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Safety profile of desmopressin tablet for enuresis in a prospective study

(2014) ADVANCES IN THERAPY. 31(12). p.1306-1316
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Abstract
This pre-specified sub-study of the desmopressin response in primary nocturnal enuresis study (DRIP study) evaluates the safety profile of the oral desmopressin tablet in children with primary nocturnal enuresis. Endpoints are adverse events and change in body mass index. The DRIP study was an open-label, intention-to-treat, phase IV, multi-national study. Overall, 936 patients were screened and 744 children aged 5-15 years with previously untreated primary nocturnal enuresis were eligible to receive the study medication desmopressin once daily as an oral tablet formulation. At each visit, adverse events were questioned and observed signs or symptoms were recorded. Overall, 222 (30%) patients experienced 404 treatment-emergent adverse events. The proportion of patients experiencing treatment-emergent adverse events was similar regardless of patient gender or age. Most treatment-emergent adverse events were experienced in three system organ classes: gastrointestinal disorders; infections and infestations; and respiratory, thoracic and mediastinal disorders and were considered unrelated to the study drug. There was a slight increase in body mass index from screening levels during the study, however, clinically not significant. Desmopressin tablet treatment is well tolerated in children with primary nocturnal enuresis, regardless of patient gender or age. The desmopressin response in primary nocturnal enuresis study (DRIP- study) was funded by Ferring.
Keywords
Desmopressin, Children, Enuresis, Safety, Tablet, MONOSYMPTOMATIC NOCTURNAL ENURESIS, CHILDREN, HYPONATREMIA

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Chicago
Van Herzeele, Charlotte, Pauline De Bruyne, Jonathan Evans, Paul Eggert, Henri Lottmann, Jens Peter Norgaard, and Johan Vande Walle. 2014. “Safety Profile of Desmopressin Tablet for Enuresis in a Prospective Study.” Advances in Therapy 31 (12): 1306–1316.
APA
Van Herzeele, C., De Bruyne, P., Evans, J., Eggert, P., Lottmann, H., Norgaard, J. P., & Vande Walle, J. (2014). Safety profile of desmopressin tablet for enuresis in a prospective study. ADVANCES IN THERAPY, 31(12), 1306–1316.
Vancouver
1.
Van Herzeele C, De Bruyne P, Evans J, Eggert P, Lottmann H, Norgaard JP, et al. Safety profile of desmopressin tablet for enuresis in a prospective study. ADVANCES IN THERAPY. 2014;31(12):1306–16.
MLA
Van Herzeele, Charlotte, Pauline De Bruyne, Jonathan Evans, et al. “Safety Profile of Desmopressin Tablet for Enuresis in a Prospective Study.” ADVANCES IN THERAPY 31.12 (2014): 1306–1316. Print.
@article{5826846,
  abstract     = {This pre-specified sub-study of the desmopressin response in primary nocturnal enuresis study (DRIP study) evaluates the safety profile of the oral desmopressin tablet in children with primary nocturnal enuresis. Endpoints are adverse events and change in body mass index. 
The DRIP study was an open-label, intention-to-treat, phase IV, multi-national study. Overall, 936 patients were screened and 744 children aged 5-15 years with previously untreated primary nocturnal enuresis were eligible to receive the study medication desmopressin once daily as an oral tablet formulation. At each visit, adverse events were questioned and observed signs or symptoms were recorded. 
Overall, 222 (30\%) patients experienced 404 treatment-emergent adverse events. The proportion of patients experiencing treatment-emergent adverse events was similar regardless of patient gender or age. Most treatment-emergent adverse events were experienced in three system organ classes: gastrointestinal disorders; infections and infestations; and respiratory, thoracic and mediastinal disorders and were considered unrelated to the study drug. There was a slight increase in body mass index from screening levels during the study, however, clinically not significant. 
Desmopressin tablet treatment is well tolerated in children with primary nocturnal enuresis, regardless of patient gender or age. 
The desmopressin response in primary nocturnal enuresis study (DRIP- study) was funded by Ferring.},
  author       = {Van Herzeele, Charlotte and De Bruyne, Pauline and Evans, Jonathan and Eggert, Paul and Lottmann, Henri and Norgaard, Jens Peter and Vande Walle, Johan},
  issn         = {0741-238X},
  journal      = {ADVANCES IN THERAPY},
  language     = {eng},
  number       = {12},
  pages        = {1306--1316},
  title        = {Safety profile of desmopressin tablet for enuresis in a prospective study},
  url          = {http://dx.doi.org/10.1007/s12325-014-0173-1},
  volume       = {31},
  year         = {2014},
}

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