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FDA Okays Antihypertensive Combo for First-Line Therapy
Posted by: admin in Pharmacy Drugs on November 22nd, 2009
LITTLE FALLS, N.J., May 13 — A combination pill containing amlodipine and olmesartan medoxomil — marketed as Azor — has received FDA approval as initial treatment for hypertensive patients likely to need multiple medications to reach blood pressure goals, the maker of the drug announced.
Daiichi Sankyo’s product, combining a calcium channel blocker and an angiotensin II receptor blocker, was originally approved in September 2007 for use alone or with other agents, but the indication for first-line therapy was recently added.
The approval was made on the basis of data from a phase III trial comparing the combination treatment with amlodipine or olmesartan medoxomil (Benicar) monotherapy and placebo in patients with mild-to-severe hypertension. (See ASH: More Proves Better in Treating Hypertension)
Through eight weeks, the combination yielded greater reductions in seated blood pressure and brought a greater percentage of patients to their blood pressure targets.
The benefits were seen in patients regardless of whether they had received antihypertensives before the study.
The only adverse reaction that occurred more with the active treatment than with placebo was edema.
Other adverse reactions included hypotension, orthostatic hypotension, rash, pruritus, palpitation, urinary frequency, and nocturia.
The drug’s label contains a boxed warning about the risk of injury or death to a developing fetus if used in the second or third trimesters of pregnancy.
Initial therapy with the combination is not recommended for patients 75 and older or those with liver problems, according to the company.
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