Effect of Lower Targets for Blood Pressure and LDL Cholesterol on Atherosclerosis in Diabetes: The SANDS Randomized Trial

• Published in: JAMA : the journal of the American Medical Association 2008-04, Vol.299 (14), p.1678-1689
• Main Authors: Howard, Barbara V, Roman, Mary J, Devereux, Richard B, Fleg, Jerome L, Galloway, James M, Henderson, Jeffrey A, Howard, Wm. James, Lee, Elisa T, Mete, Mihriye, Poolaw, Bryce, Ratner, Robert E, Russell, Marie, Silverman, Angela, Stylianou, Mario, Umans, Jason G, Wang, Wenyu, Weir, Matthew R, Weissman, Neil J, Wilson, Charlton, Yeh, Fawn, Zhu, Jianhui
• Format: Article
• Language: English
• Subjects: Adult; Adults; Antihypertensive Agents - therapeutic use; Atherosclerosis - ethnology; Atherosclerosis - etiology; Atherosclerosis - prevention & control; Blood Pressure; Cardiovascular disease; Carotid Artery, Common - diagnostic imaging; Cholesterol; Cholesterol, LDL - blood; Clinical trials; Diabetes; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - ethnology; Diabetes Mellitus, Type 2 - physiopathology; Female; Humans; Hyperlipidemias - complications; Hyperlipidemias - drug therapy; Hypertension - complications; Hypertension - drug therapy; Hypertrophy, Left Ventricular - complications; Hypertrophy, Left Ventricular - diagnostic imaging; Hypolipidemic Agents - therapeutic use; Indians, North American; Low density lipoprotein; Male; Middle Aged; Risk factors; Ultrasonography
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.299.14.1678

CONTEXT Individuals with diabetes are at increased risk for cardiovascular disease (CVD), but more aggressive targets for risk factor control have not been tested. OBJECTIVE To compare progression of subclinical atherosclerosis in adults with type 2 diabetes treated to reach aggressive targets of low-density lipoprotein cholesterol (LDL-C) of 70 mg/dL or lower and systolic blood pressure (SBP) of 115 mm Hg or lower vs standard targets of LDL-C of 100 mg/dL or lower and SBP of 130 mm Hg or lower. DESIGN, SETTING, AND PARTICIPANTS A randomized, open-label, blinded-to-end point, 3-year trial from April 2003-July 2007 at 4 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. INTERVENTIONS Participants were randomized to aggressive (n=252) vs standard (n=247) treatment groups with stepped treatment algorithms defined for both. MAIN OUTCOME MEASURES Primary end point was progression of atherosclerosis measured by common carotid artery intimal medial thickness (IMT). Secondary end points were other carotid and cardiac ultrasonographic measures and clinical events. RESULTS Mean target LDL-C and SBP levels for both groups were reached and maintained. Mean (95% confidence interval) levels for LDL-C in the last 12 months were 72 (69-75) and 104 (101-106) mg/dL and SBP levels were 117 (115-118) and 129 (128-130) mm Hg in the aggressive vs standard groups, respectively. Compared with baseline, IMT regressed in the aggressive group and progressed in the standard group (−0.012 mm vs 0.038 mm; P