The atorvastatin-fenofibrate combination reduced LDL cholesterol by 46% and triglycerides by 50%, and increased HDL cholesterol by 22%, significantly more than either monotherapy (P<0.0001 for all).
RCT (n=120)
randomly assigned
Does the combination of atorvastatin and fenofibrate improve lipid profiles compared to either drug alone in patients with type 2 diabetes and combined hyperlipidemia?
Combination therapy with atorvastatin and fenofibrate is highly effective at improving lipid profiles and reducing estimated CAD risk in patients with type 2 diabetes and combined hyperlipidemia compared to monotherapy.
p-value: p=<0.0001
OBJECTIVE: This study evaluated the effect of a atorvastatin-fenofibrate combination on lipid profile, in comparison to each drug alone, in patients with type 2 diabetes and combined hyperlipidemia (CHL). RESEARCH DESIGN AND METHODS: A total of 120 consecutive patients, who were free of coronary artery disease (CAD) at entry, were studied for a period of 24 weeks. These patients were randomly assigned to atorvastatin (20 mg/day, n = 40), micronized fenofibrate (200 mg/day, n = 40), or a combination of both (atorvastatin 20 mg/day plus fenofibrate 200 mg/day, n = 40). The effect of treatment on LDL cholesterol, triglycerides (TGs), HDL cholesterol, apolipoprotein A-I and B, lipoprotein(a), and plasma fibrinogen (PF) was recorded. Moreover, the percentage of patients that reached the American Diabetes Association treatment goals and the estimated CAD risk status were calculated. RESULTS: No patient was withdrawn from the study because of side effects. The atorvastatin-fenofibrate combination reduced total cholesterol by 37%, LDL cholesterol by 46%, TGs by 50%, and PF by 20%, whereas it increased HDL cholesterol by 22% (P 45 mg/dl. These rates were significantly higher than those of both monotherapies. Combined treatment reduced the 10-year probability for myocardial infarction from 21.6 to 4.2%. CONCLUSIONS: The atorvastatin-fenofibrate combination has a highly beneficial effect on all lipid parameters and PF in patients with type 2 diabetes and CHL. It improved patients' CAD risk status significantly more than each drug alone.
Athyros et al. (Mon,) conducted a rct in Type 2 diabetes with combined hyperlipidemia (n=120). Atorvastatin-fenofibrate combination vs. Atorvastatin 20 mg/day or micronized fenofibrate 200 mg/day alone was evaluated on Changes in lipid profile (total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol, and plasma fibrinogen) (p=<0.0001). The atorvastatin-fenofibrate combination reduced LDL cholesterol by 46% and triglycerides by 50%, and increased HDL cholesterol by 22%, significantly more than either monotherapy (P<0.0001 for all).