title: Long-term durability of the response to desmopressin in female and male nocturia patients.
abstract: OBJECTIVE
  To explore the durability of efficacy and gender differences during chronic administration of desmopressin in nocturia.
  
  
  METHODS
  This pooled analysis of three short-term efficacy studies, with extensions, of desmopressin administered as orally disintegrating tablet (ODT) or solid tablet in nocturia treatment, comprised 351 patients completing 40-56 weeks' treatment. Efficacy endpoints of change in number of nocturnal voids and duration of initial undisturbed sleep period from baseline were analyzed to determine response durability and gender differences.
  
  
  RESULTS
  The mean decrease in number of nocturnal voids during short-term treatment was maintained and further reduced during the long term. At 52 weeks, the mean decrease in number of nocturnal voids from baseline reached 1.4-2.1 voids for desmopressin ODT 25-100 µg. Following 40-week tablet treatment, the decrease in number of nocturnal voids was 0.8-1.5 for desmopressin 100-400 µg. The mean decrease in nocturnal voids (25-50 µg ODT) was greater for females than males. For females, the improvement in initial period of undisturbed sleep was 2.5-3 hr for desmopressin ODT 25-100 µg, compared with 1.3-2.6 hr for males. No gender difference in efficacy was seen in the tablet studies.
  
  
  CONCLUSIONS
  The decrease in nocturnal voids and improvement in sleep with short-term desmopressin treatment were maintained throughout long-term treatment. A durable gender difference in efficacy in favor of females was observed with desmopressin ODT 25 µg. Further, large-scale long-term trials are needed to confirm the durability of efficacy with gender-specific doses of desmopressin.
authors.affiliation: Ferring International PharmaScience Center, Copenhagen S, Denmark. kvj@ferring.com
authors.forename: Kristian Vinter
authors.initials: KV
authors.lastname: Juul
authors.forename: Bjarke M
authors.initials: BM
authors.lastname: Klein
authors.forename: Jens Peter
authors.initials: JP
authors.lastname: Nørgaard
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D017326:Clinical Trials, Phase III as Topic; D003894:Deamino Arginine Vasopressin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008134:Long-Term Care; D008297:Male; D008499:Medical Records; D053158:Nocturia / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012076:Renal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012737:Sex Factors; D011795:Surveys and Questionnaires; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D012076:Renal Agents; D013607:Tablets; D003894:Deamino Arginine Vasopressin