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ACCORD: Intensive therapy may slow progession to microvascular events
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ADA 70th Scientific Sessions
ORLANDO — Although intensive glucose control was not associated with decreased cardiovascular risk factors, it was associated with slower progression to microvascular complications, according to results of new analyses of the ACCORD trial.
Researchers for the ACCORD Study Group and ACCORD Eye Study group investigated whether each arm of the trial — intensive blood glucose, blood pressure and lipids — would reduce the progression to diabetic retinopathy in a subset of about 3,000 ACCORD study participants, compared with a standard approach.
The researchers found that intensive glycemic control (target HbA1c <6%) and intensive combination treatment of dyslipidemia with fenofibrate plus statin reduced the rate of progression to diabetic retinopathy. At 4 years, the rate of progression was 7.3% for patients in the intensive glucose group 10.4% in the standard group (OR=0.67; 95% CI, 0.51-0.87) and was 6.5% in the intensive lipid group vs. 10.2% in the standard group (OR=0.60; 95% CI, 0.42-0.87).
However, intensive BP control did not slow the progression to diabetic retinopathy (10.4% vs. 8.8%; OR=1.23; 95% CI, 0.84-1.79).
The rate of vision loss was 19.4% among patients assigned to intensive therapy vs. 15.8% among those assigned to standard therapy (HR=1.27; 95% CI, 0.99-1.62).
“The ACCORD Eye Study clearly indicates that intensive glycemic control and fibrate treatment added to statin therapy separately reduce the progression of diabetic retinopathy,” Emily Chew, MD, chief of the clinical trials branch of the division of epidemiology and clinical applications at the National Eye Institute, said at a press conference.
Results of the ACCORD Eye Study were simultaneously published in The New England Journal of Medicine.
Microvascular outcomes
Results of a second analysis were also presented here, which indicated that although intensive therapy did not reduce the risk for microvascular outcomes at the end of the study, 5 years, it did slow the progression of albuminuria (1.44 mmol/L vs. 1.63 mmol/L) as well as other measures of retinopathy and neuropathy, compared with standard therapy.
Researchers for this analysis examined patients who underwent intensive glucose-lowering for 3.5 years who were then given standard treatments for the remaining 1.5 years, compared with standard treatment, for the duration of the study. The intensively treated patients did not see a reduced incidence of CV disease.
At 5 years, the first composite outcome (dialysis or renal transplantation plus high serum creatinine or retinal photocoagulation or vitrectomy) was recorded in 556 of 5,119 patients in the intensive group vs. 586 in the standard group (HR=0.95; 95% CI, 0.85-1.07). The second composite outcome (peripheral neuropathy plus the first composite outcome) was recorded in 1,956 of 5,119 vs. 2,046 of 5,115 in the standard group (HR=0.95; 95% CI, 0.89-1.01).
The results were published simultaneously in the Lancet.
Putting data in context
Researchers for both studies cautioned that any potential benefits must be weighed against the increased risk for mortality and episodes of severe hypoglycemia that were observed with intensive glucose control. They emphasized that the positive and negative results of the study apply only to this population of middle-aged or older people with type 2 diabetes for an average of 10 years, who also had a history of CV disease or at least two risk factors.
“This is why we do research — we really need randomized, controlled trials. Assumptions are not always right and this is a good example of comparing effectiveness research which compares patient outcomes from various strategies that are available for clinicians today,” Denise Simmon-Morton, MD, PhD, director of division for the Application of Research Discoveries at NIH, said at the press conference.
The landmark ACCORD trial investigated whether CV risk in people with type 2 diabetes could be reduced using the following strategies compared with standard treatment: intensive glucose control; intensive blood pressure control; and intensive lipid control. The National Heart, Lung and Blood Institute prematurely halted the intensive blood glucose-lowering strategy after 3.5 years in February 2008 due to safety concerns caused by an unexpected higher incidence of death in the intensive glucose-lowering treatment group vs. standard treatment group. It also looked at how each of these treatments would affect other outcomes, such as mortality and microvascular outcomes. Treatment was stopped early due to increased risk for mortality in the intensive control group; these patients were then transitioned to standard therapy. – by Katie Kalvaitis and Jennifer Southall
The results are very interesting, but a little difficult to synthesize. We do not fully understand the finding of increased mortality in the intensive arm of the ACCORD trial so it is difficult to speculate on this. It really speaks to the idea of individualization. Glucose control is probably better at prevention than at helping once complications are already established.
– Sue Kirkman, MD
Senior Vice President,
Medical Affairs and Community Information, ADA
For more information:
- Cushman WC. Results of the ACCORD clinical trial. Presented at: American Diabetes Association 70th Scientific Sessions; June 25-29, 2010; Orlando.
- Ismail-Beigi F. Lancet. 2010;doi:10.1016/S0140-6736(10)60576-4.
- The ACCORD Study Group. N Eng J Med. 2010;doi:10.1056/NEJMoa1001288.
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