Cited by 462Health Promotion and Cardiovascular PreventionDiabetes, Cardiovascular Risks, and LipoproteinsDiabetes Treatment and Management

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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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Griffin, Simon J, Borch-Johnsen, Knut, Davies, Melanie J, Khunti, Kamlesh, Rutten, Guy EHM, Sandbæk, Annelli, Sharp, Stephen J, Simmons, Rebecca K, van den Donk, Maureen, Wareham, Nicholas J, Lauritzen, Torsten·2011·The Lancet

DOI 10.1016/s0140-6736(11)60698-3PMC PMC3136726

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Abstract

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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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: Griffin, Simon J
Davies, Melanie J
Khunti, Kamlesh
Rutten, Guy EHM
Sandbæk, Annelli
Sharp, Stephen J
Simmons, Rebecca K
Wareham, Nicholas J
Lauritzen, Torsten
Venue: The Lancet
Publisher: Elsevier BV
Published: 2011-07
Volume: 378
Issue: 9786
Pages: 156-167
ISSN: 0099-5355 (ISSN-L)
0140-6736
DOI: 10.1016/s0140-6736(11)60698-3
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: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
doi.org/10.15223/policy-017 (stm-asf)
doi.org/10.15223/policy-037 (stm-asf)
doi.org/10.15223/policy-012 (stm-asf)
doi.org/10.15223/policy-029 (stm-asf)
doi.org/10.15223/policy-004 (stm-asf)
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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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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