Effect of intensive treatment of hyperglycemia on microvascular complications of type 2 diabetes in ACCORD: a randomized trial
By F. Ismail-Beigi, T. Craven, M. Banerji, J. Basile, J. Calles, R. Cohen, R. Cuddihy, W. Cushman, S. Genuth, R. Grimm and 13 more. The Lancet, 2010
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Design ACCORD is a parallel group, randomized trial designed to investigate whether intensive glycemic therapy with a target HbA1c of <6.0% versus standard therapy with a target of 7.0 to 7.9% reduces cardiovascular disease (CVD) morbidity, mortality, and microvascular complications in participants with type 2 diabetes. Methods Volunteers with established type 2 diabetes, HbA1c levels ≥ 7.5% and CVD or two or more CVD risk factors were recruited at 77 clinical sites across the U.S. and Canada. Instructional materials, behavioral counseling, glucose-lowering medications and self-monitoring supplies were provided by the study. Therapeutic regimens were individualized on the basis of randomized assignment and response to therapy. This investigation examines the effect of treatment to glycemic goals on occurrence of microvascular diabetes complications. Prespecified composite outcomes were: 1) dialysis or renal transplantation, or serum creatinine >291.7 micromol/L, or retinal photocoagulation or vitrectomy, and 2) these plus peripheral neuropathy. Thirteen prespecified secondary measures of kidney, eye, and peripheral nerve function were also evaluated. Randomization was performed at clinical sites using a central randomization routine available on the study website. Both investigators and participants were unmasked to treatment arm assignment. Results A total of 10,251 participants were randomized (5,128 intensive and 5,123 standard) between January, 2001 and October, 2005. This analysis includes 10,234 patients (5,107 intensive and 5,108 standard). Intensive therapy was stopped before study end due to increased mortality, and patients were transitioned to standard therapy. Outcomes are reported at transition and at study end. At transition, the first composite outcome occurred in 443/5107 and 444/5108 participants in the intensive and standard arms, respectively (p= 0.99), and the second outcome in 1591/5107 and 1659/5108 participants in intensive and standard arms (p=0.20). Results were similar at study end. Secondary measures at study end favoring intensive therapy (p<0.05) included development of macroalbuminuria, cataract extraction, visual acuity, a score of >2.0 on the Michigan Neuropathy Screening Instrument, loss of ankle jerk and light touch. Conclusions Intensive glycemic treatment did not reduce the risk of advanced measures of microvascular outcomes, but delayed the onset of macroalbuminuria and some measures of eye complications and neuropathy. These benefits must be weighed against the increase in total and CVD-related mortality, increased weight gain, and higher risk for severe hypoglycemia.
Subfields: Endocrinology, Diabetes and Metabolism, Nephrology, Ophthalmology
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Citations in the corpus
- Standards of Medical Care in Diabetes—2014 (2013, background): “Intensive diabetes management with the goal of achieving nearnormoglycemia has been shown in large prospective randomized studies to delay the onset and progression of increased urinary albumin excretion in patients with type 1 (413) and type 2 (85,86,89,90) diabetes.”
- Standards of Medical Care in Diabetes—2012 (2011, methodology): “Many factors, including patient preferences, should be taken into account when developing a patient’s individualized goals (79).”
- Standards of Medical Care in Diabetes—2013 (2012, methodology): “Analyses from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial have shown lower rates of onset or progression of early-stage microvascular complications in the intensive glycemic control arm compared with the standard arm (89,90).”
- Diabetic Neuropathy: A Position Statement by the American Diabetes Association (2016, methodology): “The use of validated clinical instruments such as the Michigan Neuropathy Screening Instrument (MNSI) (most widely used in large cohorts of patients with type 1 and type 2 diabetes) (21,26,27,46,74,75), the modified Toronto Clinical Neuropathy Scale (mTCNS) (73), the Utah Early Neuropathy Scale (UEN”
- KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. (2012, background): “3%).(20) In the Veterans Affairs Diabetes Trial (VADT), more intensive glycemic control that achieved an HbA1c of 6.”