title: 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.
authors.affiliation: Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest University Health Sciences, Medical Center Boulevard, Winston-Salem, NC 27157, USA. wambrosi@wfubmc.edu
authors.forename: Walter T
authors.initials: WT
authors.lastname: Ambrosius
authors.forename: Ronald P
authors.initials: RP
authors.lastname: Danis
authors.forename: David C
authors.initials: DC
authors.lastname: Goff
authors.forename: Craig M
authors.initials: CM
authors.lastname: Greven
authors.forename: Hertzel C
authors.initials: HC
authors.lastname: Gerstein
authors.forename: Robert M
authors.initials: RM
authors.lastname: Cohen
authors.forename: Matthew C
authors.initials: MC
authors.lastname: Riddle
authors.forename: Michael E
authors.initials: ME
authors.lastname: Miller
authors.forename: John B
authors.initials: JB
authors.lastname: Buse
authors.forename: Denise E
authors.initials: DE
authors.lastname: Bonds
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Peterson
authors.forename: Yves D
authors.initials: YD
authors.lastname: Rosenberg
authors.forename: Letitia H
authors.initials: LH
authors.lastname: Perdue
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Esser
authors.forename: Lea A
authors.initials: LA
authors.lastname: Seaquist
authors.forename: James V
authors.initials: JV
authors.lastname: Felicetta
authors.forename: Emily Y
authors.initials: EY
authors.lastname: Chew
mesh_terms: D003430:Cross-Sectional Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D003930:Diabetic Retinopathy / Q000139:chemically induced* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D015994:Incidence; D008024:Ligands; D008269:Macular Edema / Q000139:chemically induced* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D045162:Thiazolidinediones / Q000009:adverse effects*; D014792:Visual Acuity / Q000502:physiology
chemical_list: D007004:Hypoglycemic Agents; D008024:Ligands; D045162:Thiazolidinediones; C089946:2,4-thiazolidinedione