title: Does early intensive multifactorial therapy reduce modelled cardiovascular risk in individuals with screen-detected diabetes? Results from the ADDITION-Europe cluster randomized trial.
abstract: OBJECTIVE
  Little is known about the long-term effects of intensive multifactorial treatment early in the diabetes disease trajectory. In the absence of long-term data on hard outcomes, we described change in 10-year modelled cardiovascular risk in the 5 years following diagnosis, and quantified the impact of intensive treatment on 10-year modelled cardiovascular risk at 5 years.
  
  
  METHODS
  In a pragmatic, cluster-randomized, parallel-group trial in Denmark, the Netherlands and the UK, 3057 people with screen-detected Type 2 diabetes were randomized by general practice to receive (1) routine care of diabetes according to national guidelines (1379 patients) or (2) intensive multifactorial target-driven management (1678 patients). Ten-year modelled cardiovascular disease risk was calculated at baseline and 5 years using the UK Prospective Diabetes Study Risk Engine (version 3β).
  
  
  RESULTS
  Among 2101 individuals with complete data at follow up (73.4%), 10-year modelled cardiovascular disease risk was 27.3% (sd 13.9) at baseline and 21.3% (sd 13.8) at 5-year follow-up (intensive treatment group difference -6.9, sd 9.0; routine care group difference -5.0, sd 12.2). Modelled 10-year cardiovascular disease risk was lower in the intensive treatment group compared with the routine care group at 5 years, after adjustment for baseline cardiovascular disease risk and clustering (-2.0; 95% CI -3.1 to -0.9).
  
  
  CONCLUSIONS
  Despite increasing age and diabetes duration, there was a decline in modelled cardiovascular disease risk in the 5 years following diagnosis. Compared with routine care, 10-year modelled cardiovascular disease risk was lower in the intensive treatment group at 5 years. Our results suggest that patients benefit from intensive treatment early in the diabetes disease trajectory, where the rate of cardiovascular disease risk progression may be slowed.
authors.affiliation: MRC Epidemiology Unit, Cambridge University Biomedical Campus, Cambridge, UK.
authors.forename: J A
authors.initials: JA
authors.lastname: Black
authors.forename: S J
authors.initials: SJ
authors.lastname: Sharp
authors.forename: N J
authors.initials: NJ
authors.lastname: Wareham
authors.forename: A
authors.initials: A
authors.lastname: Sandbaek
authors.forename: G E H M
authors.initials: GE
authors.lastname: Rutten
authors.forename: T
authors.initials: T
authors.lastname: Lauritzen
authors.forename: K
authors.initials: K
authors.lastname: Khunti
authors.forename: M J
authors.initials: MJ
authors.lastname: Davies
authors.forename: K
authors.initials: K
authors.lastname: Borch-Johnsen
authors.forename: S J
authors.initials: SJ
authors.lastname: Griffin
authors.forename: R K
authors.initials: RK
authors.lastname: Simmons
mesh_terms: D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy / Q000706:statistics & numerical data; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D003925:Diabetic Angiopathies / Q000517:prevention & control*; D042241:Early Diagnosis; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008955:Models, Cardiovascular; D016896:Treatment Outcome