In a randomised study 160 patients (mean age 55.1 years) with type 2 diabetes and microalbuminuria received either an intensified multiple risk factor intervention (dietary fat composition, exercise recommendation, smoking-cessation courses, ACE inhibitors irrespective of blood pressure level, aspirin, antihypertensive medication, hypoglycaemic agents, and statins or fibrates (for those with hypercholesterolaemia or hypertriglyceridaemia) or conventional care 1. Patients receiving intensive therapy had a significantly lower risk of cardiovascular disease (hazard ratio 0.47, 95% CI 0.24 to 0.73), nephropathy (HR 0.39, 95% CI 0.17 to 0.87), retinopathy (HR 0.42, 95% CI 0.21 to 0.86) and autonomic neuropathy (HR 0.37, 95% CI 0.18 to 0.79).
In the above mentioned study, after 7.8 years, all individuals were offered intensified therapy and the study continued as an observational follow-up study 2 for an additional 13.4 years. Heart-failure hospitalisations were adjudicated from patient records by an external expert committee blinded for treatment allocation. Ten patients undergoing intensive therapy vs 24 undergoing conventional therapy were hospitalised for heart failure during follow-up. The HR was 0.30 (95% CI 0.14 to 0.64), p = 0.002 in the intensive-therapy group compared with the conventional-therapy group. Including death in the endpoint did not lead to an alternate overall outcome; HR 0.51 (95% CI 0.34 to 0.76), p = 0.001. In a pooled cohort analysis, an increase in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) during the first two years of the trial was associated with incident heart failure.
Comment: The quality of evidence is downgraded by imprecise results (few patients and wide confidence intervals).
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