Magazine article Drug Topics

New ARB Approved for Hypertension by the FDA

Magazine article Drug Topics

New ARB Approved for Hypertension by the FDA

Article excerpt

Sankyo Pharma recently announced that the Food & Drug Administration has granted marketing approval for olmesartan medoxomil (Benicar) for the treatment of hypertension.

The angiotensin II receptor blocker (ARB) may be used as monotherapy or in combination with other antihypertensive agents. According to Deborah King, Pharm.D., assistant professor, division of hypertension, University of Mississippi Medical Center, olmesartan medoxomil prevents vasoconstriction by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle.

The majority of antihypertensive patients are candidates for olmesartan medoxomil therapy, said Michael Weber, M.D., associate dean for research, State University of New York Downstate Medical Center, Brooklyn. The drug is well-tolerated and reduces blood pressure very effectively. Olmesartan medoxomil appears to have a safety profile comparable to that of placebo. In clinical trials, dizziness was the only side effect that occurred in more than 1% of persons treated with olmesartan medoxomil and at a higher rate than in those treated with placebo (3% versus 1%, respectively).

Weber and King emphasized that, like ACE inhibitors and other angiotensin receptor blockers, olmesartan medoxomil is contra-- indicated during pregnancy, particularly during the second and third trimesters (pregnancy category C during the first trimester and pregnancy category D during the second and third trimesters). Drugs that act directly on the renin-angiotensin system have been associated with fetal and neonatal morbidity and mortality when given during the second and third tri-mesters. Women

should not become pregnant while taking olmesartan medoxomil, but those who do should discontinue therapy immediately.

Although dosage must be individualized, the recommended starting dosage of olmesartan medoxomil is 20 mg q. …

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