Reductions in Diabetic Renal-, Peripheral Vascular- and Eye Disease with 7.8 Years of Intensified, Multifactorial Intervention in Patients with Type 2 Diabetes and Microalbuminuria in the Steno-2 Study

Presentation Number: SAT 597
Date of Presentation: April 1st, 2017

Jens Øllgaard*1, Peter Gæde1, Peter Rossing2, Henrik Lund-Andersen3, 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 after 13.3 years follow-up.

Complications to diabetes mellitus in other organs the heart and brain are often overlooked, but are significantly reducing patient quality of life, and end stage renal disease, amputations and blindness are the most feared late complications among patients.

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.

For this sub-study, the primary end-point was time to end-stage renal disease, major amputations (defined as leg-length shortening operation) or blindness in one eye.

Secondary end-point was glomerular filtration rate < 45ml/min, minor amputations or vitrectomy, photocoagulation or intravitreous injection treatment of retinopathy.

Time to event analyses were modelled using a Cox-regression adjusted for age and sex.

Results: The relative risk of the primary outcome was reduced by 64 % in the original intensive-therapy group; HR 0.36 [95% CI 0.20 – 0.67; p=0.001].

The secondary outcome was reduced by 49 % in the intensive-therapy group; HR 0.51 [0.33 – 0.80; p=0.004]. Estimates were stable, when all-cause mortality was included in analyses.

Lower baseline GFR was associated with increased risk of the primary and secondary outcome. Further, baseline HbA1c and systolic BP was associated with the secondary outcome.

Conclusions: After 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 reduced risk of severe microvascular complications with expectedly improved long-term quality of life as a consequence.

(ClinicalTrials.gov number, NCT00320008.)

 

Nothing to Disclose: JØ, PG, PR, HL, HHP, OP