“The Department of Justice is committed to preserving the independence and objectivity of those decisions, which are cornerstones of our public health programs.” “The Anti-Kickback Statute prohibits payments intended to influence a physician’s ordering or prescribing decisions,” said Acting Assistant Attorney General Joyce R. headquarters in New Jersey, has agreed to pay the United States and state Medicaid programs $39 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce physicians to prescribe Daiichi drugs, including Azor, Benicar, Tribenzor and Welchol, the Justice Department announced today. The blood pressure lowering effect was maintained throughout the 24-hour period, with trough-to-peak ratios for systolic and diastolic response between 60% and 80%.Daiichi Sankyo Inc., a global pharmaceutical company with its U.S. A total of 2,693 subjects with essential hypertension were enrolled and received placebo or olmesartan at doses ranging from 2.5 mg to 80 mg, for 6 to 12 weeks. The anti-hypertensive activity of olmesartan was evaluated in 7 placebo controlled studies. Maintenance of the blood pressure effect over the 24-hour dosing interval was observed, with little difference in peak and trough effect. Amoldipine resulted in statistically significant placebo-corrected reductions in supine and standing blood pressures at 24 hours postdose, averaging about 12/6 mmHg in the standing position and 13/7 mmHg in the supine position. The trials enrolled a total of 1,338 subjects with mild to moderate hypertension who were treated with amoldipine or placebo once daily. The anti-hypertensive activity of amlodipine was evaluated in 15 double-blind, placebo-controlled, randomized studies. Diastolic blood pressure on this dose was reduced by 19 mm Hg, compared to 12.7 for amlodipine alone. At this dose systolic blood pressure was cut by 30.1 mm Hg, a 53% greater drop than with 10 mg amlodipine alone.
The highest combination dose was amlodipine 10 mg plus 40 mg olmesartan. Results showed that all combinations produced greater mean reductions in blood pressure than either drug alone. The subjects were placed in one of 12 treatment arms to receive placebo, monotherapy treatment with amlodipine 5 mg or 10 mg, monotherapy treatment with olmesartan medoxomil 10 mg, 20 mg, or 40 mg, or combination therapy with amlodipine/olmesartan medoxomil (Azor) at doses of 5/10 mg, 5/20 mg, 5/40 mg, 10/10 mg, 10/20 mg, and 10/40 mg. Side effects associated with the use of Azor may include, but are not limited to, the following:įDA approval of Azor was based on the results of several clinical trials.Īn 8-week, multi-center, double-blind, randomized, placebo controlled, parallel group, factorial study enrolled 1,940 subjects with mild to severe hypertension. The amlodipine component of Azor inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, and the olmesartan medoxomil component of Azor blocks the vasoconstrictor effects of angiotensin II.
Mechanism of ActionĪzor is a combination of the angiotensin II receptor antagonist olmesartan, and the calcium channel blocker amlodipine. The maximum recommended dose of Azor is 10/40. The dosage may be increased after two weeks. The drug comes in four strengths the amlodipine dose is listed first and the olmesartan dose is listed second (both in mg): 5/20, 5/40, 10/20 and 10/40. The amlodipine component of Azor inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, and the olmesartan medoxomil component of Azor blocks the vasoconstrictor effects of angiotensin II.Īzor is specifically indicated for the treatment of hypertension, alone or with other antihypertensive agents.Īzor is supplied as a tablet designed for oral administration. Azor is a combination of the angiotensin II receptor antagonist olmesartan, and the calcium channel blocker amlodipine.