Original articleThe Effects of Medical Management on the Progression of Diabetic Retinopathy in Persons with Type 2 Diabetes: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
Section snippets
The ACCORD Study
The designs of the ACCORD study and the ACCORD Eye Study have been described elsewhere.1, 6 The ACCORD study was approved by the institutional review board of each clinical center. Briefly, the ACCORD study was a multicenter study with a total of 10 251 participants randomly assigned in equal numbers to 2 glycemia management treatment arms. The intensive treatment arm aimed to achieve and maintain glycated hemoglobin (HbA1c) level <6.0%. The standard treatment arm targeted an HbA1c range of
Results
From January 2001 to October 2005, 10 251 participants were recruited in the main ACCORD trial. From October 2003 to February 2006, 3472 eligible participants were enrolled in the ACCORD Eye Study. Of these, 2856 (85% of survivors) returned for the second eye examination and fundus photographs.
Discussion
The previously reported findings of reductions in diabetic retinopathy progression resulting from the intensive treatment of hyperglycemia and dyslipidemia studied in ACCORD7 are confirmed by the analyses reported and extended by analyses of subgroups and of alternative outcome measures. In both trials, 4-year rates of the primary outcome, a composite of ≥3 steps of progression along the ETDRS diabetic retinopathy severity scale for persons or treatment of diabetic retinopathy with
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∗Supplemental material is available at www.aaojournal.org.
Financial Disclosure(s): The author(s) have made the following disclosure(s): R.P.D.: Board member – EyeKor, LLC; Consultant – Allergan, GlaxoSmithKline, Thrombogenics (Data and Safety Monitoring Board [DSMB]), Oraya, Eli Lilly. L.H.P.: Grants – National Heart, Lung, and Blood Institute, NIH. D.C.G.: Consultant to and receives payment for lectures, Speakers bureaus – Merck; DSMB – Takeda. L.A.L,: Consultant – AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Merck, Novo Nordisk, Roche, Sanofi, Servier, Takeda; Research grants – AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Merck, Novo Nordisk, Roche, and Sanofi; Speakers bureaus – AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, Merck, Novo Nordisk, Sanofi, Takeda. C.G.: Consultant – Thrombogenics. W.T.A.: Consultant – NIH/Office of Behavioral and Social Sciences Research and several DSMBs; Receives payment for the development of educational presentations, has a salary covered by NIH grants; Employed –Wake Forest School of Medicine. F.I.-.B.: Research grant – Novo-Nordisk for Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER), and Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN); Shares –Thermalin Diabetes.
Supported by 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) from the National Heart, Lung, and Blood Institute and the National Institutes of Health (NIH), with additional support from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Eye Institute, the National Institute on Aging, and the Centers for Disease Control and Prevention. General clinical research centers provided support at many sites. The following companies donated study medications, equipment, or supplies: Abbott Laboratories, Amylin Pharmaceutical, AstraZeneca Pharmaceuticals, Bayer HealthCare, Closer Healthcare, GlaxoSmithKline Pharmaceuticals, King Pharmaceuticals, Merck, Novartis Pharmaceuticals, Novo Nordisk, Omron Healthcare, Sanofi-Aventis U.S., and Takeda Pharmaceuticals.
The study was registered with ClinicalTrials.gov numbers, NCT00000620 for the ACCORD study and NCT00542178 for the ACCORD Eye Study.
See Editorial on page 2295.
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A listing of the Action to Control Cardiovascular Risk in Diabetes Eye Study Research Group is shown in the Supplementary Appendix.