MedicalResearch.com Interview with:
Oluf Pedersen, MD
Specialist in Internal Medicine and Endocrinology,
The Novo Nordisk Foundation Center for Basic Metabolic Research,
Section of Metabolic Genetics, Faculty of Health and Medical Sciences,
University of Copenhagen,
Peter Gæde and
Department of Cardiology and Endocrinology
Slagelse Hospital Copenhagen
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The Steno-2 study was the attempt to investigate the effect of an intensified, multifactorial intervention in type 2 diabetes simultaneously targeting risk factors such as hyperglycaemia, hypertension, dyslipidaemia, blood platelet aggregation, and elevated urinary albumin excretion rate as well as life style factors such as smoking, diet and a sedentary lifestyle. On top of that patients were by a dedicated team of care givers offered continued education and motivation.
A total of 160 Danish type 2 diabetes patients with microalbumuria (a biomarker of generalized vascular damage) were originally randomized either to intensified multifactorial treatment at Steno Diabetes Center, Copenhagen or to conventional multifactorial treatment at their general practitioners. The trial ended after 8 years, and patients in both of the original treatment arms were for the following 13 years given intensified multifactorial treatment as the one originally given to the intensified intervention group only.
Three previous milestone reports from the Steno-2 trial published in Lancet and New England Journal of Medicine have provided unprecedented evidence that this targeted and multifaceted approach reduces the risk of diabetic late complications such as kidney, eye or nerve disease as well as cardiovascular disease and total mortality with around fifty percent.
MedicalResearch.com: What are the main findings?
Response: In the present 21 years of follow-up after the initiation of the trial we sought to answer, whether the reductions in diabetes complications resulted in an increased life span. Further, we aimed to investigate to which extent these potentially gained life years occurred with or without major organ complications, a concern many patients express.
We demonstrate that the median increased survival time is 7.9 years longer in the original intensive-therapy group and that these gained years were followed by a similar (8.1 years) delay of new-onset cardiovascular disease such as (but not only) stroke or myocardial infarction.
Further, we found that the risks for severe microvascular complications such as blindness and end stage renal disease were reduced.
MedicalResearch.com: What should readers take away from your report?
Response: The most important message for readers is that early, continued and individualized intensive intervention against multiple risk factors in type 2 diabetes with microalbuminuria increases life span, and that the extra life length is free from severe and feared cardiovascular complications.
The intensive, multifactorial approach developed and tested in the Steno-2 trial has together with outcomes from multiple and large-scale single risk factor interventions in type 2 diabetes patients already been implemented in guidelines worldwide for care of patients with type 2 diabetes in general – and not only for those with microalbuminuria.
The present observations from the 21 years of follow-up of the Steno-2 study are another essential piece of evidence to justify these consensus recommendations. And most importantly, more epidemiological surveys are now reporting a decline in diabetes complications and mortality in the general diabetic population.
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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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