Effect of lower targets for blood pressure and LDL cholesterol on atherosclerosis in diabetes: the SANDS randomized trial.

Description

The objective of the Stop Atherosclerosis in Native Diabetics Study (SANDS) was to compare the progression of subclinical atherosclerosis in American Indian men and women who received either standard or aggressive treatment for LDL cholesterol levels and blood pressure. A total of 499 participants at least 40 years of age were randomized to either group. Atherosclerosis progression/regression was measured by common carotid intima-media thickness (IMT). Mean targets were obtained for LDL cholesterol levels [2.59 mmol/l (100 mg/dl) for standard treatment and 1.81 mmol/l (70 mg/dl) for aggressive treatment] and systolic blood pressure (130 mmHg for standard treatment and 115 mmHg for aggressive treatment). Compared to baseline, IMT regressed in the aggressive group and progressed in the standard group (-0.012 mm vs. 0.038 mm, p<0.001). Similarly, they found that left ventricular mass index showed a greater decrease in the aggressive than in the standard treatment group (-2.4 g/m2.7 vs. -1.2 g/m2.7, p=0.03). Based on these results, the authors concluded that although aggressive treatment of LDL cholesterol levels and blood pressure had clear cardiovascular benefits, more studies with longer follow-up periods are needed to investigate whether aggressive treatment of such risk factors would result in long term benefits in cardiovascular disease event rates. This paper was accompanied by an editorial by Peterson and Wang who highlighted the fact that SANDS was one of the first studies to examine the role of aggressive risk factor treatment in a high-risk primary prevention setting. Because it was a primary prevention study, annual event rates were rather low in SANDS. In order to assess hard clinical outcomes, the editorial’s authors noted that such prevention trials require larger sample sizes and longer follow-up periods. Peterson and Wang also brought up the point that trials like SANDS would benefit from looking at patient outcomes rather than measuring surrogate markers of the disease. In this regard, they mentioned several trials in which a given intervention had beneficial effects on surrogate markers without affecting “hard” clinical cardiovascular outcomes.