Efficacy, Safety, and Pharmacokinetics of Candesartan Cilexetil in Hypertensive Children Aged 6 to 17 Years

• Published in: The journal of clinical hypertension (Greenwich, Conn.) Vol. 10; no. 10; pp. 743 - 750
• Main Authors: Trachtman, Howard, Hainer, James W., Sugg, Jennifer, Teng, Renli, Sorof, Jonathan M., Radcliffe, Jerilynn
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.10.2008
• Subjects: Adolescent; Antihypertensive Agents - administration & dosage; Antihypertensive Agents - adverse effects; Antihypertensive Agents - pharmacokinetics; Benzimidazoles - administration & dosage; Benzimidazoles - adverse effects; Benzimidazoles - pharmacokinetics; Biphenyl Compounds - administration & dosage; Biphenyl Compounds - adverse effects; Biphenyl Compounds - pharmacokinetics; Blood Pressure - drug effects; Child; Double-Blind Method; Drug Administration Schedule; Female; Humans; Hypertension - drug therapy; Male; Original Papers; Tetrazoles - administration & dosage; Tetrazoles - adverse effects; Tetrazoles - pharmacokinetics; Treatment Outcome
• ISSN: 1524-6175; 1751-7176
• DOI: 10.1111/j.1751-7176.2008.00022.x

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 17 years. Seventy‐one percent were 12 years of age or older, 71% were male, and 47% were black. Systolic (SBP)/diastolic (DBP) blood pressure declined 8.6/4.8–11.2/8.0 mm Hg with candesartan and 3.7/1.8 mm Hg with placebo (P<.01 compared to placebo for SBP and for the mid and high doses for DBP; placebo‐corrected 4.9/3.0–7.5/6.2 mm 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 17 years and has a pharmacokinetic profile that is similar to that in adults.