AURORA: Statins show no benefit for patients undergoing hemodialysis

Those with end-stage renal disease face more severe calcifications and did not benefit from rosuvastatin treatment.

Statin therapy did not prevent or treat heart disease in patients with end-stage renal disease on hemodialysis, according to results from the AURORA trial.

“The vascular disease these patients are suffering from is so different, with a lot of calcification, which may not be treatable with statins,” Bengt Fellstrom, MD, from University Hospital, Uppsala, Sweden, said during a press conference.

AURORA was a large-scale, double blind, placebo-controlled study in which researchers randomized 2,776 patients to receive rosuvastatin 10 mg daily (Crestor, AstraZeneca) or placebo in order to determine whether initiating a statin during maintenance dialysis influenced CV-related events or death. Patients were aged 50 to 80 years with end-stage renal disease who had been receiving dialysis for at least three months (mean duration 3.5 years). The researchers enrolled the patients at 284 centers in 25 countries. Patients on dialysis who were already taking statins were excluded. Mean follow-up time was 3.2 years.

During the course of the study, 1,296 patients died; half died from CV causes. No patients were lost to follow up. The primary end point – time to CV death, nonfatal MI or nonfatal stroke – was not met, although the statin reduced LDL 43% in the treatment population (P<0.0001).

The patients tolerated therapy well, and there was no different in adverse events between groups.

Limitations of the trial include the exclusion criteria; those already on statins were not allowed in the study, and no patient younger than 50-years-old was permitted to participate.

“The AURORA trial is the largest-ever study of CV events in end-stage renal disease patients on hemodialysis treatment,” Fellstrom said. “The lack of CV benefits with statins both in AURORA and 4D suggests that CVD in hemodialysis patients is different compared with that in a nonrenal population. There is definitely a need for further research and an analysis of data to explore new approaches and treatment strategies for reduction of the high risk of CVD in end-stage renal disease patients.” – by Judith Rusk

The only caveat is that there is quite a large number of patients excluded from this trial because they happened to be on lipid-lowering agents. But it is unclear whether they are on lipid-lowering agents because of physician preference or they have indications. In a way, it does [change practice], because a lot of physicians felt that patients with renal disease should be on lipid-lowering agents to improve outcomes. This puts a bit of a damper on it and causes hesitation – perhaps that’s not right. We have to wait for the SHARP trial which is a much larger trial…until then we have to use our judgment.

Udho Thadani, MD

Cardiology Today Editorial Board member

For more information:

Fellstrom B. Effect of rosuvastatin vs. placebo on CV outcomes in patients with end-stage renal disease on hemodialysis: Results of the AURORA study. #413. Presented at: American College of Cardiology 58th Annual Scientific Sessions; March 29-31; Orlando.