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Effect of renal function on antihypertensive drug safety and efficacy in children.

Publication ,  Journal Article
Watt, KM; Avant, D; Sherwin, J; Benjamin, DK; Hornik, C; Li, JS; Smith, PB
Published in: Pediatr Nephrol
January 2018

BACKGROUND: Hypertension and chronic kidney disease (CKD) are common comorbidities. Guidelines recommend treating hypertension in children with CKD because it is a modifiable risk factor for subsequent cardiovascular disease. Children with CKD are frequently excluded from antihypertensive drug trials. Consequently, safety and efficacy data for antihypertensive drugs are lacking in children with CKD. METHODS: We determined the incidence of adverse events in 10 pediatric antihypertensive trials to determine the effect of renal function on antihypertensive safety and efficacy in children. These trials were submitted to the US Food and Drug Administration from 1998 to 2005. We determined the number and type of adverse events reported during the trials and compared these numbers in participants with normal renal function and those with decreased function (defined as an estimated glomerular filtration rate [eGFR] <90 mL/min/1.73 m2 calculated using the original Schwartz equation). RESULTS: Among the 1,703 children in the 10 studies, 315 had decreased renal function. We observed no difference between the two cohorts in the incidence of adverse events or adverse drug reactions related to study drug. Only 5 participants, all with decreased renal function, experienced a serious adverse event; none was recorded by investigators to be study drug-related. Among treated participants, children with decreased renal function who received a high dose of study drug had a significantly larger drop in diastolic blood pressure compared with children with normal renal function. CONCLUSIONS: These data show that antihypertensive treatment in children with renal dysfunction can be safe and efficacious, and consideration should be given to their inclusion in selected drug development programs.

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Published In

Pediatr Nephrol

DOI

EISSN

1432-198X

Publication Date

January 2018

Volume

33

Issue

1

Start / End Page

139 / 146

Location

Germany

Related Subject Headings

  • Urology & Nephrology
  • Renal Insufficiency, Chronic
  • Male
  • Kidney
  • Infant
  • Hypertension
  • Humans
  • Glomerular Filtration Rate
  • Female
  • Child, Preschool
 

Citation

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Watt, K. M., Avant, D., Sherwin, J., Benjamin, D. K., Hornik, C., Li, J. S., & Smith, P. B. (2018). Effect of renal function on antihypertensive drug safety and efficacy in children. Pediatr Nephrol, 33(1), 139–146. https://doi.org/10.1007/s00467-017-3763-8
Watt, Kevin M., Debbie Avant, Jennifer Sherwin, Daniel K. Benjamin, Christoph Hornik, Jennifer S. Li, and P Brian Smith. “Effect of renal function on antihypertensive drug safety and efficacy in children.Pediatr Nephrol 33, no. 1 (January 2018): 139–46. https://doi.org/10.1007/s00467-017-3763-8.
Watt KM, Avant D, Sherwin J, Benjamin DK, Hornik C, Li JS, et al. Effect of renal function on antihypertensive drug safety and efficacy in children. Pediatr Nephrol. 2018 Jan;33(1):139–46.
Watt, Kevin M., et al. “Effect of renal function on antihypertensive drug safety and efficacy in children.Pediatr Nephrol, vol. 33, no. 1, Jan. 2018, pp. 139–46. Pubmed, doi:10.1007/s00467-017-3763-8.
Watt KM, Avant D, Sherwin J, Benjamin DK, Hornik C, Li JS, Smith PB. Effect of renal function on antihypertensive drug safety and efficacy in children. Pediatr Nephrol. 2018 Jan;33(1):139–146.
Journal cover image

Published In

Pediatr Nephrol

DOI

EISSN

1432-198X

Publication Date

January 2018

Volume

33

Issue

1

Start / End Page

139 / 146

Location

Germany

Related Subject Headings

  • Urology & Nephrology
  • Renal Insufficiency, Chronic
  • Male
  • Kidney
  • Infant
  • Hypertension
  • Humans
  • Glomerular Filtration Rate
  • Female
  • Child, Preschool