The ACCORD-Lipid study: implications for treatment of dyslipidemia in Type 2 diabetes mellitus

Addition of fenofibrate to simvastatin did not significantly reduce major cardiovascular events compared with simvastatin alone in the overall ACCORD-Lipid cohort of patients with Type 2 diabetes (2.2

Effect: null; HR 0.92; CI: 95% CI 0.79-1.08

In the prespecified subgroup of T2DM patients with significant dyslipidemia (triglycerides >=204 mg/dl and HDL-C <=34 mg/dl, representing 17% of the cohort), fenofibrate plus simvastatin was associate

Effect: improvement; 31% lower event rate

Fenofibrate added to simvastatin increased HDL-C by 6.3% (from 0.98 to 1.05 mmol/l) and decreased triglycerides by 21.2% (from 1.85 to 1.37 mmol/l) at 1 year, with no difference in LDL-C between group

Effect: improvement; HDL-C +6.3%, triglycerides -21.2%

Combination therapy with fenofibrate and simvastatin was not associated with increased risk of myopathy compared with simvastatin alone, with muscle symptom rates of 40.1% vs 40.5% (p=0.79), elevated

Effect: null; 40.1% vs 40.5%

Fenofibrate added to simvastatin caused significantly more frequent serum creatinine elevations compared with simvastatin alone, in women (27.9% vs 18.7%, p<0.001) and men (36.7% vs 18.5%, p<0.001), t

Effect: adverse; Women: 27.9% vs 18.7%; Men: 36.7% vs 18.5%

Fenofibrate added to simvastatin was associated with a significantly higher rate of liver enzyme elevation (ALT >5x ULN) compared with simvastatin alone (0.6% vs 0.2%, p=0.03), though absolute rates w

Effect: adverse; 0.6% vs 0.2%

Fenofibrate added to simvastatin reduced progression of albuminuria in T2DM patients, with microalbuminuria reduced by 8.1% (p=0.01) and macroalbuminuria reduced by 14.6% (p=0.03) compared with simvas

Effect: improvement; Microalbuminuria -8.1%, macroalbuminuria -14.6%

Fenofibrate added to simvastatin reduced progression of diabetic retinopathy by 36.3% (p=0.006) compared with simvastatin alone, measured by combined progression on funduscopic examination and need fo

Effect: improvement; -36.3%