title: Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  The primary objective was to investigate the efficacy of desmopressin orally disintegrating tablet versus placebo in patients with nocturia. Pharmacodynamics, safety and patient-reported quality of life (QoL) outcomes were also evaluated. One of several benefits of the new formulation is increased bioavailability. Exploring lower doses allows for a better evaluation of therapeutic effect versus tolerability.
  
  
  METHODS
  This was a 4-week, randomized, double-blind study comparing 10, 25, 50, or 100 µg desmopressin versus placebo in adults with defined nocturia.
  
  
  RESULTS
  The intent to treat population comprised 757 patients experiencing ∼3 voids/night and a high prevalence of nocturnal polyuria (∼90%). Increasing doses of desmopressin were associated with decreasing numbers of nocturnal voids and voided volume, greater proportions of subjects with >33% reduction in nocturnal voids, and increased duration of first sleep period. The lowest dose reaching statistical significance (P < 0.05 vs. placebo) varied by endpoint. Improvements were clinically meaningful, meaning that patients actually had fewer nightly voids. Post hoc analyses by gender suggested a lower minimum effective dose for women. Desmopressin was generally well tolerated. Reductions in serum sodium to <125 mmol/L in six women (taking >25 µg desmopressin) and two men (aged 67 and 82) taking 100 µg, support lower and gender-specific dosing to reduce the small but clinically significant risk of hyponatraemia. Each void reduced/hour of sleep gained was associated with significant improvements in QoL.
  
  
  CONCLUSIONS
  Desmopressin orally disintegrating tablet is an effective and well-tolerated treatment for patients with nocturia. Further exploration of the lower dose range is warranted.
authors.affiliation: Department of Urology, SUNY Downstate Medical School, Brooklyn, NY, USA. urojock@aol.com
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Weiss
authors.forename: Norman R
authors.initials: NR
authors.lastname: Zinner
authors.forename: Bjarke M
authors.initials: BM
authors.lastname: Klein
authors.forename: Jens Peter
authors.initials: JP
authors.lastname: Nørgaard
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D050034:Antidiuretic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003894:Deamino Arginine Vasopressin / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D053158:Nocturia / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D050034:Antidiuretic Agents; D003894:Deamino Arginine Vasopressin