6/28/23, 12:49 AM AURORA Pathway Feedback Search Clinical Topics Home Studies AURORA AURORA Disease Disease Disease Acute ischemic stroke Chronic kidney disease Dyslipidem 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 N = 2776 62.0% male 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) https://web.pathway.md/studies/recq9Dg4sgQeTUu0y 1/2 6/28/23, 12:49 AM AURORA Pathway Primary outcome Death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke (events per 100 patient-years) 9.5 9.5 9.2 7.1 4.8 2.4 No significant difference 0.0 Rosuvastatin Placebo 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. Open reference URL https://web.pathway.md/studies/recq9Dg4sgQeTUu0y 2/2