Tolerability and efficacy of duloxetine in a nontrial situation.
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.
Duckett
J R A
JR
Department of Obstetrics and Gynaecology, Medway Maritime Hospital, Gillingham, Kent, UK. jraduckett@hotmail.com
Vella
M
M
Kavalakuntla
G
G
Basu
M
M
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
D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes