A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes: The Anglo–Danish–Dutch Study of Intensive treatment in people with screen-detected diabetes in primary care (ADDITION-Europe) study

Background: Intensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain. Objective: To quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes. Design: Pragmatic, multicentre, cluster-randomised, parallel-group trial. Setting: Three hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK. Participants: Individuals aged 40–69 years with screen-detected diabetes. Interventions: Screening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol. Main outcome measures: The primary end point was a composite of first cardiovascular event (cardiovascular mortality/morbidity, revascularisation and non-traumatic amputation) during a mean [standard deviation (SD)] follow-up of 5.3 (1.6) years. Secondary end points were (1) all-cause mortality; (2) microvascular outcomes (kidney function, retinopathy and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective Diabetes Study outcomes model [version 1.3;