Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial
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Background Intensive treatment of multiple cardiovascular risk factors can halve mortality among people with established type 2 diabetes. We investigated the effect of early multifactorial treatment after diagnosis by screening.Methods In a pragmatic, cluster-randomised, parallel-group trial done in Denmark, the Netherlands, and the UK, 343 general practices were randomly assigned screening of registered patients aged 40-69 years without known diabetes followed by routine care of diabetes or screening followed by intensive treatment of multiple risk factors. The primary endpoint was first cardiovascular event, including cardiovascular mortality and morbidity, revascularisation, and non-traumatic amputation within 5 years. Patients and staff assessing outcomes were unaware of the practice's study group assignment. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00237549.Findings Primary endpoint data were available for 3055 (99·9%) of 3057 screen-detected patients. The mean age was 60·3 (SD 6·9) years and the mean duration of follow-up was 5·3 (SD 1·6) years. Improvements in cardiovascular risk factors (HbA(1c) and cholesterol concentrations and blood pressure) were slightly but significantly better in the intensive treatment group. The incidence of first cardiovascular event was 7·2% (13·5 per 1000 person-years) in the intensive treatment group and 8·5% (15·9 per 1000 person-years) in the routine care group (hazard ratio 0·83, 95% CI 0·65-1·05), and of all-cause mortality 6·2% (11·6 per 1000 person-years) and 6·7% (12·5 per 1000 person-years; 0·91, 0·69-1·21), respectively.Interpretation An intervention to promote early intensive management of patients with type 2 diabetes was associated with a small, non-significant reduction in the incidence of cardiovascular events and death.Funding National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Wellcome Trust, UK Medical Research Council, UK NIHR Health Technology Assessment Programme, UK National Health Service R&D, UK National Institute for Health Research, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, Novo Nordisk, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Merck.
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The ADDITION trial showed that microvascular or macrovascular events were not significantly reduced after 5 or 10 years (17% and 13% reduction, respectively), while intervention only slightly improved HbA1c.
“The ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care) trial showed that microvascular or macrovascular events were not significantly reduced after 5 or 10 years (17% and 13% reduction, respectively), while intervention only slightly improved HbA1c.364,365”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [365]
The positive effects of intensive multifactorial treatment were not observed in clinical intervention trials for T2DM in primary care and early in the disease trajectory.
“These positive effects were not observed in the clinical intervention trials of intensified, multifactorial treatment for T2DM in primary care and early in the disease trajectory.”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [365]
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- Authors
- Griffin, S. J., Borch-Johnsen, K., Davies, M. J., Khunti, K., Rutten, G. E., Sandbæk, A., Sharp, S. J., Simmons, R. K., van den Donk, M., Wareham, N. J., & Lauritzen, T.
- Affiliations
- University of Cambridge (GB)
- University of Leicester (GB)
- University Medical Center Utrecht (NL)
- Aarhus University (DK)
- Wellcome/MRC Institute of Metabolic Science (GB)
- Corresponding author
- Griffin, Simon J
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2011-07
- Volume
- 378
- Issue
- 9786
- Pages
- 156-167
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC3136726
- OpenAlex
- W2146392529
- Cited by
- 462
- References
- 43
- Citations by year
- 2026: 7 · 2025: 12 · 2024: 17 · 2023: 14 · 2022: 21 · 2021: 18 · 2020: 35 · 2019: 31 · 2018: 30 · 2017: 38 · 2016: 30 · 2015: 49 · 2014: 46 · 2013: 46 · 2012: 56
- FWCI
- 50.01
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion)
- Figshare (submittedVersion, cc-by)
- Leicester Research Archive (University of Leicester) (submittedVersion, other-oa)
- Funders
- the Wellcome Trust (G061895)
- the Medical Research Council (G0001164)
- the NIHR Health Technology Assessment Programme (08/116/300)
- National Health Service R&D support funding (RP-PG-0606-1259)
- Department of Health and ad hoc Support Sciences, the NIHR Health Technology Assessment Programme (08/116/300)
- the Department of Health NIHR Programme Grant funding scheme (RP-PG-0606-1272)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health Promotion and Cardiovascular Prevention
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- type 2 diabetes, cardiovascular risk management, diabetes screening, cardiovascular events, cardiovascular mortality, all-cause mortality, revascularization, non-traumatic amputation, HbA1c, blood pressure, cholesterol, general practice, primary prevention, secondary prevention, risk stratification
- MeSH terms
- Aged, Denmark, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Female, United Kingdom, Humans, Hypoglycemic Agents, Male, Mass Screening, Middle Aged, Netherlands, Risk Factors, Cluster Analysis, Outcome Assessment, Health Care, Intention to Treat Analysis
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