Results unequivocally support early, aggressive, and sustained risk factor control in patients with complicated type 2 diabetes.
Intervention combined exercise, diet, and drugs, with 21 years of follow-up
Type-2 diabetics lived nearly 8 years longer when treated with an intensive, multifactorial approach that employed behavioral and pharmacological interventions.
The 160 patients with type-2 diabetes mellitus and microalbuminuria, now followed for 21 years, received either conventional or intensified therapy.
Thirty-eight intensive-therapy patients died during the follow-up period compared with 55 conventional-therapy patient deaths during the same time (HR 0.55, 95% CI 0.36-0.83, P=0.005). This translated to a median survival period 7.9 years longer for the intensive-therapy cohort (95% CI 2.2-9.6), as well as a median delay of 8.1 years to a first cardiovascular event (95% CI 4.0-12.6 years), the investigators reported in the journal Diabetologia.
"The outcome of our study is very encouraging and emphasizes the need for early and intensified treatment of multiple modifiable risk factors for a poor prognosis of patients with type 2 diabetes," said lead study author Peter Gaede, MD, of the University of Southern Denmark in Odense, in a statement.
Patient data came from Steno-2, a study started in 1993 that enrolled 160 Danish patients of European descent, mostly in their 50s, with type 2 diabetes mellitus and microalbuminuria. Components of the intervention included exercise, changes in diet, and drugs to improve glucose, blood pressure, and lipid parameters. The intensive therapy provided in the study was, the authors wrote, "target-driven, with stepwise implementation of both behavioral and pharmacological treatment following a structured approach."
"This long-term follow-up of the Steno-2 study demonstrates beyond any doubt the sustainability of the intensified and multipronged treatment approach of type-2 diabetes patients with microalbuminuria introduced by us more than 21 years ago," study co-author Hans-Henrik Parving, MD, of National University Hospital in Copenhagen. "The benefits for the patients in terms of a major extension of life and a halving of new cardiovascular complications speak for themselves."
The authors calculated that the conventional group had a median survival time of 13.3 years, but were unable to calculate median survival time for the intensive group after randomization, since fewer than half had died before the end of follow-up. As a result, "the calculated differences in median survival might thus underestimate the real difference," Gaede and colleagues noted.
Median time to a first cardiovascular event or death was 8.0 years in the conventional-therapy group, compared with 16.1 years in the intensive-therapy group. The overall adjusted mortality rate fell 45% for intensive-therapy patients during the follow-up period, while the absolute risk reduction in mortality in the intensive-therapy group was 21%.
As one might expect, patients in both groups with a post-baseline cardiovascular event had a higher mortality rate than those without (HR 3.08, 95% CI 1.82-5.19) and an increase in mortality of 2.08 per extra event (95% CI 1.73-2.51).
There were no observed differences in non-cardiovascular mortality rates between the two groups.
"We must emphasize the significance of early, intensified risk factor control in patients with complicated type-2 diabetes," wrote Gaede and colleagues in the study. "This approach is already broadly implemented according to clinical guidelines and the present findings should lead to even more focus on the potential preventive effects."
Source Reference: Gaede P, et al "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" Diabetologia 2016; DOI: 10.1007/s00125-016-4065-6.
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Carstensen is employed by the Steno Diabetes Center, which is owned by Novo Nordisk A/S.
Rossing has equity interest in Novo Nordisk A/S, research contracts with AbbVie, Novo Nordisk A/S and Novartis and has received consulting honoraria from AstraZeneca, BMS, Boehringer Ingellheim, Eli Lilly, Novo Nordisk, Astellas and AbbVie) (all to institution).
Lund-Andersen is a consultant at Steno Diabetes Center.
Parving has equity interest in Merck and has received consulting honoraria from AbbVie and Novartis.
Pedersen has equity interest in Novo Nordisk A/S.