Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2010 Mar;128(3):312-8.
doi: 10.1001/archophthalmol.2009.310.

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

Affiliations
Randomized Controlled Trial

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

Walter T Ambrosius et al. Arch Ophthalmol. 2010 Mar.

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
ACCORD-Eye recruitment flow chart. ACCORD-Eye began recruitment after initiation of the main trial.

Comment in

  • Macular edema and thiazolidinediones.
    Colucciello M, Ryan E. Colucciello M, et al. Arch Ophthalmol. 2010 Dec;128(12):1630-1; author reply 1631-2. doi: 10.1001/archophthalmol.2010.287. Arch Ophthalmol. 2010. PMID: 21149797 No abstract available.

References

    1. Colucciello M. Vision Loss Due to Macular Edema Induced by Rosiglitazone Treatment of Diabetes Mellitus. Arch Ophthalmol. 2005;123:1273–1275. - PubMed
    1. Ryan EH, Han DP, Ramsay RC, Cantrill HL, Bennett SR, Dev S, Williams DF. Diabetic macular edema associated with glitazone use. Retina. 2006;26:562–570. - PubMed
    1. Wooltorton E, Kendall C. Rosiglitazone (Avandia) and macular edema. CMAJ. 2006;174(5):623. - PMC - PubMed
    1. GlaxoSmithKline, “Dear Doctor”. [accessed February 13, 2006]. letter, http://www.hc-sc.gc.ca/dhpmps/medeff/advisories-avis/prof/2005/avandia_a....
    1. GlaxoSmithKline, “Dear Doctor”. [accessed February 13, 2006]. letter, http://www.fda.gov/medwatch/safety/2006/Avandia_DHCPletter.pdf.

Publication types

Associated data