Background Intensified multifactorial intervention — withtight glucose regulation and the use of renin–angiotensinsystem blockers, aspirin, and lipid-lowering agents —has been shown to reduce the risk of nonfatal cardiovasculardisease among patients with type 2 diabetes mellitus and microalbuminuria.We evaluated whether this approach would have an effect on therates of death from any cause and from cardiovascular causes.
Methods In the Steno-2 Study, we randomly assigned 160 patientswith type 2 diabetes and persistent microalbuminuria to receiveeither intensive therapy or conventional therapy; the mean treatmentperiod was 7.8 years. Patients were subsequently followed observationallyfor a mean of 5.5 years, until December 31, 2006. The primaryend point at 13.3 years of follow-up was the time to death fromany cause.
Results Twenty-four patients in the intensive-therapy groupdied, as compared with 40 in the conventional-therapy group(hazard ratio, 0.54; 95% confidence interval [CI], 0.32 to 0.89;P=0.02). Intensive therapy was associated with a lower riskof death from cardiovascular causes (hazard ratio, 0.43; 95%CI, 0.19 to 0.94; P=0.04) and of cardiovascular events (hazardratio, 0.41; 95% CI, 0.25 to 0.67; P<0.001). One patientin the intensive-therapy group had progression to end-stagerenal disease, as compared with six patients in the conventional-therapygroup (P=0.04). Fewer patients in the intensive-therapy grouprequired retinal photocoagulation (relative risk, 0.45; 95%CI, 0.23 to 0.86; P=0.02). Few major side effects were reported.
Conclusions In at-risk patients with type 2 diabetes, intensiveintervention with multiple drug combinations and behavior modificationhad sustained beneficial effects with respect to vascular complicationsand on rates of death from any cause and from cardiovascularcauses. (ClinicalTrials.gov number, NCT00320008
[ClinicalTrials.gov]
.)
Source Information
From the Steno Diabetes Center, Copenhagen (P.G., H.L.-A., O.P.); Department of Ophthalmology, Glostrup University Hospital, Glostrup (H.L.-A.); Department of Medical Endocrinology, Rigshospitalet Copenhagen University Hospital, Copenhagen (H.-H.P.); and Faculty of Health Sciences, University of Aarhus, Aarhus (H.-H.P., O.P.) — all in Denmark.
Address reprint requests to Dr. Pedersen at the Steno Diabetes Center, 2820 Gentofte, Copenhagen, Denmark, or at oluf{at}steno.dk.
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