Wei Zhao1, Valérie Biran, Evelyne Jacqz-Aigrain. 1. Department of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Clinical Investigation Center CIC9202, INSERM, 48 Boulevard Sérurier, 75935, Paris Cedex 19, France, wei.zhao@rdb.aphp.fr.
Abstract
BACKGROUND AND OBJECTIVE: Amikacin clearance has recently been proposed as a marker of renal maturation in neonates. However, the predictive value of this marker is still unknown. The objective of the present exploratory study was to evaluate the predictive performance of renal maturation model derived from amikacin to predict the glomerular filtration rate (GFR) and vancomycin clearance in neonates. METHODS: The GFR and vancomycin clearance in neonates were predicted using a maturation model derived from amikacin via estimation and simulation in a cohort of 116 neonates using non-linear mixed-effects modeling NONMEM® software. RESULTS: Our results demonstrate good correlations between predicted and observed GFR and vancomycin clearance in neonates. The square of the correlation coefficient, and means of the prediction error (2.5th-97.5th percentiles) and absolute prediction error (2.5th-97.5th percentiles) are 0.96, 1.2 % (-39.7 to 30.0 %) and 12.3 % (0.4-39.7 %), respectively, for GFR, and 0.97, -11.3 % (-38.2 to 15.4 %) and 14.0 % (0.5-38.2 %), respectively, for vancomycin. The prediction error is not significantly correlated with age. CONCLUSION: An amikacin maturation model can precisely reflect maturation of glomerular filtration and thus predict the dosage regimens of other renally excreted drugs by glomerular filtration in neonates.
BACKGROUND AND OBJECTIVE:Amikacin clearance has recently been proposed as a marker of renal maturation in neonates. However, the predictive value of this marker is still unknown. The objective of the present exploratory study was to evaluate the predictive performance of renal maturation model derived from amikacin to predict the glomerular filtration rate (GFR) and vancomycin clearance in neonates. METHODS: The GFR and vancomycin clearance in neonates were predicted using a maturation model derived from amikacin via estimation and simulation in a cohort of 116 neonates using non-linear mixed-effects modeling NONMEM® software. RESULTS: Our results demonstrate good correlations between predicted and observed GFR and vancomycin clearance in neonates. The square of the correlation coefficient, and means of the prediction error (2.5th-97.5th percentiles) and absolute prediction error (2.5th-97.5th percentiles) are 0.96, 1.2 % (-39.7 to 30.0 %) and 12.3 % (0.4-39.7 %), respectively, for GFR, and 0.97, -11.3 % (-38.2 to 15.4 %) and 14.0 % (0.5-38.2 %), respectively, for vancomycin. The prediction error is not significantly correlated with age. CONCLUSION: An amikacin maturation model can precisely reflect maturation of glomerular filtration and thus predict the dosage regimens of other renally excreted drugs by glomerular filtration in neonates.
Authors: T A Golper; H M Noonan; L Elzinga; D Gilbert; R Brummett; J L Anderson; W M Bennett Journal: Clin Pharmacol Ther Date: 1988-05 Impact factor: 6.875
Authors: Lyonne K van Rossum; Karlien Cransberg; Yolanda B de Rijke; Robert Zietse; Jan Lindemans; Arnold G Vulto Journal: Pediatr Nephrol Date: 2005-04-15 Impact factor: 3.714
Authors: Isabelle K Delattre; Flora T Musuamba; Philippe Jacqmin; Fabio S Taccone; Pierre-François Laterre; Roger K Verbeeck; Frédérique Jacobs; Pierre Wallemacq Journal: Clin Biochem Date: 2012-04-05 Impact factor: 3.281
Authors: Brian J Anderson; Karel Allegaert; John N Van den Anker; Veerle Cossey; Nicholas H G Holford Journal: Br J Clin Pharmacol Date: 2006-07-21 Impact factor: 4.335
Authors: Karel Allegaert; Brian J Anderson; John N van den Anker; Sophie Vanhaesebrouck; Francis de Zegher Journal: Ther Drug Monit Date: 2007-06 Impact factor: 3.681
Authors: S Cristea; K Allegaert; A C Falcao; F Falcao; R Silva; A Smits; C A J Knibbe; E H J Krekels Journal: Antimicrob Agents Chemother Date: 2019-07-25 Impact factor: 5.191
Authors: Roosmarijn F W De Cock; Karel Allegaert; Janneke M Brussee; Catherine M T Sherwin; Hussain Mulla; Matthijs de Hoog; Johannes N van den Anker; Meindert Danhof; Catherijne A J Knibbe Journal: Pharm Res Date: 2014-05-02 Impact factor: 4.200
Authors: Esther J H Janssen; Pyry A J Välitalo; Karel Allegaert; Roosmarijn F W de Cock; Sinno H P Simons; Catherine M T Sherwin; Johan W Mouton; Johannes N van den Anker; Catherijne A J Knibbe Journal: Antimicrob Agents Chemother Date: 2015-12-07 Impact factor: 5.191
Authors: Sinziana Cristea; Anne Smits; Aida Kulo; Catherijne A J Knibbe; Mirjam van Weissenbruch; Elke H J Krekels; Karel Allegaert Journal: Antimicrob Agents Chemother Date: 2017-11-22 Impact factor: 5.191
Authors: A Smits; R F W De Cock; K Allegaert; S Vanhaesebrouck; M Danhof; C A J Knibbe Journal: Antimicrob Agents Chemother Date: 2015-07-27 Impact factor: 5.191
Authors: Evelyn Dhont; Tatjana Van Der Heggen; Annick De Jaeger; Johan Vande Walle; Peter De Paepe; Pieter A De Cock Journal: Pediatr Nephrol Date: 2018-10-29 Impact factor: 3.714