Population pharmacodynamic model for low molecular weight heparin nadroparin in morbidly obese and non-obese patients using anti-Xa levels as endpoint.

Purpose: In absence of specific dosing guidelines, the optimal dose of low molecular weight heparins for thrombosis prophylaxis in morbidly obese patients (BMI > 40 kg/m) remains unknown. In order to guide dosing in this patient group, a pharmacodynamics model is developed for nadroparin in morbidly...

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Publicado en:European Journal of Clinical Pharmacology Vol. 71; no. 1; pp. 25 - 35
Autores principales: Diepstraten, Jeroen, Janssen, Esther, Hackeng, Christian, Dongen, Eric, Wiezer, René, Ramshorst, Bert, Knibbe, Catherijne
Formato: equations & formulas research tables/charts Journal Article
Publicado: Springer Nature Jan2015
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Jan2015
      vid: 71
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      pub: Springer Nature
      place: New York, New York
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        100209209
        10.1007/s00228-014-1760-4
        103866212
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        atl: Population pharmacodynamic model for low molecular weight heparin nadroparin in morbidly obese and non-obese patients using anti-Xa levels as endpoint.
      aug:
        au:
          Diepstraten, Jeroen
          Janssen, Esther
          Hackeng, Christian
          Dongen, Eric
          Wiezer, René
          Ramshorst, Bert
          Knibbe, Catherijne
        affil: Department of Clinical Pharmacy, St. Antonius Hospital, Koekoekslaan 1 3435 CM Nieuwegein The Netherlands
      sug:
        subj:
          Heparin, Low-Molecular-Weight Administration and Dosage
          Heparin, Low-Molecular-Weight Pharmacodynamics
          Obesity
          Body Weight
          Venous Thromboembolism Prevention and Control
          Human
          Descriptive Statistics
          Data Analysis Software
          Multicenter Studies
          Prospective Studies
          Biological Assay
          Validity
          Wilcoxon Signed Rank Test
          Fisher's Exact Test
          Simulations
          Male
          Female
          Adult
          Middle Age
          Metabolic Clearance Rate
          Confidence Intervals
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Male
          Female
      ab: Purpose: In absence of specific dosing guidelines, the optimal dose of low molecular weight heparins for thrombosis prophylaxis in morbidly obese patients (BMI > 40 kg/m) remains unknown. In order to guide dosing in this patient group, a pharmacodynamics model is developed for nadroparin in morbidly obese and non-obese patients using anti-Xa levels as an endpoint, thereby characterizing the influence of excessive body weight on different pharmacodynamic model parameters. Methods: Twenty-eight morbidly obese and seven non-obese patients receiving 5700 IU and 2850 IU subcutaneous (s.c.) nadroparin for surgery, respectively, were included with a mean total body weight (TBW) of 135 kg (range 72-252 kg). Up to 11 anti-Xa levels were collected from the start until 24 h after nadroparin administration. Population pharmacodynamic modelling with covariate analysis was performed using NONMEM. Results: In a two-compartment pharmacodynamic model with baseline endogenous anti-Xa levels, the effect of nadroparin was found to be delayed and could be best described using a transit compartment. TBW was the most predictive covariate for clearance (CL = 23.0 mL/min × (TBW/70)), while lean body weight (LBW) proved the most predictive covariate for central volume of distribution (V1 = 7.0 L × (LBW/60)). Conclusions: A pharmacodynamic model was developed characterizing anti-Xa levels after s.c. administration of nadroparin in patients weighing between 72 and 252 kg with TBW and LBW as the major determinants for clearance and volume of distribution, respectively.
      pubtype: Academic Journal
      doctype:
        equations & formulas
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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