Objective
The ADVANCE trial aimed to evaluate the risks and benefits of routine blood pressure (BP) lowering—regardless of baseline BP—and the impact of intensive glucose control in patients with type 2 diabetes who were at high risk of cardiovascular events. This large-scale study was conducted by The George Institute.
Trial Design and Methodology
The study was a randomized, double-masked, factorial-assignment trial involving 11,138 participants. The participants were categorized based on age at diabetes diagnosis (≤50, 51–60, and >60 years) and by duration of diabetes (≤5, 6–10, and >10 years). These groupings allowed researchers to assess whether the timing of diagnosis and disease duration influenced the benefits of intensive glucose control.
Inclusion Criteria
Eligible participants had type 2 diabetes diagnosed at age 30 years or older and were at least 55 years old at the time of enrollment. They also had to be at high risk of cardiovascular events, defined by one or more of the following:
History of major macrovascular disease (e.g., stroke, myocardial infarction, angioplasty, bypass surgery, or limb amputation due to vascular disease)
History of major microvascular disease (e.g., nephropathy, proliferative retinopathy, macular edema, or diabetic blindness)
A diabetes duration of 10 years or more
Presence of other vascular risk factors (e.g., smoking, high cholesterol, low HDL, microalbuminuria)
Age ≥65 years
Results
Analysis of the data from the 11,138 participants showed that intensive glucose control significantly reduced the risk of major macrovascular and microvascular events, with a hazard ratio of 0.90 (95% CI: 0.82–0.98). These benefits were consistent across all subgroups, irrespective of age at diagnosis or diabetes duration. There was no significant heterogeneity among subgroups (P for heterogeneity = 0.86 for age at diagnosis, and 0.47 for diabetes duration). Additionally, similar consistent benefits were seen for outcomes such as all-cause mortality, cardiovascular death, and individual vascular events.
Conclusion
The ADVANCE trial supports the use of intensive glucose lowering in patients with type 2 diabetes, regardless of how old they were when diagnosed or how long they had been living with the disease. This strategy effectively reduces the risk of vascular complications and death.