Patients treated with ezetimibe/simvastatin, 10/20 mg/d achieved significantly greater mean reductions in LDL-C levels (-53.6%) than those treated with atorvastatin, 10 mg/d (-38.3%; or 20 mg/d (-44.6%). Ezetimibe/simvastatin provides superior lipid-modifying benefits compared with atorvastatin monotherapy in patients with type 2 diabetes and hypercholesterolemia.
In a double-blind, randomized, multicenter study, Dr. Ronald B. Goldberg, of the University of Miami, Florida, and colleagues compared the safety and efficacy of the recommended starting dose and the next highest dose of ezetimibe/simvastatin and atorvastatin in patients with type 2 diabetes and hypercholesterolemia.
One thousand two hundred twenty-two adults were randomized to the recommended starting dose of ezetimibe/simvastatin (10/20 mg/d) versus atorvastatin (10 mg/d or 20 mg/d), or the next highest dose of ezetimibe/simvastatin (10/40 mg/d) versus atorvastatin (40 mg/d). The treatment was given daily for 6 weeks.
The main efficacy end point was the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels. The secondary efficacy measure was the proportion of patients who attained LDL-C levels less than 70 mg/dL.
Other efficacy measures included the proportion of patients who attained LDL-C levels less than 100 mg/dL; percent change from baseline in total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglyceride levels; and changes in high-sensitivity C-reactive protein. The results of the study are published in the December issue of Mayo Clinic Proceedings.
Patients treated with ezetimibe/simvastatin, 10/20 mg/d achieved significantly greater mean reductions in LDL-C levels (-53.6%) than those treated with atorvastatin, 10 mg/d (-38.3%; p < 0.001) or 20 mg/d (-44.6%; p < 0.001).
Significantly greater mean reductions were also observed in patients treated with the higher dose of ezetimibe/simvastatin, 10/40 mg/d (-57.6%) compared to higher dose of atorvastatin, 40 mg (-50.9%; p < 0.001).
Ezetimibe/simvastatin was also superior to atorvastatin in attainment of LDL-C levels less than 70 mg/dL and 100 mg/dL.
Compared with atorvastatin, ezetimibe/simvastatin resulted in greater increases from baseline in HDL-C levels. Ezetimibe/simvastatin was also superior in lowering total cholesterol and non-HDL-C levels.
"Ezetimibe/simvastatin, 10/20 mg/d, decreased levels of high-sensitivity C-reactive protein and triglycerides significantly more than atorvastatin, 10 mg/d (p = 0.02)," Dr. Goldberg’s team explains. "At the other dose, reductions in high-sensitivity C-reactive protein and triglyceride levels were comparable."
There were no significant differences in adverse clinical or laboratory events between the ezetimibe/simvastatin groups and the atorvastatin groups.
Dr. Goldberg’s group concludes that "ezetimibe/simvastatin was consistently superior to atorvastatin in reducing LDL-C levels at both the recommended usual starting and next highest doses in patients with type 2 diabetes and hypercholesterolemia."
Mayo Clin Proc 2006;81:1579-1588.
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