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Effects of Medical Therapies on Retinopathy Progression in Type 2 Diabetes

Methods

In a randomized trial, we enrolled 10,251 participants with type 2 diabetes who were at high risk for cardiovascular disease to receive either intensive or standard treatment for glycemia (target glycated hemoglobin level, <6.0% or 7.0 to 7.9%, respectively) and also for dyslipidemia (160 mg daily of fenofibrate plus simvastatin or placebo plus simvastatin) or for systolic blood-pressure control (target, <120 or <140 mm Hg). A subgroup of 2856 participants was evaluated for the effects of these interventions at 4 years on the progression of diabetic retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study Severity Scale (as assessed from seven-field stereoscopic fundus photographs, with 17 possible steps and a higher number of steps indicating greater severity) or the development of diabetic retinopathy necessitating laser photocoagulation or vitrectomy.

Results

At 4 years, the rates of progression of diabetic retinopathy were 7.3% with intensive glycemia treatment, versus 10.4% with standard therapy (adjusted odds ratio, 0.67; 95% confidence interval [CI], 0.51 to 0.87; P=0.003); 6.5% with fenofibrate for intensive dyslipidemia therapy, versus 10.2% with placebo (adjusted odds ratio, 0.60; 95% CI, 0.42 to 0.87; P=0.006); and 10.4% with intensive blood-pressure therapy, versus 8.8% with standard therapy (adjusted odds ratio, 1.23; 95% CI, 0.84 to 1.79; P=0.29).

Conclusions

Intensive glycemic control and intensive combination treatment of dyslipidemia, but not intensive blood-pressure control, reduced the rate of progression of diabetic retinopathy. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov numbers, NCT00000620 for the ACCORD study and NCT00542178 for the ACCORD Eye study.)

Dr. Goff reports receiving grant support or pending grant support from Merck and money for serving as a data and safety monitoring board member for a trial of a diabetes medication from Takeda; Dr. Cushman, consulting fees from Novartis, Takeda, Sanofi-Aventis, Bristol-Myers Squibb, King Pharmaceuticals, Daiichi–Sankyo, Gilead, Theravance, Pharmacopeia, and Sciele and grant support or pending grant support from Novartis, GlaxoSmithKline, and Merck; Dr. Ginsberg, advisory fees from Merck, Merck–Schering Plough, and Bristol-Myers Squibb–AstraZeneca; consulting fees from Merck, Abbott–AstraZeneca, Bristol-Myers Squibb, Roche, Isis–Genzyme, GlaxoSmithKline, Novartis, Pfizer, and Regeneron–Sanofi-Aventis; grant support or pending grant support from Merck, Isis–Genzyme, Roche, and AstraZeneca; payment for development of education presentations from Pfizer; and payment for travel and accommodation expenses from all these companies; Dr. Elam, payment for development of education presentations from Pfizer, Abbott Pharmaceuticals, and Merck–Schering Plough; and Dr. Gerstein, consulting fees from Sanofi-Aventis, GlaxoSmithKline, Eli Lilly, Novo Nordisk, AstraZeneca, Bristol-Myers Squibb, Roche, Medtronic, Merck, Bayer, Bioavail, and Jansen Ortho; grant support or pending grant support from Sanofi-Aventis, GlaxoSmithKline, Novo Nordisk, Merck, Pronova, and Roche; honoraria from Sanofi-Aventis, GlaxoSmithKline, Solvay, Boehringer Ingelheim, Servier, Bayer, Eli Lilly, Novo Nordisk, and Takeda; and payment for travel and accommodation expenses from all these companies; Dr. Schubart reports participating in trials sponsored by Sanofi-Aventis, Merck, and Johnson & Johnson. No other potential conflict of interest relevant to this article was reported.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Source Information

Address reprint requests to Dr. Chew at the National Institutes of Health, Bldg. 10, Clinical Research Center, Rm. 3-2531, 10 Center Dr., Mail Stop Center 1204, Bethesda, MD 20892, or at Dit e-mailadres wordt beveiligd tegen spambots. JavaScript dient ingeschakeld te zijn om het te bekijken..

Members of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Group are listed in Section 1 of the Supplementary Appendix (available with the full text of this article at NEJM.org), and members of the ACCORD Eye Study Group are listed in Section 2 of the Supplementary Appendix.

 
Bron: The NEW ENGLAND JOURNAL of MEDICINE

http://www.nejm.org/doi/full/10.1056/NEJMoa1001288

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