77 to 1.09)
Safety outcomes
Significant differences in mean change in LDL cholesterol levels at 3 months (42.9% vs. 1.9%, p < 0.001).
Conclusion
In patients, 50 to 80 years of age, who were undergoing maintenance hemodialysis, rosuvastatin was not superior to placebo with respect to death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke (events per 100 patient-years).
Reference
Fellstrom BC, Jardine AG, Schmieder RE et al. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009 Apr 2;360(14):1395-407.
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