Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus*

Aim:  This randomized, double‐blind study evaluated the efficacy of switching from atorvastatin (ATV) 10 mg to ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg, EZE/SIMVA 10/40 mg or doubling the dose of ATV from 10 to 20 mg in patients with type 2 diabetes (T2D). Methods:  Eligible patients had haemoglobin A 1C ≤10%, were aged ≥18 years and were on ATV 10 mg for ≥6 weeks before study entry. After a 4‐week open‐label ATV 10 mg run‐in, patients were randomized to EZE/SIMVA 10/20 mg (n = 220), EZE/SIMVA 10/40 mg (n = 222) or ATV 20 g (n = 219) daily for 6 weeks. Results:  Greater (p ≤ 0.001) reductions in low‐density lipoprotein cholesterol (LDL‐C) (the primary end‐point) were achieved by switching to EZE/SIMVA 10/20 mg (26.2%) or 10/40 mg (30.1%) than by doubling the dose of ATV to 20 mg (8.5%). EZE/SIMVA 10/20 mg and 10/40 mg produced greater (p ≤ 0.001) reductions in total cholesterol, non‐high‐density lipoprotein cholesterol (HDL‐C) and apolipoprotein B relative to ATV 20 mg. A reduction (p ≤ 0.050) in C‐reactive protein was observed with EZE/SIMVA 10/40 mg vs. ATV 20 mg. Similar reductions in triglycerides were observed across the three groups, and none of the treatments produced a significant change in HDL‐C. A greater (p ≤ 0.001) proportion of patients achieved LDL‐C <2.5 mmol/l with EZE/SIMVA 10/20 mg (90.5%) and 10/40 mg (87.0%) than with ATV 20 mg (70.4%). Both EZE/SIMVA doses were generally well tolerated, with an overall safety profile similar to ATV 20 mg. Conclusions:  EZE/SIMVA 10/20 and 10/40 mg provided greater lipid‐altering efficacy than doubling the dose of ATV from 10 to 20 mg and were well tolerated in patients with T2D.