Reducing low-density lipoprotein cholesterol (LDL-C) and systolic blood pressure (SBP) to lower targets in individuals with Type 2 diabetes resulted in regression of carotid intimal medial thickness (IMT) and greater decrease in left ventricular mass, according to the SANDS randomized trial published in the April 9 issue of the Journal of the American Medical Association.
Barbara V. Howard, PhD, of the MedStar Research Institute in Hyattsville, Md., and colleagues said they undertook the SANDS (Stop Atherosclerosis in Native Diabetics Study) trial because individuals with diabetes are at increased risk for cardiovascular disease (CVD), but more aggressive targets for risk factor control have not been tested.
The researchers sought to compare progression of subclinical atherosclerosis in adults with Type 2 diabetes treated to reach aggressive targets of LDL-C of 70 mg/dL or lower and SBP of 115 mm Hg or lower versus standard targets of LDL-C of 100 mg/dL or lower and SBP of 130 mm Hg or lower.
To achieve the endpoints, the investigators conducted a randomized, open-label, blinded-to-end point, three-year trial from April 2003 to July 2007 at four clinical centers in Oklahoma, Arizona and South Dakota. Participants were 499 American Indian men and women, aged 40 years or older with Type 2 diabetes and no prior CVD events, the authors wrote.
Among the participants, 252 were randomized to an aggressive treatment, and 247 partook in standard treatment with stepped treatment algorithms defined for both.
The investigators said the primary endpoint was progression of atherosclerosis measured by common carotid artery IMT, and the secondary end points were other carotid and cardiac ultra-sonographic measures and clinical events.
Howard and colleagues found that the mean target LDL-C and SBP levels for both groups were reached and maintained. The mean levels for LDL-C in the last 12 months averaged 72 and 104 mg/dL and SBP levels were 117 and 129 mm Hg in the aggressive versus standard groups, respectively, according to the researchers.
Compared with baseline, the researchers concluded that IMT regressed in the aggressive group and progressed in the standard group (–0.012 mm vs. 0.038 mm); carotid arterial cross-sectional area also regressed (–0.02 mm 2 vs. 1.05 mm 2); and there was greater decrease in left ventricular mass index (–2.4 g/m 2.7 vs. –1.2 g/m 2.7) in the aggressive group. The investigators said that rates of adverse events (38.5 percent and 26.7 percent) and serious adverse events (four vs. one participants) related to blood pressure medications were higher in the aggressive group. Clinical CVD events (1.6/100 and 1.5/100 person-years) did not differ significantly between groups, the authors wrote.
Overall, Howard and colleagues found that the clinical events were lower than expected and did not differ significantly between groups.
The authors also noted that further follow-up is needed to determine whether these improvements will result in lower long-term CVD event rates and costs and favorable risk-benefit outcomes.