Effect of Statins Alone Versus Statins Plus Ezetimibe on Carotid Atherosclerosis in Type 2 Diabetes: The SANDS (Stop Atherosclerosis in Native Diabetics Study) Trial

Objectives: This secondary analysis from the SANDS (Stop Atherosclerosis in Native Diabetics Study) trial examines the effects of lowering low-density lipoprotein cholesterol (LDL-C) with statins alone versus statins plus ezetimibe on common carotid artery intima-media thickness (CIMT) in patients with type 2 diabetes and no prior cardiovascular event. Background: It is unknown whether the addition of ezetimibe to statin therapy affects subclinical atherosclerosis. Methods: Within an aggressive group (target LDL-C ≤70 mg/dl; non–high-density lipoprotein cholesterol ≤100 mg/dl; systolic blood pressure ≤115 mm Hg), change in CIMT over 36 months was compared in diabetic individuals >40 years of age receiving statins plus ezetimibe versus statins alone. The CIMT changes in both aggressive subgroups were compared with changes in the standard subgroups (target LDL-C ≤100 mg/dl; non–high-density lipoprotein cholesterol ≤130 mg/dl; systolic blood pressure ≤130 mm Hg). Results: Mean (95% confidence intervals) LDL-C was reduced by 31 (23 to 37) mg/dl and 32 (27 to 38) mg/dl in the aggressive group receiving statins plus ezetimibe and statins alone, respectively, compared with changes of 1 (−3 to 6) mg/dl in the standard group (p < 0.0001) versus both aggressive subgroups. Within the aggressive group, mean CIMT at 36 months regressed from baseline similarly in the ezetimibe (−0.025 [−0.05 to 0.003] mm) and nonezetimibe subgroups (−0.012 [−0.03 to 0.008] mm) but progressed in the standard treatment arm (0.039 [0.02 to 0.06] mm), intergroup p < 0.0001. Conclusions: Reducing LDL-C to aggressive targets resulted in similar regression of CIMT in patients who attained equivalent LDL-C reductions from a statin alone or statin plus ezetimibe. Common carotid artery IMT increased in those achieving standard targets. (Stop Atherosclerosis in Native Diabetics Study [SANDS]; NCT00047424) [Copyright &y& Elsevier]