A targeted, multifactorial intervention reduced mortality in patients with type 2 diabetes and microalbuminuria

摘要

QuestionnnIn patients with type 2 diabetes and microalbuminuria, does an intensive, targeted multifactorial intervention reduce mortality in the long term? nnMethodsnnDesign: Randomized controlled trial (the Steno-2 Study).nnAllocation: {Concealed}†.*nnBlinding: Blinded {data collectors and outcome assessors}†.*nnFollow-up period: Mean 13.3 years.nnSetting: A diabetes center in Denmark.nnPatients: 160 patients (mean age 55 y) with type 2 diabetes and persistent microalbuminuria. {Exclusion criteria included stimulated serum C-peptide level < 600 pmol/L, pancreatic insufficiency or pancreatitis, nondiabetic kidney disease, cancer, or life-threatening disease.}‡nnIntervention: Intensive therapy (IT, n = 80) or conventional therapy (CT, n = 80) for a mean trial period of 7.8 years followed by observation of survivors for a mean 5.5 years. IT comprised medications {angiotensin-converting enzyme inhibitors; vitamins C and E; aspirin; and drugs for hyperglycemia, dyslipidemia, and hypertension};‡ behavior modification {low-fat diet, exercise, and smoking cessation};‡ and targets for blood pressure (BP) (< 130/80 mm Hg), glycated hemoglobin (Hb) (< 6.5%), cholesterol (< 175 mg/dL), and triglycerides (< 150 mg/dL).nnOutcomes: Included all-cause mortality, cardiovascular (CV) mortality, CV events (composite of CV mortality, nonfatal stroke, nonfatal myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention or revascularization, and amputation), diabetic nephropathy, retinopathy, and neuropathy.nnPatient follow-up: 98% (intention-to-treat analysis).nnnMain resultsnnThe IT group had lower rates of all-cause mortality, CV mortality, CV events, diabetic nephropathy, retinopathy, and autonomic neuropathy than did the CT group (Table). Groups did not differ for peripheral neuropathy. nnConclusionnnIntensive therapy reduced mortality and morbidity in patients with type 2 diabetes and microalbuminuria at 5.5 years following a 7.8-year randomized trial.