Solifenacin, Darifenacin and Trospium for Overactive Bladder: Guidelines, Clinical and Cost-Effectiveness

Title: Solifenacin, Darifenacin and Trospium for Overactive Bladder: Guidelines, Clinical and Cost-Effectiveness

Date: 13 November 2007

Research question:

1. What is the clinical benefit and harm of using solifenacin, darifenacin, or trospium for patients with overactive bladder?

2. What is the cost-effectiveness of using solifenacin, darifenacin, or trospium for patients with overactive bladder?

3. What are the guidelines of using solifenacin, darifenacin, or trospium for patients with overactive bladder?

4. What Canadian and international advisories have been released regarding the use of solifenacin, darifenacin, or trospium for patients with overactive bladder?

Methods:

A limited literature search was conducted on key health technology assessment resources, including PubMed, the Cochrane Library (Issue 4, 2007), University of York Centre for Reviews and Dissemination (CRD) databases, ECRI, EuroScan, international HTA agencies, and a focused Internet search. Results include articles published between 2002 and the present, and are limited to English language publications only. Filters were applied to limit the retrieval to HTA/systematic reviews, guidelines, economic evaluations and clinical studies. Internet links are provided, where available.

Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report.

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Results:

The results are listed below and additional references of interest are included in the attached appendix. No relevant health technology assessments or advisories were identified in the literature search.

Health technology assessments

No literature identified.

Systematic reviews and meta-analyses

1. Roxburgh C, Cook J, Dublin N. Anticholinergic drugs versus other medications for overactive bladder syndrome in adults. Cochrane Database Syst Rev 2007;(3):CD003190. PubMed: PM17636716

2. Nabi G, Cody JD, Ellis G, Herbison P, Hay-Smith J. Anticholinergic drugs versus placebo for overactive bladder syndrome in adults. Cochrane Database Syst Rev 2006;(4):CD003781. PubMed: PM17054185

3. Chapple C, Khullar V, Gabriel Z, Dooley JA. The effects of antimuscarinic treatments in overactive bladder: a systematic review and meta-analysis. Eur Urol 2005;48(1):5-26. PubMed: PM15885877

4. Hay-Smith J, Herbison P, Ellis G, Moore K. Anticholinergic drugs versus placebo for overactive bladder syndrome in adults. Cochrane Database Syst Rev 2002;(3):CD003781. PubMed: PM12137711

Economic analyses and cost information

1. Ko Y, Malone DC, Armstrong EP. Pharmacoeconomic evaluation of antimuscarinic agents for the treatment of overactive bladder. Pharmacotherapy 2006;26(12):1694- 702. PubMed: PM17125433

Randomized controlled trials

1. Chapple C, DuBeau C, Ebinger U, Rekeda L, Viegas A. Darifenacin treatment of patients >or= 65 years with overactive bladder: results of a randomized, controlled, 12- week trial. Curr Med Res Opin 2007;23(10):2347-58. PubMed: PM17706004

2. Staskin D, Sand P, Zinner N, Dmochowski R. Once daily trospium chloride is effective and well tolerated for the treatment of overactive bladder: results from a multicenter phase III trial. J Urol 2007;178(3 Pt 1):978-83. PubMed: PM17632131

3. Yamaguchi O, Marui E, Kakizaki H, Itoh N, Yokota T, Okada 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(3):579- 87. PubMed: PM17669143

Solifenacin, Darifenacin and Trospium for Overactive Bladder 2

4. Hill S, Khullar V, Wyndaele JJ, Lheritier K. Dose response with darifenacin, a novel once-daily M3 selective receptor antagonist for the treatment of overactive bladder: results of a fixed dose study. Int Urogynecol J Pelvic Floor Dysfunct 2006;17(3):239-47. PubMed: PM15999217

5. Rudy D, Cline K, Harris R, Goldberg K, Dmochowski R. Time to onset of improvement in symptoms of overactive bladder using antimuscarinic treatment. BJU Int 2006;97(3):540- 6. PubMed: PM16469022

6. Rudy D, Cline K, Harris R, Goldberg K, Dmochowski R. Multicenter phase III trial studying trospium chloride in patients with overactive bladder. Urology 2006;67(2):275- 80. PubMed: PM16461077

7. Zinner N, Susset J, Gittelman M, Arguinzoniz M, Rekeda L, Haab F. Efficacy, tolerability and safety of darifenacin, an M(3) selective receptor antagonist: an investigation of warning time in patients with OAB. Int J Clin Pract 2006;60(1):119-26. PubMed: PM16409440

8. Chapple CR, Abrams P. Comparison of darifenacin and oxybutynin in patients with overactive bladder: assessment of ambulatory urodynamics and impact on salivary flow. Eur Urol 2005;48(1):102-9. PubMed: PM15936869

9. Lipton RB, Kolodner K, Wesnes K. Assessment of cognitive function of the elderly population: effects of darifenacin. J Urol 2005;173(2):493-8. PubMed: PM15643227

10. Steers W, Corcos J, Foote J, Kralidis G. An investigation of dose titration with darifenacin, an M3-selective receptor antagonist. BJU Int 2005;95(4):580-6. PubMed: PM15705084

11. Zinner N, Tuttle J, Marks L. Efficacy and tolerability of darifenacin, a muscarinic M3 selective receptor antagonist (M3 SRA), compared with oxybutynin in the treatment of patients with overactive bladder. World J Urol 2005;23(4):248-52. PubMed: PM16096831

12. Cardozo L, Lisec M, Millard R, van Vierssen TO, Kuzmin I, Drogendijk TE, et al. Randomized, double-blind placebo controlled trial of the once daily antimuscarinic agent solifenacin succinate in patients with overactive bladder. J Urol 2004;172(5 Pt 1):1919- 24. PubMed: PM15540755

13. Chapple CR, Arano P, Bosch JL, De RD, Kramer AE, Ridder AM. 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(1):71-7. PubMed: PM14678372

14. Chapple CR, Rechberger T, Al-Shukri S, Meffan P, Everaert K, Huang M, 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(3):303-10. PubMed: PM14764127

Solifenacin, Darifenacin and Trospium for Overactive Bladder 3

15. Haab F, Stewart L, Dwyer P. Darifenacin, an M3 selective receptor antagonist, is an effective and well-tolerated once-daily treatment for overactive bladder. Eur Urol 2004;45(4):420-9. PubMed: PM15041104

16. Zinner N, Gittelman M, Harris R, Susset J, Kanelos A, Auerbach S. Trospium chloride improves overactive bladder symptoms: a multicenter phase III trial. J Urol 2004;171(6 Pt 1):2311-5, quiz. PubMed: PM15126811

Observational studies

1. Garely AD, Lucente V, Vapnek J, Smith N. Solifenacin for overactive bladder with incontinence: symptom bother and health-related quality of life outcomes. Ann Pharmacother 2007;41(3):391-8. PubMed: PM17341526

2. Hill S, Elhilali M, Millard RJ, Dwyer PL, Lheritier K, Kawakami FT, et al. Long-term darifenacin treatment for overactive bladder in patients aged 65 years and older: analysis of results from a 2-year, open-label extension study. Curr Med Res Opin 2007;23(11):2697-704. PubMed: PM17892634

3. Mallett V, Burks D, Garely AD, Smith N. Solifenacin treatment for overactive bladder in black patients: patient-reported symptom bother and health-related quality of life outcomes. Curr Med Res Opin 2007;23(4):821-31. PubMed: PM17407639

4. Metello J, Nogueira B, Torgal M, Colaco J, Vieira A, Goncalves V, et al. Comparison of the efficacy and tolerability of solifenacin succinate with or without previous use of trospium chloride. Int Urogynecol J Pelvic Floor Dysfunct 2007;18(9):1021-5. PubMed: PM17211528

5. Ohtake A, Saitoh C, Yuyama H, Ukai M, Okutsu H, Noguchi Y, et al. Pharmacological characterization of a new antimuscarinic agent, solifenacin succinate, in comparison with other antimuscarinic agents. Biol Pharm Bull 2007;30(1):54-8. PubMed: PM17202659

6. Haab F, Corcos J, Siami P, Glavind K, Dwyer P, Steel M, et al. Long-term treatment with darifenacin for overactive bladder: results of a 2-year, open-label extension study. BJU Int 2006;98(5):1025-32. PubMed: PM16879437

7. Kelleher C, Cardozo L, Kobashi K, Lucente V. Solifenacin: as effective in mixed urinary incontinence as in urge urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2006;17(4):382-8. PubMed: PM16283422

8. Kuipers M, Smulders R, Krauwinkel W, Hoon T. Open-label study of the safety and pharmacokinetics of solifenacin in subjects with hepatic impairment. J Pharmacol Sci 2006;102(4):405-12. PubMed: PM17170513

9. Cardozo L, Dixon A. Increased warning time with darifenacin: a new concept in the management of urinary urgency. J Urol 2005;173(4):1214-8. PubMed: PM15758755

10. Chapple CR, Martinez-Garcia R, Selvaggi L, Toozs-Hobson P, Warnack W, Drogendijk T, 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(3):464-70. PubMed: PM15990220

Solifenacin, Darifenacin and Trospium for Overactive Bladder 4

11. Haab F, Cardozo L, Chapple C, Ridder AM. Long-term open-label solifenacin treatment associated with persistence with therapy in patients with overactive bladder syndrome. Eur Urol 2005;47(3):376-84. PubMed: PM15716204

12. Krauwinkel WJ, Smulders RA, Mulder H, Swart PJ, Taekema-Roelvink ME. Effect of age on the pharmacokinetics of solifenacin in men and women. Int J Clin Pharmacol Ther 2005;43(5):227-38. PubMed: PM15906588

13. Staskin DR, Harnett MD. Effect of trospium chloride on somnolence and sleepiness in patients with overactive bladder. Curr Urol Rep 2004;5(6):423-6. PubMed: PM15541209

Guidelines and recommendations

1. Management of urinary incontinence in primary care. A national clinical guideline [SIGN publication; no. 79]. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2004. Available: http://www.sign.ac.uk/pdf/sign79.pdf (accessed 2007 Nov 9).

Prepared by:

Karen Cimon, Research Assistant Health Technology Inquiry Service Email: [email protected] Tel: 1-866-898-8439

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Appendix – Further information:

Review articles

1. Brubaker L, FitzGerald MP. Nocturnal polyuria and nocturia relief in patients treated with solifenacin for overactive bladder symptoms. Int Urogynecol J Pelvic Floor Dysfunct 2007;18(7):737-41. PubMed: PM17131169

2. Cardozo L, Castro-Diaz D, Gittelman M, Ridder A, Huang M. Reductions in overactive bladder-related incontinence from pooled analysis of phase III trials evaluating treatment with solifenacin. Int Urogynecol J Pelvic Floor Dysfunct 2006;17(5):512-9. PubMed: PM16625311

3. Chapple CR, Cardozo L, Steers WD, Govier FE. Solifenacin significantly improves all symptoms of overactive bladder syndrome. Int J Clin Pract 2006;60(8):959-66. PubMed: PM16893438

4. Millard RJ, Halaska M. Efficacy of solifenacin in patients with severe symptoms of overactive bladder: a pooled analysis. Curr Med Res Opin 2006;22(1):41-8. PubMed: PM16393429

5. Staskin DR, Te AE. Short- and long-term efficacy of solifenacin treatment in patients with symptoms of mixed urinary incontinence. BJU Int 2006;97(6):1256-61. PubMed: PM16686722

6. Wagg A, Wyndaele JJ, Sieber P. Efficacy and tolerability of solifenacin in elderly subjects with overactive bladder syndrome: a pooled analysis. Am J Geriatr Pharmacother 2006;4(1):14-24. PubMed: PM16730617

7. Abrams P, Swift S. Solifenacin is effective for the treatment of OAB dry patients: a pooled analysis. Eur Urol 2005;48(3):483-7. PubMed: PM16005564

8. Chapple C, Steers W, Norton P, Millard R, Kralidis G, Glavind K, et al. A pooled analysis of three phase III studies to investigate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist, in the treatment of overactive bladder. BJU Int 2005;95(7):993-1001. PubMed: PM15839920

9. Foote J, Glavind K, Kralidis G, Wyndaele JJ. Treatment of overactive bladder in the older patient: pooled analysis of three phase III studies of darifenacin, an M3 selective receptor antagonist. Eur Urol 2005;48(3):471-7. PubMed: PM15990219

10. Kelleher CJ, Cardozo L, Chapple CR, Haab F, Ridder AM. Improved quality of life in patients with overactive bladder symptoms treated with solifenacin. BJU Int 2005;95(1):81-5. PubMed: PM15638900

11. McDonagh MS. Selover D, Santa J, Lopez S. Drug class review on agents for overactive bladder: final report. Portland (OR): Oregon Evidence-based Practice Center, Oregon Health & Science University; 2005. Available: http://www.ohsu.edu/drugeffectiveness/reports/documents/OAB%20Final%20Report%2 0Update%203.pdf (accessed 2007 Nov 9).

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