Increased Survival and Reduced Macrovascular Disease with 7.8 Years of Intensified, Multifactorial Intervention in Patients with Type 2 Diabetes and Microalbuminuria in the Steno-2 Study

Presentation Number: OR11-1
Date of Presentation: April 1st, 2017

Jens Øllgaard*1, Peter Gæde1, Peter Rossing2, Hans Henrik Parving3 and Oluf Pedersen4
1Slagelse Hospital, Denmark, 2Steno Diabetes Center, Denmark, 3Rigshospitalet, Denmark, 4University of Copenhagen, Copenhagen, Denmark

Abstract

Introduction: Intensified multifactorial intervention for 7.8 years in patients with type 2 diabetes mellitus and microalbuminuria reduced risk of macro- and microvascular complications. Here we seek to investigate the durability of this approach with a total of 21 years follow-up in a post hoc analysis including endpoints as recommended in FDA-guidelines.

Methods: 160 patients with type 2 diabetes and microalbuminuria were assigned to conventional or intensified, multi-factorial therapy targeting multiple risk factors. Mean treatment duration was 7.8 years. After 7.8 years the study continued as an observational follow-up with all patients treated as the original intensive-therapy group. Time to event was modelled using Cox-regressions adjusted for age and sex.

The primary endpoint was survival time after randomization and survival time before first CVD event.

The secondary endpoint was the relative risk reduction in a 3 point MACE defined as death of CVD, coronary artery disease (CAD: non-fatal or fatal acute myocardial infarction or cardiac revascularization) and cerebrovascular disease (defined as non-fatal and fatal ischemic or hemorrhagic stroke) analyzed both as a composite- and separate endpoints.

Results: Overall median survival time was 7.9 [95% CI 2.2 – 9.6; p = 0.005] years longer in the original intensive-therapy group compared to standard treatment. Time before first CVD-event was 8.1 [4.0 – 12.6; p = 0.001] years longer in the intensive therapy group.

Hazard rates of both the composite and separate secondary endpoints were all decreased with intensified therapy. HR of the composite endpoint was 0.36 [95 % CI 0.23 – 0.57; p < 0.001], of CAD 0.43 [0.23 – 0.77; p = 0.005] and cerebrovascular disease 0.26 [0.12 – 0.55; p < 0.001]. In addition, the risk of recurrent events was significantly decreased in the intensive-therapy group (p = 0.049 for CAD and p = 0.003 for stroke).

Conclusions: At 21.2 years of follow up of 7.8 years of intensified, multifactorial, target driven treatment of type 2 diabetes mellitus with microalbuminuria, we demonstrate significantly increased life span and reduced risk of macrovascular complications.

(ClinicalTrials.gov number, NCT00320008.)

 

Disclosure: JØ: , Novo Nordisk. Nothing to Disclose: PG, PR, HHP, OP