Abstract 15027: A Comparison of Switching to Ezetimibe/Simvastatin (10 mg/20 mg) versus Doubling the Statin Dose to Simvastatin 40 mg or Atorvastatin 20 mg or Switching to Rosuvastatin 10 mg in Patients with Cardiovascular Disease and Diabetes Mellitus
The objective was to assess the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of switching to ezetimibe/simvastatin 10/20 mg (EZ/S) vs doubling the baseline statin dose (to simvastatin [S] 40 mg or atorvastatin [A] 20 mg) or switching to rosuvastatin 10 mg (R) in subjects 18-79 years with CVD and diabetes mellitus with LDL-C≥70 and ≤160 mg/dl. After a 6-week, open-label run-in during which subjects received S20 mg or A10 mg, 808 subjects were randomized according to the run-in statin (Stratum 1=S20 mg or Stratum 2=A10 mg) to EZ/S, doubling the statin dose, or R in a 2:1:2 ratio for 6 weeks. The percent change in LDL-C and other lipids was assessed using a constrained longitudinal data analysis method with terms for treatment, time, time-by-treatment interaction, stratum, and time-by-stratum interaction. Percent patients achieving LDL-C<70 mg/dL was assessed using a logistic regression model with terms for treatment and stratum. Tolerability was assessed. Switching to EZ/S resulted in significantly greater reductions in LDL-C vs doubling the statin dose (-23.1% vs -8.4%; p<0.001) and when switched to EZ/S vs doubling the statin dose in subpopulations of patients treated with S20 mg (-21.6% vs. -8.0%) or A10 mg (-24.6% vs -8.9%) at baseline (both p<0.001). The LDL-C reduction was numerically greater in subjects switched to EZ/S vs switching to R (Δ=-3.81, 95% CI: -7.78, 0.17; p =0.060). Significantly more patients reached LDL-C<70 mg/dl with EZ/S (54.5%) vs doubling the statin dose (27.0%) or vs R (42.5%) in the overall population (all p<0.001) and within each stratum separately (Stratum 1: EZ/S: 53.2% vs. S40: 24.4%; Stratum 2: EZ/S: 55.8% vs A20: 29.6%; all p<0.001). The overall safety profile was generally similar between treatment groups. In CVD subjects with diabetes mellitus already treated with S20 mg or A10 mg but not at LDL-C<70 mg/dL, switching to combination EZ/S provided significantly greater reductions in LDL-C vs doubling the baseline statin dose and significantly greater achievement of LDL-C targets vs doubling the baseline statin dose or switching to R.
- © 2011 by American Heart Association, Inc.