New ARB approved for hypertension by the FDA

May 20, 2002

Sankyo Pharma recently announced that the US Food and 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.

 

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New ARB approved for hypertension by the FDA

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 contraindicated 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.d., said Weber. This dosage can be titrated up to 40 mg q.d. after two weeks, if a further reduction in blood pressure is necessary. King pointed out that initial dosage adjustments are not necessary for those with renal or hepatic impairment or for older persons. In patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function) olmesartan medoxomil should be initiated under close medical supervision and a lower starting dose should be considered.

King feels olmesartan medoxomil offers an excellent advantage over other ARBs. It lowers blood pressure with better efficacy compared with other ARBs and is coming onto the market at a cheaper price. According to Weber, what is drawing attention to ARBs is that they may protect patients from the consequences of hypertension more effectively than other drug classes. Some ARBs have been found to prevent strokes and exert a renoprotective effect.

Weber mentioned that, with newer, more aggressive treatment guidelines for hypertension, as many as 67% of hypertensive patients will require two or more medications to control blood pressure. Patients filling a prescription for olmesartan medoxomil may also be filling a prescription for other medications such as calcium-channel blockers or diuretics.

Charlotte LoBuono

TIPS TO REMEMBER: Benicar

  • In general, laboratory monitoring of patients on Benicar is not necessary, except for potassium levels and serum creatinine at baseline.

  • Benicar can be taken in the morning or evening, with or without food.

  • Although approved to treat hypertension, Benicar can be used to treat other conditions, such as heart failure in patients who are intolerant of ACE inhibitors.

 

Charlotte LoBuono. New ARB approved for hypertension by the FDA. Drug Topics 2002;10:26.