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Secondary SANDS analysis

The Journal of the American College of Cardiology has published the results of a secondary analysis of the SANDS Trial (Stop Atherosclerosis in Native Diabetics Study). These results have been reported in Pulse.

The original study was an open-label study conducted in native North Americans with type 2 diabetes that aimed to assess the progression of subclinical atherosclerosis as measured by carotid intimal medial thickness (CIMT) by comparing standard therapy with aggressive therapy.

Patients in the standard group were treated to a systolic blood pressure target of 130mmHg and an LDL-C of 2.6mmol/L while those in the aggressive group were treated to 115mmHg and 1.8mmol/L. CIMT regressed in the aggressive group and progressed in the standard group over the 3 year follow up of the study.

The secondary analysis has compared those patients in the aggressive arm of the study based on inclusion of ezetimibe in therapy. This analysis found no difference in the changes in CIMT between patients on monotherapy with a statin and those who were also treated with ezetimibe.

The results of this analysis are limited by the open-label nature of this study and the small size of the study population. Additionally, there is no reporting of the statin doses used because this study was target driven rather than treatment driven. It is therefore possible that ezetimibe was used in patients who were not at target on maximum dose of a statin or who could not tolerate higher doses.

Action: Further research is needed to determine whether treatment with ezetimibe produces a reduction in cardiovascular events in any patient group. Clinicians should continue to implement current guidance when considering using ezetimibe.