David L. Bronson, MD, FACP
Does intensive glucose or blood pressure (BP) control, or the addition of fenofibrate to statin therapy, reduce risk for progression of diabetic retinopathy more than standard therapies in patients with type 2 diabetes?
Randomized controlled trial (Action to Control Cardiovascular Risk in Diabetes [ACCORD] Eye study). ClinicalTrials.gov NCT00542178.
Blinded (outcome assessors).†
68 centers in the USA and Canada.
3472 patients (mean age 62 y, 62% men) who had type 2 diabetes and glycated hemoglobin (HbA1c) level ≥ 7.5%, and were at high risk for cardiovascular disease. Exclusion criteria included previous laser photocoagulation or vitrectomy for proliferative diabetic retinopathy.
All patients were randomized to intensive glucose control targeting HbA1c levels < 6.0% (n = 1429 with 4 y follow-up) or standard glucose control targeting HbA1c levels 7.0% to 7.9% (n = 1427). Patients were also randomized in a 2 x 2 factorial manner to intensive BP control targeting systolic BP < 120 mm Hg (n = 647) or standard BP control targeting systolic BP < 140 mm Hg (n = 616), or for patients with dyslipidemia, simvastatin plus fenofibrate, 160 mg/d (n = 806), or simvastatin plus placebo (n = 787). Intensive glucose control therapy was stopped early because of increased mortality after a mean 3.5 years of follow-up.
Composite endpoint of diabetic retinopathy progression (increase ≥ 3 steps on the 17-step Early Treatment Diabetic Retinopathy Study Severity scale, higher number of steps = greater severity) or development of proliferative diabetic retinopathy with need for photocoagulation therapy or vitrectomy.
82% (intention-to-treat analysis).
The main results are in the Table.
Intensifying glucose control and adding fenofibrate to simvastatin each reduced development or progression of diabetic retinopathy in patients with type 2 diabetes; intensive and standard blood pressure control did not differ.
Medical therapy to reduce development or progression of diabetic retinopathy in patients with type 2 diabetes‡
‡Abbreviations defined in Glossary. RRR, RRI, NNT, and CI calculated from data in article.
David L. Bronson. Intensifying glucose control and adding fenofibrate to simvastatin each reduced progression of retinopathy in type 2 diabetes. Ann Intern Med. 2010;153:JC5–10. doi: 10.7326/0003-4819-153-10-201011160-02010
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Published: Ann Intern Med. 2010;153(10):JC5-10.
Cardiology, Coronary Risk Factors, Diabetes, Dyslipidemia, Endocrine and Metabolism.
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