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 Pediatric Service, 'Campus Bio-Medico' University of Rome, from April 2014 to April 2017 in the study, of these 23 were excluded. The study was characterized by 2 phases. During Phase 1 a careful patient's medical history was 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 possible adverse effects were checked during the Phase 2. The study was carried out in compliance with the Helsinki Declaration. RESULTS: Among 237 patients included in the study 11 male and 6 female (n=17; 7.2%) patients with a mean age 10.06±2.49 years, reported 22 adverse effects, with an absolute risk of 7.17%. In particular, 5 neurological symptoms, 3 gastrointestinal effects, 4 sleep disturbances, 8 psycho-behavioral disorders, 2 symptoms of fatigue were reported. CONCLUSION: In our study MELT with its higher bioavailability guaranteed lower frequency of adverse effects which resolved spontaneously and rapidly. The MELT formulation actually represents the first line and safe treatment for the NE.