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

Urology

Research output: Contribution to journal › Article

50 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

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

Efficacy, safety, and pharmacokinetics of candesartan cilexetil in hypertensive children aged 6 to 17 years. / Trachtman, Howard; Hainer, James W.; Sugg, Jennifer; Teng, Renli; Sorof, Jonathan M.; Radcliffe, Jerilynn; Vande Walle, Johan; Szabo, Laszio; Tulassay, Tivadar; Turi, Sandor; Marova, Eva; Jurko, Alexander; Horakova, Maria; Achtel, Robert; Barcia, John; Batisky, Donald; Brophy, Patrick; Falkner, Bonita; Flynn, Joseph; Jenkins, Randall; Kusnoor, Vijay; Miller, Kenneth; Paredes, Ana; Restaino, Irene; Sherbotie, Joseph; Zilleruelo, Gaston; Chiang, Myra; Assadi, Farahnak; Nagaraj, Shashi; Sullivan, Janice; Aigbe, Michael; Portman, Ronald; Mak, Robert; Moritz, Michael; Williams, Robert; Kupferman, Juan; Neufeld, Naomi; Stewart, Jimmy; Hanevold, Coral; Hazan, Lydia; Blummer, Jeffery; Henshaw, Melissa; Headley, David; Trachtman, Howard; Primack, William; Feldenberg, L. Richard.

In: Journal of Clinical Hypertension, Vol. 10, No. 10, 10.2008, p. 743-750.

Research output: Contribution to journal › Article

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

Trachtman, Howard ; Hainer, James W. ; Sugg, Jennifer ; Teng, Renli ; Sorof, Jonathan M. ; Radcliffe, Jerilynn ; Vande Walle, Johan ; Szabo, Laszio ; Tulassay, Tivadar ; Turi, Sandor ; Marova, Eva ; Jurko, Alexander ; Horakova, Maria ; Achtel, Robert ; Barcia, John ; Batisky, Donald ; Brophy, Patrick ; Falkner, Bonita ; Flynn, Joseph ; Jenkins, Randall ; Kusnoor, Vijay ; Miller, Kenneth ; Paredes, Ana ; Restaino, Irene ; Sherbotie, Joseph ; Zilleruelo, Gaston ; Chiang, Myra ; Assadi, Farahnak ; Nagaraj, Shashi ; Sullivan, Janice ; Aigbe, Michael ; Portman, Ronald ; Mak, Robert ; Moritz, Michael ; Williams, Robert ; Kupferman, Juan ; Neufeld, Naomi ; Stewart, Jimmy ; Hanevold, Coral ; Hazan, Lydia ; Blummer, Jeffery ; Henshaw, Melissa ; Headley, David ; Trachtman, Howard ; Primack, William ; Feldenberg, L. Richard. / Efficacy, safety, and pharmacokinetics of candesartan cilexetil in hypertensive children aged 6 to 17 years. In: Journal of Clinical Hypertension. 2008 ; Vol. 10, No. 10. pp. 743-750.

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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.",

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AU - Assadi, Farahnak

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AU - Sullivan, Janice

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