Safety Profile of Desmopressin Tablet for Enuresis in a Prospective Study
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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.
KeywordsChildren Desmopressin Enuresis Safety Tablet
The desmopressin response in primary nocturnal enuresis study (DRIP study) was funded by Ferring. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. All named authors meet the 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.
Conflict of interest
C. Van Herzeele, J. Evans and P. Eggert declare that they have no actual or potential conflict of interest. P. De Bruyne received an independent Grant for Strategic Basic Research of the Agency for Innovation by Science and Technology in Flanders (IWT). H. Lottmann is a lecturer and advisor for Ferring Pharmaceuticals. J. Norgaard is a full time employee of Ferring Pharmaceuticals. J. Vande Walle is a lecturer, investigator and advisor for Ferring Pharmaceuticals.
Compliance with ethics guidelines
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki declaration of 1975, as revised in 2000 and 2008. Informed consent was obtained from all patients before being included in the study.