Efficacy of fesoterodine compared with extended‐release tolterodine in men and women with overactive bladder

Medientyp: E-Artikel
Titel: Efficacy of fesoterodine compared with extended‐release tolterodine in men and women with overactive bladder
Beteiligte: Ginsberg, David; Schneider, Tim; Kelleher, Con; Van Kerrebroeck, Philip; Swift, Steven; Creanga, Dana; Martire, Diane L.
Erschienen: Wiley, 2013
Erschienen in: BJU International
Sprache: Englisch
DOI: 10.1111/bju.12174
ISSN: 1464-4096; 1464-410X
Schlagwörter: Urology
Entstehung:
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Beschreibung: <jats:sec><jats:title>Objective</jats:title><jats:p><jats:list list-type="bullet"> <jats:list-item><jats:p>To assess the efficacy of fesoterodine 8 mg vs extended‐release (<jats:styled-content style="fixed-case">ER</jats:styled-content>) tolterodine 4 mg for overactive bladder (<jats:styled-content style="fixed-case">OAB</jats:styled-content>) symptoms in terms of patient‐reported outcomes in women and in men.</jats:p></jats:list-item> </jats:list></jats:p></jats:sec><jats:sec><jats:title>Subjects and Methods</jats:title><jats:p><jats:list list-type="bullet"> <jats:list-item><jats:p>Pooled data from two 12‐week, randomized, double‐blind, double‐dummy studies were analysed.</jats:p></jats:list-item> <jats:list-item><jats:p>Participants eligible for the studies were ≥18 years old, had self‐reported <jats:styled-content style="fixed-case">OAB</jats:styled-content> symptoms for ≥3 months in 3‐day baseline diaries and had ≥8 micturitions and ≥1 urgency urinary incontinence (<jats:styled-content style="fixed-case">UUI</jats:styled-content>) episode per 24 h.</jats:p></jats:list-item> <jats:list-item><jats:p>Individuals were randomized to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks), <jats:styled-content style="fixed-case">ER</jats:styled-content> tolterodine (4 mg), or placebo.</jats:p></jats:list-item> <jats:list-item><jats:p>Changes from baseline in 3‐day bladder diary variables and scores from the <jats:styled-content style="fixed-case">P</jats:styled-content>atient <jats:styled-content style="fixed-case">P</jats:styled-content>erception of <jats:styled-content style="fixed-case">B</jats:styled-content>ladder <jats:styled-content style="fixed-case">C</jats:styled-content>ondition (<jats:styled-content style="fixed-case">PPBC</jats:styled-content>), <jats:styled-content style="fixed-case">U</jats:styled-content>rgency <jats:styled-content style="fixed-case">P</jats:styled-content>erception <jats:styled-content style="fixed-case">S</jats:styled-content>cale (<jats:styled-content style="fixed-case">UPS</jats:styled-content>), and <jats:styled-content style="fixed-case">O</jats:styled-content>veractive <jats:styled-content style="fixed-case">B</jats:styled-content>ladder <jats:styled-content style="fixed-case">Q</jats:styled-content>uestionnaire (<jats:styled-content style="fixed-case">OAB</jats:styled-content>‐q), were assessed, as was the ‘diary‐dry’ rate (the proportion of subjects with >0 <jats:styled-content style="fixed-case">UUI</jats:styled-content> episodes according to baseline diary and no <jats:styled-content style="fixed-case">UUI</jats:styled-content> episodes according to post‐baseline diary).</jats:p></jats:list-item> <jats:list-item><jats:p>The primary endpoint was the change from baseline to week 12 in UUI episodes.</jats:p></jats:list-item> </jats:list></jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p><jats:list list-type="bullet"> <jats:list-item><jats:p>At week 12, women showed significantly greater improvement with fesoterodine 8 mg (<jats:italic>n</jats:italic> = 1374) than with <jats:styled-content style="fixed-case">ER</jats:styled-content> tolterodine 4 mg (<jats:italic>n</jats:italic> = 1382) and placebo (<jats:italic>n</jats:italic> = 679) in <jats:styled-content style="fixed-case">UUI</jats:styled-content> episodes (primary endpoint), micturition frequency, urgency episodes, and all other diary endpoints (except nocturnal micturitions versus ER tolterodine), and also in scores on the <jats:styled-content style="fixed-case">PPBC</jats:styled-content>, <jats:styled-content style="fixed-case">UPS</jats:styled-content>, and all <jats:styled-content style="fixed-case">OAB</jats:styled-content>‐q scales and domains (all <jats:italic>P</jats:italic> < 0.005).</jats:p></jats:list-item> <jats:list-item><jats:p>Diary‐dry rates in women were significantly greater with fesoterodine (63%) than with tolterodine (57%; <jats:italic>P</jats:italic> = 0.002) or placebo (48%; <jats:italic>P</jats:italic> < 0.0001).</jats:p></jats:list-item> <jats:list-item><jats:p>In men, there were no significant differences in improvement in <jats:styled-content style="fixed-case">UUI</jats:styled-content> episodes between any treatment groups at week 12. Improvements in men were significantly greater with fesoterodine 8 mg (<jats:italic>n</jats:italic> = 265) than with <jats:styled-content style="fixed-case">ER</jats:styled-content> tolterodine (<jats:italic>n</jats:italic> = 275) for severe urgency and the <jats:styled-content style="fixed-case">OAB</jats:styled-content>‐q Symptom Bother domain and were also significantly greater with fesoterodine than with placebo (<jats:italic>n</jats:italic> = 133) for micturition frequency, urgency episodes, severe urgency episodes, <jats:styled-content style="fixed-case">PPBC</jats:styled-content> responses and scores on all <jats:styled-content style="fixed-case">OAB</jats:styled-content>‐q scales and domains at week 12 (all <jats:italic>P</jats:italic> < 0.04).</jats:p></jats:list-item> <jats:list-item><jats:p>The most frequently reported treatment‐emergent adverse events in both genders were dry mouth (women: fesoterodine, 29%; <jats:styled-content style="fixed-case">ER</jats:styled-content> tolterodine, 15%; placebo, 6%; men: fesoterodine, 21%; <jats:styled-content style="fixed-case">ER</jats:styled-content> tolterodine, 13%; placebo, 5%) and constipation (women: fesoterodine, 5%; <jats:styled-content style="fixed-case">ER</jats:styled-content> tolterodine, 4%; placebo, 2%; men: fesoterodine, 5%; <jats:styled-content style="fixed-case">ER</jats:styled-content> tolterodine, 3%; placebo, 1%).</jats:p></jats:list-item> <jats:list-item><jats:p>Urinary retention rates were low in women (fesoterodine, <1%; <jats:styled-content style="fixed-case">ER</jats:styled-content> tolterodine, <1%; placebo, 0%) and men (fesoterodine, 2%; <jats:styled-content style="fixed-case">ER</jats:styled-content> tolterodine <1%; placebo, 2%).</jats:p></jats:list-item> </jats:list></jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p><jats:list list-type="bullet"> <jats:list-item><jats:p>This analysis supports the superiority of fesoterodine 8 mg over <jats:styled-content style="fixed-case">ER</jats:styled-content> tolterodine 4 mg on diary endpoints, including <jats:styled-content style="fixed-case">UUI</jats:styled-content>, symptom bother and health‐related quality of life in women.</jats:p></jats:list-item> <jats:list-item><jats:p>In men, fesoterodine 8 mg was superior to <jats:styled-content style="fixed-case">ER</jats:styled-content> tolterodine 4 mg for improving severe urgency and symptom bother.</jats:p></jats:list-item> </jats:list></jats:p></jats:sec>

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