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Diabetologia. 2016 Nov;59(11):2298-2307. doi: 10.1007/s00125-016-4065-6. Epub 2016 Aug 16.

Years of life gained by multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised trial.

Author information

1
Department of Cardiology and Endocrinology, Slagelse Hospital, Slagelse, Denmark.
2
Institute for Regional Health Research, University of Southern Denmark, Odense, Denmark.
3
Steno Diabetes Center, Gentofte, Denmark.
4
Faculty of Health, Aarhus University, Aarhus, Denmark.
5
Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
6
Capital Region Eye Clinic, Copenhagen, Denmark.
7
Department of Medical Endocrinology, Rigshospitalet, Copenhagen, Denmark.
8
Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 1, DK-2100, Copenhagen, Denmark. oluf@sund.ku.dk.

Abstract

AIMS/HYPOTHESIS:

The 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.

METHODS:

The 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.

RESULTS:

Thirty-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/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. 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.

KEYWORDS:

Albuminuria; Cardiovascular disease; Diabetes complications; Diabetes mellitus, type 2; Diabetic nephropathy; Diabetic neuropathy; Diabetic retinopathy; Follow-up studies; Humans

Comment in

PMID:
27531506
PMCID:
PMC5506099
DOI:
10.1007/s00125-016-4065-6
[Indexed for MEDLINE]
Free PMC Article

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