Randomised controlled trial of intensive multifactorial treatment for cardiovascular risk in patients with screen-detected type 2 diabetes: 1-year data from the ADDITION Netherlands study

Janssen, P. G. H.; Gorter, Kees J.; Stolk, Ronald P.; Rutten, Guy E.H.M.

doi:10.3399/bjgp09x394851

Cited by 68 publications

(94 citation statements)

References 25 publications

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“…8 Prescribing increasing numbers of drugs to individuals with clinical diabetes has a significant impact on CVD risk reduction, 3,38,39 a finding that may now be extended to modelled CVD risk among people with screen-detected diabetes. While prescription of lipid-lowering or antidiabetic drugs was associated with CVD risk reduction in the present study cohort, prescribing or increasing antihypertensive medication was not.…”

Section: Comparison With Existing Literaturementioning

confidence: 99%

“…One-year results from the Dutch centre of the ADDITION-Europe trial (Anglo-DanishDutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care), 7 showed that intensive multifactorial treatment of screen-detected individuals was associated with significant reduction in cardiovascular risk factors without worsening quality of life. 8 Nonetheless, uncertainties persist concerning the potential magnitude of risk reduction achievable in the first year after diagnosis, and the factors associated with reduction in risk.…”

Section: Introductionmentioning

confidence: 99%

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Cardiovascular risk reduction following diagnosis of diabetes by screening: 1-year results from the ADDITION-Cambridge trial cohort

Charles

Simmons²,

Williams³

et al. 2012

Br J Gen Pract

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Section: Comparison With Existing Literaturementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Cardiovascular risk reduction following diagnosis of diabetes by screening: 1-year results from the ADDITION-Cambridge trial cohort

Charles

Simmons²,

Williams³

et al. 2012

Br J Gen Pract

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“…The characteristics of the interventions to promote IT in each centre have been described previously [47][48][49]57 and are summarised in Table 1. We aimed to educate and support general practitioners (GPs) and practice nurses in target-driven management (using medication and promotion of a healthy lifestyle) of hyperglycaemia, blood pressure and cholesterol, based on the stepwise regimen used in the Steno-2 study.…”

Section: Interventionmentioning

confidence: 99%

“…Participating practices in the Netherlands and the UK have been described previously. 43,48,49 All four centres had a diabetes prevalence of 3.5% and a nationally representative mean patient list of ≈7000 individuals (n = 7378 RC group, n = 7160 IT group). Baseline sociodemographic, biochemical, clinical and treatment characteristics of individuals in the two randomised groups were well matched overall (see Table 3).…”

mentioning

confidence: 99%

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

Simmons

Borch‐Johnsen

Lauritzen

et al. 2016

Health Technol Assess

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BackgroundIntensive 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.ObjectiveTo quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes.DesignPragmatic, multicentre, cluster-randomised, parallel-group trial.SettingThree hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK.ParticipantsIndividuals aged 40–69 years with screen-detected diabetes.InterventionsScreening 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 measuresThe 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;©Isis Innovation Ltd 2010; seewww.dtu.ox.ac.uk/outcomesmodel(accessed 27 January 2016)].ResultsWe included 3055 (RC,n = 1377; IT,n = 1678) of the 3057 recruited patients [mean (SD) age 60.3 (6.9) years] in intention-to-treat analyses. Prescription of glucose-lowering, antihypertensive and lipid-lowering medication increased in both groups, more so in the IT group than in the RC group. There were clinically important improvements in cardiovascular risk factors in both study groups. Modest but statistically significant differences between groups in reduction in glycated haemoglobin (HbA1c) levels, blood pressure and cholesterol favoured the IT group. The incidence of first cardiovascular event [IT 7.2%, 13.5 per 1000 person-years; RC 8.5%, 15.9 per 1000 person-years; hazard ratio 0.83, 95% confidence interval (CI) 0.65 to 1.05] and all-cause mortality (IT 6.2%, 11.6 per 1000 person-years; RC 6.7%, 12.5 per 1000 person-years; hazard ratio 0.91, 95% CI 0.69 to 1.21) did not differ between groups. At 5 years, albuminuria was present in 22.7% and 24.4% of participants in the IT and RC groups, respectively [odds ratio (OR) 0.87, 95% CI 0.72 to 1.07), retinopathy in 10.2% and 12.1%, respectively (OR 0.84, 95% CI 0.64 to 1.10), and neuropathy in 4.9% and 5.9% (OR 0.95, 95% CI 0.68 to 1.34), respectively. The estimated glomerular filtration rate increased between baseline and follow-up in both groups (IT 4.31 ml/minute; RC 6.44 ml/minute). Health status, well-being, diabetes-specific quality of life and treatment satisfaction did not differ between the groups. The intervention cost £981 per patient and was not cost-effective at costs ≥ £631 per patient.ConclusionsCompared with RC, IT was associated with modest increases in prescribed treatment, reduced levels of risk factors and non-significant reductions in cardiovascular events, microvascular complications and death over 5 years. IT did not adversely affect patient-reported outcomes. IT was not cost-effective but might be if delivered at a reduced cost. The lower than expected event rate, heterogeneity of intervention delivery between centres and improvements in general practice diabetes care limited the achievable differences in treatment between groups. Further follow-up to assess the legacy effects of early IT is warranted.Trial registrationClinicalTrials.gov NCT00237549.Funding detailsThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 64. See the NIHR Journals Library website for further project information.

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“…Care (ADDITION) oceniano dostępność zintensyfikowanego leczenia wieloczynnikowego dla chorych na cukrzycę typu 2 w praktyce lekarza ogólnego [288]. Częstość występowania pierwszego zdarzenia sercowo-naczyniowego wynosiła 7,2% (13,5 na 1000 osobolat) w grupie leczonej intensywnie i 8,5% (15,9 na 1000 osobolat) w grupie otrzymującej rutynową opiekę (HR 0,83; 95% CI 0,65-1,05), a liczba zgonów z jakiejkolwiek przyczyny wynosiła odpowiednio 6,2% (11,6 na 1000 osobolat) i 6,7% (12,5 na 1000 osobolat) (HR 0,91; 95% CI 0,69-1,21).…”

Section: W Badaniu Anglo-danish-dutch Study Of Intensive Treatment Inunclassified

Wytyczne ESC dotyczące cukrzycy, stanu przedcukrzycowego i chorób układu sercowo- -naczyniowego opracowane we współpracy z EASD

Rydén

Grant

Anker³

et al. 2013

Kardiol Pol

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Randomised controlled trial of intensive multifactorial treatment for cardiovascular risk in patients with screen-detected type 2 diabetes: 1-year data from the ADDITION Netherlands study

Cited by 68 publications

References 25 publications

Cardiovascular risk reduction following diagnosis of diabetes by screening: 1-year results from the ADDITION-Cambridge trial cohort

Cardiovascular risk reduction following diagnosis of diabetes by screening: 1-year results from the ADDITION-Cambridge trial cohort

Wytyczne ESC dotyczące cukrzycy, stanu przedcukrzycowego i chorób układu sercowo- -naczyniowego opracowane we współpracy z EASD

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