Objective: The aim of this study was to evaluate adverse effects of oral desmopressin lyophilisate (MELT)in enuretic children.Material and methods: We enrolled 260 children with nocturnal enuresis (NE) referred to the PediatricService, ‘Campus Bio-Medico’ University of Rome, from April 2014 to April 2017 in the study, of these 23were excluded. The study was characterized by 2 phases. During Phase 1 a careful patient’s medical historywas obtained and physical examination was performed. After 3 months of treatment with MELT (Minirin/DDAVP®) at the dose of 120 mcg a day, a micturition diary was kept, adherence to therapy and any possibleadverse effects were checked during the Phase 2. The study was carried out in compliance with the HelsinkiDeclaration.Results: Among 237 patients included in the study 11 male and 6 female (n=17; 7.2%) patients with a meanage 10.06±2.49 years, reported 22 adverse effects, with an absolute risk of 7.17%. In particular, 5 neurologicalsymptoms, 3 gastrointestinal effects, 4 sleep disturbances, 8 psycho-behavioral disorders, 2 symptomsof fatigue were reported.Conclusion: In our study MELT with its higher bioavailability guaranteed lower frequency of adverse effectswhich resolved spontaneously and rapidly. The MELT formulation actually represents the first line andsafe treatment for the NE.
The adverse effects of oral desmopressin lyophilisate (MELT): personal experience on enuretic children
Ferrara, Pietro;Petitti, Tommasangelo
2018-01-01
Abstract
Objective: The aim of this study was to evaluate adverse effects of oral desmopressin lyophilisate (MELT)in enuretic children.Material and methods: We enrolled 260 children with nocturnal enuresis (NE) referred to the PediatricService, ‘Campus Bio-Medico’ University of Rome, from April 2014 to April 2017 in the study, of these 23were excluded. The study was characterized by 2 phases. During Phase 1 a careful patient’s medical historywas obtained and physical examination was performed. After 3 months of treatment with MELT (Minirin/DDAVP®) at the dose of 120 mcg a day, a micturition diary was kept, adherence to therapy and any possibleadverse effects were checked during the Phase 2. The study was carried out in compliance with the HelsinkiDeclaration.Results: Among 237 patients included in the study 11 male and 6 female (n=17; 7.2%) patients with a meanage 10.06±2.49 years, reported 22 adverse effects, with an absolute risk of 7.17%. In particular, 5 neurologicalsymptoms, 3 gastrointestinal effects, 4 sleep disturbances, 8 psycho-behavioral disorders, 2 symptomsof fatigue were reported.Conclusion: In our study MELT with its higher bioavailability guaranteed lower frequency of adverse effectswhich resolved spontaneously and rapidly. The MELT formulation actually represents the first line andsafe treatment for the NE.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
