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Lack of association between thiazolidinediones and macular edema in type 2 diabetes: the ACCORD eye substudy.

ABSTRACT: OBJECTIVE:To assess the cross-sectional association of thiazolidinediones with diabetic macular edema (DME). METHODS:The cross-sectional association of DME and visual acuity with thiazolidinediones was examined by means of baseline fundus photographs and visual acuity measurements from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Visual acuity was assessed in 9690 participants in the ACCORD trial, and 3473 of these participants had fundus photographs that were centrally read in a standardized fashion by masked graders to assess DME and retinopathy from October 23, 2003, to March 10, 2006. RESULTS:Among the subsample, 695 (20.0%) people had used thiazolidinediones, whereas 217 (6.2%) people had DME. Thiazolidinedione use was not associated with DME in unadjusted (odds ratio [OR], 1.01; 95% confidence interval [CI], 0.71-1.44; P = .95) and adjusted (OR, 0.97; 95% CI, 0.67-1.40; P = .86) analyses. Significant associations with DME were found for retinopathy severity (P < .001) and age (OR, 0.97; 95% CI, 0.952-0.997; P = .03) but not for hemoglobin A(1c) (P = .06), duration of diabetes (P = .65), sex (P = .72), and ethnicity (P = .20). Thiazolidinedione use was associated with slightly greater visual acuity (0.79 letter; 95% CI, 0.20-1.38; P = .009) of uncertain clinical significance. CONCLUSIONS:In a cross-sectional analysis of data from the largest study to date, no association was observed between thiazolidinedione exposure and DME in patients with type 2 diabetes; however, we cannot exclude a modest protective or harmful association. Trial Registration clinicaltrials.gov Identifier: NCT00542178.

SUBMITTER: Ambrosius WT

PROVIDER: S-EPMC3010554 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature

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Lack of association between thiazolidinediones and macular edema in type 2 diabetes: the ACCORD eye substudy.

Ambrosius Walter T WT Danis Ronald P RP Goff David C DC Greven Craig M CM Gerstein Hertzel C HC Cohen Robert M RM Riddle Matthew C MC Miller Michael E ME Buse John B JB Bonds Denise E DE Peterson Kevin A KA Rosenberg Yves D YD Perdue Letitia H LH Esser Barbara A BA Seaquist Lea A LA Felicetta James V JV Chew Emily Y EY

Archives of ophthalmology (Chicago, Ill. : 1960) 20100301 3

<h4>Objective</h4>To assess the cross-sectional association of thiazolidinediones with diabetic macular edema (DME).<h4>Methods</h4>The cross-sectional association of DME and visual acuity with thiazolidinediones was examined by means of baseline fundus photographs and visual acuity measurements from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Visual acuity was assessed in 9690 participants in the ACCORD trial, and 3473 of these participants had fundus photographs that ...[more]

PMID: 20212201

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Project description:BackgroundMacular edema is secondary to leakage from diseased retinal capillaries and is an important cause of poor central visual acuity in patients with diabetic retinopathy.ObjectivesThis review evaluated the effectiveness and safety of intraocular steroids in treating diabetic macular edema (DME).Search strategyWe searched CENTRAL, MEDLINE, EMBASE in June 2007, reference lists, Science Citation Index and conference proceedings.Selection criteriaWe included randomized clinical trials (RCTs) evaluating any form of intravitreal steroids for treating DME.Data collection and analysisTwo authors independently assessed eligibility, methodological quality and extracted data. We performed meta-analyses when appropriate.Main resultsSeven studies, involving 632 DME eyes were included. Four examined the effectiveness of intravitreal triamcinolone acetate injection (IVTA), three examined intravitreal steroids implantation (fluocinolone acetonide implant (FAI) or dexamethasone drug delivery system (DDS)). Two trials were at low risk of bias, one was at median risk of bias, two were at high risk of bias and the remaining two were at unclear risk of bias. The preponderance of data suggest a beneficial effect from IVTA. Comparing IVTA with controls, the mean difference in visual acuity was -0.15 LogMAR (95% CI -0.21 to -0.09) at 3 months (based on three trials), -0.23 LogMAR (95% CI -0.33 to -0.13) at 6 months (two trials), -0.29 LogMAR (95% CI -0.47 to -0.11) at 9 months (one trial), and -0.11 LogMAR (95% CI -0.20 to -0.03) at 24 months (one trial), all in favor of IVTA. The relative risk (RR) for one or more lines improvement in visual acuity was 2.85 (95% CI 1.59 to 5.10) at 3 months (two trials), 1.25 (95% CI 0.66 to 2.38) at 6 months (one trial), and 2.17 (95% CI 1.15 to 4.11) at 24 months (one trial), all in favor of IVTA. We did not find evidence for three or more lines improvement in visual acuity. The mean difference in retinal thickness was -131.97 um (95% CI -169.08 to -94.86) at 3 months (two trials), -135.00 um (95% CI -194.50 to -75.50) at 6 months (one trial), -133.00 um (95% CI -199.86 to -66.14) at 9 months (one trial), and -59.00 um (95% CI -103.50 to -14.50) at 24 months (one trial), all in favor of IVTA. The RR for at least one grade macular edema resolution was 5.15 (95% CI 2.23 to 11.88) at 3 months in favor of IVTA (one trial). Two trials reported improved clinical outcome when FAI was compared to standard of care. Beneficial effect was also observed in one dexamethasone DDS trial. Increased intraocular pressure and cataract formation were side effects requiring monitoring and management.Authors' conclusionsRCTs included in this review suggest that steroids placed inside the eye by either intravitreal injection or surgical implantation may improve visual outcomes in eyes with persistent or refractory DME. Since the studies in our report focused on chronic or refractory DME, the question arises whether intravitreal steroids therapy could be of value in other stages of DME, especially the earlier stages either as standalone therapy or in combination with other therapies, such as laser photocoagulation.

Project description:Importance:The comorbidity of chronic kidney disease and diabetic retinopathy (DR) is well known. However, to our knowledge, no cohort study has demonstrated the effect of chronic kidney disease on the development or progression of DR. Objective:To investigate the association of chronic kidney disease with the development of DR and diabetic macular edema (DME) in type 2 diabetes. Design, Setting, and Participants:This 8-year prospective cohort study that was conducted in 2 medical centers in Taiwan included 2135 patients with type 2 diabetes. Exposures:The baseline and mean follow-up renal profiles including serum creatinine level, estimated glomerular filtration rate (eGFR), and urinary albumin/creatinine ratio (ACR). Main Outcomes and Measures:Diabetic retinopathy and DME were detected with nonmydriatic fundus photography. Cox regression analyses was used to evaluate the hazard ratios (HRs) for the renal profiles of new-onset DR, proliferative DR, and DME. Results:The mean (SD) age of the study participants was 63.4 (11.9) years and 1025 (48%) were women. A higher serum creatinine level (HR of 2.358 for an increase of 1 mg/dL [to convert to micromoles per liter, multiply by 76.25]; 95% CI, 1.901-2.924; P < .001), an estimated glomerular filtration rate of less than 60 mL/min/1.73m2 (40-60: HR, 2.235; 95% CI, 1.351-4.035; P = .002; 30-45: HR, 2.625; 95% CI, 1.436-4.798; P = .002; <30: HR, 5.488; 95% CI, 2.739-10.993; P < .001), and a urinary albumin to creatinine ratio (ACR) of more than 30 mg/g (31-300: HR, 3.202; 95% CI, 2.029-5.053; P < .001; >300: HR, 6.652; 95% CI, 3.922-11.285; P < .001) at baseline were all associated with the development of proliferative DR. A baseline urinary ACR of more than 30 mg/g (31-300: HR, 1.563; 95% CI, 1.078-2.267; P = .02; >300: HR, 2.707; 95% CI, 1.640-4.470; -2.707; P < 0.001) was associated with the development of DME. After adjusting the baseline values, the mean follow-up renal profiles, including a higher serum creatinine level (HR, 2.369 per mg/dL; 95% CI, 1.704-3.293; P < .001), an estimated glomerular filtration rate of less than 30 mL/min/1.73m2 (HR, 4.215; 95% CI, 1.265-14.039; P = .02), and a urinary ACR of more than 30 mg/g (31-300: HR, 2.344; 95% CI, 1.200-4.503; P = .01; >300: HR, 4.193; 95% CI, 1.638-10.735; P = .003) were still correlated with new-onset PDR during the follow-up periods. Conclusions and Relevance:Abnormal renal profiles at baseline, including a high serum creatinine level, low estimated glomerular filtration rate, and high urinary ACR, were associated with the development of PDR in patients with type 2 diabetes. A high baseline urinary ACR was associated with DME. Abnormal mean follow-up renal profiles were still correlated with new-onset PDR after adjusting for baseline values. Aggressive treatment for chronic kidney disease may have a role in preventing the deterioration of DR.

Project description:BACKGROUND:People with type 2 diabetes are at risk of cognitive impairment and brain atrophy. We aimed to compare the effects on cognitive function and brain volume of intensive versus standard glycaemic control. METHODS:The Memory in Diabetes (MIND) study was done in 52 clinical sites in North America as part of Action to Control Cardiovascular Risk in Diabetes (ACCORD), a double two-by-two factorial parallel group randomised trial. Participants (aged 55-80 years) with type 2 diabetes, high glycated haemoglobin A(1c) (HbA(1c)) concentrations (>7·5%; >58 mmol/mol), and a high risk of cardiovascular events were randomly assigned to receive intensive glycaemic control targeting HbA(1c) to less than 6·0% (42 mmol/mol) or a standard strategy targeting HbA(1c) to 7·0-7·9% (53-63 mmol/mol). Randomisation was via a centralised web-based system and treatment allocation was not masked from clinic staff or participants. We assessed our cognitive primary outcome, the Digit Symbol Substitution Test (DSST) score, at baseline and at 20 and 40 months. We assessed total brain volume (TBV), our primary brain structure outcome, with MRI at baseline and 40 months in a subset of participants. We included all participants with follow-up data in our primary analyses. In February, 2008, raised mortality risk led to the end of the intensive treatment and transition of those participants to standard treatment. We tested our cognitive function hypotheses with a mixed-effects model that incorporated information from both the 20 and 40 month outcome measures. We tested our MRI hypotheses with an ANCOVA model that included intracranial volume and factors used to stratify randomisation. This study is registered with ClinicalTrials.gov, number NCT00182910. FINDINGS:We consecutively enrolled 2977 patients (mean age 62·5 years; SD 5·8) who had been randomly assigned to treatment groups in the ACCORD study. Our primary cognitive analysis was of patients with a 20-month or 40-month DSST score: 1378 assigned to receive intensive treatment and 1416 assigned to receive standard treatment. Of the 614 patients with a baseline MRI, we included 230 assigned to receive intensive treatment and 273 assigned to receive standard treatment in our primary MRI analysis at 40 months. There was no significant treatment difference in mean 40-month DSST score (difference in mean 0·32, 95% CI -0·28 to 0·91; p=0·2997). The intensive-treatment group had a greater mean TBV than the standard-treatment group (4·62, 2·0 to 7·3; p=0·0007). INTERPRETATION:Although significant differences in TBV favoured the intensive treatment, cognitive outcomes were not different. Combined with the non-significant effects on other ACCORD outcomes, and increased mortality in participants in the intensive treatment group, our findings do not support the use of intensive therapy to reduce the adverse effects of diabetes on the brain in patients with similar characteristics to those of our participants. FUNDING:US National Institute on Aging and US National Heart, Lung, and Blood Institute.

Dataset Information

Lack of association between thiazolidinediones and macular edema in type 2 diabetes: the ACCORD eye substudy.

Publications

Lack of association between thiazolidinediones and macular edema in type 2 diabetes: the ACCORD eye substudy.

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