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.

Figure 1.

Patients randomized to rosuvastatin show a sustained reduction in LDL-cholesterol, triglycerides, and hsCRP levels. The figure shows mean levels of LDL-C (A), TG (B), HDL_C (C) and median (95% CI) levels of hs CRP (D) in subjects randomized to rosuvastatin or placebo. *P < 0.0001; **P < 0.0002 for between group comparison of the percentage change between baseline and three months.

Figure 2.

Patients randomized to rosuvastatin have a reduced composite cardiac event rate. The figure shows Kaplan-Meier curved for cardiac events by treatment group.

Figure 3.

The disposition of patients is similar between randomizations groups.