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, J G Lee, 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, J G Lee

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 >or= 8 voids per 24 h and episodes of urgency or urgency incontinence >or= 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.

Trial registration: ClinicalTrials.gov NCT00189800.

Figures

Figure 1
Figure 1
Patient disposition
Figure 2
Figure 2
(A) Changes in the mean daily micturition frequency. (B) The mean micturition volume per voiding (ml). (C) The mean daily urgency incontinence frequency. (D) The mean daily number of urgency episodes. (E) The mean number of nocturia episodes

References

    1. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology in lower urinary tract function: report from the Standardisation Sub-Committee of the International Continence Society. Urology. 2003;61:37–49.
    1. Milsom I, Stewart W, Thuroff J. The prevalence of overactive bladder. Am J Manag Care. 2000;11(Suppl.):S565–73.
    1. Chapple CR. Muscarinic receptor antagonists in the treatment of overactive bladder. Urology. 2000;55(Suppl. 5A):33–46.
    1. Appell RA, Sand P, Dmochowski R, et al. Overactive Bladder: Judging Effective Control and Treatment Study Group Prospective randomized controlled trial of extended-release oxybutynin chloride and tolterodine tartrate in the treatment of overactive bladder: results of the OBJECT Study. Mayo Clin Proc. 2001;76:358–63.
    1. Kelleher CJ, Cardozo LD, Khullar V, et al. A medium-term analysis of the subjective efficacy of treatment for women with detrusor instability and low bladder compliance. Br J Obstet Gynaecol. 1997;104:988–93.
    1. Ikeda K, Kobayashi S, Suzuki M, et al. M3 receptor antagonism by the novel antimuscarinic agent solifenacin in the urinary bladder and salivary gland. Naun-Schmied Arch Pharmacol. 2002;366:97–103.
    1. Chapple CR, Arano P, Bosch JL, et al. Solifenacin appears effective and well tolerated in patients with symptomatic idiopathic detrusor overactivity in a placebo- and tolterodine-controlled phase 2 dose-finding study. BJU Int. 2004;93:71–7.
    1. Cardozo L. Randomized, double-blind placebo-controlled trial of once-daily antimuscarinic agent solifenacin succinate in patients with overactive bladder. J Urol. 2004;172:1919–24.
    1. Chapple CR, Rechberger T, Al-Shukri S, et al. Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder. BJU Int. 2004;93:303–10.
    1. Chapple CR, Martinez-Garcia R, Selvaggi L, et al. A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial. Eur Urol. 2005;48:464–70.
    1. Chapple CR, Fianu-Jonsson A, Indig M, et al. Treatment outcomes in the STAR study: a subanalysis of solifenacin 5 mg and tolterodine ER 4 mg. Eur Urol. 2007;52:1195–203.
    1. Haab F, Cardozo L, Chapple C, et al. Long-term open-label solifenacin treatment associated with persistence with therapy in patients with overactive bladder syndrome. Eur Urol. 2005;47:376–84.
    1. Kelleher CJ, Cardozo LD, Khullar V, et al. A new questionnaire to assess the quality of life of urinary incontinence in women. Br J Obstet Gynecol. 1997;104:1374–9.
    1. Oh SJ, Park HG, Paick SH, et al. Translation and linguistic validation of Korean version of the King’s Health Questionnaire instrument. The Korean Journal of Urology. 2005;46:438–50.
    1. Herbison P, Hay-Smith J, Ellis G, et al. Effectiveness of anticholinergic drugs compared with placebo in the treatment of overactive bladder: systematic review. BMJ. 2003;326:841–8.
    1. Landis RJ, Kaplan S, Swift S, et al. Efficacy of antimuscarinic therapy for overactive bladder with varying degree of incontinence severity. J Urol. 2004;171:752–6.
    1. Yamaguchi O, Marui E, Kakizaki H, et al. Randomized, double-blind, placebo- and propiverine-controlled trial of the once-daily antimuscarinic agent solifenacin in Japanese patients with overactive bladder. BJU Int. 2007;100:579–87.
    1. Versi E, Appell R, Mobley D, et al. Dry mouth with conventional and controlled-release oxybutynin in urinary incontinence. Obstet Gynecol. 2000;95:718–21.
    1. Diokno AC, Appell RA, Sand PK, et al. for the OPERA Trial Prospective, randomized, double-blind study of the efficacy and tolerability of the extended release formulations of oxybutynin and tolterodine for overactive bladder: results of the OPERA Trial. Mayo Clin Proc. 2003;78:687–95.
    1. Hatanaka T, Ukai M, Ohtake A, et al. In Vitro Tissue Selectivity Profile of Solifenacin Succinate (YM905) for Urinary Bladder Over Salivary Gland in Rats and Monkeys. Florence: International Continence Society Meeting; 2003. abstract 3.
    1. Smulders RA, Van Alphen WW, Visser JN, et al. Multiple Dosing With YM905, a Novel, Bladder-Selective Antimuscarinic, in Healthy men: Safety, Tolerability, and Pharmacokinetics. Heidelberg: International Continence Society Meeting; 2002. abstract 439.
    1. Kelleher CJ, Cardozo L, Chapple CR, et al. Improved quality of life in patients with overactive bladder symptoms treated with solifenacin. BJU Int. 2005;95:81–5.

Source: PubMed

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