Angiotensin Receptor Blocker to Prevent Microalbuminuria?

Abstract

Haller H, Ito S, Izzo JL Jr, Januszewicz A, Katayama S, Menne J, Mimran A, Rabelink TJ, Ritz E, Ruilope LM, Rump LC, Viberti G, for the ROADMAP Trial Investigators: Olmesartan for delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med 364:907–917, 2011 Objective. Microalbuminuria is a predictor of cardiovascular disease (CVD), as well as diabetes-related nephropathy. This study was designed to determine whether the occurrence of microalbuminuria could be prevented or delayed in patients with type 2 diabetes with the angiotensin receptor blocker (ARB) olmesartan. Design and methods. This study was a randomized, multicenter, double-blind, controlled trial of 4,447 patients with type 2 diabetes. The patients were 18–75 years of age and had normoalbuminuria at the onset of the trial. They were randomized to receive either placebo or olmesartan, 40 mg daily, for a median of 3.2 years. During the trial, patients were treated to a blood pressure of < 130/90 mmHg using conventional antihypertensive medications (excluding ACE inhibitors, ARBs, or aldosterone blockers except for the ARB olmesartan in the active treatment group). Patients who had used ACE inhibitors or ARBs during the 6-month period leading up to the study were excluded. Blood pressure was measured with an automated device at each follow-up visit. The blood pressure value used was the mean of three measurements taken at 3-minute intervals by an automated device. The primary outcome was the elapsed time until the initial onset of microalbuminuria. Urine was tested by validated measurements of morning spot urine samples. Microalbuminuria was described in this trial as a urinary albumin (mg) to creatinine (g) ratio of > 35 in women or > 25 in men. Any new abnormal albumin-to-creatinine ratio was confirmed by another positive result (out …