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The 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.

ABSTRACT: To report additional ocular outcomes of intensive treatment of hyperglycemia, blood pressure, and dyslipidemia in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study.Double 2×2 factorial, multicenter, randomized clinical trials in people with type 2 diabetes who had cardiovascular disease or cardiovascular risk factors. In the glycemia trial, targets of intensive and standard treatment were: hemoglobin A1c <6.0% and 7.0% to 7.9%, respectively, and in the blood pressure trial: systolic blood pressures of <120 and <140 mmHg, respectively. The dyslipidemia trial compared fenofibrate plus simvastatin with placebo plus simvastatin.Of the 3472 ACCORD Eye Study participants enrolled, 2856 had 4-year data (85% of survivors).Eye examinations and fundus photographs were taken at baseline and year 4. Photographs were graded centrally for retinopathy severity and macular edema using the Early Treatment Diabetic Retinopathy Study (ETDRS) methods.Three or more steps of progression on the ETDRS person scale or treatment of retinopathy with photocoagulation or vitrectomy.As previously reported, there were significant reductions in the primary outcome in the glycemia and dyslipidemia trials, but no significant effect in the blood pressure trial. Results were similar for retinopathy progression by 1, 2, and 4 or more steps on the person scale and for ? 2 steps on the eye scale. In the subgroup of patients with mild retinopathy at baseline, effect estimates were large (odds ratios, ?0.30; P < 0.001), but did not reach nominal significance for participants with no retinopathy or for those with moderate to severe retinopathy at baseline.Slowing of progression of retinopathy by intensive treatment of glycemia was observed in ACCORD participants, whose average age and diabetes duration were 62 and 10 years, respectively, and who had cardiovascular disease or cardiovascular risk factors. The effect seemed stronger in patients with mild retinopathy. Similar slowing of progression was observed in patients treated with fenofibrate, with no effect observed with intensive blood pressure treatment. This is the second study to confirm the benefits of fenofibrate in reducing diabetic retinopathy progression, and fenofibrate should be considered for treatment of diabetic retinopathy.

SUBMITTER: Chew EY

PROVIDER: S-EPMC4252767 | biostudies-other | 2014 Dec

REPOSITORIES: biostudies-other

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The 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.

Chew Emily Y EY Davis Matthew D MD Danis Ronald P RP Lovato James F JF Perdue Letitia H LH Greven Craig C Genuth Saul S Goff David C DC Leiter Lawrence A LA Ismail-Beigi Faramarz F Ambrosius Walter T WT

Ophthalmology 20140829 12

<h4>Purpose</h4>To report additional ocular outcomes of intensive treatment of hyperglycemia, blood pressure, and dyslipidemia in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study.<h4>Design</h4>Double 2×2 factorial, multicenter, randomized clinical trials in people with type 2 diabetes who had cardiovascular disease or cardiovascular risk factors. In the glycemia trial, targets of intensive and standard treatment were: hemoglobin A1c <6.0% and 7.0% to 7.9%, respectively, and ...[more]

PMID: 25172198

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Project description:BACKGROUND:We investigated whether intensive glycemic control, combination therapy for dyslipidemia, and intensive blood-pressure control would limit the progression of diabetic retinopathy in persons with type 2 diabetes. Previous data suggest that these systemic factors may be important in the development and progression of diabetic retinopathy. 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.)

Project description:ImportanceA patient’s perceived barriers to diabetes self-management (DSM) may affect his or her risk of diabetic retinopathy (DR); however, few studies have examined this association.ObjectiveTo examine the association between perceived barriers to DSM and the severity spectrum of DR in Asian patients with type 2 diabetes.Design, setting, and participantsA cross-sectional clinic-based study, the Singapore Diabetes Management Project, was conducted from December 28, 2010, to March 20, 2013, at the Singapore National Eye Centre, a tertiary eye care institute. After excluding patients with type 1 diabetes and ungradable fundus images, 361 participants were included in the analyses. Statistical analysis was conducted from July 20 to September 8, 2017.ExposureThe degree of perceived barriers to DSM was assessed using a 23-item questionnaire comprising items about knowledge of DSM, access to care, and confidence in health care professionals. Rasch analysis was used to optimize the scale’s psychometric properties, with lower scores indicating a higher degree of self-perceived barriers.Main outcomes and measuresDiabetic retinopathy was graded from 2-field retinal images into categories of no DR (Early Treatment Diabetic Retinopathy Study levels 10-15; n = 154), mild to moderate DR (levels 20-43; n = 112), and severe DR (levels ≥53 and/or presence of clinically significant macular edema; n = 95) using the modified Airlie House classification system of DR. Multinomial logistic regression models were used to assess the association between perceived barriers and severity of DR in the worse-affected eye.ResultsAmong the 361 participants (105 women and 256 men; mean [SD] age, 57 [8] years), a greater magnitude of perceived barriers to DSM was independently associated with higher odds of having any DR (odds ratio, 1.32; 95% CI, 1.06-1.66), mild to moderate DR (odds ratio, 1.30; 95% CI, 1.01-1.68), and severe DR (odds ratio, 1.36; 95% CI, 1.03-1.79). This association was independent of diabetes control (hemoglobin A1c, blood pressure, and lipid levels), presenting visual acuity, and socioeconomic indicators.Conclusions and relevanceThese results suggest that greater perceived barriers to DSM are independently associated with severity of DR. Although longitudinal data are needed, these findings suggest that evidence-based interventions to reduce patient-, practitioner-, and system-related barriers to diabetes care may help reduce the risk of DR.

Dataset Information

The 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.

Publications

The 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.

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