Abstract 14129: Effects of Intensive Lipid Lowering in Type Patients With 2 Diabetes With or Without Chronic Mild to Moderate Kidney Disease
Background: The role of intensive lipid therapy in diabetic patients remains controversial. We investigated the impact of chronic kidney disease (CKD) at baseline on the outcome of diabetic patients during standard or intensive lipid therapy in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial.
Methods: Among 5,464 participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial, 3,554 (65.1%) were free of CKD at baseline, while 756 (13.8%) had Stage 1 CKD, 734 (13.4%) Stage 2 CKD, and 420 (7.7%) Stage 3 CKD, using current guideline criteria. Patients were randomized to Simvastatin plus fenofibrate vs. Simvastatin plus placebo. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death, while several prespecified secondary outcomes were also assessed.
Results: There were no significant differences in the primary and secondary outcomes between intensive and standard lipid therapy in patients with CKD. In patients without CKD however, the addition of fenofibrate was associated with a significantly 36% lower rate of cardiovascular mortality (hazard ratio: 0.64; 95% CI: 0.42-0.97, P value for CKD by treatment interaction:0.05) and 44% lower rate of fatal or non-fatal congestive heart failure (hazard ratio: 0.56; 95% CI: 0.37-0.84, P-value for CKD by treatment interaction: 0.03). Addition of finofibrate had no beneficial effect on the primary end point or any other secondary end point in patients without CKD.
Conclusions: Exploratory subgroup analyses suggest that intensive lipid therapy with fenofibrate added to statin is associated with heterogeneity in treatment effect on cardiovascular mortality and CHF, according to baseline CKD status, with a benefit for non-CKD participants but no benefit for not CKD participants. Therefore, the addition of fenofibrate to standard statin therapy may be an attractive option in diabetics without CKD.
- © 2013 by American Heart Association, Inc.