OBJECTIVE: In the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, ∼4 years of intensive versus standard glycemic control in participants with type 2 diabetes and other cardiovascular risk factors had a neutral effect on the composite cardiovascular outcome, increased cardiovascular and total mortality, and reduced nonfatal myocardial infarction. Effects of the intervention during prolonged follow-up were analyzed. RESEARCH DESIGN AND METHODS: All surviving ACCORD participants were invited to participate in the ACCORD Follow-on (ACCORDION) study, during which participants were treated according to their health care provider's judgment. Cardiovascular and other health-related outcomes were prospectively collected and analyzed using an intention-to-treat approach according to the group to which participants were originally allocated. RESULTS: A total of 8,601 people, representing 98% of those who did not suffer a primary outcome or death during the ACCORD trial, were monitored for a median of 8.8 years and a mean of 7.7 years from randomization. Intensive glucose lowering for a mean of 3.7 years had a neutral long-term effect on the primary composite outcome (nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death), death from any cause, and an expanded composite outcome that included all-cause death. Moreover, the risk of cardiovascular mortality noted during the active phase (hazard ratio 1.49; 95% CI 1.19, 1.87; P < 0.0001) decreased (HR 1.20; 95% CI 1.03, 1.39; P = 0.02). CONCLUSIONS: In high-risk people with type 2 diabetes monitored for 9 years, a mean of 3.7 years of intensive glycemic control had a neutral effect on death and nonfatal cardiovascular events but increased cardiovascular-related death.
Bibliographical noteFunding Information:
ACCORD was supported by National Heart, Lung, and Blood Institute contracts N01-HC-95178, N01-HC-95179, N01-HC-95180, N01-HC-95181, N01-HC-95182, N01-HC-95183, N01-HC-95184; IAA #Y1-HC-9035; and IAA #Y1-HC-1010. Other components of the National Institutes of Health, including the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Eye Institute, contributed funding. The Centers for Disease Control and Prevention funded substudies within ACCORD on cost-effectiveness and health-related quality of life. General Clinical Research Centers provided support at many sites. This material is also the result of work supported with resources and the use of facilities at the Veterans Affairs medical centers, as listed previously. ACCORDION activities were supported by National Heart, Lung, and Blood Institute contract HHSN268201100027C. The contents do not represent the views of the National Institutes of Health, the U.S. Department of Veterans Affairs, or the U.S. Government. During ACCORD, the following companies provided study medications, equipment, or supplies: Abbott Laboratories (Abbott Park, IL), Amylin Pharmaceutical (San Diego, CA), AstraZenecaPharmaceuticalsLP(Wilmington,DE), Bayer HealthCare LLC (Tarrytown, NY), Closer Healthcare, Inc. (Tequesta, FL), GlaxoSmithKline Pharmaceuticals (Philadelphia, PA), King Pharmaceuticals, Inc. (Bristol, TN), Merck & Co., Inc. (Whitehouse Station, NJ), Novartis Pharmaceuticals, Inc. (East Hanover, NJ), Novo Nordisk, Inc. (Princeton, NJ), Omron Healthcare, Inc. (Schaumburg, IL), Sanofi U.S. (Bridgewater, NJ), Schering-Plough Corporation (Kenilworth, NJ), and Takeda Pharmaceuticals (Deerfield, IL).
© 2016 by the American Diabetes Association.