Lars Viktrup1, Ilker Yalcin. 1. Duloxetine Urinary Incontinence Study Group, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. viktrupla@lilly.com
Abstract
OBJECTIVE: To identify poor responders, we evaluated the impact of demographic characteristics and comorbidities on efficacy using an integrated database including data from four large randomized controlled trials. Duloxetine has been shown to be effective in women with stress urinary incontinence (SUI). STUDY DESIGN: A total of 1913 women 22-83 years of age with predominant SUI (diagnosed using a validated clinical algorithm) were randomly assigned to receive placebo (n = 955) or duloxetine (n = 958) for 12 weeks. Efficacy outcome variables included a weekly incontinence episodes frequency (IEF) from patient-completed diaries, the Incontinence Quality-of-Life (I-QOL) questionnaire score, and a Patient Global Impression of Improvement rating. Subgroups selected a priori included: ethnicity, age, body mass index (BMI), chronic lung disease, hypoestrogenism, diabetes mellitus, and depression. For safety comparisons, adverse events were compared across age and ethnicity subgroups. RESULTS:Reduction in IEF was minimal and not significantly different between duloxetine and placebo in women with chronic lung disease. The decrease in IEF for women > or =65 years of age was slightly diminished for duloxetine and placebo groups, but the treatment differences were maintained. There was a significantly different I-QOL improvement by BMI subgroup, with greater increases in scores associated with a higher BMI (>28 kg/m2). There were no other notable subgroup impacts on efficacy. CONCLUSIONS: With the possible exception of chronic lung disease, no characteristic was identified that predicted a lack of treatment response with duloxetine in the treatment of women with SUI. Elderly patients may experience lower response rates to duloxetine presumably due to age related changes in the lower urinary tract.
RCT Entities:
OBJECTIVE: To identify poor responders, we evaluated the impact of demographic characteristics and comorbidities on efficacy using an integrated database including data from four large randomized controlled trials. Duloxetine has been shown to be effective in women with stress urinary incontinence (SUI). STUDY DESIGN: A total of 1913 women 22-83 years of age with predominant SUI (diagnosed using a validated clinical algorithm) were randomly assigned to receive placebo (n = 955) or duloxetine (n = 958) for 12 weeks. Efficacy outcome variables included a weekly incontinence episodes frequency (IEF) from patient-completed diaries, the Incontinence Quality-of-Life (I-QOL) questionnaire score, and a Patient Global Impression of Improvement rating. Subgroups selected a priori included: ethnicity, age, body mass index (BMI), chronic lung disease, hypoestrogenism, diabetes mellitus, and depression. For safety comparisons, adverse events were compared across age and ethnicity subgroups. RESULTS: Reduction in IEF was minimal and not significantly different between duloxetine and placebo in women with chronic lung disease. The decrease in IEF for women > or =65 years of age was slightly diminished for duloxetine and placebo groups, but the treatment differences were maintained. There was a significantly different I-QOL improvement by BMI subgroup, with greater increases in scores associated with a higher BMI (>28 kg/m2). There were no other notable subgroup impacts on efficacy. CONCLUSIONS: With the possible exception of chronic lung disease, no characteristic was identified that predicted a lack of treatment response with duloxetine in the treatment of women with SUI. Elderly patients may experience lower response rates to duloxetine presumably due to age related changes in the lower urinary tract.