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


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.
Department of Public Health, Section of General Practice, University of Aarhus, Aarhus, Denmark annelli.sandbaek@alm.au.dk.
Annelli
A
Sandbæk
MRC Epidemiology Unit, Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, U.K.
Simon J
SJ
Griffin
MRC Epidemiology Unit, Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, U.K.
Stephen J
SJ
Sharp
MRC Epidemiology Unit, Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, U.K.
Rebecca K
RK
Simmons
Steno Diabetes Centre, Gentofte, DenmarkHolbæk Hospital, Holbæk, Denmark.
Knut
K
Borch-Johnsen
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
Guy E H M
GE
Rutten
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
Maureen
M
van den Donk
MRC Epidemiology Unit, Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, U.K.
Nicholas J
NJ
Wareham
Department of Public Health, Section of General Practice, University of Aarhus, Aarhus, Denmark.
Torsten
T
Lauritzen
Department of Cardiovascular Sciences, University of Leicester, Leicester, U.K.
Melanie J
MJ
Davies
Department of Health Sciences, University of Leicester, Leicester, U.K.
Kamlesh
K
Khunti
D000328:Adult; D000368:Aged; D016000:Cluster Analysis; D003718:Denmark / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000628:therapy; D003925:Diabetic Angiopathies / Q000453:epidemiology*; D003929:Diabetic Neuropathies / Q000453:epidemiology*; D005260:Female; D005500:Follow-Up Studies; D058006:General Practice / Q000379:methods; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D011320:Primary Health Care / Q000379:methods; D055502:Secondary Prevention; D011795:Surveys and Questionnaires; D006113:United Kingdom / Q000453:epidemiology