坎地沙坦酯在6至17岁高血压儿童中的疗效、安全性及药代动力学

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

作者信息

Trachtman Howard, Hainer James W, Sugg Jennifer, Teng Renli, Sorof Jonathan M, Radcliffe Jerilynn

机构信息

Division of Pediatric Nephrology, Schneider Children's Hospital, New Hyde Park, NY, USA.

出版信息

J Clin Hypertens (Greenwich). 2008 Oct;10(10):743-50. doi: 10.1111/j.1751-7176.2008.00022.x.

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 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.

摘要

这项为期4周的随机、双盲、安慰剂对照研究(N = 240)、1年的开放标签试验(N = 233)以及单剂量药代动力学研究(N = 22)评估了坎地沙坦酯(3种剂量)在6至17岁高血压儿童中的应用。71%的儿童年龄在12岁及以上,71%为男性,47%为黑人。使用坎地沙坦时收缩压(SBP)/舒张压(DBP)下降8.6/4.8 - 11.2/8.0 mmHg,使用安慰剂时下降3.7/1.8 mmHg(SBP以及DBP的中高剂量与安慰剂相比P<0.01;校正安慰剂后为4.9/3.0 - 7.5/6.2 mmHg)。然而,剂量的斜率与零无差异(P>0.05)。1年后的有效率(SBP和DBP <第95百分位数)为53%。6至12岁和12至17岁儿童的药代动力学特征相似,且与成年人相当。8名服用坎地沙坦的患者因不良事件停药。坎地沙坦是一种对6至17岁儿童有效的、耐受性良好的抗高血压药物,其药代动力学特征与成年人相似。

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