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Antihypertensive Efficacy and Safety of Amlodipine Maleate in the Treatment of Patients with Mild to Moderate Essential Hypertension: Comparison with Amlodipine Besylate
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Abstract
Material and methods The study was carried out as a randomized, double blind and parallel trial. It was performed in seven study centers in Poland. Patients, aged 18 to 75 years, with diastolic blood pressure between 95 and 114 mm Hg were included in the study. All enrolled patients were given placebo once daily in a single blind fashion for two weeks. Then patients were randomly assigned to take whether amlodipine maleate or amlodipine besylate 5 mg once daily in a double blind fashion. After 6 weeks of treatment in patients whose diastolic blood pressure remained 90 mm Hg or higher, the dose of each drug was increased to 10 mg once daily. The primary efficacy variable was the mean change in diastolic blood pressure from the end of treatment measured after 12 weeks, to baseline values after placebo run-in period at week 2.
Results 219 patients (mean age 45.5 lat - 154 male, 65 female) were included in the final per-protocol analysis of the efficacy of the studied drugs. After 6 weeks of treatment the drug dose was increased in 47 (43%) and 51 (47%) patients in the amlodipine maleate and amlodipine besylate groups respectively (p = NS). After 12 weeks of treatment the mean change in diastolic blood pressure in the amlodipine maleate group was –17.5 mm Hg compared to the –18.4 mm Hg in the amlodipine besylate group (p = NS). There was no difference in the percentage of patients reaching the goal of diastolic blood pressure lowering to 90 mm Hg between the studied groups (93.6% vs. 92.7%). 35 patients in the amlodipine maleate group and 47 patients in the amlodipine besylate group reported adverse reactions (28.9% vs. 37.9%, p = NS).
Conclusions Amlodipine maleate and amlodipine besylate were equally effective in the treatment of patients with mild to moderate essential hypertension. During 12 weeks of treatment incidence of adverse reactions was comparable in the studied groups.
Abstract
Material and methods The study was carried out as a randomized, double blind and parallel trial. It was performed in seven study centers in Poland. Patients, aged 18 to 75 years, with diastolic blood pressure between 95 and 114 mm Hg were included in the study. All enrolled patients were given placebo once daily in a single blind fashion for two weeks. Then patients were randomly assigned to take whether amlodipine maleate or amlodipine besylate 5 mg once daily in a double blind fashion. After 6 weeks of treatment in patients whose diastolic blood pressure remained 90 mm Hg or higher, the dose of each drug was increased to 10 mg once daily. The primary efficacy variable was the mean change in diastolic blood pressure from the end of treatment measured after 12 weeks, to baseline values after placebo run-in period at week 2.
Results 219 patients (mean age 45.5 lat - 154 male, 65 female) were included in the final per-protocol analysis of the efficacy of the studied drugs. After 6 weeks of treatment the drug dose was increased in 47 (43%) and 51 (47%) patients in the amlodipine maleate and amlodipine besylate groups respectively (p = NS). After 12 weeks of treatment the mean change in diastolic blood pressure in the amlodipine maleate group was –17.5 mm Hg compared to the –18.4 mm Hg in the amlodipine besylate group (p = NS). There was no difference in the percentage of patients reaching the goal of diastolic blood pressure lowering to 90 mm Hg between the studied groups (93.6% vs. 92.7%). 35 patients in the amlodipine maleate group and 47 patients in the amlodipine besylate group reported adverse reactions (28.9% vs. 37.9%, p = NS).
Conclusions Amlodipine maleate and amlodipine besylate were equally effective in the treatment of patients with mild to moderate essential hypertension. During 12 weeks of treatment incidence of adverse reactions was comparable in the studied groups.
Keywords
amlodipine; multi-center study; antihypertensive efficacy; side effects; essential hypertension
About this articleTitle
Antihypertensive Efficacy and Safety of Amlodipine Maleate in the Treatment of Patients with Mild to Moderate Essential Hypertension: Comparison with Amlodipine Besylate
Journal
Issue
Article type
Original paper
Pages
163-172
Published online
2003-07-21
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707
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1406
Bibliographic record
Nadciśnienie tętnicze 2003;7(3):163-172.
Keywords
amlodipine
multi-center study
antihypertensive efficacy
side effects
essential hypertension
Authors
Andrzej Januszewicz
Magdalena Makowiecka-Cieśla
Aleksander Prejbisz
Leszek Bieniaszewski
Marko Boh
Tomasz Grodzicki
Bożena Patera-Górnikiewicz
Andrzej Tykarski
Krystyna Widecka
Andrzej Więcek
Bogdan Wyrzykowski
w imieniu Grupy Badaczy