Statins The AURORA Trial Reference Fellstrom BC. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009;360. A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis: An Assessment of Survival and Cardiovascular Events

Background In patients with a high cardiovascular risk, statins are found to reduce the incidence of cardiovascular events.

Aim To investigate the effects of statin therapy in patients undergoing regular hemodialysis treatment.

Method Study design: Aurora was a randomized, double-blind, placebo-controlled multicenter trial. Study population: The subjects included both male and females patients between 50 and 80 years of age, those have end-stage renal disease and were treated with regular hemodialysis or hemofilteration for at least 3 months. The major exclusion criteria was statin therapy in previous 6 months, possible kidney transplant in the coming year, neoplastic, gastrointestinal, infectious or metabolic diseases, history of malignant conditions, active liver disease, and hypothyroidism.

Dosage regimen: A total of 2776 subjects were randomly divided to receive either Rosuvastatin 10 mg/day (n=1391) or placebo (n=1385). The follow-up visits were scheduled at 3 months after randomization and every 6 months subsequently. End points: Primary end point of the study was evaluation of the time to a major cardiovascular event (a non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular reasons). Secondary end point included all cause mortality, cardiovascular event-free survival, procedures for stenosis or thrombosis of the vascular access for the long-term hemodialysis and coronary or peripheral revascularization.

Results The mean duration of the study medication was 2.4 years. After 3 months, the LDL level in the Rosuvastatin group was found to be 42.9% lower than the baseline level as compared to the 1.9% reduction in the placebo group. The cholesterol level was found to decrease by 26.6% in the Rosuvastatin group as compared to the 0.5% reduction in the placebo group. A 16.2% reduction was found in the triglyceride levels in the Rosuvastatin group as compared to the 0.9% increase in the placebo group. The elevated high-sensitivity C-reactive protein levels were reduced by 11.5% in the Rosuvastatin group as compared to those in the placebo group. The primary outcome occurred in 396 patients in the Rosuvastatin group and 408 patients in the placebo group.

Conclusion The AURORA trial examined the effects of statin therapy on the increased cardiovascular risk associated with maintenance hemodialysis therapy. Rosuvastatin was found to have no effect on the primary end point of non- fatal myocardial infarction, non-fatal stroke or death from cardiovascular reasons. The findings suggest that in such patients, a reduction in the LDL cholesterol levels by statins does not reduce the cardiovascular risk. Statin therapy reduces the LDL and cholesterol levels; however, it does not necessarily reduce the cardiovascular risk in patients with maintenance hemodialysis therapy.