2270 ADMINISTRATION OF FEDOVAPAGON CAUSES A DOSE-RESPONSIVE REDUCTION IN NOCTURNAL POLYURIA INDEX

Abstract

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Urodynamics Testing1 Apr 20132270 ADMINISTRATION OF FEDOVAPAGON CAUSES A DOSE-RESPONSIVE REDUCTION IN NOCTURNAL POLYURIA INDEX Georg Golor, Hilary McElwaine-Johnn, Rachel Handy, Christopher Yea, and John Lambert Georg GolorGeorg Golor Berlin, Germany More articles by this author , Hilary McElwaine-JohnnHilary McElwaine-Johnn Southampton, United Kingdom More articles by this author , Rachel HandyRachel Handy Southampton, United Kingdom More articles by this author , Christopher YeaChristopher Yea Southampton, United Kingdom More articles by this author , and John LambertJohn Lambert Harrow, United Kingdom More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2199AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Nocturia, defined as waking to void at least once per night between periods of sleep, is a common complaint and shows an age-dependent increase in both prevalence and severity. It has been linked to age-dependent loss in circadian release of nocturnal vasopressin which leads to over production of urine at night (nocturnal polyuria, NPU). NPU is generally diagnosed in subjects aged >65 years when night time urine production exceeds 33% of the total 24 hour (h) urine production. Fedovapagon (VA106483), a novel non-peptide drug, is a selective vasopressin V2-receptor agonist in development for the treatment of nocturia. METHODS Thirty older male subjects (aged >65 years) with a history of BPH and nocturia (mean age 69.2 years [SD 3.2]) were randomised in this IEC approved double-blind, placebo-controlled, five-way cross-over study. Each subject received five treatment periods, each of 2 nights, comprising 0.5 mg - 1 mg - 2 mg - 4 mg fedovapagon and placebo administered in a double-blind fashion in a randomised treatment sequence, each separated by a 1 night single-blind placebo. Subjects had free access to fluid throughout the study, ensuring thirst was satisfied at all times. Subjects were dosed with Investigational Medicinal Product (IMP) at approximately 9 pm. Subjects were prompted to void 1 h post IMP (bedtime void) and again at 9 h (first morning void). Urine voided after the prompted bedtime void and up to and including the first morning void was included in the NUV. 24 h urine volume was assessed throughout the study period. Nocturnal polyuria index (NPUI) was calculated as NUV / 24 h urine volume × 100%. RESULTS There was no discernible effect of fedovapagon treatment on the overall 24 h urine volume. Fedovapagon reduced NPUI in a dose responsive manner from 37.1% following placebo to 24.6% at the 4 mg dose. Fedovapagon was effective on the first night of dosing. There was no apparent carry-over effect of fedovapagon on nocturnal polyuria indices during the single-blind treatment between randomised treatment periods. CONCLUSIONS Fedovapagon treatment was well tolerated in the study population. The dose-responsive reduction in NPUI on fedovapagon shown in this study indicates a shift of urine production from the night time period to the daytime period in this population of older male subjects with nocturia and BPH. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e930-e931 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Georg Golor Berlin, Germany More articles by this author Hilary McElwaine-Johnn Southampton, United Kingdom More articles by this author Rachel Handy Southampton, United Kingdom More articles by this author Christopher Yea Southampton, United Kingdom More articles by this author John Lambert Harrow, United Kingdom More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...