The adverse effects of oral desmopressin lyophilisate (MELT): personal experience on enuretic children

Özet

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