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Amlodipine and Olmesartan Study Results Released; Late Breaker,Presented at American Society of Hypertension Twenty-Second Annual,Scientific Meeting (ASH 2007)

First Release of Data for New Combination

PARSIPPANY, N.J., May 21, 2007 /PRNewswire/ -- Combining the calcium channel blocker amlodipine besylate with the angiotensin receptor blocker olmesartan medoxomil, produced significant mean reductions in seated systolic and diastolic blood pressure in patients with hypertension, according to data presented at the American Society of Hypertension's Twenty-Second Annual Scientific Meeting and Exposition (ASH 2007). The Phase III registration trial data was presented for the first time at today's "late breaker" session at the ASH meeting in Chicago. Daiichi Sankyo, Inc. filed a New Drug Application (NDA) in November 2006 for a fixed-dose combination of the two antihypertensives. This investigational agent of amlodipine besylate/olmesartan medoxomil (AZOR(TM)) is under regulatory review in the United States, including trade name review.

"All combinations of amlodipine and olmesartan produced significantly greater mean reductions in both diastolic and systolic blood pressure than either medication alone," said Steven G. Chrysant, MD, of the Oklahoma Cardiovascular and Hypertension Center and the University of Oklahoma School of Medicine, and lead investigator on the study. "All combinations with amlodipine 10 mg demonstrated a lower incidence of edema versus amlodipine 10 mg monotherapy," he added.

Amlodipine 10 mg/day plus olmesartan 40 mg/day reduced systolic blood pressure an average of 30.1 mm Hg and the diastolic reading an average of 19.0 mm Hg. These results were in comparison with mean reductions of 19.7 mm Hg systolic/12.7 mm Hg diastolic for amlodipine 10 mg alone (placebo= 4.8/3.1 mm Hg). When compared to amlodipine 10 mg alone, amlodipine 10 mg/day plus olmesartan 40 mg/day resulted in a 53 percent greater reduction in systolic blood pressure. Amlodipine combined with olmesartan provides two complimentary mechanisms of action to lower blood pressur
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