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Pharmacokinetics and Pharmacodynamics of the Oral Disintegrating Tablet of Desmopressin in Adults with Nocturnal Polyuria: A Pilot Study

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Abstract

Introduction

The higher sensitivity to desmopressin (dDAVP) found in women and older patients with nocturnal polyuria (NP) has partially been unraveled, leading to adaptation of the dosage based on gender. However, besides age and gender, other factors might play a role in differences in sensitivity and side effects. The aim of this study is to design a pharmacokinetic/pharmacodynamic (PD) assay to identify appropriate treatment for different groups of patients, primarily dependent on differences in age and gender.

Methods

This interventional pilot study was carried out in Ghent University Hospital, Belgium, between 2011 and 2013. Patients with NP were subjected to a water load test (15 mL/kg), as well as an administration of 120 µg dDAVP oral disintegrating tablet (ODT) followed by blood analysis to determine plasma dDAVP levels and urine analysis for diuresis rate, osmolality, free water clearance and sodium clearance.

Results

Six female and six male patients were included (range 30–89 years old; mean age 69 years; SD 18). Three groups based on plasma dDAVP levels were found: (1) high (only women), (2) intermediate (only men) and (3) low plasma levels. For the nighttime samples (3–12 h after intake) men presented with significantly higher variation in PD response, whereas 12–15 h after dDAVP ODT intake women presented with a less predictable outcome, although all patients but one (female) have a prolonged PD effect.

Conclusion

This study suggests the need for individualized dose titration rather than fixed dose regimens in NP patients with bothersome symptoms. Gender, body weight and results of nocturnal free water and sodium clearance need to be taken into account for more accurate individualized treatment to result in high response rates and low side effects.

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Acknowledgments

This study was funded by an unrestricted grant from Ferring Pharmaceuticals. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published.

Disclosures

A.-S. Goessaert received an unrestricted research grant from Ferring; K. Everaert and J. Vande Walle both received grants from Ferring and are also consultants for Ferring and Astellas; P. Hoebeke has nothing to disclose.

Compliance with ethics guidelines

All patients signed an informed consent for being included in the study. The study was executed in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki declaration of 1964, as revised in 2013. Institutional board permission was obtained before the study was conducted (EC2011/566).

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Authors and Affiliations

  1. Urology Department, Ghent University Hospital, Ghent, Belgium

    An-Sofie Goessaert, Karel Everaert & Piet Hoebeke

  2. Pediatric Nephrology Department, Ghent University Hospital, Ghent, Belgium

    Johan Vande Walle

Authors
  1. An-Sofie Goessaert
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  2. Karel Everaert
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  3. Piet Hoebeke
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  4. Johan Vande Walle
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Corresponding author

Correspondence to An-Sofie Goessaert.

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Goessaert, AS., Everaert, K., Hoebeke, P. et al. Pharmacokinetics and Pharmacodynamics of the Oral Disintegrating Tablet of Desmopressin in Adults with Nocturnal Polyuria: A Pilot Study. Adv Ther 32, 799–808 (2015). https://doi.org/10.1007/s12325-015-0247-8

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  • DOI: https://doi.org/10.1007/s12325-015-0247-8

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