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

Rebecca K. Simmons, Knut Borch-Johnsen, Torsten Lauritzen, Guy E.H.M. Rutten, Annelli Sandbæk, Maureen Van Den Donk, James A. Black, Libo Tao, Edward C.F. Wilson, Melanie J. Davies, Kamlesh Khunti, Stephen J. Sharp, Nicholas J. Wareham, Simon J. Griffin*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

3 Citations (Scopus)

Abstract

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;

Original languageEnglish
Pages (from-to)1-86
Number of pages86
JournalHealth Technology Assessment
Volume20
Issue number64
DOIs
Publication statusPublished - 1 Aug 2016

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