Skip to main content
SpringerLink
Log in

Candesartan Cilexetil

In Children and Adolescents Aged 1 to <17 Years with Hypertension

  • Adis Drug Profile
  • Published:
American Journal of Cardiovascular Drugs Aims and scope Submit manuscript

Abstract

Candesartan cilexetil is the orally administered prodrug of candesartan, an angiotensin II subtype 1 receptor antagonist.

The pharmacokinetics (area under the plasma concentration-time curve and maximum plasma concentration) of candesartan do not appear to be affected by age, sex, or weight, with a similar exposure observed in children aged 1 to <6 years or >6 years and adults.

Therapy with candesartan cilexetil 0.05, 0.20, and 0.40 mg/kg/day for 4 weeks was effective in the treatment of hypertension in children aged 1 to <6 years, inducing significant dose-dependent reductions from baseline in sitting SBP (SSBP) [primary endpoint] and sitting DBP (SDBP) in the double-blind phase of a randomized, parallel-group, multinational, dose-ranging clinical study. The criteria for antihypertensive response (SBP and DBP values that were less than the 95th percentile) were met by 28–66% of patients. The beneficial antihypertensive effects of candesartan cilexetil therapy were sustained for up to 160 weeks.

No significant difference from zero in the slope of the placebo-adjusted change in SSBP (primary endpoint) and SDBP was observed across the three candesartan cilexetil treatment groups (candesartan cilexetil 2,8, or 16 mg/day in patients weighing <50 kg and candesartan cilexetil 4, 16, or 32 mg/day in patients weighing ≥50 kg) during the double-blind phase of a randomized, double-blind, parallel-group, placebo-controlled, multinational, dose-ranging study in children and adolescents aged 6 to <17 years. Nonetheless, candesartan cilexetil demonstrated significantly greater changes from baseline to the end of the double-blind phase than placebo in SSBP and SDBP, with a significantly higher proportion of patients receiving candesartan cilexetil meeting the criteria for antihypertensive response than those receiving placebo. Antihypertensive response rates were sustained for 52 weeks.

Candesartan cilexetil therapy for up to 160 weeks was generally well tolerated in clinical studies in children and adolescents aged 1 to <17 years with hypertension.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Hansen ML, Gunn PW, Kaelber DC. Underdiagnosis of hypertension in children and adolescents. JAMA 2007 Aug; 298(8): 874–9.

    Article  PubMed  CAS  Google Scholar 

  2. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics 2004 Aug; 114 (2 Suppl. 4th Report): 555–76.

  3. Lurbe E, Cifkova R, Cruickshank JK, et al. Management of high blood pressure in children and adolescents: recommendations of the European Society of Hypertension. J Hypertens 2009 Sep; 27(9): 1719–42.

    Article  PubMed  CAS  Google Scholar 

  4. Flynn JT. Pediatric hypertension: recent trends and accomplishments, future challenges. Am J Hypertens 2008 Jun; 21(6): 605–12.

    Article  PubMed  Google Scholar 

  5. AstraZeneca. Atacand® (candesartan cilexetil) tablets: prescribing information [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020838s03llb1.pdf [Accessed 2010 Jul 2].

  6. McClellan KJ, Goa KL. Candesartan cilexetil: a review of its use in essential hypertension. Drugs 1998 Nov; 56(5): 847–69.

    Article  PubMed  CAS  Google Scholar 

  7. Easthope SE, Jarvis B. Candesartan cilexetil: an update of its use in essential hypertension. Drugs 2002; 62(8): 1253–87.

    Article  PubMed  CAS  Google Scholar 

  8. Fenton C, Scott LJ. Candesartan cilexetil: a review of its use in the management of chronic heart failure. Drugs 2005; 65(4): 537–58.

    Article  PubMed  CAS  Google Scholar 

  9. Melian EB, Jarvis B. Candesartan cilexetil plus hydrochlorothiazide combination: a review of its use in hypertension. Drugs 2002; 62(5): 787–816.

    Article  PubMed  CAS  Google Scholar 

  10. Trachtman H, Hainer JW, Sugg J, et al. Efficacy, safety, and pharmacokinetics of candesartan cilexetil in hypertensive children aged 6 to 17 years. J Clin Hypertens 2008 Oct; 10(10): 743–50.

    Article  CAS  Google Scholar 

  11. Schaefer F, Van De Walle J, Zurowska A, et al. Efficacy, safety and pharmacokinetics of candesartan cilexetil in hypertensive children from 1 to less than 6 years of age. J Hypertens 2010 May; 28(5): 1083–90.

    Article  PubMed  CAS  Google Scholar 

  12. AstraZeneca. An open-label extension study of candesartan cilexetil in hypertensive pediatric subjects ages 1 to <11 years: a long-term study [online]. Available from URL: http://www.astrazenecaclinicaltrials.com/drug-products/drug products/?itemId=8592674 [Accessed 2010 Sep 14].

  13. AstraZeneca. Atacand dose range finding study in pediatric subjects 6 to <17 years of age. [ClinicalTrials.gov identifier NCT00244634]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2010 Jul 6].

  14. AstraZeneca. Atacand dose ranging in hypertensive pediatric subjects 1 year to less than 6 years of age. [ClinicalTrials.gov identifier NCT00244621]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2010 Jul 6].

  15. AstraZeneca. Study to characterize the long-term clinical experience of Atacand in hypertensive children ages 1 to <11 years (HIP). [ClinicalTrials.gov identifier NCT00690612]. US National Institutes of Health, Clinical Trials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2010 Jul 6].

  16. Meier CM, Simonetti GD, Ghiglia S, et al. Palatability of angiotensin II antagonists among nephropathic children. Br J Clin Pharmacol 2007 May; 63(5): 628–31.

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Adis, a Wolters Kluwer Business, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand

    Sheridan M. Hoy & Gillian M. Keating

Authors
  1. Sheridan M. Hoy
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Gillian M. Keating
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sheridan M. Hoy.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Hoy, S.M., Keating, G.M. Candesartan Cilexetil. Am J Cardiovasc Drugs 10, 335–342 (2010). https://doi.org/10.2165/11206300-000000000-00000

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/11206300-000000000-00000

Keywords

Search

Navigation