Rosuvastatin in Diabetic Hemodialysis Patients

Abstract

A randomized, placebo-controlled trial in diabetic patients receiving hemodialysis showed no effect of atorvastatin on a composite cardiovascular endpoint, but analysis of the component cardiac endpoints suggested that atorvastatin may significantly reduce risk. Because 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, we conducted a post hoc analysis to determine whether rosuvastatin might reduce the risk of cardiac events in diabetic patients receiving hemodialysis. Among the 731 participants with diabetes, traditional risk factors such as LDL-C, smoking, and BP did not associate with cardiac events (cardiac death and nonfatal myocardial infarction). At baseline, only age and high-sensitivity C-reactive protein were independent risk factors for cardiac events. Assignment to rosuvastatin associated with a nonsignificant 16.2% reduction in risk for the AURORA trial's composite primary endpoint of cardiac death, nonfatal MI, or fatal or nonfatal stroke (HR 0.84; 95% CI 0.65 to 1.07). There was no difference in overall stroke, but the rosuvastatin group had more hemorrhagic strokes than the placebo group (12 versus two strokes, respectively; HR, 5.21; 95% CI 1.17 to 23.27). Rosuvastatin treatment significantly reduced the rates of cardiac events by 32% among patients with diabetes (HR 0.68; 95% CI 0.51 to 0.90). In conclusion, among hemodialysis patients with diabetes mellitus, rosuvastatin might reduce the risk of fatal and nonfatal cardiac events.

Lipid abnormalities in kidney disease and management strategies

“…Authors suggested several possibilities contributing to these findings which include exclusion of patients < 50 years of age and those who have been on statin, high percentage of patients leaving the study, and lower than expected yearly cardiovascular event rates. In post hoc analysis of this trial among diabetics (n = 731), rosuvastatin did not have significant effect on primary end-point although rosuvastatin group had significant decrease in cardiovascular events (HR = 0.68, 95%CI: 0.51-0.90) [55] . SHARP trial [35] included CKD patients on dialysis as well as not on dialysis.…”

Dyslipidemia in diabetic nephropathy

“…Rosuvastatin significantly reduced the LDL-C levels, but it was not able to inhibit cardiovascular events [85]. However, a sub-analysis of the AURORA trial demonstrated that rosuvastatin reduced cardiovascular events (32 % reduction compared to control) in patients with diabetes on hemodialysis [86]. On the other hand, statin therapy failed to show secondary prevention of cardiovascular events in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) study [87].…”

CKD and Sudden Cardiac Death

“…These results differ from two other placebo-controlled statin trials in dialysis populations that did not demonstrate a reduction in cardiovascular death, MI and stroke, 89,90 although secondary analyses from the AURORA study suggest some benefit from rosuvastatin treatment in dialysis patients with diabetes. 91 This failure to achieve statistical significance in primary trials may have derived from the smaller number of participants enrolled in these trials. The SHARP study also noted that statin therapy was safe in patients with kidney disease.…”