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Ongoing Landmark ROADMAP Study Demonstrates Significant Improvement in Blood Pressure Control at One Year, According to Blinded Results
Date:5/8/2009

First-Ever Trial to Evaluate Whether Olmesartan Medoxomil Prevents Onset of Early Kidney Disease in Type 2 Diabetes Patients

SAN FRANCISCO, May 8 /PRNewswire/ -- Blinded one-year blood pressure (BP) reduction data from the ongoing landmark study ROADMAP (Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention), were presented today at the American Society of Hypertension (ASH) Twenty-Fourth Annual Scientific Meeting and Exposition (ASH 2009) in San Francisco. ROADMAP is the first-ever large-scale clinical trial, being conducted in 19 European countries to evaluate whether the angiotensin II receptor blocker (ARB) olmesartan medoxomil can prevent the onset of microalbuminuria in patients with type 2 diabetes (T2DM). Microalbuminuria is an early sign of kidney disease, as well as an important risk factor of cardiovascular disease (CVD).(1) The secondary objective of the ROADMAP trial includes incidence of cardiovascular and renal morbidity and mortality. A qualitative parameter in the secondary objective was to measure cuff blood pressure (BP).

The double-blinded one-year data presented at ASH 2009 showed that a strict BP control (<130/80) regimen in the ROADMAP trial improved BP compared to baseline in T2DM patients. The data presented represents the blinded total patient population, which includes patients randomized either to olmesartan or placebo in addition to standard antihypertensive treatment (excluding RAS inhibition). After one year of treatment, 61 percent of patients in ROADMAP achieved the recommended BP goal of <130/80 mm Hg, a significant increase from a baseline of 28 percent controlled. The prevalence of Stage 1 and Stage 2 hypertension decreased from 32 to 11 percent and from 9 to 2 percent, respectively. ROADMAP was designed to allow analysis of BP responses and potential renal and CVD risk benefits across a wide range of patients with dia
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SOURCE Daiichi Sankyo, Inc.
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