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To the Editor: Dr Howard and colleagues¹ reported a 0.012-mm reduction in carotid intimal media thickness (IMT) among participants randomized to aggressive blood pressure/low-density lipid cholesterol–lowering treatment and a 0.038-mm increase in carotid IMT among participants randomized to standard treatment after 36 months in the Stop Atherosclerosis in Native Diabetics Study (SANDS). Randomization is assumed to equally distribute all known and unknown confounders between experimental groups. However, potential confounders may be unevenly distributed between groups in small trials or within strata of large trials and subsequently induce bias despite randomization.² Such accidental bias is possible in SANDS because at baseline 82% of participants in the aggressive treatment group concomitantly received oral hypoglycemic medications compared with 73% in the standard treatment group (P = .02). Oral hypoglycemic medications such as metformin and pioglitazone have demonstrated beneficial effects on carotid IMT independent of glycemic control,^3-4 and both medications are common components of . . . [Full Text of this Article]

Eva L. Evans, MPH
eevans@hsc.unt.edu

Rohit P. Ojha, MPH; Lori A. Fischbach, PhD, MPH
Department of Epidemiology
University of North Texas Health Science Center
Fort Worth

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