Most studies on prevention and treatment of diabetes tend to focus on individual risk factors, although in practice patients normally receive simultaneous treatment for several risk factors.
The multicentre, international ADDITION-EUROPE study investigated the effect of promoting intensive treatment of multiple risk factors among people with screen-detected type 2 diabetes over 5 years.1
The rationale for the 10-year follow-up was to assess the long-term effects of guidelines, education, training and audit for primary care teams on outcomes for people with diabetes detected by screening.
How was this study conducted?
General practices from four centres (Denmark, Cambridge [UK], Leicester [UK], and the Netherlands) were randomly assigned by computer-generated list to provide screening followed by routine care of diabetes, or screening followed by intensive multifactorial treatment.
Population-based stepwise screening programmes among people aged 40-69 years (50-69 years in the Netherlands), between April 2001, and December 2006, identified patients with type 2 diabetes.
Allocation was concealed from patients.
Following the 5-year follow-up, no attempts were made to maintain differences in treatment between study groups.
This was a post-hoc analysis of cardiovascular (CV) and renal outcomes over 10 years following randomisation, including 5 years post-intervention follow-up.
The primary endpoint was a composite of first CV event, including CV mortality, cardiovascular morbidity (non-fatal myocardial infarction and non-fatal stroke), revascularisation, and non-traumatic amputation.
Of 3233 individuals with screen-detected diabetes, 3057 agreed to participate and 3031 entered the 10-year follow-up analysis (1379 in routine care and 1678 in intensive treatment); mean duration of follow-up was 9.61 years.
Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA1c, blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up.
By 10 years, 443 participants had a first CV event and 465 died.
There was no significant difference between groups in the incidence of the primary composite outcome (16.1 per 1000 person-years in the routine care group vs 14.3 per 1000 person-years in the intensive treatment group; HR 0.87, 95% CI 0.73-1.04; p = 0.14) or all-cause mortality (15.6 vs 14.3 per 1000 person-years; HR 0.90, 0.76-1.07).
After 10 years, mean HbA1c was <7.0%, mean systolic blood pressure <135/85 mmHg and mean total cholesterol was 4.1 mmol/l.
How does this study impact clinical practice?
CV risk factors improved in both groups in the 10 years following detection by screening.
Intensive treatment of people with screen-detected diabetes is feasible in primary care.
Sustained reductions in glycaemia and related CV risk factors over 10 years among people with screen-detected diabetes managed in primary care are thus achievable.
The differences in prescribed treatment and CV risk factors in the 5 years following diagnosis were not maintained at 10 years, and the difference in CV events and mortality remained non-significant.
Griffin SJ, Rutten GEHM, et al. Long-term effects of intensive multifactorial therapy in individuals with screen-detected type 2 diabetes in primary care: 10-year follow-up of the ADDITION-Europe cluster-randomised trial. Lancet Diabetes Endocrinol. 2019;7(12):925-37.
This is a highlights summary of an oral session given at the EASD 2020 Virtual Meeting and presented by:
Simon Griffin, MD
MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, UK
The presenting authors of the original session had no part in the creation of this conference highlights summary.
The content is produced by Infomedica. The summary text was drafted by Patrick Moore, PhD, and reviewed by Marco Gallo, MD, an independent external expert, and approved by Florian Toti, MD, the scientific editor of the program.