Neurourology and urodynamics · 2012
Efficacy and tolerability of fesoterodine versus tolterodine in older and younger subjects with overactive bladder: a post hoc, pooled analysis from two placebo-controlled trials.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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DuBeau Catherine E, Morrow Jon D, Kraus Stephen R, Creanga Dana, Bavendam Tamara
Аннотация
AIMS: To assess the efficacy and tolerability of fesoterodine 8 mg versus tolterodine extended release (ER) 4 mg in subjects with overactive bladder (OAB) stratified by age (<65, 65-74, and ≥75 years).
METHODS: This was a post hoc analysis of data from two double-blind trials. Subjects reporting ≥1 urgency urinary incontinence (UUI) episode and ≥8 micturitions/24 hr at baseline were randomized to fesoterodine (4 mg for 1 week, 8 mg for 11 weeks), tolterodine ER 4 mg, or placebo. Subjects completed 3-day bladder diaries, Urgency Perception Scale (UPS), Patient Perception of Bladder Condition (PPBC), and OAB questionnaire (OAB-q) at baseline and week 12. The primary endpoint in both studies was change from baseline to week 12 in UUI episodes.
RESULTS: Among subjects <65 years (n = 2,670), improvements in UUI episodes, micturitions, urgency episodes, severe urgency episodes, frequency-urgency sum, UPS, PPBC, and all OAB-q scales and domains were significantly greater with fesoterodine versus tolterodine ER, and diary-dry rates were significantly higher. Among subjects 65-74 years (n = 990), improvements in mean voided volume per void, PPBC, and OAB-q Symptom Bother and Coping were significantly greater with fesoterodine versus tolterodine ER. Among subjects aged ≥75 years (n = 448), improvements in urgency episodes, severe urgency episodes, frequency-urgency sum, UPS, and OAB-q Symptom Bother were significantly greater with fesoterodine versus tolterodine ER. Both active treatments produced significant improvements in most outcomes versus placebo across age groups. Adverse event rates were similar among age groups.
CONCLUSIONS: Fesoterodine 8 mg consistently improved several OAB-related variables versus tolterodine ER 4 mg in subjects aged <65, 65-74, and ≥75 years, with some differences reaching statistical significance, and was generally well tolerated.
METHODS: This was a post hoc analysis of data from two double-blind trials. Subjects reporting ≥1 urgency urinary incontinence (UUI) episode and ≥8 micturitions/24 hr at baseline were randomized to fesoterodine (4 mg for 1 week, 8 mg for 11 weeks), tolterodine ER 4 mg, or placebo. Subjects completed 3-day bladder diaries, Urgency Perception Scale (UPS), Patient Perception of Bladder Condition (PPBC), and OAB questionnaire (OAB-q) at baseline and week 12. The primary endpoint in both studies was change from baseline to week 12 in UUI episodes.
RESULTS: Among subjects <65 years (n = 2,670), improvements in UUI episodes, micturitions, urgency episodes, severe urgency episodes, frequency-urgency sum, UPS, PPBC, and all OAB-q scales and domains were significantly greater with fesoterodine versus tolterodine ER, and diary-dry rates were significantly higher. Among subjects 65-74 years (n = 990), improvements in mean voided volume per void, PPBC, and OAB-q Symptom Bother and Coping were significantly greater with fesoterodine versus tolterodine ER. Among subjects aged ≥75 years (n = 448), improvements in urgency episodes, severe urgency episodes, frequency-urgency sum, UPS, and OAB-q Symptom Bother were significantly greater with fesoterodine versus tolterodine ER. Both active treatments produced significant improvements in most outcomes versus placebo across age groups. Adverse event rates were similar among age groups.
CONCLUSIONS: Fesoterodine 8 mg consistently improved several OAB-related variables versus tolterodine ER 4 mg in subjects aged <65, 65-74, and ≥75 years, with some differences reaching statistical significance, and was generally well tolerated.
Предметные рубрики MeSH
AdolescentAdultAge FactorsAgedAged, 80 and overBenzhydryl CompoundsCresolsFemaleHumansMaleMiddle AgedMuscarinic AntagonistsPhenylpropanolamineQuality of LifeRandomized Controlled Trials as TopicSurveys and QuestionnairesTime FactorsTolterodine TartrateTreatment OutcomeUrinary BladderUrinary Bladder, OveractiveUrinary Incontinence, UrgeUrinationYoung Adult