Tolerability and efficacy of duloxetine in a nontrial situation

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.