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Tolerability and efficacy of duloxetine in a nontrial situation
Author(s) -
Duckett JRA,
Vella M,
Kavalakuntla G,
Basu M
Publication year - 2007
Publication title -
bjog: an international journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.157
H-Index - 164
eISSN - 1471-0528
pISSN - 1470-0328
DOI - 10.1111/j.1471-0528.2007.01288.x
Subject(s) - tolerability , duloxetine , discontinuation , medicine , adverse effect , observational study , population , clinical global impression , urology , anesthesia , placebo , alternative medicine , environmental health , pathology
Objective To assess the tolerability and efficacy of duloxetine in a nontrial situation. Design Prospective observational study. Setting Urogynaecology Unit, District General Hospital, UK. Population 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. Main outcome measures 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). Conclusion 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.