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New Data Shows AZOR(R) (amlodipine and olmesartan medoxomil) Significantly Improves 24-Hour Ambulatory Blood Pressure
Date:5/8/2009

severe aortic stenosis.

Severe Obstructive Coronary Artery Disease

Patients, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.

Congestive Heart Failure

In general, calcium channel blockers should be used with caution in patients with heart failure.

Impaired Renal Function

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar effects would be expected with AZOR because of the olmesartan medoxomil component.

Hepatic Impairment

Since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with severely impaired hepatic function, caution should be exercised when administering AZOR to patients with severe hepatic impairment.

Laboratory Tests

There was a greater decrease in hemoglobin and hematocrit in the combination product compared to either component alone.

Adverse Reactions

The only adverse reaction that occurred in greater than or equal to 3 percent of patients treated with AZOR and more frequently than placebo was edema. The placebo-subtracted incidence was 5.7 percent (5/20 mg), 6.2 percent (5/40 mg), 13.3 percent (10/20 mg), and 11.2 percent (10/40 mg). The edema incidence for placebo was 12.3 percent.

Adverse reactions seen at lower rates but at about the same or greater incidence as in patients receiving placebo included hypotension, orthostatic hypotension,
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SOURCE Daiichi Sankyo, Inc.
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