Safety of the Recent Oral Lyophilisate Formulation (MELT) in Pediatric Patients-A Review

P. Ferrara^1,2, F. Ianniello¹, E. Del Vescovo², G. Sodero², A. Gatto¹ and A. Ruggiero¹

¹Institute of Pediatrics, Catholic University Medical School, Rome, Italy.

²Campus  Bio-Medico University, Rome, Italy.

Corresponding Author E-mail: pietro.ferrara@unicatt.it

Abstract: To review the safety of the recent oral lyophilisate formulation of desmopressin (MELT) in the pharmacological therapy for nocturnal enuresis (NE) and diabetes insipidus in pediatric patients. We searched for published reviews and references from PubMed-MEDLINE, Embase, and CENTRAL and did also a new search spanning the period Jan 1, 2000, until July 31, 2017 by using the terms MELT enuresis, MELT desmopressin, sublingual desmopressin, lyophilisate desmopressin. We evaluated all studies about side effects and effectiveness of MELT in pediatric patients. Twelve articles were analyzed with 1275 pediatric patients (<18 years old). The indication was enuresis in 1269 patients and central diabetes insipidus in 6 patients. In 11 studies desmopressin was administered alone while in 1 study in association with Tolterodina. In 3 studies were reported side effects in only 60 patients. The reported side effects in pediatric population were nausea, lethargy, lower limb weakness, headache, diarrhea, viral gastroenteritis, hyponatremia. Our review confirm that the MELT formulation of desmopressin guarantee the same response of other formulations with a lower doses and a lowest number of side effects. We believe according with the literature that this formulation is actually an effective and safe treatment for NE.

Keywords: Enuresis; MELT; Safety

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