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Pharmacokinetics of desmopressin administered as tablet and oral lyophilisate formulation in children with monosymptomatic nocurnal enuresis

Pauline De Bruyne (UGent) , Ann De Guchtenaere (UGent) , Charlotte Van Herzeele (UGent) , Ann Raes (UGent) , Jo Dehoorne (UGent) , Piet Hoebeke (UGent) , Erik Van Laecke (UGent) and Johan Vande Walle (UGent)
(2014) EUROPEAN JOURNAL OF PEDIATRICS. 173(2). p.223-228
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Abstract
Desmopressin 120 mu g oral lyophilisate and 200 mu g tablet are considered bioequivalent, based on extrapolation of studies in a limited number of adults and on one dose-finding study of desmopressin oral lyophilisate in children. However, no comparative pharmacokinetic study in children was executed confirming this statement. No data are available on the influence of food intake on the bioavailability of desmopressin tablet in a pediatric setting, although studies in adults have documented that food intake results in a significantly lower desmopressin plasma concentration. In this study, we analyzed plasma concentrations of desmopressin oral lyophilisate and tablet with concomitant food intake. Twenty-three children with monosymptomatic nocturnal enuresis (mean age, 12.7 years) were recruited. Two tests were performed on two separate days in identical conditions with a standardized food and fluid intake. Desmopressin was administered as desmopressin tablet or desmopressin oral lyophilisate immediately after a meal. Desmopressin plasma concentration was measured at 1 h, 2 h, and 6 h postdosing. No significant difference in plasma concentration of 120 mu g desmopressin oral lyophilisate and 200 mu g tablet was demonstrated, even with concomitant food intake. A significant difference in variability was found, identifying a smaller variance for desmopressin oral lyophilisate plasma concentrations at all time points. This study demonstrates comparable plasma levels for desmopressin oral lyophilisate, despite the lower dose. The dosage for desmopressin oral lyophilisate is more predictable due to the significantly smaller variance. Therefore, desmopressin oral lyophilisate seems more suitable, especially in the younger age group for which time interval between dinner and drug administration is limited.
Keywords
Desmopressin, Pharmacokinetics, Monosymptomatic nocturnal enuresis, Children, SAFETY

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MLA
De Bruyne, Pauline, Ann De Guchtenaere, Charlotte Van Herzeele, et al. “Pharmacokinetics of Desmopressin Administered as Tablet and Oral Lyophilisate Formulation in Children with Monosymptomatic Nocurnal Enuresis.” EUROPEAN JOURNAL OF PEDIATRICS 173.2 (2014): 223–228. Print.
APA
De Bruyne, P., De Guchtenaere, A., Van Herzeele, C., Raes, A., Dehoorne, J., Hoebeke, P., Van Laecke, E., et al. (2014). Pharmacokinetics of desmopressin administered as tablet and oral lyophilisate formulation in children with monosymptomatic nocurnal enuresis. EUROPEAN JOURNAL OF PEDIATRICS, 173(2), 223–228.
Chicago author-date
De Bruyne, Pauline, Ann De Guchtenaere, Charlotte Van Herzeele, Ann Raes, Jo Dehoorne, Piet Hoebeke, Erik Van Laecke, and Johan Vande Walle. 2014. “Pharmacokinetics of Desmopressin Administered as Tablet and Oral Lyophilisate Formulation in Children with Monosymptomatic Nocurnal Enuresis.” European Journal of Pediatrics 173 (2): 223–228.
Chicago author-date (all authors)
De Bruyne, Pauline, Ann De Guchtenaere, Charlotte Van Herzeele, Ann Raes, Jo Dehoorne, Piet Hoebeke, Erik Van Laecke, and Johan Vande Walle. 2014. “Pharmacokinetics of Desmopressin Administered as Tablet and Oral Lyophilisate Formulation in Children with Monosymptomatic Nocurnal Enuresis.” European Journal of Pediatrics 173 (2): 223–228.
Vancouver
1.
De Bruyne P, De Guchtenaere A, Van Herzeele C, Raes A, Dehoorne J, Hoebeke P, et al. Pharmacokinetics of desmopressin administered as tablet and oral lyophilisate formulation in children with monosymptomatic nocurnal enuresis. EUROPEAN JOURNAL OF PEDIATRICS. 2014;173(2):223–8.
IEEE
[1]
P. De Bruyne et al., “Pharmacokinetics of desmopressin administered as tablet and oral lyophilisate formulation in children with monosymptomatic nocurnal enuresis,” EUROPEAN JOURNAL OF PEDIATRICS, vol. 173, no. 2, pp. 223–228, 2014.
@article{4252484,
  abstract     = {Desmopressin 120 mu g oral lyophilisate and 200 mu g tablet are considered bioequivalent, based on extrapolation of studies in a limited number of adults and on one dose-finding study of desmopressin oral lyophilisate in children. However, no comparative pharmacokinetic study in children was executed confirming this statement. No data are available on the influence of food intake on the bioavailability of desmopressin tablet in a pediatric setting, although studies in adults have documented that food intake results in a significantly lower desmopressin plasma concentration. In this study, we analyzed plasma concentrations of desmopressin oral lyophilisate and tablet with concomitant food intake. Twenty-three children with monosymptomatic nocturnal enuresis (mean age, 12.7 years) were recruited. Two tests were performed on two separate days in identical conditions with a standardized food and fluid intake. Desmopressin was administered as desmopressin tablet or desmopressin oral lyophilisate immediately after a meal. Desmopressin plasma concentration was measured at 1 h, 2 h, and 6 h postdosing. No significant difference in plasma concentration of 120 mu g desmopressin oral lyophilisate and 200 mu g tablet was demonstrated, even with concomitant food intake. A significant difference in variability was found, identifying a smaller variance for desmopressin oral lyophilisate plasma concentrations at all time points. This study demonstrates comparable plasma levels for desmopressin oral lyophilisate, despite the lower dose. The dosage for desmopressin oral lyophilisate is more predictable due to the significantly smaller variance. Therefore, desmopressin oral lyophilisate seems more suitable, especially in the younger age group for which time interval between dinner and drug administration is limited.},
  author       = {De Bruyne, Pauline and De Guchtenaere, Ann and Van Herzeele, Charlotte and Raes, Ann and Dehoorne, Jo and Hoebeke, Piet and Van Laecke, Erik and Vande Walle, Johan},
  issn         = {0340-6199},
  journal      = {EUROPEAN JOURNAL OF PEDIATRICS},
  keywords     = {Desmopressin,Pharmacokinetics,Monosymptomatic nocturnal enuresis,Children,SAFETY},
  language     = {eng},
  number       = {2},
  pages        = {223--228},
  title        = {Pharmacokinetics of desmopressin administered as tablet and oral lyophilisate formulation in children with monosymptomatic nocurnal enuresis},
  url          = {http://dx.doi.org/10.1007/s00431-013-2108-2},
  volume       = {173},
  year         = {2014},
}

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