title: Tolerability and efficacy of duloxetine in a nontrial situation.
abstract: OBJECTIVE
  To assess the tolerability and efficacy of duloxetine in a nontrial situation.
  
  
  METHODS
  Prospective observational study.
  
  
  METHODS
  Urogynaecology Unit, District General Hospital, UK.
  
  
  METHODS
  Two hundred and twenty-two women with a diagnosis of urodynamic stress incontinence (USI) or mixed USI and detrusor overactivity (DOA) took duloxetine for 4 weeks.
  
  
  METHODS
  The results of therapy were assessed with a Patient Global Impression of Improvement (PGI-I) questionnaire. One hundred and forty-eight (67%) women were initially treated with 40 mg twice a day, 67 (30%) women were treated with an escalating dose initially at 20 mg twice a day increasing to 40 mg twice a day after 2 weeks and seven (3%) women were started on a dose of 20 mg twice a day which they continued.
  
  
  METHODS
  Discontinuation rates and PGI-I scores.
  
  
  RESULTS
  Overall 146/222 (66%) women discontinued therapy due to adverse effects or lack of efficacy. Significantly more women starting on the 40 mg twice a day dose stopped due to adverse effects when compared with the escalating dose (P < 0.025). Of the women who tolerated therapy, 80 out of 120 (67%) had a PGI-I score indicating an improvement. However, the overall rate of improvement was 37%. PGI-I scores and discontinuation rates were not significantly different between the group with USI and the group with mixed USI and DOA (P > 0.05).
  
  
  CONCLUSIONS
  In a nontrial situation duloxetine is poorly tolerated. Introducing an escalating dose may improve tolerability. A similar number of women with USI and mixed incontinence had a PGI-I score indicating improvement.
authors.affiliation: Department of Obstetrics and Gynaecology, Medway Maritime Hospital, Gillingham, Kent, UK. jraduckett@hotmail.com
authors.forename: J R A
authors.initials: JR
authors.lastname: Duckett
authors.forename: M
authors.initials: M
authors.lastname: Vella
authors.forename: G
authors.initials: G
authors.lastname: Kavalakuntla
authors.forename: M
authors.initials: M
authors.lastname: Basu
mesh_terms: D004305:Dose-Response Relationship, Drug; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D014550:Urinary Incontinence, Stress / Q000188:drug therapy*; D028761:Withholding Treatment
chemical_list: D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes