Efficacy, safety, and pharmacokinetics of candesartan cilexetil in hypertensive children aged 6 to 17 years

Howard Trachtman; James W. Hainer; Jennifer Sugg; Renli Teng; Jonathan M. Sorof; Jerilynn Radcliffe; Johan Vande Walle; Laszio Szabo; Tivadar Tulassay; Sandor Turi; Eva Marova; Alexander Jurko; Maria Horakova; Robert Achtel; John Barcia; Donald Batisky; Patrick Brophy; Bonita Falkner; Joseph Flynn; Randall Jenkins; Vijay Kusnoor; Kenneth Miller; Ana Paredes; Irene Restaino; Joseph Sherbotie; Gaston Zilleruelo; Myra Chiang; Farahnak Assadi; Shashi Nagaraj; Janice Sullivan; Michael Aigbe; Ronald Portman; Robert Mak; Michael Moritz; Robert Williams; Juan Kupferman; Naomi Neufeld; Jimmy Stewart; Coral Hanevold; Lydia Hazan; Jeffery Blummer; Melissa Henshaw; David Headley; Howard Trachtman; William Primack; L. Richard Feldenberg

doi:10.1111/j.1751-7176.2008.00022.x

Efficacy, safety, and pharmacokinetics of candesartan cilexetil in hypertensive children aged 6 to 17 years

Howard Trachtman, James W. Hainer, Jennifer Sugg, Renli Teng, Jonathan M. Sorof, Jerilynn Radcliffe, Johan Vande Walle, Laszio Szabo, Tivadar Tulassay, Sandor Turi, Eva Marova, Alexander Jurko, Maria Horakova, Robert Achtel, John Barcia, Donald Batisky, Patrick Brophy, Bonita Falkner, Joseph Flynn, Randall JenkinsVijay Kusnoor, Kenneth Miller, Ana Paredes, Irene Restaino, Joseph Sherbotie, Gaston Zilleruelo, Myra Chiang, Farahnak Assadi, Shashi Nagaraj, Janice Sullivan, Michael Aigbe, Ronald Portman, Robert Mak, Michael Moritz, Robert Williams, Juan Kupferman, Naomi Neufeld, Jimmy Stewart, Coral Hanevold, Lydia Hazan, Jeffery Blummer, Melissa Henshaw, David Headley, Howard Trachtman, William Primack, L. Richard Feldenberg

Research output: Contribution to journal › Article › peer-review

59 Scopus citations

Abstract

This 4-week randomized, double blind, placebo-controlled study (N=240), 1-year open label trial (N=233), and single-dose pharmacokinetic study (N=22) evaluated candesartan cilexetil (3 doses) in hypertensive children aged 6 to 17years. Seventy-one percent were 12years of age or older, 71% were male, and 47% were black. Systolic (SBP)/diastolic (DBP) blood pressure declined 8.6/4.8-11.2/8.0mm Hg with candesartan and 3.7/ 1.8mm Hg with placebo (P<.01 compared to placebo for SBP and for the mid and high doses for DBP; placebo-corrected 4.9/3.0-7.5/6.2mm Hg). The slopes for dose were not, however, different from zero (P>.05). The response rate (SBP and DBP <95th percentile) after 1 year was 53%. The pharmacokinetic profiles in 6- to 12- and 12- to 17-year-olds were similar and were comparable to adults. Eight candesartan patients discontinued treatment because of an adverse event. Candesartan is an effective, well-tolerated antihypertensive agent for children aged 6 to 17years and has a pharmacokinetic profile that is similar to that in adults.

Original language	English (US)
Pages (from-to)	743-750
Number of pages	8
Journal	Journal of Clinical Hypertension
Volume	10
Issue number	10
DOIs	https://doi.org/10.1111/j.1751-7176.2008.00022.x
State	Published - Oct 2008
Externally published	Yes

ASJC Scopus subject areas

Internal Medicine
Endocrinology, Diabetes and Metabolism
Cardiology and Cardiovascular Medicine

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10.1111/j.1751-7176.2008.00022.x

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Trachtman, H., Hainer, J. W., Sugg, J., Teng, R., Sorof, J. M., Radcliffe, J., Vande Walle, J., Szabo, L., Tulassay, T., Turi, S., Marova, E., Jurko, A., Horakova, M., Achtel, R., Barcia, J., Batisky, D., Brophy, P., Falkner, B., Flynn, J., ... Feldenberg, L. R. (2008). Efficacy, safety, and pharmacokinetics of candesartan cilexetil in hypertensive children aged 6 to 17 years. Journal of Clinical Hypertension, 10(10), 743-750. https://doi.org/10.1111/j.1751-7176.2008.00022.x

Trachtman, H, Hainer, JW, Sugg, J, Teng, R, Sorof, JM, Radcliffe, J, Vande Walle, J, Szabo, L, Tulassay, T, Turi, S, Marova, E, Jurko, A, Horakova, M, Achtel, R, Barcia, J, Batisky, D, Brophy, P, Falkner, B, Flynn, J, Jenkins, R, Kusnoor, V, Miller, K, Paredes, A, Restaino, I, Sherbotie, J, Zilleruelo, G, Chiang, M, Assadi, F, Nagaraj, S, Sullivan, J, Aigbe, M, Portman, R, Mak, R, Moritz, M, Williams, R, Kupferman, J, Neufeld, N, Stewart, J, Hanevold, C, Hazan, L, Blummer, J, Henshaw, M, Headley, D, Trachtman, H, Primack, W & Feldenberg, LR 2008, 'Efficacy, safety, and pharmacokinetics of candesartan cilexetil in hypertensive children aged 6 to 17 years', Journal of Clinical Hypertension, vol. 10, no. 10, pp. 743-750. https://doi.org/10.1111/j.1751-7176.2008.00022.x

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title = "Efficacy, safety, and pharmacokinetics of candesartan cilexetil in hypertensive children aged 6 to 17 years",

abstract = "This 4-week randomized, double blind, placebo-controlled study (N=240), 1-year open label trial (N=233), and single-dose pharmacokinetic study (N=22) evaluated candesartan cilexetil (3 doses) in hypertensive children aged 6 to 17years. Seventy-one percent were 12years of age or older, 71% were male, and 47% were black. Systolic (SBP)/diastolic (DBP) blood pressure declined 8.6/4.8-11.2/8.0mm Hg with candesartan and 3.7/ 1.8mm Hg with placebo (P<.01 compared to placebo for SBP and for the mid and high doses for DBP; placebo-corrected 4.9/3.0-7.5/6.2mm Hg). The slopes for dose were not, however, different from zero (P>.05). The response rate (SBP and DBP <95th percentile) after 1 year was 53%. The pharmacokinetic profiles in 6- to 12- and 12- to 17-year-olds were similar and were comparable to adults. Eight candesartan patients discontinued treatment because of an adverse event. Candesartan is an effective, well-tolerated antihypertensive agent for children aged 6 to 17years and has a pharmacokinetic profile that is similar to that in adults.",

author = "Howard Trachtman and Hainer, {James W.} and Jennifer Sugg and Renli Teng and Sorof, {Jonathan M.} and Jerilynn Radcliffe and {Vande Walle}, Johan and Laszio Szabo and Tivadar Tulassay and Sandor Turi and Eva Marova and Alexander Jurko and Maria Horakova and Robert Achtel and John Barcia and Donald Batisky and Patrick Brophy and Bonita Falkner and Joseph Flynn and Randall Jenkins and Vijay Kusnoor and Kenneth Miller and Ana Paredes and Irene Restaino and Joseph Sherbotie and Gaston Zilleruelo and Myra Chiang and Farahnak Assadi and Shashi Nagaraj and Janice Sullivan and Michael Aigbe and Ronald Portman and Robert Mak and Michael Moritz and Robert Williams and Juan Kupferman and Naomi Neufeld and Jimmy Stewart and Coral Hanevold and Lydia Hazan and Jeffery Blummer and Melissa Henshaw and David Headley and Howard Trachtman and William Primack and Feldenberg, {L. Richard}",

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AU - Teng, Renli

AU - Sorof, Jonathan M.

AU - Radcliffe, Jerilynn

AU - Vande Walle, Johan

AU - Szabo, Laszio

AU - Tulassay, Tivadar

AU - Turi, Sandor

AU - Marova, Eva

AU - Jurko, Alexander

AU - Horakova, Maria

AU - Achtel, Robert

AU - Barcia, John

AU - Batisky, Donald

AU - Brophy, Patrick

AU - Falkner, Bonita

AU - Flynn, Joseph

AU - Jenkins, Randall

AU - Kusnoor, Vijay

AU - Miller, Kenneth

AU - Paredes, Ana

AU - Restaino, Irene

AU - Sherbotie, Joseph

AU - Zilleruelo, Gaston

AU - Chiang, Myra

AU - Assadi, Farahnak

AU - Nagaraj, Shashi

AU - Sullivan, Janice

AU - Aigbe, Michael

AU - Portman, Ronald

AU - Mak, Robert

AU - Moritz, Michael

AU - Williams, Robert

AU - Kupferman, Juan

AU - Neufeld, Naomi

AU - Stewart, Jimmy

AU - Hanevold, Coral

AU - Hazan, Lydia

AU - Blummer, Jeffery

AU - Henshaw, Melissa

AU - Headley, David

AU - Trachtman, Howard

AU - Primack, William

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Efficacy, safety, and pharmacokinetics of candesartan cilexetil in hypertensive children aged 6 to 17 years

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