International Urogynecology Journal

, Volume 18, Issue 8, pp 919–929

Effect of dose escalation on the tolerability and efficacy of duloxetine in the treatment of women with stress urinary incontinence

  • David Castro-Diaz
  • Paulo C. R. Palma
  • Céline Bouchard
  • Francois Haab
  • Christian Hampel
  • Roberto Carone
  • Sebastian Zepeda Contreras
  • Henry Rodriguez Ginorio
  • Simon Voss
  • Ilker Yalcin
  • Richard C. Bump
  • Duloxetine Dose Escalation Study Group
Original Article

Abstract

To assess the impact of duloxetine dose escalation on tolerability and efficacy, 516 women with stress urinary incontinence were randomized to receive placebo or duloxetine in one of three regimens: 40 mg BID for 8 weeks, 40 mg QD for 2 weeks escalating to 40 mg BID for 6 weeks or 20 mg BID for 2 weeks escalating to 40 mg BID for 6 weeks. A non-inferiority analysis confirmed that the 20 mg BID starting dose was significantly better than the other two duloxetine regimens for nausea reduction (16.5% vs 25.2% and 29.4%). There were also significant differences in the discontinuation rates (7.5% vs 11.8% and 16.2%). The efficacy after 4 weeks was significantly better with duloxetine than with placebo. Starting duloxetine at 20 mg BID for 2 weeks before increasing to 40 mg BID significantly improved tolerability but did not impact duloxetine efficacy after all the subjects had been on 40 mg BID for at least 2 weeks.

Keywords

Stress urinary incontinence Duloxetine Dose escalation Tolerability Pharmacological treatment 

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Copyright information

© International Urogynecology Journal 2006

Authors and Affiliations

  • David Castro-Diaz
    • 1
  • Paulo C. R. Palma
    • 2
  • Céline Bouchard
    • 3
  • Francois Haab
    • 4
  • Christian Hampel
    • 5
  • Roberto Carone
    • 6
  • Sebastian Zepeda Contreras
    • 7
  • Henry Rodriguez Ginorio
    • 8
  • Simon Voss
    • 9
  • Ilker Yalcin
    • 9
  • Richard C. Bump
    • 9
  • Duloxetine Dose Escalation Study Group
  1. 1.Hospital Universitario De CanariasSanta Cruz De TenerifeSpain
  2. 2.Hospital das Clínicas da UNICAMPCampinasBrazil
  3. 3.Clinique de Recherche en Santé de la FemmeQuébec CityCanada
  4. 4.Hospital TenonParisFrance
  5. 5.Johannes Gutenberg UniversityMainzGermany
  6. 6.Hospital Colle Della MaddalenaTorinoItaly
  7. 7.Hospital Universitario de SaltilloSaltilloMexico
  8. 8.Torre Hospital Auxilio MutuoSan JuanPuerto Rico
  9. 9.Lilly Research LaboratoriesIndianapolisUSA

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