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Duloxetine versus placebo for the treatment of women with stress predominant urinary incontinence in Taiwan: a double-blind, randomized, placebo-controlled trial.

Lin AT, Sun MJ, Tai HL, Chuang YC, Huang ST, Wang N, Zhao YD, Beyrer J, Wulster-Radcliffe M, Levine L, Chang C, Viktrup L - BMC Urol (2008)

Bottom Line: Decrease in IEF was significantly greater in duloxetine-treated than placebo-treated women (69.98% vs 42.56%, P < .001).Discontinuations due to adverse events were significantly greater for duloxetine-treated than placebo-treated women (26.7% vs 6.6%; P = .003).Data provide evidence for the safety and efficacy of duloxetine for the treatment for Taiwanese women with SUI.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Urology, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan. lintl@vghtpe.gov.tw

ABSTRACT

Background: This manuscript compares the efficacy and safety of duloxetine with placebo in Taiwanese women with SUI.

Methods: Taiwanese women with SUI were were randomly assigned to placebo (n = 61) or duloxetine 80 mg/day (n = 60) in this double-blind, 8-week, placebo-controlled study. Outcome variables included: incontinence episode frequency (IEF), Incontinence Quality of Life questionnaire (I-QOL) scores, and Patient Global Impression of Improvement rating (PGI-I).

Results: Decrease in IEF was significantly greater in duloxetine-treated than placebo-treated women (69.98% vs 42.56%, P < .001). No treatment differences in I-QOL scores were significant. There were significant differences in PGI-I rating. Treatment-emergent adverse events (TEAEs) were experienced by more duloxetine-treated than placebo-treated women (80.0% vs 44.3%; P < .001). Discontinuations due to adverse events were significantly greater for duloxetine-treated than placebo-treated women (26.7% vs 6.6%; P = .003).

Conclusion: Data provide evidence for the safety and efficacy of duloxetine for the treatment for Taiwanese women with SUI.

Trial registration: ClinicalTrials.gov Identifier: NCT00475358.

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Related in: MedlinePlus

Study design and the timing of acquisition of urinary diary and quality of life measurements reported.
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Figure 1: Study design and the timing of acquisition of urinary diary and quality of life measurements reported.

Mentions: The study design and timing of acquisition of diaries and other variables are depicted in Figure 1. After a 2-week, no drug, lead-in period, women were randomized to 80 mg duloxetine (40 mg twice daily) or placebo for 8 weeks with post-randomization evaluation every 4 weeks. The treatment phase of the core registration trials was 12 weeks; however, the majority of the these adverse events emerged within the first 4 weeks and the number of duloxetine responders (≥ 50% reduction in median percent incontinence episode frequency [IEF]) did not change significantly after 4 weeks post-randomization. An 8-week trial was therefore considered sufficient.


Duloxetine versus placebo for the treatment of women with stress predominant urinary incontinence in Taiwan: a double-blind, randomized, placebo-controlled trial.

Lin AT, Sun MJ, Tai HL, Chuang YC, Huang ST, Wang N, Zhao YD, Beyrer J, Wulster-Radcliffe M, Levine L, Chang C, Viktrup L - BMC Urol (2008)

Study design and the timing of acquisition of urinary diary and quality of life measurements reported.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2266773&req=5

Figure 1: Study design and the timing of acquisition of urinary diary and quality of life measurements reported.
Mentions: The study design and timing of acquisition of diaries and other variables are depicted in Figure 1. After a 2-week, no drug, lead-in period, women were randomized to 80 mg duloxetine (40 mg twice daily) or placebo for 8 weeks with post-randomization evaluation every 4 weeks. The treatment phase of the core registration trials was 12 weeks; however, the majority of the these adverse events emerged within the first 4 weeks and the number of duloxetine responders (≥ 50% reduction in median percent incontinence episode frequency [IEF]) did not change significantly after 4 weeks post-randomization. An 8-week trial was therefore considered sufficient.

Bottom Line: Decrease in IEF was significantly greater in duloxetine-treated than placebo-treated women (69.98% vs 42.56%, P < .001).Discontinuations due to adverse events were significantly greater for duloxetine-treated than placebo-treated women (26.7% vs 6.6%; P = .003).Data provide evidence for the safety and efficacy of duloxetine for the treatment for Taiwanese women with SUI.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Urology, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan. lintl@vghtpe.gov.tw

ABSTRACT

Background: This manuscript compares the efficacy and safety of duloxetine with placebo in Taiwanese women with SUI.

Methods: Taiwanese women with SUI were were randomly assigned to placebo (n = 61) or duloxetine 80 mg/day (n = 60) in this double-blind, 8-week, placebo-controlled study. Outcome variables included: incontinence episode frequency (IEF), Incontinence Quality of Life questionnaire (I-QOL) scores, and Patient Global Impression of Improvement rating (PGI-I).

Results: Decrease in IEF was significantly greater in duloxetine-treated than placebo-treated women (69.98% vs 42.56%, P < .001). No treatment differences in I-QOL scores were significant. There were significant differences in PGI-I rating. Treatment-emergent adverse events (TEAEs) were experienced by more duloxetine-treated than placebo-treated women (80.0% vs 44.3%; P < .001). Discontinuations due to adverse events were significantly greater for duloxetine-treated than placebo-treated women (26.7% vs 6.6%; P = .003).

Conclusion: Data provide evidence for the safety and efficacy of duloxetine for the treatment for Taiwanese women with SUI.

Trial registration: ClinicalTrials.gov Identifier: NCT00475358.

Show MeSH
Related in: MedlinePlus