The Framingham and UK Prospective Diabetes Study (UKPDS) risk equations do not reliably estimate the probability of cardiovascular events in a large ethnically diverse sample of patients with diabetes: the Action in Diabetes and Vascular Disease: Preterax and Diamicron-MR Controlled Evaluation (ADVANCE) Study

Kengne, André Pascal; Patel, Anushka; Colagiuri, Stephen; Heller, Simon; Hamet, Pavel; Marre, Michel; Pan, Changyu; Zoungas, Sophia; Grobbee, Diederick E.; Neal, Bruce; Chalmers, John; Woodward, Mark

doi:10.1007/s00125-010-1681-4

Cited by 118 publications

(100 citation statements)

References 36 publications

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“…The ADDITION cohort included people with screen-detected diabetes. Other research 125,133 has shown that the UKPDS-OM tends to overestimate absolute CVD risk, a finding replicated in our own investigation of the suitability of the UKPDS-OM to extrapolate ADDITION study data. 96 Furthermore, the utility decrements for MI and stroke derived from the ADDITION study were smaller than those in the UKPDS, a finding that is consistent with contemporary patients receiving better care and hence reporting higher quality of life.…”

Section: Strengths and Limitationssupporting

confidence: 80%

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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Section: Strengths and Limitationssupporting

confidence: 80%

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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“…There were relatively few events observed at HbA 1c levels less than 6.5% making the estimates of the associations at these HbA 1c levels less precise than at higher levels. Moreover, the selective nature of trial participants and the potential influence of randomised treatments may affect the generalisability of the findings, although the ADVANCE participants are fairly typical of current populations with type 2 diabetes managed in the community [19]. Finally, despite extensive multiple variable adjustment, these analyses may be unable to completely eliminate the effects of residual confounding attributable to disease severity.…”

Section: Discussionmentioning

confidence: 99%

Association of HbA1c levels with vascular complications and death in patients with type 2 diabetes: evidence of glycaemic thresholds

et al. 2011

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Aims/hypothesis There is conflicting evidence regarding appropriate glycaemic targets for patients with type 2 diabetes. Here, we investigate the relationship between HbA 1c and the risks of vascular complications and death in such patients. Methods Eleven thousand one hundred and forty patients were randomised to intensive or standard glucose control in the Action in Diabetes and Vascular disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. Glycaemic exposure was assessed as the mean of HbA 1c measurements during follow-up and prior to the first event. Adjusted risks for each HbA 1c decile were estimated using Cox models. Possible differences in the association between HbA 1c and risks at different levels of HbA 1c were explored using linear spline models. Results There was a non-linear relationship between mean HbA 1c during follow-up and the risks of macrovascular events, microvascular events and death. Within the range of HbA 1c studied (5.5-10.5%), there was evidence of 'thresholds', such that below HbA 1c levels of 7.0% for macrovascular events and death, and 6.5% for microvascular events, there was no significant change in risks (all p>0.8). Above these thresholds, the risks increased significantly: every 1% higher HbA 1c level was associated with a 38% higher risk of a macrovascular event, a 40% higher risk of a microvascular event and a 38% higher risk of death (all p<0.0001).To convert values for HbA 1c in % into mmol/mol subtract 2.15 and multiply by 10.929. Electronic supplementary material The online version of this article

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“…Studies were largely conducted in Europe or the USA, and almost exclusively included Caucasian patients, though the largest study was a multi-ethnic study, including populations from different countries [16]. The proportion of Caucasians in studies varies between 30 and 100%.…”

Section: Characteristics Of Studiesmentioning

confidence: 99%

Comparative performance of diabetes-specific and general population-based cardiovascular risk assessment models in people with diabetes mellitus

Echouffo‐Tcheugui

Kengne

2013

Diabetes & Metabolism

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Cited by 118 publications

References 36 publications

Association of HbA1c levels with vascular complications and death in patients with type 2 diabetes: evidence of glycaemic thresholds

Comparative performance of diabetes-specific and general population-based cardiovascular risk assessment models in people with diabetes mellitus

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