title: Safety profile of desmopressin tablet for enuresis in a prospective study.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Desmopressin tablet treatment is well tolerated in children with primary nocturnal enuresis, regardless of patient gender or age.
  
  
  BACKGROUND
  The desmopressin response in primary nocturnal enuresis study (DRIP- study) was funded by Ferring.
authors.affiliation: Department of Pediatric Nephrology, University Hospital Ghent, De Pintelaan 185, 9000, Ghent, Belgium, charlotte.vanherzeele@ugent.be.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Van Herzeele
authors.forename: Pauline
authors.initials: P
authors.lastname: De Bruyne
authors.forename: Jonathan
authors.initials: J
authors.lastname: Evans
authors.forename: Paul
authors.initials: P
authors.lastname: Eggert
authors.forename: Henri
authors.initials: H
authors.lastname: Lottmann
authors.forename: Jens Peter
authors.initials: JP
authors.lastname: Norgaard
authors.forename: Johan
authors.initials: J
authors.lastname: Vande Walle
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D050034:Antidiuretic Agents / Q000008:administration & dosage / Q000009:adverse effects; D015992:Body Mass Index; D002648:Child; D002675:Child, Preschool; D003894:Deamino Arginine Vasopressin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D053206:Nocturnal Enuresis / Q000188:drug therapy*; D011446:Prospective Studies; D063189:Symptom Assessment; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D050034:Antidiuretic Agents; D013607:Tablets; D003894:Deamino Arginine Vasopressin