title: Intensive multifactorial intervention improves modelled coronary heart disease risk in screen-detected Type 2 diabetes mellitus: a cluster randomized controlled trial.
abstract: OBJECTIVE
  To compare the effects of intensive multifactorial cardiovascular risk intervention with standard care in screen-detected Type 2 diabetes.
  
  
  METHODS
  Twenty general practices randomly invited 30 950 adults without diagnosed diabetes for screening (World Health Organization, 1999). In a cluster randomized controlled trial, screen-detected cases were assigned by practice allocation to receive intensive protocol-driven cardiovascular risk management (n = 146) or standard care (n = 199) according to local guidelines. Intensive intervention was designed to achieve an HbA(1c) of 48 mmol/mol (6.5%), blood pressure < 130/80 mmHg and total cholesterol < 3.5 mmol/l. Primary outcome was modelled 5-year coronary heart disease risk (UKPDS-CHD). Analysis was via intention to treat.
  
  
  RESULTS
  After 1.1 years 339 (98%) individuals were still participating. There were significant reductions in HbA(1c) , blood pressure and total cholesterol from baseline in both groups [mean change for total study population -27.7 mmol/mol (-0.62%), -11.64/10.01 mmHg, -1.11 mmol/l]. After adjustment for baseline and clustering, significant inter-group differences were observed in mean changes from baseline for HbA(1c) {-28.5 mmol/mol [-0.7% (1.4)] vs. -27.5 mmol/mol [-0.6% (1.6)], P = 0.001}, blood pressure [systolic -16.2 (19.6) vs. -8.4 (18.6) mmHg, P < 0.001], total cholesterol [-1.3 (1.3) vs. -1.0 (1.2) mmol/l, P < 0.001] and weight [-3.8 (5.5) vs. -2.2 (5.5) kg, P = 0.01] in favour of intensive treatment. UKPDS 5-year coronary heart disease risk was reduced by 3.2% and 2.3%, respectively (P < 0.0001). Intensive intervention was associated with more lipid-lowering and anti-hypertensive but not hypoglycaemic medication use [odds ratios 2.5 (1.4-4.4), 5.5 (2.4-11.5), 1.6 (0.8-2.3); compared with standard care, P < 0.001, P = 0.003, P = 0.65]. Treatment satisfaction responses were superior with intensive intervention, with no increase in self-reported hypoglycaemia.
  
  
  CONCLUSIONS
  Intensive intervention in patients with diabetes identified through systematic non-risk-factor-based screening significantly reduces modelled coronary heart disease risk. This is achieved predominantly with lipid-lowering and anti-hypertensive treatments with no adverse effect on quality of life or hypoglycaemia.
authors.affiliation: Department of Cardiovascular Sciences, Leicester Royal Infirmary, University of Leicester, Leicester, UK. david.webb@uhl-tr.nhs.uk
authors.forename: D R
authors.initials: DR
authors.lastname: Webb
authors.forename: K
authors.initials: K
authors.lastname: Khunti
authors.forename: L J
authors.initials: LJ
authors.lastname: Gray
authors.forename: B T
authors.initials: BT
authors.lastname: Srinivasan
authors.forename: A
authors.initials: A
authors.lastname: Farooqi
authors.forename: N
authors.initials: N
authors.lastname: Wareham
authors.forename: S C
authors.initials: SC
authors.lastname: Griffin
authors.forename: M J
authors.initials: MJ
authors.lastname: Davies
mesh_terms: D000328:Adult; D001786:Blood Glucose; D001794:Blood Pressure; D016000:Cluster Analysis; D003327:Coronary Disease / Q000188:drug therapy / Q000517:prevention & control*; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy; D003925:Diabetic Angiopathies / Q000188:drug therapy / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000188:drug therapy / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D008297:Male; D008403:Mass Screening; D011788:Quality of Life; D012307:Risk Factors
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents