IngentaConnect Onset of efficacy of tolterodine extended release in patients wit...

Abstract:

Objective: To assess the onset of efficacy of tolterodine extended release (ER) in patients with overactive bladder (OAB).

Research design and methods: A post hoc analysis was conducted using 3-day bladder diary data from a 12-week, multicenter, prospective, open-label study of tolterodine ER (4 mg qd) in patients (aged ≥ 18 years) with urinary frequency (≥ 8 micturitions/24 h) and urgency (strong and sudden desire to urinate) with or without urgency urinary incontinence (UUI).

Main outcome measures: Changes in micturition frequency, urgency, and UUI episodes/24 h were evaluated for treatment Days 5, 6, and 7. The percentages of patients who achieved normal micturition frequency (< 8/day) and 50%, 70%, 90%, and 100% reductions in urgency and UUI episodes (i.e., responders) were determined at Days 5, 6, and 7. Week 12 data are presented as a referent for the magnitude of treatment efficacy during Week 1.

Results: This analysis included 698 patients. On Day 5, there were significant reductions in all three diary variables (all p < 0.0001), and improvements continued on Days 6 and 7. More than half of the patients reported ≥ 50% reductions in urgency or UUI episodes on Day 5. Responder rates for all three symptoms increased through Week 12.

Conclusions: Patients with OAB experienced significant reductions in OAB symptoms as early as Day 5 of treatment with tolterodine ER. These data extend the findings of a previous analysis, in which all 3 days of the bladder diary were pooled, that demonstrated improvements in micturition frequency, urgency episodes, and UUI episodes in patients with OAB after 1 week of treatment with tolterodine ER. Limitations are that efficacy was not assessed before Day 5, this was a post hoc analysis, and the study was not placebo-controlled.

Keywords: BLADDER; TOLTERODINE; URINARY INCONTINENCE; URINARY TRACT

Document Type: Research article

DOI: 10.1185/030079907X178801

Affiliations: 1: University of Medicine and Dentistry of New Jersey, Stratford, NJ, USA 2: University of Texas Health Science Center at San Antonio, San Antonio, TX, USA 3: Pfizer Inc, New York, NY, USA

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Onset of efficacy of tolterodine extended release in patients with overactive bladder