Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: A randomised, prospective, double-blind, multicentre study

M. S. Choo, J. Z. Lee, J. B. Lee, Y. H. Kim, H. C. Jung, K. S. Lee, J. C. Kim, J. T. Seo, J. S. Paick, H. J. Kim, Y. G. Na, Jeong Gu Lee

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Abstract

Purpose: We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder (OAB) in Korean patients. Materials and methods: The study was randomised, double-blind, tolterodine-controlled trial in Korea. Patients had average frequency of ≥ 8 voids per 24 h and episodes of urgency or urgency incontinence ≥ 3 during 3-day voiding diary period. Patients were randomised to 12-week double-blind treatment with either tolterodine immediate release (IR) 2 mg twice daily (TOL4) or solifenacin 5 mg (SOL5) or 10 mg (SOL10) once daily. The outcome measure was mean change in daily micturition frequency, volume, daily frequency of urgency incontinence, urgency and nocturia from baseline to week 12. Quality of life was assessed using the King's Health Questionnaire. Results: A total of 357 were randomised and 329 were evaluated for efficacy. All voiding parameters recorded in micturition diary improved after treatment in all three groups. Mean changes in volume voided were 19.30 ml (26.69%) in TOL4, 30.37 ml (25.89%) in SOL5 and 37.12 ml (33.36%) in SOL10 group (p = 0.03). Speed of onset of SOL10 efficacy on urgency incontinence was faster than that of SOL5 and TOL4. Quality of life improved in all three groups. Dry mouth was the most common adverse event; its incidence was the lowest in SOL5 group (7.63%, compared with 19.49% and 18.64% in SOL10 and TOL4 groups respectively). Conclusions: Solifenacin succinate 5 and 10 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg. Solifenacin 5 mg is a recommended starting dose in Korean patients with OAB.

Original languageEnglish
Pages (from-to)1675-1683
Number of pages9
JournalInternational Journal of Clinical Practice
Volume62
Issue number11
DOIs
Publication statusPublished - 2008 Nov 1

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Overactive Urinary Bladder
Double-Blind Method
Multicenter Studies
Safety
Urination
Quality of Life
Nocturia
Korea
Solifenacin Succinate
Mouth
Therapeutics
Outcome Assessment (Health Care)
Tolterodine Tartrate
Incidence
Health

ASJC Scopus subject areas

  • Medicine(all)

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Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder : A randomised, prospective, double-blind, multicentre study. / Choo, M. S.; Lee, J. Z.; Lee, J. B.; Kim, Y. H.; Jung, H. C.; Lee, K. S.; Kim, J. C.; Seo, J. T.; Paick, J. S.; Kim, H. J.; Na, Y. G.; Lee, Jeong Gu.

In: International Journal of Clinical Practice, Vol. 62, No. 11, 01.11.2008, p. 1675-1683.

Research output: Contribution to journalArticle

Choo, M. S. ; Lee, J. Z. ; Lee, J. B. ; Kim, Y. H. ; Jung, H. C. ; Lee, K. S. ; Kim, J. C. ; Seo, J. T. ; Paick, J. S. ; Kim, H. J. ; Na, Y. G. ; Lee, Jeong Gu. / Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder : A randomised, prospective, double-blind, multicentre study. In: International Journal of Clinical Practice. 2008 ; Vol. 62, No. 11. pp. 1675-1683.
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abstract = "Purpose: We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder (OAB) in Korean patients. Materials and methods: The study was randomised, double-blind, tolterodine-controlled trial in Korea. Patients had average frequency of ≥ 8 voids per 24 h and episodes of urgency or urgency incontinence ≥ 3 during 3-day voiding diary period. Patients were randomised to 12-week double-blind treatment with either tolterodine immediate release (IR) 2 mg twice daily (TOL4) or solifenacin 5 mg (SOL5) or 10 mg (SOL10) once daily. The outcome measure was mean change in daily micturition frequency, volume, daily frequency of urgency incontinence, urgency and nocturia from baseline to week 12. Quality of life was assessed using the King's Health Questionnaire. Results: A total of 357 were randomised and 329 were evaluated for efficacy. All voiding parameters recorded in micturition diary improved after treatment in all three groups. Mean changes in volume voided were 19.30 ml (26.69{\%}) in TOL4, 30.37 ml (25.89{\%}) in SOL5 and 37.12 ml (33.36{\%}) in SOL10 group (p = 0.03). Speed of onset of SOL10 efficacy on urgency incontinence was faster than that of SOL5 and TOL4. Quality of life improved in all three groups. Dry mouth was the most common adverse event; its incidence was the lowest in SOL5 group (7.63{\%}, compared with 19.49{\%} and 18.64{\%} in SOL10 and TOL4 groups respectively). Conclusions: Solifenacin succinate 5 and 10 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg. Solifenacin 5 mg is a recommended starting dose in Korean patients with OAB.",
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T1 - Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder

T2 - A randomised, prospective, double-blind, multicentre study

AU - Choo, M. S.

AU - Lee, J. Z.

AU - Lee, J. B.

AU - Kim, Y. H.

AU - Jung, H. C.

AU - Lee, K. S.

AU - Kim, J. C.

AU - Seo, J. T.

AU - Paick, J. S.

AU - Kim, H. J.

AU - Na, Y. G.

AU - Lee, Jeong Gu

PY - 2008/11/1

Y1 - 2008/11/1

N2 - Purpose: We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder (OAB) in Korean patients. Materials and methods: The study was randomised, double-blind, tolterodine-controlled trial in Korea. Patients had average frequency of ≥ 8 voids per 24 h and episodes of urgency or urgency incontinence ≥ 3 during 3-day voiding diary period. Patients were randomised to 12-week double-blind treatment with either tolterodine immediate release (IR) 2 mg twice daily (TOL4) or solifenacin 5 mg (SOL5) or 10 mg (SOL10) once daily. The outcome measure was mean change in daily micturition frequency, volume, daily frequency of urgency incontinence, urgency and nocturia from baseline to week 12. Quality of life was assessed using the King's Health Questionnaire. Results: A total of 357 were randomised and 329 were evaluated for efficacy. All voiding parameters recorded in micturition diary improved after treatment in all three groups. Mean changes in volume voided were 19.30 ml (26.69%) in TOL4, 30.37 ml (25.89%) in SOL5 and 37.12 ml (33.36%) in SOL10 group (p = 0.03). Speed of onset of SOL10 efficacy on urgency incontinence was faster than that of SOL5 and TOL4. Quality of life improved in all three groups. Dry mouth was the most common adverse event; its incidence was the lowest in SOL5 group (7.63%, compared with 19.49% and 18.64% in SOL10 and TOL4 groups respectively). Conclusions: Solifenacin succinate 5 and 10 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg. Solifenacin 5 mg is a recommended starting dose in Korean patients with OAB.

AB - Purpose: We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder (OAB) in Korean patients. Materials and methods: The study was randomised, double-blind, tolterodine-controlled trial in Korea. Patients had average frequency of ≥ 8 voids per 24 h and episodes of urgency or urgency incontinence ≥ 3 during 3-day voiding diary period. Patients were randomised to 12-week double-blind treatment with either tolterodine immediate release (IR) 2 mg twice daily (TOL4) or solifenacin 5 mg (SOL5) or 10 mg (SOL10) once daily. The outcome measure was mean change in daily micturition frequency, volume, daily frequency of urgency incontinence, urgency and nocturia from baseline to week 12. Quality of life was assessed using the King's Health Questionnaire. Results: A total of 357 were randomised and 329 were evaluated for efficacy. All voiding parameters recorded in micturition diary improved after treatment in all three groups. Mean changes in volume voided were 19.30 ml (26.69%) in TOL4, 30.37 ml (25.89%) in SOL5 and 37.12 ml (33.36%) in SOL10 group (p = 0.03). Speed of onset of SOL10 efficacy on urgency incontinence was faster than that of SOL5 and TOL4. Quality of life improved in all three groups. Dry mouth was the most common adverse event; its incidence was the lowest in SOL5 group (7.63%, compared with 19.49% and 18.64% in SOL10 and TOL4 groups respectively). Conclusions: Solifenacin succinate 5 and 10 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg. Solifenacin 5 mg is a recommended starting dose in Korean patients with OAB.

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