| Summary: | Background: Intensive glucose control reduces the risk of vascular complications while increasing the risk of severe hypoglycaemia at a group-level. We sought to estimate individual beneficial and adverse effects of intensive glucose control in patients with type 2 diabetes.<br/> Methods: We performed a post-hoc analysis of ADVANCE, a randomized controlled trial evaluating standard versus intensive glucose control (glycated haemoglobin target ≤6.5%). In 11,140 participants, we estimated the individual 5-year absolute risk reduction (ARR) of the composite outcome of major micro- and macrovascular events and absolute risk increase (ARI) of severe hypoglycaemia with intensive compared to standard glucose control. Predictions were based on competing risks models including clinical characteristics and randomized treatment. <br/> Results: Based on these models, 76% of patients had a substantial estimated 5-year ARR of major vascular events (≥1%, 5-year number-needed-to-benefit [NNTB5] ≤100) and 1% had a small ARR (≤0.5%, NNTB5≥200). Similarly, 36% of patients had a substantial estimated ARI of severe hypoglycaemia (number-needed-to-harm [NNTH5] ≤100) and 29% had a small ARI (NNTH5≥200). When assigning similar or half the weight to severe hypoglycaemia compared with a major vascular event, net benefit was positive in 85% or 99% of patients. Limiting intensive treatment to the 85% patient subgroup had no significant effect on the overall incidence of major vascular events and severe hypoglycaemia compared with treating all. <br/> Conclusions: Taking account of the effects of intensive glucose control on major micro- and macrovascular events and severe hypoglycaemia for individual patients, the estimated net benefit was positive in the majority of patients in ADVANCE. The estimated individual effects can inform treatment decisions, once individual weights assigned to positive and adverse effects have been specified.
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