Clinic blood pressure responses to two amlodipine salt formulations, adipate and besylate, in adult Korean patients with mild to moderate hypertension: A multicenter, randomized, double-blind, parallel-group, 8-week comparison

Hae Young Lee, Hyun Jae Kang, Bon Kwon Koo, Byung Hee Oh, Kang Heung-Sun, Kee Sik Kim, Hong Seog Seo, Young Moo Ro, Jin Ho Kang, Choi Jae Woong, Seung Jae Joo, Moo Hyun Kim, Shin Joon-Han, Junghan Yoon, Seong Hoon Park, Jeong Jin-Ok, Ahn Kyoung Lu, Rhim Chong-Yun, Kyu Jeong Yeon, Kyung Mi ParkDong Kwon Lim, So Youn Park

Research output: Contribution to journalArticle

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Abstract

Background: The commercially available formulation of amlodipine is conjugated with besylate salt to increase water solubility. Recently, a new amlodipine salt formulation has been developed in which the free base of amlodipine is conjugated with a chemically different salt, adipate. Objective: The goal of this study was to compare the antihypertensive effect and tolerability of amlodipine adipate with those of amlodipine besylate in patients with mild to moderate hypertension. Methods: This was a multicenter, randomized, double-blind, parallel-group study in which patients received 8 weeks of treatment with either amlodipine adipate or amlodipine besylate. The primary efficacy variable was noninferiority of the difference in mean changes from baseline in trough diastolic blood pressure (DBP) after 8 weeks of treatment. Secondary efficacy variables included mean changes in DBP, systolic blood pressure (SBP), and response rate (defined as the proportion of patients whose DBP was <90 mm Hg or whose DBP had decreased from baseline by ≥10 mm Hg). The incidence of adverse events (AEs) was also assessed. Results: Two hundred eleven patients were randomly assigned to receive amlodipine adipate (n = 106) or amlodipine besylate (n = 105). Study patients were primarily female (54.5%), with a mean (SD) age of 52.2 (9.6) years and a mean body weight of 67.1 (10.2) kg; there were no between-group differences in demographic profiles. After 4 weeks of randomized treatment, 58 (27.5%) patients (29 [27.4%] amlodipine adipate, 29 [27.6%] amlodipine besylate) had not achieved a mean DBP <90 mm Hg, and their dose was doubled. Mean DBP changes at 8 weeks were -15.2 (7.3) mm Hg in the amlodipine adipate group and -142 (7.4) mm Hg in the amlodipine besylate group (P = NS). Because the 95% CI for the difference in mean DBP changes between groups (-0.53 to 2.55) was within the prespecified lower limit (-4 mm Hg), amlodipine adipate was considered noninferior to amlodipine besylate. Mean SBP changes were -24.9 ( 12.1 ) mm Hg in the amlodipine adipate group and -22.0 (14.7) mm Hg in the amlodipine besylate group (P = NS). The response rates were 92.0% for amlodipine adipate and 95.4% for amlodipine besylate (P = NS). The overall incidence of clinical AEs was 20.8% in the amlodipine adipate group and 25.7% in the amlodipine besylate group (P = NS). Drug-related clinical AEs occurred in 5.7% and 12.4% of patients in the respective treatment groups (P = NS). Serum uric acid levels decreased significantly from baseline in both groups (P < 0.001). Conclusions: Eight weeks of treatment with amlodipine adipate produced significant reductions from baseline in blood pressure in these patients with mild to moderate hypertension. The efficacy of amlodipine adipate was not inferior to that of amlodipine besylate. Tolerability was comparable between the 2 treatment groups.

Original languageEnglish
Pages (from-to)728-739
Number of pages12
JournalClinical Therapeutics
Volume27
Issue number6
DOIs
Publication statusPublished - 2005 Jan 1

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Benzenesulfonates
Amlodipine
Salts
Blood Pressure
Hypertension
adipic acid

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Lee, Hae Young ; Kang, Hyun Jae ; Koo, Bon Kwon ; Oh, Byung Hee ; Heung-Sun, Kang ; Kim, Kee Sik ; Seo, Hong Seog ; Ro, Young Moo ; Kang, Jin Ho ; Woong, Choi Jae ; Joo, Seung Jae ; Kim, Moo Hyun ; Joon-Han, Shin ; Yoon, Junghan ; Park, Seong Hoon ; Jin-Ok, Jeong ; Lu, Ahn Kyoung ; Chong-Yun, Rhim ; Yeon, Kyu Jeong ; Park, Kyung Mi ; Lim, Dong Kwon ; Park, So Youn. / Clinic blood pressure responses to two amlodipine salt formulations, adipate and besylate, in adult Korean patients with mild to moderate hypertension : A multicenter, randomized, double-blind, parallel-group, 8-week comparison. In: Clinical Therapeutics. 2005 ; Vol. 27, No. 6. pp. 728-739.
@article{4aa1705ab7a847c999ba6bdedfaa0b40,
title = "Clinic blood pressure responses to two amlodipine salt formulations, adipate and besylate, in adult Korean patients with mild to moderate hypertension: A multicenter, randomized, double-blind, parallel-group, 8-week comparison",
abstract = "Background: The commercially available formulation of amlodipine is conjugated with besylate salt to increase water solubility. Recently, a new amlodipine salt formulation has been developed in which the free base of amlodipine is conjugated with a chemically different salt, adipate. Objective: The goal of this study was to compare the antihypertensive effect and tolerability of amlodipine adipate with those of amlodipine besylate in patients with mild to moderate hypertension. Methods: This was a multicenter, randomized, double-blind, parallel-group study in which patients received 8 weeks of treatment with either amlodipine adipate or amlodipine besylate. The primary efficacy variable was noninferiority of the difference in mean changes from baseline in trough diastolic blood pressure (DBP) after 8 weeks of treatment. Secondary efficacy variables included mean changes in DBP, systolic blood pressure (SBP), and response rate (defined as the proportion of patients whose DBP was <90 mm Hg or whose DBP had decreased from baseline by ≥10 mm Hg). The incidence of adverse events (AEs) was also assessed. Results: Two hundred eleven patients were randomly assigned to receive amlodipine adipate (n = 106) or amlodipine besylate (n = 105). Study patients were primarily female (54.5{\%}), with a mean (SD) age of 52.2 (9.6) years and a mean body weight of 67.1 (10.2) kg; there were no between-group differences in demographic profiles. After 4 weeks of randomized treatment, 58 (27.5{\%}) patients (29 [27.4{\%}] amlodipine adipate, 29 [27.6{\%}] amlodipine besylate) had not achieved a mean DBP <90 mm Hg, and their dose was doubled. Mean DBP changes at 8 weeks were -15.2 (7.3) mm Hg in the amlodipine adipate group and -142 (7.4) mm Hg in the amlodipine besylate group (P = NS). Because the 95{\%} CI for the difference in mean DBP changes between groups (-0.53 to 2.55) was within the prespecified lower limit (-4 mm Hg), amlodipine adipate was considered noninferior to amlodipine besylate. Mean SBP changes were -24.9 ( 12.1 ) mm Hg in the amlodipine adipate group and -22.0 (14.7) mm Hg in the amlodipine besylate group (P = NS). The response rates were 92.0{\%} for amlodipine adipate and 95.4{\%} for amlodipine besylate (P = NS). The overall incidence of clinical AEs was 20.8{\%} in the amlodipine adipate group and 25.7{\%} in the amlodipine besylate group (P = NS). Drug-related clinical AEs occurred in 5.7{\%} and 12.4{\%} of patients in the respective treatment groups (P = NS). Serum uric acid levels decreased significantly from baseline in both groups (P < 0.001). Conclusions: Eight weeks of treatment with amlodipine adipate produced significant reductions from baseline in blood pressure in these patients with mild to moderate hypertension. The efficacy of amlodipine adipate was not inferior to that of amlodipine besylate. Tolerability was comparable between the 2 treatment groups.",
author = "Lee, {Hae Young} and Kang, {Hyun Jae} and Koo, {Bon Kwon} and Oh, {Byung Hee} and Kang Heung-Sun and Kim, {Kee Sik} and Seo, {Hong Seog} and Ro, {Young Moo} and Kang, {Jin Ho} and Woong, {Choi Jae} and Joo, {Seung Jae} and Kim, {Moo Hyun} and Shin Joon-Han and Junghan Yoon and Park, {Seong Hoon} and Jeong Jin-Ok and Lu, {Ahn Kyoung} and Rhim Chong-Yun and Yeon, {Kyu Jeong} and Park, {Kyung Mi} and Lim, {Dong Kwon} and Park, {So Youn}",
year = "2005",
month = "1",
day = "1",
doi = "10.1016/j.clinthera.2005.06.011",
language = "English",
volume = "27",
pages = "728--739",
journal = "Clinical Therapeutics",
issn = "0149-2918",
publisher = "Excerpta Medica",
number = "6",

}

Lee, HY, Kang, HJ, Koo, BK, Oh, BH, Heung-Sun, K, Kim, KS, Seo, HS, Ro, YM, Kang, JH, Woong, CJ, Joo, SJ, Kim, MH, Joon-Han, S, Yoon, J, Park, SH, Jin-Ok, J, Lu, AK, Chong-Yun, R, Yeon, KJ, Park, KM, Lim, DK & Park, SY 2005, 'Clinic blood pressure responses to two amlodipine salt formulations, adipate and besylate, in adult Korean patients with mild to moderate hypertension: A multicenter, randomized, double-blind, parallel-group, 8-week comparison', Clinical Therapeutics, vol. 27, no. 6, pp. 728-739. https://doi.org/10.1016/j.clinthera.2005.06.011

Clinic blood pressure responses to two amlodipine salt formulations, adipate and besylate, in adult Korean patients with mild to moderate hypertension : A multicenter, randomized, double-blind, parallel-group, 8-week comparison. / Lee, Hae Young; Kang, Hyun Jae; Koo, Bon Kwon; Oh, Byung Hee; Heung-Sun, Kang; Kim, Kee Sik; Seo, Hong Seog; Ro, Young Moo; Kang, Jin Ho; Woong, Choi Jae; Joo, Seung Jae; Kim, Moo Hyun; Joon-Han, Shin; Yoon, Junghan; Park, Seong Hoon; Jin-Ok, Jeong; Lu, Ahn Kyoung; Chong-Yun, Rhim; Yeon, Kyu Jeong; Park, Kyung Mi; Lim, Dong Kwon; Park, So Youn.

In: Clinical Therapeutics, Vol. 27, No. 6, 01.01.2005, p. 728-739.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Clinic blood pressure responses to two amlodipine salt formulations, adipate and besylate, in adult Korean patients with mild to moderate hypertension

T2 - A multicenter, randomized, double-blind, parallel-group, 8-week comparison

AU - Lee, Hae Young

AU - Kang, Hyun Jae

AU - Koo, Bon Kwon

AU - Oh, Byung Hee

AU - Heung-Sun, Kang

AU - Kim, Kee Sik

AU - Seo, Hong Seog

AU - Ro, Young Moo

AU - Kang, Jin Ho

AU - Woong, Choi Jae

AU - Joo, Seung Jae

AU - Kim, Moo Hyun

AU - Joon-Han, Shin

AU - Yoon, Junghan

AU - Park, Seong Hoon

AU - Jin-Ok, Jeong

AU - Lu, Ahn Kyoung

AU - Chong-Yun, Rhim

AU - Yeon, Kyu Jeong

AU - Park, Kyung Mi

AU - Lim, Dong Kwon

AU - Park, So Youn

PY - 2005/1/1

Y1 - 2005/1/1

N2 - Background: The commercially available formulation of amlodipine is conjugated with besylate salt to increase water solubility. Recently, a new amlodipine salt formulation has been developed in which the free base of amlodipine is conjugated with a chemically different salt, adipate. Objective: The goal of this study was to compare the antihypertensive effect and tolerability of amlodipine adipate with those of amlodipine besylate in patients with mild to moderate hypertension. Methods: This was a multicenter, randomized, double-blind, parallel-group study in which patients received 8 weeks of treatment with either amlodipine adipate or amlodipine besylate. The primary efficacy variable was noninferiority of the difference in mean changes from baseline in trough diastolic blood pressure (DBP) after 8 weeks of treatment. Secondary efficacy variables included mean changes in DBP, systolic blood pressure (SBP), and response rate (defined as the proportion of patients whose DBP was <90 mm Hg or whose DBP had decreased from baseline by ≥10 mm Hg). The incidence of adverse events (AEs) was also assessed. Results: Two hundred eleven patients were randomly assigned to receive amlodipine adipate (n = 106) or amlodipine besylate (n = 105). Study patients were primarily female (54.5%), with a mean (SD) age of 52.2 (9.6) years and a mean body weight of 67.1 (10.2) kg; there were no between-group differences in demographic profiles. After 4 weeks of randomized treatment, 58 (27.5%) patients (29 [27.4%] amlodipine adipate, 29 [27.6%] amlodipine besylate) had not achieved a mean DBP <90 mm Hg, and their dose was doubled. Mean DBP changes at 8 weeks were -15.2 (7.3) mm Hg in the amlodipine adipate group and -142 (7.4) mm Hg in the amlodipine besylate group (P = NS). Because the 95% CI for the difference in mean DBP changes between groups (-0.53 to 2.55) was within the prespecified lower limit (-4 mm Hg), amlodipine adipate was considered noninferior to amlodipine besylate. Mean SBP changes were -24.9 ( 12.1 ) mm Hg in the amlodipine adipate group and -22.0 (14.7) mm Hg in the amlodipine besylate group (P = NS). The response rates were 92.0% for amlodipine adipate and 95.4% for amlodipine besylate (P = NS). The overall incidence of clinical AEs was 20.8% in the amlodipine adipate group and 25.7% in the amlodipine besylate group (P = NS). Drug-related clinical AEs occurred in 5.7% and 12.4% of patients in the respective treatment groups (P = NS). Serum uric acid levels decreased significantly from baseline in both groups (P < 0.001). Conclusions: Eight weeks of treatment with amlodipine adipate produced significant reductions from baseline in blood pressure in these patients with mild to moderate hypertension. The efficacy of amlodipine adipate was not inferior to that of amlodipine besylate. Tolerability was comparable between the 2 treatment groups.

AB - Background: The commercially available formulation of amlodipine is conjugated with besylate salt to increase water solubility. Recently, a new amlodipine salt formulation has been developed in which the free base of amlodipine is conjugated with a chemically different salt, adipate. Objective: The goal of this study was to compare the antihypertensive effect and tolerability of amlodipine adipate with those of amlodipine besylate in patients with mild to moderate hypertension. Methods: This was a multicenter, randomized, double-blind, parallel-group study in which patients received 8 weeks of treatment with either amlodipine adipate or amlodipine besylate. The primary efficacy variable was noninferiority of the difference in mean changes from baseline in trough diastolic blood pressure (DBP) after 8 weeks of treatment. Secondary efficacy variables included mean changes in DBP, systolic blood pressure (SBP), and response rate (defined as the proportion of patients whose DBP was <90 mm Hg or whose DBP had decreased from baseline by ≥10 mm Hg). The incidence of adverse events (AEs) was also assessed. Results: Two hundred eleven patients were randomly assigned to receive amlodipine adipate (n = 106) or amlodipine besylate (n = 105). Study patients were primarily female (54.5%), with a mean (SD) age of 52.2 (9.6) years and a mean body weight of 67.1 (10.2) kg; there were no between-group differences in demographic profiles. After 4 weeks of randomized treatment, 58 (27.5%) patients (29 [27.4%] amlodipine adipate, 29 [27.6%] amlodipine besylate) had not achieved a mean DBP <90 mm Hg, and their dose was doubled. Mean DBP changes at 8 weeks were -15.2 (7.3) mm Hg in the amlodipine adipate group and -142 (7.4) mm Hg in the amlodipine besylate group (P = NS). Because the 95% CI for the difference in mean DBP changes between groups (-0.53 to 2.55) was within the prespecified lower limit (-4 mm Hg), amlodipine adipate was considered noninferior to amlodipine besylate. Mean SBP changes were -24.9 ( 12.1 ) mm Hg in the amlodipine adipate group and -22.0 (14.7) mm Hg in the amlodipine besylate group (P = NS). The response rates were 92.0% for amlodipine adipate and 95.4% for amlodipine besylate (P = NS). The overall incidence of clinical AEs was 20.8% in the amlodipine adipate group and 25.7% in the amlodipine besylate group (P = NS). Drug-related clinical AEs occurred in 5.7% and 12.4% of patients in the respective treatment groups (P = NS). Serum uric acid levels decreased significantly from baseline in both groups (P < 0.001). Conclusions: Eight weeks of treatment with amlodipine adipate produced significant reductions from baseline in blood pressure in these patients with mild to moderate hypertension. The efficacy of amlodipine adipate was not inferior to that of amlodipine besylate. Tolerability was comparable between the 2 treatment groups.

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