Results From the EUREXA Trial and Effectiveness of QI Strategies for Diabetes

On June 9, The Lancet published a special diabetes issue and included results from the Europe Exenatide (EUREXA) trial as well as a study that looked at effectiveness of quality improvement strategies on the management of diabetes.

In the EUREXA trial, the longest randomized controlled study of a GLP-1 receptor agonist to date, study authors looked at options for treatment escalation of glycaemic control in patients with type 2 diabetes after failure of first-line treatment with metformin.

Metformin is widely used as a first-line glucose lowering drug, but selection of the most appropriate treatment after metformin failure is poorly established. The authors aimed to assess the durability of glycaemic control achieved with GLP-1 receptor agonist exenatide twice a day and sulphonylurea glimepiride in patients with type 2 diabetes inadequately controlled by metformin alone.

The study was an open-label, randomized controlled trial at 128 centers in 14 countries between Sept. 5, 2006 and March 29, 2011. Authors randomly assigned 515 patients to the exenatide group and 514 to the glimepiride group and found that "exenatide twice daily as add-on to metformin reduced worsening of glycaemic control and rate of hypoglycaemia compared with add-on glimepiride in patients with type 2 diabetes inadequately controlled by metformin alone."

"Our findings provide evidence for a beneficial effect of exenatide twice daily versus usual care with glimepiride, for deterioration of glycaemia in patients with type 2 diabetes," said the study authors. "Randomized controlled head-to-head studies are important to guide clinical decisions, especially for new treatments different from the standard of care, which, according to our findings, would be a sulphonylurea."

In a featured commentary, Sten Madsbad, MD, of the Hvidovre Hospital and University of Copenhagen noted, "after the lessons learned from rosiglitazone the U.S. Food and Drug Administration now requires the assessment of cardiovascular risks of new diabetic drugs both before and after approval, and results of cardiovascular outcome studies for the different GLP-1 receptor agonists are expected after 2015."

A study that looked at effectiveness of quality improvement (QI) strategies found that many trials of QI strategies showed improvements in care for diabetes. "Interventions targeting the system of chronic disease management along with patient-mediated QI strategies should be an important component of interventions aimed at improving diabetes management," study authors noted.

Authors looked at 48 cluster randomized controlled trials, including 2538 clusters and 84865 patients, and 94 patient-randomized trials including 38664 patients, and aimed to assess the effects of QI strategies on glycated haemoglobin (HbA), vascular risk management, microvascular complication monitoring, and smoking cessation in patients with diabetes.

Results showed QI strategies increased the likelihood that patients received aspirin, antihypertensive drugs, and screenings for retinopathy, renal function, and foot abnormalities. However, statin use, hypertension control and smoking cessation were not significantly increased.

The authors noted how their findings "suggest that QI strategies that aim to optimize the systems of care should (wherever feasible) be included in programs to improve diabetes management, irrespective of HbA. Interventions targeting patients might be beneficial irrespective of baseline HbA, whereas interventions targeting providers only seem beneficial when baseline HbA is greater than 8 percent."

Authors of the commentary added, "Redesigning care to use the skills of all members of the health-care team might provide both the impetus and the ability for patients and practices to move beyond glycaemic control to create a comprehensive, patient-centered, and effective model of diabetes care."

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