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Olmesartan Medoxomil and Amlodipine Equally Effective for Mild to Moderate Hypertension: Presented at ASH

By Jill Stein

NEW YORK, NY -- May 19, 2002 -- Olmesartan medoxomil and amlodipine appear to be equally safe and effective for the management of mild to moderate hypertension.

Study results also show that the two agents produce similar decreases in both cuff and ambulatory systolic and diastolic blood pressure.

Dr. Steven G. Chrysant, with the University of Oklahoma, Oklahoma City, reported the findings here Friday at the 17^th Annual Scientific Meeting of the American Society of Hypertension (ASH).

His group compared the efficacy and safety of the newest angiotensin receptor blocker, olmesartan medoxomil, with amlodipine, one of the most commonly prescribed antihypertensives, in patients with mild to moderate hypertension.

All participants in the trial had a seated cuff diastolic blood pressure of 100 mm Hg to 115 mm Hg and daytime ambulatory diastolic blood pressure of at least 90 mm Hg.

Following a four-week placebo run-in period, 440 subjects were randomised to eight weeks' treatment with placebo or the recommended starting doses of amlodipine 5 mg or olmesartan medoxomil 20 mg. The three treatment groups were similar with respect to baseline demographic and clinical characteristics.

Olmesartan medoxomil treatment and amlodipine treatment decreased blood pressure at all measures significantly more than placebo, and there were no significant differences in blood pressure-lowering efficacy between the two active treatments on any measure, Dr. Chrysant said

Ambulatory systolic/diastolic blood pressure was decreased by 2.5/1.6 mm Hg in subjects taking placebo, 12.9/7.4 mm Hg in subjects taking amlodipine, and 13.0/8.2 mm Hg in subjects taking olmesartan medoxomil.

Similar findings were observed for cuff blood pressure measurements.

The incidence of treatment-emergent laboratory adverse events was 4.3 percent for olmesartan medoxomil, 9.1 percent for amlodipine, and 9.1 percent for placebo. These differences were not statistically significant.

"The only noticeable differences in adverse events was a significantly higher rate of nausea" with amlodipine, Dr. Chrysant noted. In the amlodipine group 2.7 percent of patients reported nausea, compared with no reports of nausea among the olmesartan medoxomil and placebo patients (p<0.039)

Overall, the results demonstrate that olmesartan medoxomil is a highly effective and well-tolerated antihypertensive agent in patients with mild to moderate essential hypertension, he said.

The data also show that decreases in blood pressure with olmesartan medoxomil were similar to those with amlodipine and greater than those with placebo. More patients treated with olmesartan medoxomil versus those treated with amlodipine achieved the more rigorous diastolic blood pressure goal of less than 85 mm Hg, suggesting that small changes in blood pressure can translate into better blood pressure control among hypertensive patients, he added.

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