Increased mortality in patients with diabetes associated with olmesartan for the prevention/delay of microalbuminuria onset: a matter of concern?

Microalbuminuria cannot be ignored by cardiologists because it is considered a predictor of coronary artery disease in patients with type 2 diabetes. Angiotensin II receptor blockers (ARB-II) have been accepted nephroprotective agents in patients with type 2 diabetes with microalbuminuria since publication of the Irbesartan Patients with Diabetes and Microalbuminuria (IRMA-2) study. In patients with macroalbuminuria, the Reduction of Endpoints in NIDDM with Angiotensin II Antagonist Losartan (RENAAL) and Irbesartan in Diabetic Nephropathy Trial (IDNT) studies showed a slowing of progression to terminal kidney disease. However, in patients with diabetes with microalbuminuria, the Diabetic Retinopathy Candesartan Trial (DIRECT) showed no significant reduction in microalbuminuria. Recently, the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study has been published. Interestingly, it found that the use of olmesartan vs placebo to be associated with a significantly reduced incidence of microalbuminuria (23% relative reduction). However, it also showed increased incidence of cardiovascular death with olmesartan