Effect of early multifactorial therapy compared with routine care on microvascular outcomes at 5 years in people with screen-detected diabetes: a randomized controlled trial: the ADDITION-Europe Study

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  • Annelli Sandbæk
  • Simon J Griffin
  • ,
  • Stephen J Sharp
  • ,
  • Rebecca K Simmons, Denmark
  • Knut Borch-Johnsen
  • ,
  • Guy E H M Rutten
  • ,
  • Maureen van den Donk
  • ,
  • Nicholas J Wareham
  • ,
  • Torsten Lauritzen
  • Melanie J Davies
  • ,
  • Kamlesh Khunti

OBJECTIVE: To determine the benefit of multifactorial treatment on microvascular complications among people with type 2 diabetes detected by screening.

RESEARCH DESIGN AND METHODS: This study was a multicenter cluster randomized controlled trial in primary care with randomization at the practice level. In four centers in Denmark; Cambridge, U.K.; the Netherlands; and Leicester, U.K., 343 general practices participated in the trial. Eligible for follow-up were 2,861 of the 3,057 people with diabetes detected by screening included in the original trial. Biomedical data on nephropathy were collected in 2,710 (94.7%) participants, retinal photos in 2,190 (76.6%), and questionnaire data on peripheral neuropathy in 2,312 (80.9%). The prespecified microvascular end points were analyzed by intention to treat. Results from the four centers were pooled using fixed-effects meta-analysis.

RESULTS: Five years after diagnosis, any kind of albuminuria was present in 22.7% of participants in the intensive treatment (IT) group and in 24.4% in the routine care (RC) group (odds ratio 0.87 [95% CI 0.72-1.07]). Retinopathy was present in 10.2% of the IT group and 12.1% of the RC group (0.84 [0.64-1.10]), and severe retinopathy was present in one patient in the IT group and seven in the RC group. Neuropathy was present in 4.9% and 5.9% (0.95 [0.68-1.34]), respectively. Estimated glomerular filtration rate increased between baseline and follow-up in both groups (4.31 and 6.44 mL/min, respectively).

CONCLUSIONS: Compared with RC, an intervention to promote target-driven, intensive management of patients with type 2 diabetes detected by screening was not associated with significant reductions in the frequency of microvascular events at 5 years.

Original languageEnglish
JournalDiabetes Care
Pages (from-to)2015-23
Number of pages9
Publication statusPublished - Jul 2014

    Research areas

  • Adult, Aged, Cluster Analysis, Denmark, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Diabetic Neuropathies, Female, Follow-Up Studies, General Practice, Great Britain, Humans, Male, Mass Screening, Middle Aged, Netherlands, Primary Health Care, Questionnaires, Secondary Prevention

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