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      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

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          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.

          Electronic supplementary material

          The 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.

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          Most cited references 28

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          10-year follow-up of intensive glucose control in type 2 diabetes.

          During the United Kingdom Prospective Diabetes Study (UKPDS), patients with type 2 diabetes mellitus who received intensive glucose therapy had a lower risk of microvascular complications than did those receiving conventional dietary therapy. We conducted post-trial monitoring to determine whether this improved glucose control persisted and whether such therapy had a long-term effect on macrovascular outcomes. Of 5102 patients with newly diagnosed type 2 diabetes, 4209 were randomly assigned to receive either conventional therapy (dietary restriction) or intensive therapy (either sulfonylurea or insulin or, in overweight patients, metformin) for glucose control. In post-trial monitoring, 3277 patients were asked to attend annual UKPDS clinics for 5 years, but no attempts were made to maintain their previously assigned therapies. Annual questionnaires were used to follow patients who were unable to attend the clinics, and all patients in years 6 to 10 were assessed through questionnaires. We examined seven prespecified aggregate clinical outcomes from the UKPDS on an intention-to-treat basis, according to previous randomization categories. Between-group differences in glycated hemoglobin levels were lost after the first year. In the sulfonylurea-insulin group, relative reductions in risk persisted at 10 years for any diabetes-related end point (9%, P=0.04) and microvascular disease (24%, P=0.001), and risk reductions for myocardial infarction (15%, P=0.01) and death from any cause (13%, P=0.007) emerged over time, as more events occurred. In the metformin group, significant risk reductions persisted for any diabetes-related end point (21%, P=0.01), myocardial infarction (33%, P=0.005), and death from any cause (27%, P=0.002). Despite an early loss of glycemic differences, a continued reduction in microvascular risk and emergent risk reductions for myocardial infarction and death from any cause were observed during 10 years of post-trial follow-up. A continued benefit after metformin therapy was evident among overweight patients. (UKPDS 80; Current Controlled Trials number, ISRCTN75451837.) 2008 Massachusetts Medical Society
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            The Danish National Patient Register.

            The Danish National Patient Register (NPR) was established in 1977, and it is considered to be the finest of its kind internationally. At the onset the register included information on inpatient in somatic wards. The content of the register has gradually been expanded, and since 2007 the register has included information on all patients in Danish hospitals. Although the NPR is overall a sound data source, both the content and the definitions of single variables have changed over time. Changes in the organisation and provision of health services may affect both the type and the completeness of registrations. The NPR is a unique data source. Researchers using the data should carefully consider potential fallacies in the data before drawing conclusions.
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              The Danish Civil Registration System.

              The Danish Civil Registration System (CRS) was established in 1968, and all persons alive and living in Denmark were registered for administrative use. CRS includes individual information on the unique personal identification number, name, gender, date of birth, place of birth, citizenship, identity of parents and continuously updated information on vital status, place of residence and spouses. Since 1968, CRS has recorded current and historical information on all persons living in Denmark. Among persons born in Denmark in 1960 or later it contains complete information on maternal identity. For women born in Denmark in April 1935 or later it contains complete information on all their children. CRS contains complete information on immigrations and emigrations from 1969 onwards, permanent residence in a Danish municipality from 1971 onwards, and full address in Denmark from 1977 onwards. CRS in connection with other registers and biobanks will continue to provide the basis for significant knowledge relevant to the aetiological understanding and possible prevention of human diseases.
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                Author and article information

                Affiliations
                [1 ]GRID grid.452905.f, Department of Cardiology and Endocrinology, , Slagelse Hospital, ; Slagelse, Denmark
                [2 ]ISNI 0000 0001 0728 0170, GRID grid.10825.3e, Institute for Regional Health Research, , University of Southern Denmark, ; Odense, Denmark
                [3 ]ISNI 0000 0004 0646 7285, GRID grid.419658.7, , Steno Diabetes Center, ; Gentofte, Denmark
                [4 ]ISNI 0000 0001 1956 2722, GRID grid.7048.b, Faculty of Health, , Aarhus University, ; Aarhus, Denmark
                [5 ]ISNI 0000 0001 0674 042X, GRID grid.5254.6, Faculty of Health Sciences, , University of Copenhagen, ; Copenhagen, Denmark
                [6 ]Capital Region Eye Clinic, Copenhagen, Denmark
                [7 ]GRID grid.475435.4, Department of Medical Endocrinology, , Rigshospitalet, ; Copenhagen, Denmark
                [8 ]ISNI 0000 0001 0674 042X, GRID grid.5254.6, 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
                Contributors
                oluf@sund.ku.dk
                Journal
                Diabetologia
                Diabetologia
                Diabetologia
                Springer Berlin Heidelberg (Berlin/Heidelberg )
                0012-186X
                1432-0428
                16 August 2016
                16 August 2016
                2016
                : 59
                : 11
                : 2298-2307
                27531506 5506099 4065 10.1007/s00125-016-4065-6
                © The Author(s) 2016

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100004191, Novo Nordisk;
                Categories
                Article
                Custom metadata
                © Springer-Verlag Berlin Heidelberg 2016

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