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ADVANCE: intensive glucose control reduced micro- and macrovascular disease together by 10%

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American Diabetes Association 68th Scientific Sessions

Results of the ADVANCE study released yesterday during the American Diabetes Association 68th Scientific Sessions detailed the effects of intensive glucose control on microvascular and macrovascular disease in patients with diabetes.

After five years of treatment with an intensive glucose lowering strategy, patients in ADVANCE achieved a target HbA1c of 6.5%. Compared with patients who received standard treatment, patients in the intensive glucose lowering arm had an overall lower risk of serious diabetes complications of 10% (HR=0.90; 95% CI, 0.82-0.98), largely driven by a reduction in nephropathy of 21% (HR=0.79; 95% CI, 0.66-0.93).

ADVANCE enrolled 11,140 patients from Asia, Australia, Europe and North America in a 2x2 factorial design, to measure the effects of routine blood pressure lowering and tighter glucose control on micro- and macrosvascular complications. The primary endpoints of the study were major macrovascular events including CVD death, nonfatal MI and nonfatal stroke, and major microvascular events including new or worsening nephropathy or retinopathy. Patients in the intensive glucose lowering arm were given modified-release glicazide in addition to metformin, TZDs, acarbose or insulin.

Some baseline characteristics of the patients included mean age of 65.8 years, mean BP of 145/81 mm Hg, and a mean BMI of 28. Sixty-nine percent had a history of hypertension, 75% were receiving concurrent BP-lowering therapy, 91% were receiving oral hypoglycemic agents and 40% had a history of micro- or mascrovascular disease.

“We were able to achieve an HbA1c mean level of 6.5% with remarkably few side effects, suggesting that the whole regimen including glicazide MR was very well tolerated. The study showed no evidence of any increased risk of death when blood glucose was intensively controlled, there was no clear increase in weight and the incidence of hypoglycemic events was remarkably low,” said Stephen MacMahon, PhD, a co-principal investigator of ADVANCE. MacMahon is also director of The George Institute for International Health and professor of cardiovascular medicine and epidemiology at the University of Sydney.

“This study makes it more clear for clinicians the kind of goals we should be aiming for,” Simon Heller, MD, also an ADVANCE investigator, said during a press conference. Heller is also a professor of clinical diabetes in the Academic Unit of Diabetes, Endocrinology and Metabolism at the University of Sheffield, United Kingdom.