Abstract
Aims/hypothesisThe aim of this work was to study the potential long-term impact of a 7.8 years intensified, multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria in terms of gained years of life and years free from incident cardiovascular disease.MethodsThe original intervention (mean treatment duration 7.8 years) involved 160 patients with type 2 diabetes and microalbuminuria who were randomly assigned (using sealed envelopes) to receive either conventional therapy or intensified, multifactorial treatment including both behavioural and pharmacological approaches. After 7.8 years the study continued as an observational follow-up with all patients receiving treatment as for the original intensive-therapy group. The primary endpoint of this follow-up 21.2 years after intervention start was difference in median survival time between the original treatment groups with and without incident cardiovascular disease. Non-fatal endpoints and causes of death were adjudicated by an external endpoint committee blinded for treatment allocation.ResultsThirty-eight intensive-therapy patients vs 55 conventional-therapy patients died during follow-up (HR 0.55 [95% CI 0.36, 0.83], p = 0.005). The patients in the intensive-therapy group survived for a median of 7.9 years longer than the conventional-therapy group patients. Median time before first cardiovascular event after randomisation was 8.1 years longer in the intensive-therapy group (p = 0.001). The hazard for all microvascular complications was decreased in the intensive-therapy group in the range 0.52 to 0.67, except for peripheral neuropathy (HR 1.12).Conclusions/interpretationAt 21.2 years of follow-up of 7.8 years of intensified, multifactorial, target-driven treatment of type 2 diabetes with microalbuminuria, we demonstrate a median of 7.9 years of gain of life. The increase in lifespan is matched by time free from incident cardiovascular disease.Trial registration:ClinicalTrials.gov registration no. NCT00320008.Funding:The study was funded by an unrestricted grant from Novo Nordisk A/S.Electronic supplementary materialThe online version of this article (doi:10.1007/s00125-016-4065-6) contains peer-reviewed but unedited supplementary material, which is available to authorised users.
Highlights
Type 2 diabetes mellitus is a complex disorder often featuring adiposity, hypertension, dyslipidaemia and increased blood platelet aggregation in addition to hyperglycaemia, giving rise to an increased risk of macro- and microvascular damage and reduced life expectancy
Conclusions/interpretation At 21.2 years of follow-up of 7.8 years of intensified, multifactorial, target-driven treatment of type 2 diabetes with microalbuminuria, we demonstrate a median of 7.9 years of gain of life
Patients with type 2 diabetes mellitus have increased risk for early mortality [2] and may suffer from multiple organ damage with recurrent event rates of up to 15% per year during follow-up of various trials [3,4,5,6,7,8] even though recent surveys suggest favourable changes in diabetes-related complications including death [9, 10]. This follow-up, a randomised trial of intensified vs standard multifactorial intervention for 7.8 years in patients with type 2 diabetes mellitus and microalbuminuria, was designed to address the median differences in lifespan with and without incident cardiovascular events between the originally intensified vs conventionally treated patients
Summary
Type 2 diabetes mellitus is a complex disorder often featuring adiposity, hypertension, dyslipidaemia and increased blood platelet aggregation in addition to hyperglycaemia, giving rise to an increased risk of macro- and microvascular damage and reduced life expectancy. Patients with type 2 diabetes mellitus have increased risk for early mortality [2] and may suffer from multiple organ damage with recurrent event rates of up to 15% per year during follow-up of various trials [3,4,5,6,7,8] even though recent surveys suggest favourable changes in diabetes-related complications including death [9, 10]. We use the term ‘years of life gained’ to emphasise the decreased life expectancy in patients with type 2 diabetes mellitus and microalbuminuria.
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