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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

betes classified from normotension to hypertension, and to test whether this extensive subgrouping might provide additional insight for practicing physicians.

"It is essential to manage blood pressure very aggressively in diabetics because their heart attack and stroke rates are more closely related to their blood pressure levels than to their blood sugar levels," said Joseph L. Izzo, Jr., M.D., Professor of Medicine and Pharmacology at SUNY-Buffalo and Director of Medicine at the Erie County Medical Center in Buffalo. "In ROADMAP, to date, we have achieved some of the lowest BP levels ever in a clinical trial.

About ROADMAP

ROADMAP is a randomized, double-blind, placebo-controlled, parallel-group, multi-center Phase III study being conducted at 262 collaborating centers in 19 European countries. The primary goal of the study is to test the hypothesis that treatment of T2DM patients with 40 mg of olmesartan medoxomil will prevent or delay the occurrence of microalbuminuria in comparison to a regimen that excludes agents that directly block the RAS. The secondary objective is to test the hypothesis that treatment with olmesartan medoxomil has a positive effect on cardiovascular and renal morbidity and mortality.

The study involves 4,449 men and women with T2DM with normoalbuminuria (less than or equal to 35 mg albumin/g urine creatinine for women and less than or equal to 25 mg albumin/g urine creatinine for men) at the outset, and who have at least one additional cardiovascular risk factor, including patients being treated for hypertension. Patients were randomized to receive 40 mg of olmesartan medoxomil or placebo for an average of five years. Patients with hypertension were also treated at the investigator's discretion with diuretics, alpha- or beta-blockers or calcium channel antagonists to achieve a target BP of <130/80. Patients requiring treatment with an ARB or ACEi were withdr
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SOURCE Daiichi Sankyo, Inc.
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