Predictive Performance of a Vancomycin Population Pharmacokinetic Model in Neonates

详细信息    查看全文

• 作者：Chris Stockmann ; Adam L. Hersh ; Jessica K. Roberts…
• 关键词：Infectious diseases ; MRSA ; Neonates ; Pharmacokinetics ; Staphylococcus aureus ; Vancomycin
• 刊名：Infectious Diseases and Therapy
• 出版年：2015
• 出版时间：June 2015
• 年：2015
• 卷：4
• 期：2
• 页码：187-198
• 全文大小：958 KB
• 参考文献：1.Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis An Off Pub Infect Dis Soc Am. 2011;52(3):e18-5.View Article
  2.Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology–drug disposition, action, and therapy in infants and children. New Eng J Med. 2003;349(12):1157-7.PubMed View Article
  3.Stockmann C, Roberts JK, Yu T, et al. Vancomycin pharmacokinetic models: informing the clinical management of drug-resistant bacterial infections. Expert Rev Anti Infect Ther. 2014;12(11):1371-8.PubMed View Article
  4.Ringenberg T, Robinson C, Meyers R, et al. Achievement of therapeutic vancomycin trough serum concentrations with empiric dosing in neonatal intensive care unit patients. Pediat Infect Dis J; 2015; (Epub ahead of print).
  5.Vandendriessche A, Allegaert K, Cossey V, Naulaers G, Saegeman V, Smits A. Prospective validation of neonatal vancomycin dosing regimens is urgently needed. Curr Ther Res Clin Exp. 2014;76:51-.PubMed Central PubMed View Article
  6.Jacqz-Aigrain E, Zhao W, Sharland M, van den Anker JN. Use of antibacterial agents in the neonate: 50?years of experience with vancomycin administration. Sem Fetal Neo Med. 2013;18(1):28-4.View Article
  7.Frymoyer A, Hersh AL, El-Komy MH, et al. Association Between Vancomycin Trough Concentration and AUC in Neonates. Antimicr Agents Chemother; 2014.
  8.Sheiner LB, Beal S, Rosenberg B, Marathe VV. Forecasting individual pharmacokinetics. Clin Pharmacol Ther. 1979;26(3):294-05.PubMed
  9.Sheiner LB, Rosenberg B, Melmon KL. Modelling of individual pharmacokinetics for computer-aided drug dosage. Comput Biomed Res Int J. 1972;5(5):411-9.View Article
  10.Sheiner LB, Beal SL. Bayesian individualization of pharmacokinetics: simple implementation and comparison with non-Bayesian methods. J Pharm Sci. 1982;71(12):1344-.PubMed View Article
  11.Schumacher GE, Barr JT. Bayesian approaches in pharmacokinetic decision making. Clin Pharm. 1984;3(5):525-0.PubMed
  12.Srivastava T, Alon US, Althahabi R, Garg U. Impact of standardization of creatinine methodology on the assessment of glomerular filtration rate in children. Pediatr Res. 2009;65(1):113-.PubMed View Article
  13.Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 1981;9(4):503-2.PubMed View Article
  14.Brendel K, Comets E, Laffont C, Laveille C, Mentre F. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res. 2006;23(9):2036-9.PubMed Central PubMed View Article
  15.Brendel K, Comets E, Laffont C, Mentre F. Evaluation of different tests based on observations for external model evaluation of population analyses. J Pharmacokinet Pharmacodyn. 2010;37(1):49-5.PubMed Central PubMed View Article
  16.US FDA. Guidance for industry: population pharmacokinetics [online]. Available from: http://?www.?fda.?gov/?downloads/?Drugs/?Guidances/?UCM072137.?pdf . Accessed 18 Sep 2014.
  17.Brendel K, Dartois C, Comets E, et al. Are population pharmacokinetic and/or pharmacodynamic models adequately evaluated? A survey of the literature from 2002 to 2004. Clin Pharmacokinet. 2007;46(3):221-4.PubMed Central PubMed View Article
  18.Lee JY, Garnett CE, Gobburu JV, et al. Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008. Clin Pharmacokinet. 2011;50(10):627-5.PubMed View Article
  19.Neely MN, Youn G, Jones B, et al. Are vancomycin trough concentrations adequate for optimal dosing? Antimicrob Agents Chemother. 2014;58(1):309-6.PubMed Central PubMed View Article
  20.Nunn MO, Corallo CE, Aubron C, Poole S, Dooley MJ, Cheng AC. Vancomycin dosing: assessment of time to therapeutic concentration and predictive accuracy of pharmacokinetic modeling software. Annal Pharmacother. 2011;45(6):757-3.View Article
  21.Rybak MJ, Lomaestro BM, Rotschafer JC, et al. Vancomycin therapeutic guidelines: a summary of consensus recommendations from the infectious diseases Society of America, the American Society of Health-System Pharmacists, and the Society of Infectious Diseases Pharmacists. Clin Infect Dis An Off Pub Infect Dis Soc Am. 2009;49(3):325-.View Article
  
• 作者单位：Chris Stockmann (1) (2)
  Adam L. Hersh (2)
  Jessica K. Roberts (1)
  Jiraganya Bhongsatiern (3)
  Ernest K. Korgenski (4)
  Michael G. Spigarelli (1)
  Catherine M. T. Sherwin (1)
  Adam Frymoyer (5)
  
  1. Division of Clinical Pharmacology, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA
  2. Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA
  3. James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA
  4. Pediatric Clinical Program, Intermountain Healthcare, Salt Lake City, UT, USA
  5. Department of Pediatrics, Stanford University, Palo Alto, CA, USA
  
• 刊物主题：Internal Medicine; Infectious Diseases;
• 出版者：Springer Healthcare
• ISSN：2193-6382

文摘

Introduction The pharmacokinetics of vancomycin are highly variable among neonates, which makes dosing challenging in this population. However, adequate drug exposure is critical, especially when treating methicillin-resistant Staphylococcus aureus (MRSA) infections. Utilization of population pharmacokinetic models and Bayesian methods offers the potential for developing individualized therapeutic approaches. To meet this need, a neonatal vancomycin population pharmacokinetic model was recently published. The current study sought to externally evaluate the predictive performance and generalizability of this model. Methods A retrospective chart review of neonates who received vancomycin and had ? peak and ? trough concentrations at five Intermountain Healthcare neonatal intensive care units from 2006 to 2013 was performed and served as the external validation cohort. The published population pharmacokinetic model was implemented in NONMEM 7.2 with the structural and variance parameter values set equal to the estimates reported previously. The model was then used to predict the first peak and trough concentration for each neonate in the validation cohort and the model prediction error and absolute prediction error were calculated. Normalized prediction distribution errors (NPDE) were also evaluated. Results A total of 243 neonates were studied with a median postmenstrual age of 33 (range: 23-4)?weeks and a median weight of 1.6 (range: 0.4-.8)?kg. The model predicted the observed vancomycin concentrations with reasonable precision. For all vancomycin concentrations, the median prediction error was ?.8 (95% CI: ?.4 to ?.4) mg/L and the median absolute prediction error was 3.0 (95% CI: 2.7-.5) mg/L. No trends in NPDE across weight, postmenstrual age, serum creatinine, or time after dose were observed. Conclusion An evaluation of a recently published neonatal vancomycin population pharmacokinetic model in a large external dataset supported the predictive performance and generalizability of the model. This model may be useful in evaluating neonatal vancomycin dosing regimens and estimating the extent of drug exposure.