You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Non-Neurogenic Voiding Dysfunction I1 Apr 20101528 FAST-DISSOLVING DESMOPRESSIN (MELT) IS WELL TOLERATED IN NOCTURIA: RESULTS OF A RANDOMIZED, PLACEBO-CONTROLLED STUDY Jeffrey P. Weiss, Jeffrey A. Snyder, William Travis Ellison, Laurence H. Belkoff, and Bjarke M. Klein Jeffrey P. WeissJeffrey P. Weiss Brooklyn, NY More articles by this author , Jeffrey A. SnyderJeffrey A. Snyder Denver, CO More articles by this author , William Travis EllisonWilliam Travis Ellison Greer, SC More articles by this author , Laurence H. BelkoffLaurence H. Belkoff Bala Cynwyd, PA More articles by this author , and Bjarke M. KleinBjarke M. Klein Copenhagen, Denmark More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1279AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Desmopressin administered in tablet form is an effective and generally well-tolerated treatment for nocturia in adults, with hyponatremia being the only potentially serious adverse event (AE). A fast-dissolving oral lyophilisate (Melt) formulation of desmopressin has been developed, the tolerability of which was assessed in a broad adult population treated for nocturia. Efficacy results showed that doses ≥25 μg were effective in significantly reducing nocturia. METHODS This was a Phase 3 randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of 4 doses of desmopressin Melt for the treatment of nocturia in adults. Subjects ≥18 years of age, with an average of ≥2 voids per night, were eligible for inclusion. In Part I (28 days), subjects were randomized to 1 of 5 treatment groups: placebo or desmopressin Melt 10 μg, 25 μg, 50 μg or 100 μg. All treatments were administered orally 1 hour before bedtime. Safety was assessed by monitoring AEs, generally elicited using a standard non-leading question, although subjects were specifically questioned about dry mouth. Blood samples were analyzed for serum sodium. Subjects completing Part I were eligible to continue into Part II (non-placebo controlled) for which safety data will be reported elsewhere. RESULTS A total of 799 subjects were randomized to Part I of the study. The incidence of AEs was generally similar across the placebo and desmopressin Melt dose groups (see Table, which includes overall incidence of AEs and most frequent treatment-related AEs). Hyponatremia (AEs ‘hyponatremia' or ‘blood sodium decrease', or serum sodium <130 mmol/L) tended to occur early in treatment – usually during the first week – was dose-related at doses of ≥50 μg (see Table), and was more common in subjects ≥65 years of age (serum sodium <130 mmol/L in 1% and 7% of subjects <65 compared with ≥65 years of age, respectively). CONCLUSIONS Desmopressin Melt was generally well tolerated with low rates of drug-related AEs, especially hyponatremia, and dry mouth reported at rates similar to placebo. Early monitoring of changes in serum sodium and oral fluid intake reduction are essential to avoid the sequelae of hyponatremia especially in the elderly. © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byWeiss J, van Kerrebroeck P, Klein B and Nørgaard J (2011) Excessive Nocturnal Urine Production is a Major Contributing Factor to the Etiology of NocturiaJournal of Urology, VOL. 186, NO. 4, (1358-1363), Online publication date: 1-Oct-2011. Volume 183Issue 4SApril 2010Page: e589-e590 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jeffrey P. Weiss Brooklyn, NY More articles by this author Jeffrey A. Snyder Denver, CO More articles by this author William Travis Ellison Greer, SC More articles by this author Laurence H. Belkoff Bala Cynwyd, PA More articles by this author Bjarke M. Klein Copenhagen, Denmark More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...