Randomised controlled trial of intensive multifactorial treatment for cardiovascular risk in patients with screen-detected type 2 diabetes: 1-year data from the ADDITION Netherlands study

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Abstract
Background A growing body of evidence suggests that earlier diagnosis and treatment of diabetes may be benefical; however, definitive evidence is lacking. Aim To evaluate the effectiveness of an intensified multifactorial treatment on cardiovascular risk factors in patients with screen-detected type 2 diabetes. Design of study Randomised controlled trial. Setting Seventy-nine general practices in the southwestern region of the Netherlands. Method In this randomised trial, patients diagnosed with diabetes by screen-detection were assigned to intensified (n = 255) or routine treatment (n = 2,13), and followed over 1 year. Intensified treatment consisted of pharmacological treatment combined with lifestyle education to achieve haemoglobin A1c (HbA1c) <7.0%, blood pressure <135/85 mmHg and cholesterol <5.0 mmol/l (4.5 mmol/l if cardiovascular disease was present). Health-related quality of life (HRQoL) was assessed using the Short Form (SF)-36 Analyses were performed using generalised estimating equations models. Results Changes in body mass index were 0.2 (routine care) versus -1.4 kg/m(2) (intensified treatment), P<0.001; systolic blood pressure -19 versus -33 mmHg, P<0.001; diastolic blood pressure -7 versus -12 mmHg P<0.001; HbA1c -0.9% versus -1.1%, P = 0.03; cholesterol -0.5 versus -1.2 mmol/l, P<0.001; high-density lipoprotein cholesterol 0.1 versus 0.1 mmol/l, p = 0.26; low-density lipoprotein cholesterol -0.5 versus -1.0 mmol/l, P<0.001; triglycerides -0.3 versus -0.4 mmol/l, P = 0.71. No difference in HRQoL between the two groups was reported. Conclusion Intensified multifactorial treatment of patients with screen-detected diabetes in general practice reduces cardiovascular risk factor levels significantly without worsening HRQoL.