The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) Observational Follow‐Up Study: Benefits of RAS Blockade With Olmesartan Treatment Are Sustained After Study Discontinuation

Abstract

Background The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study showed that 40 mg Olmesartan medoxomil ( OM ) versus placebo delayed microalbuminuria onset in patients with type 2 diabetes and normoalbuminuria. Methods and Results One thousand seven hundred and fifty‐eight ROADMAP patients (placebo arm: 877; OM arm: 881) participated in the observational follow up ( OFU ) with an average of 3.3 years. They received standard medical care and micro‐ and macrovascular events were documented. During observational follow‐up 62.9% and 60.1% in the former OM and placebo group, respectively, received treatment with a RAS blocking agent. During the OFU period the systolic blood pressure ( SBP ) increased to mean values of 135 mm Hg in both groups. Patients who had developed microalbuminuria during ROADMAP had a higher incidence of cardio‐ and cerebrovascular events ( OR 1.77, CI 1.03 to 3.03, P =0.039) during the OFU period compared with patients in whom this was not the case. Diabetic retinopathy was significantly reduced in the former OM group (8 [0.9%] versus 23 [2.6%], OR : 0.34, CI 0.15 to 0.78, P =0.011) and the rate of microalbuminuria was numerically reduced. Congestive heart failure requiring hospitalization (3 [0.3%] versus 12 [1.4%], OR : 0.23, CI 0.06 to 0.85, P =0.027) was reduced and there was a trend of reduced cardio‐/cerebrovascular events ( OM versus Pb: 73 [8.3%] versus 86 [9.8%] patients). Seven (0.8%) deaths (including 2 CV events) were reported in former placebo patients versus 3 (0.3%) (non‐ CV events) in former OM patients. Conclusions Development of microalbuminuria is a valid marker for future CV events. RAS blockade with Olmesartan might cause sustained reduction (legacy effect) of micro‐ and macrovascular events.