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