Clinical efficacy and tolerability of extended-release tolterodine and
immediate-release oxybutynin in Japanese and Korean patients with an overactive
bladder: a randomized, placebo-controlled trial.
Author(s): Homma Y(1), Paick JS, Lee JG, Kawabe K; Japanese and Korean Tolterodine Study
Group.
Affiliation(s): Author information:
(1)Department of Urology, Tokyo University, Tokyo, Japan. homma-uro@umin.ac.jp
Publication date & source: 2003, BJU Int. , 92(7):741-7
OBJECTIVE: To compare extended-release (ER) tolterodine and immediate-release
(IR) oxybutynin with placebo in Japanese and Korean patients with an overactive
bladder (OAB).
PATIENTS AND METHODS: Men and women aged >or= 20 years with symptoms of urinary
urgency, urinary frequency (>or= 8 micturitions/24 h), urge incontinence (>or= 5
episodes/week) and symptoms of OAB for >or= 6 months were randomized to
double-blind treatment with tolterodine ER 4 mg once daily, oxybutynin IR 3 mg
three times daily or placebo for 12 weeks. Efficacy assessments included changes
from baseline in numbers of incontinence episodes per week, voids/24 h and mean
volume voided/void. Patient perceptions of bladder condition, urgency and
treatment benefit were also assessed.
RESULTS: In all, 608 patients were randomized to treatment with tolterodine
(240), oxybutynin (246) or placebo (122). More patients prematurely withdrew on
oxybutynin (23%) than with tolterodine (10.4%) or placebo (16.4%). After 12 weeks
of treatment, the median number of incontinence episodes/week was reduced
significantly more in the tolterodine (79%; P= 0.0027) and oxybutynin groups
(76.5%; P= 0.0168) than on placebo (46.4%). There were also significantly greater
improvements in the number of voids/24 h and volume voided/void with tolterodine
and oxybutynin than with placebo. More patients in the tolterodine and oxybutynin
than in the placebo groups reported improvements in perceived bladder condition,
ability to hold urine and treatment benefit. Patients treated with oxybutynin
reported more adverse events than those treated with tolterodine or placebo. Dry
mouth was significantly more common with oxybutynin than with tolterodine (53.7%
vs. 33.5%; P < 0.001), and occurred in 9.8% of placebo patients.
CONCLUSION: Tolterodine ER has similar efficacy but is better tolerated than
oxybutynin IR in Japanese and Korean patients with OAB.
Erratum in
BJU Int. 2004 May;93(7):1135.
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