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Amlodipine Besylate/Benazepril HCl Combination Works Best for Lowering Blood Pressure: Presented at ACCP

By Mike Fillon

TAMPA, FL -- October 12, 2003 -- The combination of amlodipine besylate/benazepril hydrochloride (AML/BZP) is effective and well tolerated for first-line treatment of patients with severe systolic hypertension, according to results reported here on September 23^rd at the 32^nd Annual Meeting of the American College of Clinical Pharmacology.

The 7^th report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC-7) recommended initial combination therapy for patients whose blood pressure (BP) is at least 20/10 mm Hg above goal levels. Patients with State 2 hypertension, by definition, meet the JNC-7 recommendation for initiating combination antihypertensive therapy.

This 12-week, randomised, multicentre, double-blind, parallel-group study was designed to compare the efficacy and safety of initial antihypertensive therapy using the fixed-dose combination of AML/BZP against that of AML alone in subjects with Stage 2 hypertension. The study included 364 subjects who were treated at 52 sites in the United States.

After a 72-hour wash-out period, eligible subjects were randomised to dose level 1 (AML/BZP 5/20 mg or AML 10 mg). After 2 weeks on dose level 1, subjects who did reach the target blood pressure of 130/85 mm Hg or less were titrated to dose level 2 (AML/BZP 10/20 mg or AML 10 mg). Subjects who achieved the target level at Week 2 remained at dose level 1. If, at any subsequent visit, a subject's blood pressure level was less than 130/85 mm Hg, the dose was titrated to dose level 2. Downward dose adjustment to the previous dose level was not permitted.

Hydrochlorothiazide 12.5 mg was added only in subjects who were on dose level 2 for at least 3 weeks and had systolic blood pressure levels between 180 mm Hg and 210 mm Hg, and/or the diastolic levels between 110 mm Hg and 120 mm Hg.

At any time during the study, any subject with a systolic measurement greater than 210 mm Hg and/or diastolic level greater than 120 mm Hg was discontinued from the study.

The researchers found that the fixed-dose combination of AML/BZP provided significantly greater efficacy and better tolerability compared with AML monotherapy in the initial treatment of subjects with State 2 hypertension. Also, the combination therapy resulted in maximum benefit in subjects with the highest blood pressure levels at baseline.

"Recent data indicate [that] fixed-dose combination therapy with amlodipine besylate/benazepril HCl may better equip hypertensive patients to reach their BP goal more quickly than conventional combination therapy," said researcher Oliseyenum Nwose, Novartis Pharmaceuticals, Corp., East Hanover, New Jersey, United States, adding, "it offers comparable or improved BP control and tolerability compared to higher doses of monotherapy."

Nwose also said that fixed-dose combination therapy may enhance medication adherence by use of a single capsule once-daily. "Because of these potential advantages, the use of combination antihypertensive therapy as initial treatment may be recommended, particularly in patients with target-organ damage or more severe initial levels of hypertension," he concluded.


[Study Title: Therapy with Amlodipine Besylate/Benazepril HCl Provides Superior Control in Patients With Severe Systolic Hypertension. Abstract 84]

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