of lowering LDL-C with statins alone vs statins plus ezetimibe on common CIMT in patients with type 2 diabetes and no known prior cardiovascular events. The SANDS Trial was a randomized, open labeled, blinded to outcomes, 3-year trial examining the effects of aggressive goals for LDL-C (Յ70 mg/dL) non-high-density lipoprotein cholesterol (Ͻ100 mg/dL) and blood pressure (Ͻ115/75 mm Hg) reduction vs standard goals of Ͻ100 mg/dL, Ͻ130mg/dL, and Ͻ130/80 mm Hg, respectively, in 499 Native American patients with type 2 diabetes. The primary outcome was change in CIMT after 36 months of treatment.Ezetimibe is an antihyperlipidemic medication used to lower cholesterol levels. It acts by decreasing cholesterol absorption in the intestine and can be used alone or with other cholesterol-lowering medications. It is generally indicated for use when cholesterol levels cannot be controlled with statins alone.The authors compared CIMT levels for 36 months in diabetic individuals aged Ͼ40 years receiving statins plus ezetimibe vs statins alone. The CIMT changes in both aggressive subgroups were compared with changes in the standard subgroups. LDL-C was reduced by 31 mg/dL (range, 23-37 mg/dL) and 32 mg/dL (range, 27-38 mg/dL) in the aggressive group by statins plus ezetimibe and statins alone, respectively. This was compared with changes of 1 mg/dL (range Ϫ3 to 6 mg/dL) in the standard group vs both aggressive subgroups (P Ͻ .0001). Within the aggressive group, mean CIMT at 36 months regressed in the ezetimibe and nonezetimibe subgroups but progressed in the standard treatment arm (Ϫ0.025, Ϫ0.012, and 0.039 mm, respectively; P Ͻ .0001).Comment: CIMT is considered a marker of future cardiovascular risk and thus can serve as a short-term surrogate for potential long-term cardiovascular events. The current trial has, therefore, two potential significant implications. The first is that ezetimibe does not provide any advantage over a statin alone in reducing long-term cardiovascular risk. The results would therefore seem to confirm the Enhanced Trial (N Engl J Med 2008;358: 1431-43) of 720 patients with familial hypercholesterolemia where there was no statistically significant difference in the primary end point of mean increase in CIMT over 24 months in the patients treated with statins alone vs statin plus ezetimibe. The second point is that it does appear possible to actually reduce surrogate markers of future atherosclerosis by aggressively lowering cholesterol beyond standard target levels. In its early stages, atherosclerosis may be a reversible disease.
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