The efficacy and safety of ezetimibe/simvastatin combination compared with intensified lipid-lowering treatment strategies in diabetic subjects with and without metabolic syndrome

Aims: The objective was to assess the consistency of effect of switching to ezetimibe/simvastatin 10/20mg versus doubling the baseline statin dose (to simvastatin 40mg or atorvastatin 20mg) or switching to rosuvastatin 10mg across subgroups of subjects with (n=617) and without (n=191) metabolic syndrome (MetS). Methods: This was a post hoc analysis of a randomized, double-blind, 6-week study of adults 18-79years with cardiovascular disease and diabetes mellitus with low-density lipoprotein cholesterol (LDL-C) ≥70 and ≤160mg/dl. The percent change in LDL-C and other lipids was estimated within each subgroup separately. Safety and tolerability were assessed. Results: In subjects with MetS, percent changes in LDL-C and other lipids were greater with ezetimibe/simvastatin versus doubling baseline statin or numerically greater versus switching to rosuvastatin, except high-density lipoprotein cholesterol and apolipoprotein (Apo) AI (mean percent changes in LDL-C were: -22.49% ezetimibe/simvastatin, -9.64% doubled baseline statin and -19.20% rosuvastatin). In subjects without MetS, percent changes in LDL-C, total cholesterol and Apo B were greater with ezetimibe/simvastatin versus doubling baseline statin or numerically greater versus switching to rosuvastatin (mean percent changes in LDL-C were: -25.14% ezetimibe/simvastatin, -4.75% doubled baseline statin and -19.75% rosuvastatin). Safety profiles were generally similar. Conclusion: These results showed that switching to ezetimibe/simvastatin 10/20mg was more effective at reducing LDL-C, total cholesterol and Apo B versus doubling the baseline statin dose to simvastatin 40mg or atorvastatin 20mg or switching to rosuvastatin 10mg regardless of MetS status. These results were generally similar to those of the full cohort.