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

Y. Homma, J. S. Paick, Jeong Gu Lee, K. Kawabe

Research output: Contribution to journalArticle

100 Citations (Scopus)

Abstract

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 ≥ 20 years with symptoms of urinary urgency, urinary frequency (≥ 8 micturitions/24 h), urge incontinence (≥ 5 episodes/week) and symptoms of OAB for ≥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.

Original languageEnglish
Pages (from-to)741-747
Number of pages7
JournalBJU International
Volume92
Issue number7
DOIs
Publication statusPublished - 2003 Nov 1

Fingerprint

Overactive Urinary Bladder
Randomized Controlled Trials
Placebos
Urinary Bladder
Tolterodine Tartrate
oxybutynin
Urge Urinary Incontinence
Therapeutics
Urination
Mouth
Urine

Keywords

  • Efficacy
  • Overactive bladder
  • Oxybutynin
  • Placebo
  • Side effects
  • Tolterodine
  • Trial

ASJC Scopus subject areas

  • Urology

Cite this

@article{ac8ce2862bd44694b8df50d5d32f9221,
title = "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",
abstract = "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 ≥ 20 years with symptoms of urinary urgency, urinary frequency (≥ 8 micturitions/24 h), urge incontinence (≥ 5 episodes/week) and symptoms of OAB for ≥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.",
keywords = "Efficacy, Overactive bladder, Oxybutynin, Placebo, Side effects, Tolterodine, Trial",
author = "Y. Homma and Paick, {J. S.} and Lee, {Jeong Gu} and K. Kawabe",
year = "2003",
month = "11",
day = "1",
doi = "10.1046/j.1464-410X.2003.04468.x",
language = "English",
volume = "92",
pages = "741--747",
journal = "BJU International",
issn = "1464-4096",
publisher = "Wiley-Blackwell",
number = "7",

}

TY - JOUR

T1 - Clinical efficacy and tolerability of extended-release tolterodine and immediate-release oxybutynin in Japanese and Korean patients with an overactive bladder

T2 - A randomized, placebo-controlled trial

AU - Homma, Y.

AU - Paick, J. S.

AU - Lee, Jeong Gu

AU - Kawabe, K.

PY - 2003/11/1

Y1 - 2003/11/1

N2 - 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 ≥ 20 years with symptoms of urinary urgency, urinary frequency (≥ 8 micturitions/24 h), urge incontinence (≥ 5 episodes/week) and symptoms of OAB for ≥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.

AB - 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 ≥ 20 years with symptoms of urinary urgency, urinary frequency (≥ 8 micturitions/24 h), urge incontinence (≥ 5 episodes/week) and symptoms of OAB for ≥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.

KW - Efficacy

KW - Overactive bladder

KW - Oxybutynin

KW - Placebo

KW - Side effects

KW - Tolterodine

KW - Trial

UR - http://www.scopus.com/inward/record.url?scp=0344395127&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0344395127&partnerID=8YFLogxK

U2 - 10.1046/j.1464-410X.2003.04468.x

DO - 10.1046/j.1464-410X.2003.04468.x

M3 - Article

VL - 92

SP - 741

EP - 747

JO - BJU International

JF - BJU International

SN - 1464-4096

IS - 7

ER -