title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  ClinicalTrials.gov registration no. NCT00320008.
  
  
  
  The study was funded by an unrestricted grant from Novo Nordisk A/S.
authors.affiliation: Department of Cardiology and Endocrinology, Slagelse Hospital, Slagelse, Denmark.|Institute for Regional Health Research, University of Southern Denmark, Odense, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Gæde
authors.affiliation: Department of Cardiology and Endocrinology, Slagelse Hospital, Slagelse, Denmark.|Institute for Regional Health Research, University of Southern Denmark, Odense, Denmark.|Steno Diabetes Center, Gentofte, Denmark.
authors.forename: Jens
authors.initials: J
authors.lastname: Oellgaard
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark.
authors.forename: Bendix
authors.initials: B
authors.lastname: Carstensen
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark.|Faculty of Health, Aarhus University, Aarhus, Denmark.|Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Rossing
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark.|Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.|Capital Region Eye Clinic, Copenhagen, Denmark.
authors.forename: Henrik
authors.initials: H
authors.lastname: Lund-Andersen
authors.affiliation: Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.|Department of Medical Endocrinology, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Hans-Henrik
authors.initials: HH
authors.lastname: Parving
authors.affiliation: 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.
authors.forename: Oluf
authors.initials: O
authors.lastname: Pedersen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000419:Albuminuria / Q000188:drug therapy / Q000401:mortality / Q000628:therapy; D002318:Cardiovascular Diseases / Q000517:prevention & control; D048909:Diabetes Complications / Q000517:prevention & control; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy*; D003928:Diabetic Nephropathies / Q000517:prevention & control; D003929:Diabetic Neuropathies / Q000517:prevention & control; D003930:Diabetic Retinopathy / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D013997:Time Factors
chemical_list: D007004:Hypoglycemic Agents
keywords: Albuminuria; Cardiovascular disease; Diabetes complications; Diabetes mellitus, type 2; Diabetic nephropathy; Diabetic neuropathy; Diabetic retinopathy; Follow-up studies; Humans