The AURORA Trial Source: Holdaas H, Holme I, Schmieder RE, et al. Rosuvastatin in diabetic hemodialysis patient. J Am Soc Nephrol. 2011;22(7):1335–1341.

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Presentation transcript:

The AURORA Trial Source: Holdaas H, Holme I, Schmieder RE, et al. Rosuvastatin in diabetic hemodialysis patient. J Am Soc Nephrol. 2011;22(7):1335–1341.

Background: The study in patients with diabetes receiving hemodialysis showed no effect of atorvastatin on a composite cardiovascular endpoint. However, when the analysis of component cardiac endpoints was performed, it was suggested that atorvastatin may significantly reduce risk. Since the AURORA (A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis: An Assessment of Survival and Cardiovascular Events) trial included patients with and without diabetes, post-hoc analysis was performed to determine if rosuvastatin reduces the risk of cardiac events.

Aim: To determine whether rosuvastatin might reduce the risk of cardiac events in diabetic patients receiving hemodialysis (post-hoc analysis).

Methods: Study design: Randomized, placebo-controlled trial. Patients: Diabetic patients receiving hemodialysis. Number of patients: 731 participants with diabetes, traditional risk factors such as LDL-C, smoking and BP did not associate with cardiac events (cardiac death and non-fatal myocardial infarction). Only age and high-sensitivity C-reactive protein were independent risk factors for cardiac events at baseline.

Results: Non-significant (16.2%) reduction in risk for the AURORA trial’s composite primary endpoint of cardiac death, non-fatal MI, or fatal or non-fatal stroke (HR: 0.84; 95% CI: 0.65–1.07) observed in rosuvastatin group. Rosuvastatin group had more hemorrhagic strokes than the placebo group (12 vs 2 strokes, respectively; HR: 5.21; 95% CI: 1.17–23.27). 32% reduction (significant) in the rates of cardiac events seen among patients with diabetes (HR: 0.68; 95% CI: 0.51–0.90).

Conclusion: In diabetes patients undergoing hemodialysis, rosuvastatin reduces the risk of fatal and non-fatal cardiac events.