Dose and aging effect on patients reported treatment benefit switching from the first overactive bladder therapy with tolterodine ER to fesoterodine: post-hoc analysis from an observational and retrospective study

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• 作者：David Castro-Diaz (1)
  Pilar Miranda (2)
  Francisco Sanchez-Ballester (3)
  Isabel Lizarraga (4)
  Daniel Arumí (5)
  Javier Rejas (6)
  
• 关键词：Overactive bladder ; Fesoterodine ; Tolterodine ER ; Dose escalation ; Age ; Patient ; reported treatment benefit
• 刊名：BMC Urology
• 出版年：2012
• 出版时间：December 2012
• 年：2012
• 卷：12
• 期：1
• 全文大小：334KB
• 参考文献：1. Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van KP, Victor A, Wein A: The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. / Neurourol Urodyn 2002, 21:167-78. CrossRef
  2. Abrams P, Artibani W, Cardozo L, Dmochowski R, Van KP, Sand P: Reviewing the ICS 2002 terminology report: the ongoing debate. / Neurourol Urodyn 2009, 28:287. CrossRef
  3. Wein AJ, Rovner ES: Definition and epidemiology of overactive bladder. / Urology 2002, 60:7-2. CrossRef
  4. Ellsworth P: Fesoterodine for the treatment of urinary incontinence and overactive bladder. / Ther Clin Risk Manag 2009, 5:869-76. CrossRef
  5. Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ: Prevalence and burden of overactive bladder in the United States. / World J Urol 2003, 20:327-36.
  6. Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P: Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. / Eur Urol 2006, 50:1306-314. CrossRef
  7. Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ: How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. / BJU Int 2001, 87:760-66. CrossRef
  8. Wyndaele JJ, Goldfischer ER, Morrow JD, Gong J, Tseng LJ, Guan Z, Choo MS: Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. / Int J Clin Pract 2009, 63:560-67. CrossRef
  9. Castro D, Espuna M, Prieto M, Badia X: Prevalence of overactive bladder in Spain: a population-based study. / Arch Esp Urol 2005, 58:131-38. CrossRef
  10. Martinez AE, Ruiz Cerda JL, Gomez PL, Ramirez BM, Delgado OF, Rebollo P, Gonzalez-Segura AD, Arumi D: [Prevalence of urinary incontinence and hyperactive bladder in the Spanish population: results of the EPICC study]. / Actas Urol Esp 2009, 33:159-66.
  11. Abrams P, Kelleher CJ, Kerr LA, Rogers RG: Overactive bladder significantly affects quality of life. / Am J Manag Care 2000, 6:S580-S590.
  12. Liberman JN, Hunt TL, Stewart WF, Wein A, Zhou Z, Herzog AR, Lipton RB, Diokno AC: Health-related quality of life among adults with symptoms of overactive bladder: results from a U.S. community-based survey. / Urology 2001, 57:1044-050. CrossRef
  13. Coyne KS, Payne C, Bhattacharyya SK, Revicki DA, Thompson C, Corey R, Hunt TL: The impact of urinary urgency and frequency on health-related quality of life in overactive bladder: results from a national community survey. / Value Health 2004, 7:455-63. CrossRef
  14. Patel B, Bavendam T, Badlani G: Use of antimuscarinics in the elderly. / ScientificWorldJournal 2009, 9:459-65. CrossRef
  15. Ouslander JG: Management of overactive bladder. / N Engl J Med 2004, 350:786-99. CrossRef
  16. D'Souza AO, Smith MJ, Miller LA, Doyle J, Ariely R: Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan. / J Manag Care Pharm 2008, 14:291-01.
  17. Swift SE, Siami P, Forero-Schwanhaeuser S: Diary and patient-reported outcomes in patients with severe overactive bladder switching from tolterodine extended release 4?mg/day to solifenacin treatment: an open-label, flexible-dosing, multicentre study. / Clin Drug Investig 2009, 29:305-16. CrossRef
  18. Kaplan SA, Schneider T, Foote JE, Guan Z, Carlsson M, Gong J: Superior efficacy of fesoterodine over tolterodine extended release with rapid onset: a prospective, head-to-head, placebo-controlled trial. / BJU Int 2011, 107:1432-440. CrossRef
  19. Herschorn S, Swift S, Guan Z, Carlsson M, Morrow JD, Brodsky M, Gong J: Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head-to-head placebo-controlled trial. / BJU Int 2010, 105:58-6. CrossRef
  20. Zinner N, Kobashi KC, Ebinger U, Viegas A, Egermark M, Quebe-Fehling E, Koochaki P: Darifenacin treatment for overactive bladder in patients who expressed dissatisfaction with prior extended-release antimuscarinic therapy. / Int J Clin Pract 2008, 62:1664-674. CrossRef
  21. Chapple CR, Van Kerrebroeck PE, Junemann KP, Wang JT, Brodsky M: Comparison of fesoterodine and tolterodine in patients with overactive bladder. / BJU Int 2008, 102:1128-132. CrossRef
  22. Khullar V, Rovner ES, Dmochowski R, Nitti V, Wang J, Guan Z: Fesoterodine dose response in subjects with overactive bladder syndrome. / Urology 2008, 71:839-43. CrossRef
  23. Dmochowski RR, Peters KM, Morrow JD, Guan Z, Gong J, Sun F, Siami P, Staskin DR: Randomized, double-blind, placebo-controlled trial of flexible-dose fesoterodine in subjects with overactive bladder. / Urology 2010, 75:62-8. CrossRef
  24. MacDiarmid SA: Overactive bladder: improving the efficacy of anticholinergics by dose escalation. / Curr Urol Rep 2003, 4:446-51. CrossRef
  25. Malone-Lee JG, Walsh JB, Maugourd MF: Tolterodine: a safe and effective treatment for older patients with overactive bladder. / J Am Geriatr Soc 2001, 49:700-05. CrossRef
  26. Michel MC, Schneider T, Krege S, Goepel M: Does gender or age affect the efficacy and safety of tolterodine? / J Urol 2002, 168:1027-031. CrossRef
  27. Zinner NR, Mattiasson A, Stanton SL: Efficacy, safety, and tolerability of extended-release once-daily tolterodine treatment for overactive bladder in older versus younger patients. / J Am Geriatr Soc 2002, 50:799-07. CrossRef
  28. Chapple C, DuBeau C, Ebinger U, Rekeda L, Viegas A: Darifenacin treatment of patients-gt;?or--5?years with overactive bladder: results of a randomized, controlled, 12-week trial. / Curr Med Res Opin 2007, 23:2347-358. CrossRef
  29. Kraus SR, Ruiz-Cerda JL, Martire D, Wang JT, Wagg AS: Efficacy and tolerability of fesoterodine in older and younger subjects with overactive bladder. / Urology 2010, 76:1350-357. CrossRef
  30. Stolley PD, Laporte J: The Public Health, the University, and Pharmacoepidemiology. In / Pharmacoepidemiology. Third edition. Edited by: Strom BL. John Wiley & Sons; 2000.
  31. Gallagher RM: Naturalistic study designs in samples with refractory pain: advantages and limitations. / Pain Med 2004, 5:143-45. CrossRef
  32. Castro D, Miranda P, Sanchez-Ballester F, Arumi D, Lizarraga I, Ebel C: Assessment of reasons for overactive bladder treatment change. / Actas Urol Esp 2011, 35:73-9. CrossRef
  33. Coyne KS, Zyczynski T, Margolis MK, Elinoff V, Roberts RG: Validation of an overactive bladder awareness tool for use in primary care settings. / Adv Ther 2005, 22:381-94. CrossRef
  34. Colman S, Chapple C, Nitti V, Haag-Molkenteller C, Hastedt C, Massow U: Validation of treatment benefit scale for assessing subjective outcomes in treatment of overactive bladder. / Urology 2008, 72:803-07. CrossRef
  35. Guy W: / Clinical Global Impressions: In ECDEU Assessment Manual for Psychopharmacology. Revised DHEW Pub. (ADM). Rockville, MDL: National Institute for Mental Health; 1976:218-22.
  36. Morisky DE, Green LW, Levine DM: Concurrent and predictive validity of a self-reported measure of medication adherence. / Med Care 1986, 24:67-4. CrossRef
  37. 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, 4:14-4. CrossRef
  38. Brynne N, Dalen P, Alvan G, Bertilsson L, Gabrielsson J: Influence of CYP2D6 polymorphism on the pharmacokinetics and pharmacodynamic of tolterodine. / Clin Pharmacol Ther 1998, 63:529-39. CrossRef
  39. Malhotra BK, Wood N, Sachse R: Influence of age, gender, and race on pharmacokinetics, pharmacodynamics, and safety of fesoterodine. / Int J Clin Pharmacol Ther 2009, 47:570-78.
  40. Wagg A, Khullar V, Marschall-Kehrel D, / et al.: Assessment of fesoterodine treatmetn in older people with overactive bladder: result of SOFIA, a double blind, placebo-controlled pan European trial. / Eur Urol Supplement 2011, 10:276-77. [abstract]. e 2011 CrossRef
  41. Chapple C, Van KP, Tubaro A, Haag-Molkenteller C, Forst HT, Massow U, Wang J, Brodsky M: Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. / Eur Urol 2007, 52:1204-212. CrossRef
  42. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2490/12/19/prepub
  
• 作者单位：David Castro-Diaz (1)
  Pilar Miranda (2)
  Francisco Sanchez-Ballester (3)
  Isabel Lizarraga (4)
  Daniel Arumí (5)
  Javier Rejas (6)
  
  1. Department of Urology, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Canarias, Spain
  2. Department of Gynaecology, Hospital de Fuenlabrada, Madrid, Spain
  3. Department of Urology, Hospital General Universitario de Valencia, Valencia, Spain
  4. Medical Unit, Pfizer, S.L.U., Alcobendas, (Madrid), Spain
  5. Medical Department, Pfizer Inc. Europe, Alcobendas, (Madrid), Spain
  6. Health Economics and Outcomes Research Department, Pfizer, S.L.U, Alcobendas, (Madrid), Spain
  

文摘

Background Previous randomized studies have demonstrated that fesoterodine significantly improves the Overactive Bladder (OAB) symptoms and their assessment by patients compared with tolterodine extended-release (ER). This study aimed to assess the effect of aging and dose escalation on patient-reported treatment benefit, after changing their first Overactive Bladder (OAB) therapy with tolterodine-ER to fesoterodine in daily clinical practice. Methods A post-hoc analysis of data from a retrospective, cross-sectional and observational study was performed in a cohort of 748 OAB adults patients (OAB-V8 score ?), who switched to fesoterodine from their first tolterodine-ER-based therapy within the 3-?months before study visit. Effect of fesoterodine doses (4?mg vs. 8?mg) and patient age (<65?yr vs. ?5?yr) were assessed. Patient reported treatment benefit [Treatment Benefit Scale (TBS)] and physician assessment of improvement with change [Clinical Global Impression of Improvement subscale (CGI-I)] were recorded. Treatment satisfaction, degree of worry, bother and interference with daily living activities due to urinary symptoms were also assessed. Results Improvements were not affected by age. Fesoterodine 8?mg vs. 4?mg provides significant improvements in terms of treatment benefit [TBS 97.1% vs. 88.4%, p-lt;-.001; CGI-I 95.8% vs. 90.8% p-lt;-.05)], degree of worry, bother and interference with daily-living activities related to OAB symptoms (p <0.05). Conclusions A change from tolterodine ER therapy to fesoterodine with dose escalation to 8?mg in symptomatic OAB patients, seems to be associated with greater improvement in terms of both patient-reported-treatment benefit and clinical global impression of change. Improvement was not affected by age.