Intensive multifactorial intervention improves modelled coronary heart disease risk in screen‐detected Type 2 diabetes mellitus: a cluster randomized controlled trial

Abstract

Diabet. Med. 29, 531–540 (2012)AbstractAims 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 HbA1c 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 HbA1c, 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 HbA1c{−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.Conclusion 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.