ACCORD Trial Purpose and Design (June 30, 2006). Patients with type 2 diabetes mellitus die of cardiovascular disease (CVD) at rates two to four times higher than non-diabetic populations of similar demographic characteristics. They also experience increased rates of nonfatal myocardial infarction and stroke. With the growing prevalence of obesity in the United States, CVD associated with type 2 diabetes is expected to become an even greater public health challenge in the coming decades than it is now. Expected increases in event rates will be associated with a concomitant rise in suffering and resource utilization. Despite the importance of this health problem in the North American population, there is a lack of definitive data on the effects of intensive control of glycemia and other CVD risk factors on CVD event rates in diabetic patients. The overall goal of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is to address this challenge by testing three complementary medical treatment strategies for type 2 diabetes to enhance the options for reducing the still very high rate of major CVD morbidity and mortality in this disease. The design is a randomized, multicenter, double 2 X 2 factorial design in 10,251 patients with type 2 diabetes mellitus. The trial is designed to test the effects on major CVD events of intensive glycemia control, of treatment to increase HDL-cholesterol and lower triglycerides (in the context of good LDL-C and glycemia control), and of intensive blood pressure control (in the context of good glycemia control). All 10,251 participants will be in the overarching glycemia trial. In addition, one 2 X 2 trial will also address the lipid question in 5,518 of the participants and the other 2 X 2 trial will address the blood pressure question in 4,733 of the participants. The 10,251 participants will be treated and followed for about 4 to 8 years (approximate mean of 5.6 years) at 77 Clinical Sites administratively located within 7 Clinical Center Networks in the United States and Canada. Recruitment occurred in two non-contiguous periods: an initial period that began in January 2001 for the Vanguard Phase of the trial (during which 1174 participants were randomized) and then a subsequent period beginning in January 2003 and ending in October 2005. Follow-up is scheduled to end in June 2009, with the primary results announced in early 2010. Additional information can be found at www.accordtrial.org. ACCORD Trial Update, February 6, 2008: """"""""For Safety, NHLBI Changes Intensive Blood Sugar Treatment Strategy in Clinical Trial of Diabetes and Cardiovascular Disease."""""""" The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped one treatment within a large, ongoing North American clinical trial of diabetes and cardiovascular disease 18 months early due to safety concerns after review of available data, although the study will continue. In this trial of adults with type 2 diabetes at especially high risk for heart attack and stroke, the medical strategy to intensively lower blood glucose (sugar) below current recommendations increased the risk of death compared with a less-intensive standard treatment strategy. Study participants receiving intensive blood glucose lowering treatment will now receive the less-intensive standard treatment. The ACCORD (Action to Control Cardiovascular Risk in Diabetes) study enrolled 10,251 participants. Of these, 257 in the intensive treatment group have died, compared with 203 within the standard treatment group. This is a difference of 54 deaths, or 3 per 1,000 participants each year, over an average of almost four years of treatment. The death rates in both groups were lower than seen in similar populations in other studies. Additional information can be found at: www.nhlbi.nih.gov/health/prof/heart/other/accord/. The ACCORD Eye Study examines diabetic retinopathy with 2 eye exams of fundus photography of 7 stereoscopic fields, done in the baseline year (2003) and followed up 4 to 6 years later. This substudy is designed to evaluate the effects of these medical treatments on diabetic retinopathy within the ACCORD Trial.
