How to prevent vascular complications of type 2 diabetes? Summary of the rationale, study design and results of the glycemic arm of ADVANCE study

Abstract

The article summarizes rationale, design and results of ADVANCE - the biggest ever study on type 2 diabetes. The study had two treatment arms, one aimed on control of blood pressure with the usage of Noliprel as basic drug (this arm of the study has already been summarized and the results were published in 2007), the other, discussed in details in this article, aimed on assesment of the relationship between tight glicemic control, as well as micro- and macrovascular outcomes (the results were presented on June 6, 2008 at the ADA congress and published in NEJM). The glycemic arm of the study was designed as Prospective Randomized Open with Blinded End-points (PROBE) trial. Patients were randomly allocated to intensive glucose control group receiving multifactorial intervention and pharmacotherapy based on Diaprel MR aiming at achieving target HbA_1c of 6.5% or less or to the standard treatment group. Intensive treatment of diabetes, based on Diaprel MR 120 mg (4 tabs.) daily, reduced the combined incidence of macro- and microvascular events by 10% (p = 0.01); the risk reduction of microvascular events was reduced by 14% (p = 0.01). Intensive diabetes treatment was particularly effective in prevention of the onset/progression of diabetic nephropathy (relative risk reduction by 21%; p = 0.006), with 30% of risk reduction of the onset of macroalbuminuria (p < 0.001). Contrary to the results of the ACCORD study, the ADVANCE study showed positive trend towards a reduction in cardiovascular mortality (12%) in the intensive treatment group, despite achieving comparable levels of HbA_1c.