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Vol 9, No 5 (2005)
Prace oryginalne
Published online: 2005-09-29
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Nine month follow-up of amlodipine maleate and amlodipine besylate treatment in patients with essential hypertension: does the salt form matter?

Magdalena Makowiecka-Cieśla, Andrzej Januszewicz, Aleksander Prejbisz, Leszek Bieniaszewski, Marko Boh, Tomasz Grodzicki, Bożena Patera-Górnikiewicz, Andrzej Tykarski, Krystyna Widecka, Andrzej Więcek, Bogdan Wyrzykowski
Nadciśnienie tętnicze 2005;9(5):364-373.

open access

Vol 9, No 5 (2005)
Prace oryginalne
Published online: 2005-09-29

Abstract

Background A nine-month follow-up, multicenter study was carried out to assess the efficacy and safety of amlodipine maleate, a recently launched amlodipine salt in 263 patients with essential hypertension.
Material and methods In the first phase of the trial, a 3-month equivalence assessment with the reference besylate salt has been carried out in a randomised doubleblind fashion including placebo run-in period. The equivalence margins were set to be ± 4 mm Hg. The second phase was a 6-month open non-comparative extension of the equivalence phase to provide additional information on clinical efficacy and acceptability during prolonged treatment with amlodipine maleate. Essential hypertension was defined as a sitting diastolic blood pressure (DBP) being within the range of 95-114 mm Hg and systolic blood pressure below 180 mm Hg. An adequate blood pressure control defined as reaching the target DBP of 89 mm Hg or at least 10 mm Hg reduction of DBP compared to the baseline values, was the inclusion criterion for the second phase. The primary endpoint was the mean absolute reduction of DBP at the end of the active treatment in relation to the baseline.
Results Altogether, 245 patients were analyzed in the equivalence comparative part, while 202 patients were included in the analysis of the open follow-up period. Both drugs have significantly lowered DBP and SBP after 3 months of treatment compared with the baseline values while heart rate has not been significantly changed in any of the treatment groups. The difference in these parameters between the salts was not significant. The difference in DBP reduction between the treatments was 1.27 mm Hg in favour of the besylate salt and the 90% confidence interval fell entirely within the equivalence margins. There was no difference between the salts in the percentage of patients reaching the target DBP (90.91% and 89.52% for maleate and besylate, respectively). The DBP/SBP reduction after the amlodipine maleate at the end of the 6-month second phase was –17.5/–21.2 mm Hg compared to the baseline values (paired t test, p < 0.0001). Blood pressure control was adequate during the second phase. Thirty-five patients in the amlodipine maleate group and 47 patients in the amlodipine besylate group reported adverse reactions during the 3-month comparative (28.9% and 37.9%, for maleate and besylate, respectively, p = NS). The overall incidence of amlodipine maleate-related adverse events during the second phase was 8.4%.
Conclusions In conclusion, amlodipine maleate was shown to be equivalent to the reference besylate salt in terms of antihypertensive efficacy, and safety profiles of the two salts were not significantly different. Amlodipine maleate enabled adequate blood pressure control and was shown to be well tolerated during the entire 9-month follow-up.

Abstract

Background A nine-month follow-up, multicenter study was carried out to assess the efficacy and safety of amlodipine maleate, a recently launched amlodipine salt in 263 patients with essential hypertension.
Material and methods In the first phase of the trial, a 3-month equivalence assessment with the reference besylate salt has been carried out in a randomised doubleblind fashion including placebo run-in period. The equivalence margins were set to be ± 4 mm Hg. The second phase was a 6-month open non-comparative extension of the equivalence phase to provide additional information on clinical efficacy and acceptability during prolonged treatment with amlodipine maleate. Essential hypertension was defined as a sitting diastolic blood pressure (DBP) being within the range of 95-114 mm Hg and systolic blood pressure below 180 mm Hg. An adequate blood pressure control defined as reaching the target DBP of 89 mm Hg or at least 10 mm Hg reduction of DBP compared to the baseline values, was the inclusion criterion for the second phase. The primary endpoint was the mean absolute reduction of DBP at the end of the active treatment in relation to the baseline.
Results Altogether, 245 patients were analyzed in the equivalence comparative part, while 202 patients were included in the analysis of the open follow-up period. Both drugs have significantly lowered DBP and SBP after 3 months of treatment compared with the baseline values while heart rate has not been significantly changed in any of the treatment groups. The difference in these parameters between the salts was not significant. The difference in DBP reduction between the treatments was 1.27 mm Hg in favour of the besylate salt and the 90% confidence interval fell entirely within the equivalence margins. There was no difference between the salts in the percentage of patients reaching the target DBP (90.91% and 89.52% for maleate and besylate, respectively). The DBP/SBP reduction after the amlodipine maleate at the end of the 6-month second phase was –17.5/–21.2 mm Hg compared to the baseline values (paired t test, p < 0.0001). Blood pressure control was adequate during the second phase. Thirty-five patients in the amlodipine maleate group and 47 patients in the amlodipine besylate group reported adverse reactions during the 3-month comparative (28.9% and 37.9%, for maleate and besylate, respectively, p = NS). The overall incidence of amlodipine maleate-related adverse events during the second phase was 8.4%.
Conclusions In conclusion, amlodipine maleate was shown to be equivalent to the reference besylate salt in terms of antihypertensive efficacy, and safety profiles of the two salts were not significantly different. Amlodipine maleate enabled adequate blood pressure control and was shown to be well tolerated during the entire 9-month follow-up.
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Keywords

amlodipine; multicenter study; antihypertensive efficacy; side effects; essential hypertension

About this article
Title

Nine month follow-up of amlodipine maleate and amlodipine besylate treatment in patients with essential hypertension: does the salt form matter?

Journal

Arterial Hypertension

Issue

Vol 9, No 5 (2005)

Pages

364-373

Published online

2005-09-29

Bibliographic record

Nadciśnienie tętnicze 2005;9(5):364-373.

Keywords

amlodipine
multicenter study
antihypertensive efficacy
side effects
essential hypertension

Authors

Magdalena Makowiecka-Cieśla
Andrzej Januszewicz
Aleksander Prejbisz
Leszek Bieniaszewski
Marko Boh
Tomasz Grodzicki
Bożena Patera-Górnikiewicz
Andrzej Tykarski
Krystyna Widecka
Andrzej Więcek
Bogdan Wyrzykowski

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