DOUBLE-BLIND EVALUATION OF THE DOSE-RESPONSE RELATIONSHIP OF AMLODIPINE IN ESSENTIAL-HYPERTENSION

Citation
Jl. Mehta et al., DOUBLE-BLIND EVALUATION OF THE DOSE-RESPONSE RELATIONSHIP OF AMLODIPINE IN ESSENTIAL-HYPERTENSION, The American heart journal, 125(6), 1993, pp. 1704-1709
Citations number
18
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Cardiac & Cardiovascular System
Journal title
ISSN journal
0002-8703
Volume
125
Issue
6
Year of publication
1993
Pages
1704 - 1709
Database
ISI
SICI code
0002-8703(1993)125:6<1704:DEOTDR>2.0.ZU;2-X
Abstract
To determine the dose-response efficacy of once-daily administration o f placebo or a new long-acting calcium channel blocker amlodipine in p atients with mild to moderate hypertension, a randomized, multicenter, placebo-controlled, double-blind trial was conducted. The study inclu ded 210 patients with diastolic hypertension (blood pressure 95 to 114 mm Hg) without major hematologic, renal, hepatic, cardiac, or endocri ne abnormalities. After a 4-week single-blind placebo run-in period, p atients were given placebo or amlodipine (1.25, 2.5, 5, or 10 mg) dail y for 4 weeks. To assess the antihypertensive effect of amlodipine ove r a 24-hour period, blood pressure and pulse rate at weeks 0 and 4 wer e recorded for 12 hours after the dose and then again at 24 hours. At the end of the study patients treated with all doses of amlodipine gre ater than 1.25 mg daily had significantly reduced diastolic blood pres sure in both supine and standing positions. Amlodipine, 1.25 mg daily, was also associated with a decrease in standing diastolic blood press ure. Response to treatment was greater in all amlodipine-treated patie nts than in those receiving placebo. Pulse rate in both the supine and standing positions was not significantly affected by amlodipine. At d oses of 2.5, 5.0, or 10.0 mg daily, amlodipine maintained blood pressu re below values obtained with placebo throughout the 24-hour period. T reatment with amlodipine was well tolerated and the incidence of side effects was low. Once-daily dosing with amlodipine is effective in the 24-hour control of blood pressure in patients with mild to moderate h ypertension. Because of its efficacy as monotherapy given once a day a nd its low side effect profile, amlodipine may be well suited in the t reatment of hypertension.