Comparative efficacy and safety of fenofibrate/pravastatin plus ezetimibe triple therapy
and simvastatin/ezetimibe dual therapy in type 2 diabetic patients with mixed hyperlipidaemia
and cardiovascular disease.
BACKGROUND: This study was designed to compare the efficacy and safety of a fenofibrate/pravastatin
160/40 mg fixed-dose combination plus ezetimibe 10 mg triple therapy and simvastatin
20 mg plus ezetimibe 10 mg dual therapy in patients with type 2 diabetes, mixed hyperlipidaemia
and cardiovascular disease. METHOD: After a 6-week run-in period on simvastatin 20
mg, 273 patients with non-high-density lipoprotein cholesterol (non-HDL-C) >/= 100
mg/dl or low-density lipoprotein cholesterol (LDL-C) >/= 70 mg/dl were randomised
to receive 12-week treatment with triple therapy or dual therapy, followed by a 12-week
safety period during which all patients received the triple therapy. RESULTS: At week
12, similar significant decreases in non-HDL-C were observed with both treatments.
The triple therapy has induced a greater decrease in triglycerides (between-treatment
difference: -14.6%, p = 0.007) and the dual therapy a greater decrease in LDL-C (between-treatment
difference: +5.3%, p = 0.05). Both treatments were generally well tolerated. CONCLUSION:
The fenofibrate/pravastatin plus ezetimibe therapy improves the global atherogenic
lipid profile in type 2 diabetic patients with mixed hyperlipidaemia.