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Is the extrapolated adult dose of fosinopril safe and effective in treating hypertensive children?

Publication ,  Journal Article
Li, JS; Berezny, K; Kilaru, R; Hazan, L; Portman, R; Hogg, R; Jenkins, RD; Kanani, P; Cottrill, CM; Mattoo, TK; Zharkova, L; Kozlova, L ...
Published in: Hypertension
September 2004

We evaluated the efficacy, safety, and dose-response relationship of fosinopril in children aged 6 to 16 years with hypertension or high-normal blood pressure with an associated medical condition requiring treatment. The study was a prospective, double-blind, placebo-controlled trial conducted in 78 clinical sites in the United States, Russia, and Israel. There were 4 phases: a screening phase of 10 days maximum, a 4-week dose-response phase, a placebo withdrawal phase of 2 weeks maximum, and a 52-week open-label safety phase. The primary objective of the dose-response phase was to determine whether low (0.1 mg/kg), medium (0.3 mg/kg), or high (0.6 mg/kg) doses of fosinopril based on established adult dosing affect trough seated systolic blood pressure. During the dose-response phase, all 3 doses were equally effective in lowering systolic blood pressure. During the placebo withdrawal phase, there was an adjusted mean systolic blood pressure increase of 5.2 mm Hg for the placebo group and 1.5 mm Hg for the fosinopril group, a net withdrawal effect of 3.7 mm Hg (P=0.013). Fosinopril was well tolerated; serious adverse events occurred infrequently and were generally not attributed to fosinopril. Because children appear to be more sensitive to lower doses of fosinopril than adults, starting doses for children should be < or =0.1 mg/kg.

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Published In

Hypertension

DOI

EISSN

1524-4563

Publication Date

September 2004

Volume

44

Issue

3

Start / End Page

289 / 293

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prospective Studies
  • Prodrugs
  • Male
  • Hypertension
  • Humans
  • Headache
  • Fosinopril
  • Female
  • Double-Blind Method
 

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Li, J. S., Berezny, K., Kilaru, R., Hazan, L., Portman, R., Hogg, R., … Califf, R. M. (2004). Is the extrapolated adult dose of fosinopril safe and effective in treating hypertensive children? Hypertension, 44(3), 289–293. https://doi.org/10.1161/01.HYP.0000138069.68413.f0
Li, Jennifer S., Katherine Berezny, Rakhi Kilaru, Lydie Hazan, Ronald Portman, Ronald Hogg, Randall D. Jenkins, et al. “Is the extrapolated adult dose of fosinopril safe and effective in treating hypertensive children?Hypertension 44, no. 3 (September 2004): 289–93. https://doi.org/10.1161/01.HYP.0000138069.68413.f0.
Li JS, Berezny K, Kilaru R, Hazan L, Portman R, Hogg R, et al. Is the extrapolated adult dose of fosinopril safe and effective in treating hypertensive children? Hypertension. 2004 Sep;44(3):289–93.
Li, Jennifer S., et al. “Is the extrapolated adult dose of fosinopril safe and effective in treating hypertensive children?Hypertension, vol. 44, no. 3, Sept. 2004, pp. 289–93. Pubmed, doi:10.1161/01.HYP.0000138069.68413.f0.
Li JS, Berezny K, Kilaru R, Hazan L, Portman R, Hogg R, Jenkins RD, Kanani P, Cottrill CM, Mattoo TK, Zharkova L, Kozlova L, Weisman I, Deitchman D, Califf RM. Is the extrapolated adult dose of fosinopril safe and effective in treating hypertensive children? Hypertension. 2004 Sep;44(3):289–293.

Published In

Hypertension

DOI

EISSN

1524-4563

Publication Date

September 2004

Volume

44

Issue

3

Start / End Page

289 / 293

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prospective Studies
  • Prodrugs
  • Male
  • Hypertension
  • Humans
  • Headache
  • Fosinopril
  • Female
  • Double-Blind Method