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Research

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ACCORD

Official Title

Action to Control Cardiovascular Risk in Diabetes

Status

Completed

Overview

To test treatment strategies aimed at reducing CV events in type 2 diabetes. The trial is designed to test the effects of major CVD events of intensive glycemia control, of treatment to increase HDL-cholesterol and lower triglycerides (in the context of good LDL-c and glycemias control), and of intensive blood pressure control (in the context of good glycemia control). On February 6 2008 the intensive arm of ACCORD was stopped and all intensive glycemia participants were “transitioned” to the standard glycemia arm of the trial due to an increase in mortality. All other arms continued as per protocol.

Study Design

Randomized, multicenter, double 2X2 factorial design.

Primary Endpoint

The primary endpoints are Reduction in blood Pressure, Reduction in Heart Rate, Modify lipids. Secondary endpoints: Platelet aggregation. Not adjudicated

Number of Patients

10251

Number of Sites

77

Number of Countries

2

Study Period

2001–2009

Principal Investigator

Hertzel Gerstein

Research Coordinator

Rosalie Russo

Key Publications

  • Simons-Morton DG, Genuth S, Byington RP, Gerstein HC, Friedewald WT. The burden of treatment failure in type 2 diabetes: response to Brown et al. Diabetes Care 2005;28:761-2.
  • Accord Study Group, Buse JB, Bigger JT, et al. Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol 2007;99:21i-33i.
  • Buse JB, Bigger JT, Byington RP, et al. Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol 2007;99:21i-33i.
  • Gerstein HC, Riddle MC, Kendall DM, et al. Glycemia treatment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol 2007;99:34i-43i.
  • Goff DC, Jr., Gerstein HC, Ginsberg HN, et al. Prevention of cardiovascular disease in persons with type 2 diabetes mellitus: current knowledge and rationale for the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol 2007;99:4i-20i.
  • Gerstein HC, Miller ME, Byington RP, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358:2545-59.
  • Control Group, Turnbull FM, Abraira C, et al. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia 2009;52:2288-98.
  • Ambrosius WT, Danis RP, Goff DC, Jr., et al. Lack of association between thiazolidinediones and macular edema in type 2 diabetes: the ACCORD eye substudy. Archives of ophthalmology 2010;128:312-8.
  • Chew EY, Ambrosius WT, Davis MD, et al. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med 2010;363:233-44.
  • Cushman WC, Evans GW, Byington RP, et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010;362:1575-85.
  • Ginsberg HN, Elam MB, Lovato LC, et al. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010;362:1563-74.
  • Group AS, Cushman WC, Evans GW, et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010;362:1575-85.
  • Group AS, Group AES, Chew EY, et al. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med 2010;363:233-44.
  • Miller ME, Bonds DE, Gerstein HC, et al. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ 2010;340:b5444.
  • Pop-Busui R, Evans GW, Gerstein HC, et al. Effects of cardiac autonomic dysfunction on mortality risk in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Diabetes Care 2010;33:1578-84.
  • Gerstein HC, Miller ME, Genuth S, et al. Long-term effects of intensive glucose lowering on cardiovascular outcomes. N Engl J Med 2011;364:818-28.
  • Launer LJ, Miller ME, Williamson JD, et al. Effects of intensive glucose lowering on brain structure and function in people with type 2 diabetes (ACCORD MIND): a randomised open-label substudy. Lancet Neurol 2011;10:969-77.
  • Gerstein HC, Ambrosius WT, Danis R, et al. Diabetic Retinopathy, its Progression and Incident Cardiovascular Events in the ACCORD Trial. Diabetes Care 2012.
  • Ismail-Beigi F, Craven TE, O’Connor PJ, et al. Combined intensive blood pressure and glycemic control does not produce an additive benefit on microvascular outcomes in type 2 diabetic patients. Kidney Int 2012;81:586-94.
  • Punthakee Z, Miller ME, Launer LJ, et al. Poor cognitive function and risk of severe hypoglycemia in type 2 diabetes: post hoc epidemiologic analysis of the ACCORD trial. Diabetes Care 2012;35:787-93.
  • Miller ME, Williamson JD, Gerstein HC, et al. Effects of Randomization to Intensive Glucose Control on Adverse Events, Cardiovascular Disease and Mortality in Older Versus Younger Adults in the ACCORD Trial. Diabetes Care 2013.
  • Sullivan MD, Katon WJ, Lovato LC, et al. Association of depression with accelerated cognitive decline among patients with type 2 diabetes in the ACCORD-MIND trial. JAMA psychiatry 2013;70:1041-7.
  • Hugenschmidt CE, Lovato JF, Ambrosius WT, et al. The Cross-sectional and Longitudinal Associations of Diabetic Retinopathy With Cognitive Function and Brain MRI Findings: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial. Diabetes Care 2014;37:3244-52.
  • Margolis KL, O’Connor PJ, Morgan TM, et al. Outcomes of Combined Cardiovascular Risk Factor Management Strategies in Type 2 Diabetes: The ACCORD Randomized Trial. Diabetes Care 2014;37:1721-8.
  • Punthakee Z, Miller ME, Simmons DL, et al. Durable change in glycaemic control following intensive management of type 2 diabetes in the ACCORD clinical trial. Diabetologia 2014;57:2030-7.
  • Williamson JD, Launer LJ, Bryan RN, et al. Cognitive function and brain structure in persons with type 2 diabetes mellitus after intensive lowering of blood pressure and lipid levels: a randomized clinical trial. JAMA internal medicine 2014;174:324-33.
  • Zhang Z, Lovato J, Battapady H, et al. Effect of Hypoglycemia on Brain Structure in People With Type 2 Diabetes: Epidemiological Analysis of the ACCORD-MIND MRI Trial. Diabetes Care 2014;37:3279-85.
  • Shah HS, Morieri ML, Marcovina SM, et al. Modulation of GLP-1 Levels by a Genetic Variant That Regulates the Cardiovascular Effects of Intensive Glycemic Control in ACCORD. Diabetes Care 2018;41:348-55.

For more information, please visit http://www.accordtrial.org/public/index.cfm