Evidence for the efficacy and safety of tolterodine in the treatment of overactive bladder

Bibliography

• LENDERKING WR, NACKLEY JF, RB, TESTA MA: A review of the quality-of-life aspects of urinary urge incontinence. Pharmacoeconomics (1996) 9:11–23.
   PubMed Web of Science ®Google Scholar
• JACKSON S: The patient with overactive - symptoms and quality of life issues. Urology (1997) 50(6A Suppl.):18–22.
   Google Scholar
• •A useful review of the many ways in which OAB affects quality of life.
   Google Scholar
• THOM DH: Overactive bladder: and impact on quality of life. Patient Care (2000) Winter(Suppl.):6–14.
   Google Scholar
• •An excellent overview of the epidemiology of OAB, and how the associated symptoms exert a profound effect on various aspects of quality of life.
   Google Scholar
• ABRAMS P, COYNE K, SCHMIER J, D, STEWART W, COREY R: Health-related quality-of-life in continent overactive bladder subjects: early results from the NOBLE Program. Proceedings of the 30th Annual Meeting of the International Continence Society Tampere, Finland (2000).
   Google Scholar
• •This abstract provides preliminary evidence that quality of life in patients with OAB is impaired to a similar extent regardless of whether they remain continent or not.
   Google Scholar
• MILSOM I, ABRAMS E CARDOZO L, RG, THOROFF J, WEIN AJ: How widespread are the symptoms of an overactive bladder and how do we manage them? A population-based prevalence study. BJU Int. (2001) 87(8):760–766.
   PubMedGoogle Scholar
• VERSI E, ON BEHALF OF THE STUDY GROUP: Screening initiative confirms widespread prevalence of overactive bladder in American adults. Int. Urogynecol (2001) 12:S13.
   Google Scholar
• ASH WORTH PD, HAGAN M: The meaning of incontinence: a qualitative study of non-geriatric urinary incontinence sufferers. J. Adv. Nurs. (1993) 18:1415–1423.
   PubMedGoogle Scholar
• •A novel paper describing the impact of urinary incontinence on patients' daily lives.
   Google Scholar
• VOELKER R: International group seeks todispel incontinence "taboo". JAMA (1998) 280:951–953.
   PubMed Web of Science ®Google Scholar
• ABRAMS P, WEIN AJ: The overactive bladder. A widespread and treatable condition. Erick Sparre Medical AB, Stockholm (1998).
   Google Scholar
• •Intended for primary healthcare professionals, this book provides a useful overview of the diagnosis and management of OAB.
   Google Scholar
• WAGNER TH, HU T-W: Economic costs of urinary incontinence in 1995. Urology (1998) 51:355–361.
   PubMed Web of Science ®Google Scholar
• ANDERSSON K-E: The overactive bladder: pharmacologic basis of drug treatment. Urology (1997) 50(6A Suppl.):74–84.
   Google Scholar
• •A comprehensive review of the basis for the treatment of OAB, summarising current and future treatment options.
   Google Scholar
• FANTL JA, NEWMAN DK, COLLING J et al.: Urinary incontinence in adults: acute and chronic management. Clinical Practice Guideline No. 2, 1996 Update. US Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research (1996) (AHCPR Pub No. 96–0682), Rockville, MD, US.
   Google Scholar
• ••Comprehensive guidelines, developed by apanel of experts using an extensive review of scientific literature and expert judgement, designed to assist physician and patient decisions about appropriate healthcare for urinary incontinence.
   Google Scholar
• KELLEHER CJ, CARD OZO LD, KHULLAR V, SALVATORE S: A medium term analysis of the subjective efficacy of treatment for women with detrusor instability and low bladder compliance. Br Obstet. Cynaecol. (1997) 104:988–993.
   PubMedGoogle Scholar
• •Findings show that 20% of patients remain on traditional antimuscarinics for 6 months; tolerability problems were the main reason for early treatment discontinuation.
   Google Scholar
• NILVEBRANT L: The mechanism of action of tolterodine. Rev Contemp. Pharmacother. (2000) 11:13–27.
   Web of Science ®Google Scholar
• ••An excellent paper on the pharmacology,pharmacodynamics and pharmacokinetics of tolterodine.
   Google Scholar
• NILVEBRANT L, ANDERSSON K-E, GILLBERG P-G, STAHL M, SPARF B: Tolterodine - a new bladder selective antimuscarinic agent. Eur. j Pharmacol. (1997) 327:195–207.
   PubMed Web of Science ®Google Scholar
• YONO M, YOSHIDA M, WADA Y etal.: Pharmacological effects of tolterodine on human isolated urinary bladder. Eur. Pharmacol. (1999) 368:223–230.
   Google Scholar
• NILVEBRANT L, GILLBERG P-G, SPARF B: Antimuscarinic potency and bladder selectivity of PNU200577, a major metabolite of tolterodine. Pharmacol. Toxicol. (1997) 81:169–172.
   PubMedGoogle Scholar
• •An in vitro and in vivo study with the 5-HM metabolite of tolterodine (PNU-200577), in which a similar pharmacological profile and antimuscarinic potency was apparent relative to tolterodine.
   Google Scholar
• NAERGER H, FRY CH, NILVEBRANT: Effect of tolterodine on electrically induced contractions of isolated human detrusor muscle from stable and unstable bladders. Neurourol. Urodyri. (1995) 14:524–526.
   Google Scholar
• YARKER YE, GOA KL, FITTON A: Oxybutynin: a review of its pharmacodynamic and pharmacokinetic properties, and its therapeutic use in detrusor instability. Drugs Aging (1995) 6:243–246.
   PubMed Web of Science ®Google Scholar
• •A comprehensive review of oxybutynin and its therapeutic utility in the treatment of OAB.
   Google Scholar
• STAHL MMS, EKSTROM B, SPARF B, MATTIASSON A, ANDERSSON K-E: Urodynamic and other effects of tolterodine: a novel antimuscarinic drug for the treatment of detrusor overactivity. Neurourol. Urodyri. (1995) 14:647–655.
   PubMedGoogle Scholar
• •In this study in healthy volunteers, the authors report on the immediate antimuscarinic effects of a single dose of tolterodine, with a more pronounced effect on bladder function than on salivation.
   Google Scholar
• BRYNNE N, STAHL MMS, HALLEN B et al.: Pharmacokinetics and pharmacodynamics of tolterodine in man: a new drug for the treatment of urinary bladder overactivity. mt. I Gun. Pharmacol. Ther. (1997) 35:287–295.
   Google Scholar
• CHANCELLOR MB: Tolterodine: selectivity for the bladder over effects on visual accommodation. j. Urol. (2000) 163:229.
   Google Scholar
• CHAPPLE C: Tolterodine once daily: selectivity for the bladder over effects salivation compared to Ditropan° XL. J. Ural. (2001) 165(5)(Suppl.):253.
   Google Scholar
• KATZ IR, SANDS LP, BILKER W, DIFILIPPO S, BOYCE A, D'ANGELO K: Identification of medications that cause cognitive impairment in older people: the case of oxybutynin chloride. I Am. Geriatr. Soc. (1998) 46:8–13.
   PubMed Web of Science ®Google Scholar
• TODOROVA A, VONDERHEID B, DIMPFEL W: Effects of tolterodine, trospium chloride and oxybutynin on the central nervous system. I Clin. Pharmacol. (2001) 41(6):636–644.
   PubMed Web of Science ®Google Scholar
• PAHLMAN I, D'ARGY R, L: Tissue distribution of tolterodine, a muscarinic receptor antagonist, and transfer into fetus and milk in mice. Arzrieim. Forsch. Drug Res. (2001) 51:125–133.
   PubMedGoogle Scholar
• •A comprehensive preclinical study summarising the tissue distribution of tolterodine and its metabolites in the mouse (including foetal distribution studies and excretion into maternal milk). A notable finding was low penetration of the CNS, which contrasts with findings for more lipophilic antimuscarinic drugs.
   Google Scholar
• ANDERSSON SHG, LINDGREN A, POSTLIND H: Biotransformation of tolterodine, a new muscarinic receptor antagonist, in mouse, rat and dog. Drug Metab. Dispos. (1998) 26:528–535.
   PubMedGoogle Scholar
• POSTLIND H, DANIELSON A, LINDGREN A, ANDERSSON SHG: Tolterodine, a new muscarinic receptor antagonist, is metabolized by cytochromes P450 2D6 and 3A in human liver microsomes. Drug Metab. Dispos. (1998) 26:289–293.
   PubMed Web of Science ®Google Scholar
• •This in vitro study provides a comprehensive assessment of the human CYP enzymes involved in the metabolism of tolterodine.
   Google Scholar
• ALVAN G, BECHTEL P, ISELIUS L, GUNDERT-REMY U: Hydroxylation polymorphisms of debrisoquine and mephenytoin in European populations. Eur. j. Clin. Pharmacol. (1990) 39:533–537.
   PubMed Web of Science ®Google Scholar
• BRYNNE N, DALEN P, AL VAN G, BERTILSSON L, GABRIELSSON J: Influence of CYP2D6 polymorphism on the pharmacokinetics and pharmacodynamics of tolterodine. Pharmacol. Ther. (1998) 63:529–539.
   Google Scholar
• •Demonstrates that while CYP2D6 polymorphism affects the pharmacokinetics of tolterodine, it does not appear to be of great importance for antimuscarinic response.
   Google Scholar
• LARSSON G, HALLEN B, NILVEBRANT L: Tolterodine in the treatment of overactive bladder: analysis of the pooled Phase II efficacy and safety data. Urology (1999) 53:990–998.
   PubMed Web of Science ®Google Scholar
• •This paper provides a pooled analysis, in terms of efficacy and safety, of the entire tolterodine Phase II clinical programme.
   Google Scholar
• OLSSON B, BRYNNE N, JOHANSSON, ARNBERG H: Food increases the bioavailability of tolterodine but not effective exposure. I Gun. Pharmacol. (2001) 41:298–304.
   Google Scholar
• OLSSON B, SZAMOSI J: Multiple dose pharmacokinetics of a new once daily extended release tolterodine formulation versus immediate release tolterodine. Pharmacolciri. (2001) 40:227–235.
   Google Scholar
• •A multiple-dose study in healthy volunteers, in which the new once-daily, ER formulation of tolterodine (4 mg) showed pharmacokinetic equivalence to the existing IR tablet given at a dose of 2 mg b.i.d.
   Google Scholar
• OLSSON B, SZAMOSI J: Food does not influence the pharmacokinetics of a new extended release formulation of tolterodine for once daily treatment of patients with overactive bladder. Gun. Pharmacokin (2001) 40:135–143.
   PubMed Web of Science ®Google Scholar
• •A single-dose pharmacokinetic study with an ER formulation of tolterodine, in which the pharmacokinetic profile was consistent with sustained release and no interaction with food was noted.
   Google Scholar
• PAHLMAN I, GOZZI P: Serum protein binding of tolterodine and its major metabolites in humans and several animal species. Biopharm. Drug Dispos. (1999) 20:91–99.
   PubMed Web of Science ®Google Scholar
• •The authors demonstrated that tolterodine binds to serum proteins to a higher extent than active 5-HM, with al-acid glycoprotein (orosomucoid) being the major binding protein in human serum.
   Google Scholar
• BRYNNE N: Consequences of CYP2D6 polymorphism for the disposition and dynamics of tolterodine: a novel drug in the treatment of urinary bladder overactivity (PhD thesis). Karolinska Institute, Stockholm (1998).
   Google Scholar
• BRYNNE N, FORSLUND C, HALLEN B, GUSTAFSSON LL, BERTILSSON L: Ketoconazole inhibits the metabolism of tolterodine in subjects with deficient CYP2D6 activity. Br. J. an. Pharmacol. (1999) 48:564–572.
   Google Scholar
• •Ketoconazole (an inhibitor of CYP3A4) significantly increased serum tolterodine concentrations in subjects known to be poor metabolisers. Results indicate the need for tolterodine dosage adjustment in patients receiving drugs known to inhibit CYP3A4 (e.g., azole antifungals, macrolide antibiotics, cyclosporin).
   Google Scholar
• BRYNNE N, BOTTIGER Y, HALLÉN B, BERTILSSON L: Tolterodine does not affect the human in vivo metabolism of the probe drugs caffeine, debrisoquine and omeprazole. Br. 1. Chit. Pharmacol (1999) 47:145–150.
   Google Scholar
• OTTON SV, WU D, JOFFE RT, CHEUNG SW, SELLERS EM: Inhibition by fluoxetine of cytochrome P450 2D6 activity. Chu. Pharmacol. Ther. (1992) 53:401–409.
   Google Scholar
• BRYNNE N, SVANSTROM C, ABERG-WISTEDT A, HALLÉN B, BERTILSSON: Fluoxetine inhibits the metabolism of tolterodine - pharmacokinetic implications and proposed clinical relevance. Br. 1. Chit. Pharmacol. (1999) 48:553–563.
   Google Scholar
• RAHIMY MH, HALLÉN B, NARANG PK: Lack of tolterodine effect on warfarin safety and PK/PD in healthy volunteers. PharmSci. (1998) 1 (Suppl.):S147.
   Google Scholar
• •This study in healthy volunteers demonstrated that co-administration of tolterodine and warfarin had no effect on prothrombin time or Factor VII suppression, or the pharmacokinetics of warfarin enantiomers.
   Google Scholar
• COLUCCI VJ, RIVEY MP: Tolterodine-warfarin drug interaction. Ann. Pharmacother. (1999) 33:1173–1176.
   PubMed Web of Science ®Google Scholar
• CLEMETT D, JARVIS B: Tolterodine: a review of its use in the treatment of overactive bladder. Drugs Aging (2001) 18(4):277–304.
   PubMed Web of Science ®Google Scholar
• VAN KERREBROECK E KREDER K, JONAS U, ZINNER N, WEIN A, ON BEHALF OF THE TOLTERODINE STUDY GROUP: Tolterodine once-daily: superior efficacy and tolerability in the treatment of overactive bladder. Urology (2001) 57:414–421.
   PubMedGoogle Scholar
• ••The first publication on the clinicalefficacy and tolerability of an ER formulation of tolterodine for once-daily treatment of OAB.
   Google Scholar
• ABRAMS P, JACKSON S, MATTIASSON A, KRISHNAN K, HAENDLER L: A randomised, double-blind, placebo controlled, dose ranging study of the safety and efficacy of tolterodine in patients with. Proceedings of the 26th Annual Meeting of the International Continence Society Athens, Greece (1996).
   Google Scholar
• RENTZHOG L, STANTON SL, CARD OZO L, NELSON E, FALL M, ABRAMS P: Efficacy and safety of tolterodine in patients with detrusor instability: a dose-ranging study. Br I Ural. (1998) 81:42–48.
   PubMedGoogle Scholar
• VAN KERREBROECK PEVA, AMARENCO G, THOROFF JW et al: Dose-ranging study of tolterodine in patients with detrusor hyperreflexia. Neurourol Urodyn. (1998) 17:499–512.
   PubMedGoogle Scholar
• MALONE-LEE J, WALSH JB, MAUGOURD M-F AND THE TOLTERODINE IN THE ELDERLY STUDY GROUP: Tolterodine: a safe and effective treatment for elderly patients with overactive bladder. 1. Am. Ceriatr Soc. (2001) 49(6):700–705.
   Google Scholar
• •This placebo-controlled Phase III study evaluated the safety and efficacy of tolterodine specifically in the elderly (• 65 years). The data demonstrates clinical efficacy for tolterodine, with no safety concerns, in this patient population.
   Google Scholar
• JONAS U, HOFNER K, H, HOLMDAHL TH, AND THE PARTICIPANTS OF THE INTERNATIONAL STUDY GROUP: Efficacy and safety of two doses of tolterodine versus placebo in patients with detrusor overactivity and symptoms of frequency, urge incontinence, and urgency: urodynamic evaluation. World J. Ural. (1997) 15:144–151.
   PubMed Web of Science ®Google Scholar
• JACQUETIN B, WYNDAELE J-J: Tolterodine reduces the number of incontinence episodes in patients with an overactive bladder. Eur. I Obstet. Cyriecol Reproductive Biol. (2001). In Press.
   Google Scholar
• MILLARD R, TUTTLE J, MOORE K et al.: Clinical efficacy and safety of tolterodine compared to placebo in detrusor overactivity. Ural. (1999) 161(5):1551–1555.
   PubMed Web of Science ®Google Scholar
• VAN KERREBROECK PEVA, SERMENT G, DREHER E: Clinical efficacy and safety of tolterodine compared to oxybutynin in patients with overactive bladder. Neurourol Urodyn. (1997) 16:478–479.
   Google Scholar
• ABRAMS P, FREEMAN R, C, MATTIASSON A: Tolterodine, a new antimuscarinic agent: as effective but better tolerated than oxybutynin in patients with an overactive bladder. Br. J. Ural. (1998) 81:801–810.
   PubMedGoogle Scholar
• •The results of this 12-week, Phase III study show that tolterodine is as clinically effective as, but better tolerated than, oxybutynin.
   Google Scholar
• DRUTZ HP, APPELL RA, GLEASON D, KLIMBERG I, RADOMSKI S: Clinical efficacy and safety of tolterodine compared to oxybutynin and placebo in patients with overactive bladder. Int. Urogynecol 1 (1999) 10:283–289.
   PubMedGoogle Scholar
• APPELL RA: Clinical efficacy and safety of tolterodine in the treatment of overactive bladder: a pooled analysis. Urology (1997) 50(6A Suppl.):90–96.
   Google Scholar
• ••This paper provides a pooled analysis ofthe safety, efficacy and tolerability of tolterodine in four 12-week, Phase III clinical studies in patients with OAB.
   Google Scholar
• MALONE-LEE JG, WAGG A, LARSSON G: Age comparisons of the safety and efficacy of tolterodine from twelve week studies. Proceedings of the 28th Annual Meeting of the International Continence Society Jerusalem, Israel (1998).
   Google Scholar
• WEIN AJ: A comparison of the efficacy response profile of tolterodine and oxybutynin. I Ural. (2000) 163 (Supp1):227.
   Google Scholar
• CHANCELLOR M, FREEDMAN S, MITCHESON HD, ANTOCI J, PRIMUS G, WEIN A: Tolterodine: an effective and well tolerated treatment for urge incontinence and other overactive bladder symptoms. Clin. Drug Invest. (2000) 19:83–91.
   Google Scholar
• VAN KERREBROECK PEVA: Significant decreases in perception of urgency and urge incontinence episodes with once-daily tolterodine treatment in patients with overactive bladder. Neurourol Urodyn. (2000) 19(4):493–494
   Google Scholar
• DIOKNO AC, CHANCELLOR MB, MITCHESON HD, AND THE TOLTERODINE STUDY GROUP: Tolterodine (Detrol®) improves incontinence and nocturia in urologist based study. J. Ural. (1999) 161\(Suppl. 4):256.
   Google Scholar
• HETTA J: The impact of sleep deprivationcaused by nocturia. BJU Int. (1999) 84\(Suppl. 1):27–28.
   Google Scholar
• BROWN JS, GRADY D, OUSLANDER JG, HERZOG AR, VARNER RE, POSNER SF, FOR THE HEART & ESTROGEN/PROGESTIN REPLACEMENT STUDY (HERS) RESEARCH GROUP: Prevalence of urinary incontinence and associated risk in postmenopausal women. Obstet. Cyriecal (1999) 94:66–70.
   Google Scholar
• PAYNE C, RABIN J, ON BEHALF OF THE TOLTERODINE STUDY GROUP: Tolterodine is rapidly effective in women with mixed incontinence. Proceedings of the 30th Annual Meeting of the International Continence Society Tampere, Finland (2000).
   Google Scholar
• GOESSL C, SAUTER T, MICHAEL T, BERGE B, STAEHLER M, MILLER K: Efficacy and tolerability of tolterodine in children with detrusor hyperreflexia. Urology (2000) 55:414–418.
   PubMed Web of Science ®Google Scholar
• •The first published study on the use of tolterodine in children with detrusor hyperreflexia. The results show the drug to be well tolerated and urodynamically effective.
   Google Scholar
• HJALMAS K, HELLSTROM A-L, MOGREN K, LACKGREN G, STENBERG A: The overactive bladder in children: a potential future indication for tolterodine. BJU Int. (2001) 87:569–574.
   PubMedGoogle Scholar
• •A dose-ranging safety/pharmacoltinetic study with tolterodine in children aged 5–10 years with OAB symptoms, which concluded that a dosage of 1 mg b.i.d. (IR tablets) may be the preferred dosage in this patient group.
   Google Scholar
• MUNDING M, WESSELLS H, THORNBERRY B, RIDEN D: Use of in children with dysfunctional voiding: an initial report. j Ural (2001) 165:926–928.
   PubMed Web of Science ®Google Scholar
• ABRAMS E MALONE-LEE J, JACQUETIN B et al: Twelve-month treatment of overactive bladder: efficacy and tolerability of tolterodine. Drugs Aging (2001) 18(7):551–560.
   PubMedGoogle Scholar
• APPELL RA, ABRAMS P, DRUTZ HP, VAN KERREBROECK PEVA, MILLARD R, WEIN A: Treatment of overactive bladder: long-term tolerability and efficacy of tolterodine. World J. Ural. (2001) 19:141–147.
   PubMed Web of Science ®Google Scholar
• •The authors report that tolterodine is well tolerated and maintained its clinical efficacy during 9-month open-label treatment, with high rates of patient compliance.
   Google Scholar
• VAN KERREBROECK P: Long-term (12 months) efficacy and tolerability of tolterodine once-daily in the treatment of the overactive bladder. Proceedings of the 31st Annual Meeting of International Continence Society Seoul, South Korea (2001).
   Google Scholar
• MALONE-LEE JG: The efficacy, tolerability and safety profile of tolterodine in the treatment of overactive/unstable bladder. Rev Contemp. Pharmacother. (2000) 11:29–42.
   Google Scholar
• GUAY DRP: Tolterodine, a new drug for the treatment of overactivity. Pharmacotherapy (1999) 19:267–280.
   PubMedGoogle Scholar
• MALONE-LEE, SHAFFU B, ANAND C, POWELL C: Tolterodine: superior tolerability and comparable efficacy with oxybutynin in older individuals with overactive bladder. j Ural (2001) 165(5):1452–1456.
   PubMedGoogle Scholar
• HALLÉN B, NORDGREN L, J, KVIDAL P, ECKERNAS S-A, GRAHNÉN A: Tolterodine and terodiline — ECG safety profiles. Proceedings of the 27th Annual Meeting of the International Continence Society Yokohama, Japan (1997).
   Google Scholar
• EDHOLM M, HALLEN B, DASH CH, RITSEMA VAN ECK HJ: No ECG effects of tolterodine during thiazide treatment. of the 99th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics. New Orleans, USA (1998).
   Google Scholar