7
Views
0
CrossRef citations to date
0
Altmetric
Miscellaneous

Clinical study results of tolterodine in patients with overactive bladder

Pages 155-163 | Published online: 10 Jan 2014

References

  • Abrams P, Cardozo L, Fall M et al The standardisation of terminology of lower urinary tract function: Report from the Standardisation Subcommittee of the International Continence Society. Neurourol U115417. 21(2), 167–178 (2002).
  • Thom DH. Overactive bladder: epidemiology and impact on quality of life. Patient Cate (Suppl.), 6–14 (2000).
  • MASOM I, Abrams P, Cardozo L, Roberts RG, Tharoff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 87 (9), 760–766 (2001).
  • •Large population-based survey examines the prevalence of OAB in individuals of 40 years or older in six European countries.
  • Lenderking WR, Nackley JF, Anderson RB, Testa MA. A review of the quality of life aspects of urinary urge incontinence. PhatmacoEconomics 9(1), 11–23 (1996).
  • Jackson S. The patient with an overactive bladder: symptoms and quality of life issues. Urology50 (Suppl. 6A), 18–22 (1997).
  • •Useful review of the various effects of OAB on quality of life.
  • Kobelt G, Kirchberger I, Malone-Lee J. Quality of life aspects of the overactive bladder and the effect of treatment with tolterodine. BJU Int. 83(6), 583–590 (1999).
  • Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am. I Manag: Care 6 (Suppl. 11), S580—S590 (2000).
  • McGhan WF. Cost effectiveness and quality of life considerations in the treatment of patients with overactive bladder. Am J. Manag. Care 7\(Suppl. 2), S62-S75 (2001).
  • Voelker R. International group seeks to dispel incontinence taboo. JAIVIA 280 (11), 951–953 (1998).
  • Abrams P, Coyne K, Schmier J, Revicki D, Stewart W Corey R Health-related quality of life in continent overactive bladder subject: early results from the NOBLE program. Neuroutvl Urodyn. 19,519–521 (2000).
  • •Abstract with preliminary evidence that in OAB, quality of life is impaired to a similar extent in patients with or without incontinence.
  • Anderson K-E. Pharmacology of lower urinary tract smooth muscles and penile erectile tissues. Pharmacol Rev 45(3), 253–308 (1993).
  • Fantl JA, Newman DK, Coiling J etal Urinary incontinence in adults: acute and chronic management. Clinical Practice Guidelines (2), 1–155 (1996). Extensive guidelines from a panel of experts, based on a thorough review of scientific literature and expert judgement, designed to aid physician and patient approaches to healthcare for urinary incontinence.
  • Nilvebrant L, Gillberg P-G, Sparf B. Antimuscarinic potency and bladder selectivity of PNU-200577, a major metabolite of tolterodine. Pharmacol Toxicol 81(4), 169–172 (1997).
  • Nilvebrant L, Andersson K-E, Gillberg PG, Stahl M, Sparf B. Tolterodine: a new bladder-selective antimuscarinic agent. Eur Pharmacol 327(92-93), 195–207 (1997).
  • Kelleher CJ, Cardozo LD, Khullar V. A medium term analysis of the subjective efficacy of treatment for women with detrusor instability and low bladder compliance. BE j Obstet. Gynaecol 104, 988–993 (1997).
  • Wang P, Luthin GR, Ruggieri MR Muscarinic acetylcholine receptor subtypes mediating urinary bladder contractility and coupling to GTP binding proteins. J. Pharmacol Exp. Tiler. 273(2), 959–966 (1995).
  • Yamaguchi O, Shishido K, Tamura K, Ogawa T, Fujimura T, Ohtsuka M. Evaluation of mRNAs encoding for muscarinic receptor subtypes in human detrusor muscle. Ural 156 (3), 1208–1213 (1996).
  • Yamanishi T, Chapple CR, Chess-Williams R. Which muscarinic receptor is important in the bladder? World J. Ural 19(5), 299–306 (2001).
  • Hegde SS, Eglen RM. Muscarinic receptor subtypes modulating smooth muscle contractility in the urinary bladder. Life Sci. 64(6-7), 419–428 (1999).
  • •Compared the antimuscarinic properties of tolterodine with those of oxybutynin in vitro and in vivo.
  • Hegde SS, Choppin A, Bonhaus D eta]. Functional role of M2 and M3 muscarinic receptors in the urinary bladder of rats in vitro and in vivo. Br. Phannacol 120, 1409–1418 (1997).
  • Hills CJ, Winter SA, Balfour JA. Tolterodine. Drugs 55,813–820 (1998).
  • Caulfield MP. Muscarinic receptors: characterization, coupling and function. Pharmacol flier. 58(3), 319–379 (1993).
  • Nilvebrant L. On the muscarinic receptors in the urinary bladder and the putative subclassification of muscarinic receptors. Acta. Phatmacol Toxicol (Copenh.)59 (Suppl. 1), 1–45 (1986).
  • Noronha-Blob L, Kachur JE Enantiomers of oxybutynin: in vitro pharmacological characterization at M1, M2 and M3 muscarinic receptors and in vivo effects on urinary bladder contraction, mydriasis and salivary secretion in guinea pigs. Pharmacol Exp. Trier. 256,562-567 (1991).
  • Yono M, Yoshida M, Wada Y etal Pharmacological effects of tolterodine on human isolated urinary bladder. Eur Pharmacol 368(2-3), 223–230 (1999).
  • Abrams P, Freeman R, Anderstrom C, Mattiasson A. Tolterodine, a new antimuscarinic agent: as effective but better tolerated than oxybutynin in patients with an overactive bladder. BE J. Ural 81(6), 801–810 (1998).
  • •This 12-week Phase III study showed that tolterodine was as effective as oxybutynin in OAB but was better tolerated.
  • 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 J. Pelvic Floor Dysfunct. 10 (5), 283–289 (1999).
  • Chancellor MB, Appell RA, Sathyan G, Gupta SK A comparison of the effects on saliva output of oxybutynin chloride and tolterodine tartrate. Clin ?her 23(5), 753–760 (2001).
  • Chapple CR. Tolterodine once-daily: selectivity for the bladder over effects on salivation compared to Ditropan XL. Ural 165 (Suppl. 5), 253 (2001).
  • Chapple CR, Nilvebrant L. Tolterodine: selectivity for the urinary bladder over the eye (as measured by visual accommodation) in healthy volunteers. Drugs R. & D 3 (2), 75–81 (2002).
  • 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. 26(4), 289–293 (1998).
  • •This in vitro study provides a thorough assessment of the human CYT P450 enzymes involved in tolterodine metabolism.
  • Nilvebrant L. The mechanism of action of tolterodine. Rev. Contemp. Pharmacother. 11, 13–27 (2000).
  • ••Excellent review of the mechanism ofaction, pharmacology, pharrnacodynamics and pharmacokinetics of tolterodine.
  • Brynne N, Dalén P, Alvan G, Bertilsson L, Gabrielsson J. Influence of CYP2D6 polymorphism on the pharmacokinetics and pharmacodynamics of tolterodine. Clin. Pharmacol Pier. 63(5), 529–539 (1998).
  • Larsson G, Hallén B, Nilvebrant L. Tolterodine in the treatment of overactive bladder: analysis of the pooled Phase II efficacy and safety data. Urology 53 (5), 990–998 (1999).
  • •Pooled analysis of the efficacy and safety of tolterodine in four Phase 11 clinical trials.
  • Brynne N, Stahl MM, Hallén B eta]. Pharmacokinetics and pharmacodynamics of tolterodine in man: a new drug for the treatment of urinary bladder overactivity. Int. Clin. Pharmacol flier. 35(7), 287–295 (1997).
  • Olsson B, Szamosi J. Multiple dose pharmacokinetics of a new once daily extended release tolterodine formulation versus immediate release tolterodine. Clin. Phatmacokinet. 40(3), 227–235 (2001).
  • •In this multiple-dose study in healthy volunteers, the once-daily, ER formulation of tolterodine (4 mg) was shown to be pharmacoldnetically equivalent to the IR tablet (2 mg b.i.d.).
  • Olsson B, Szamosi J. Food does not influence the pharmacokinetics of a new extended release formulation of tolterodine once daily treatment of patients with overactive bladder. Clin. Phannacokinet. 40(2), 135–143 (2001).
  • Olsson B, Brynne N, Johansson C. Food increases the bioavailability of tolterodine but not effective exposure. I Clin. Pharmacol 41(3), 298–304 (2001).
  • Pahlman I, Gozzi P. Serum protein binding of tolterodine and its major metabolites in humans and several animal species. Biopharm. Drug Dispos. 20(2), 91–99 (1999).
  • Pharmacia & Upjohn. Detrol tolterodine tartrate tablets prescribing information. Pharmacia & Upjohn Co., Kalamazoo, MI, USA (2001).
  • Pharmacia & Upjohn. Detrol LA tolterodine tartrate extended release capsules prescribing information. Pharmacia & Upjohn Co., Kalamazoo, MI, USA (2000).
  • Brynne N, Bottiger Y, Hallen B, Bertilsson L. Tolterodine does not affect the human in vivo metabolism of the probe drugs caffeine, debrisoquine and omeprazole. BE Clin. Pharmacol 47 (2), 145–150 (1999).
  • Brynne N, Apéria B, Aberg-Wistedt etal Inhibition of tolterodine metabolism by fluoxetine with minor change in antimuscarinic activity. Eur. I Clin. Pharmacol 52 (Suppl. A),130 (1997).
  • Brynne N, Forslund C, Hallen B, Gustafsson LL, Bertilsson L. Ketoconazole inhibits the metabolism of tolterodine in subjects with deficient CYP2D6 activity. Brj Clin Pharmacol 48 (4), 564–572 (1999).
  • •In healthy volunteers, ketoconazole (an inhibitor of CY P450 3A4) significantly increased serum tolterodine concentrations in poor metabolizers showing the need for tolterodine dosage adjustment in patients receiving drugs known to inhibit CY P450 3A4.
  • Rentzhog L, Stanton SL, Cardozo L, Nelson E, Fall M, Abrams P. Efficacy and safety of tolterodine in patients with detrusor instability: a dose-ranging study. BE I U1191. 81(1), 42–48 (1998).
  • Van Kerrebroeck PE, Amarenco G, Thuroff JW eta]. Dose-ranging study of tolterodine in patients with detrusor hyper-reflexia. Neumurol Uroclyn. 17(5), 499–512 (1998).
  • Jonas U, Hofner K, Madesbacher 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. The International Study Group. Worldj Ural 15 (2), 144–151 (1997).
  • Jacquetin B, Wyndaele J-J. Tolterodine reduces the number of urge incontinence episodes in patients with an overactive bladder. Eur. j Obstet. Cynecol Reprod Biol. 98(1), 97–102 (2001).
  • Malone-Lee JG, Walsh JB, Maugourd ME and the Tolterodine in the Elderly Study Group. Tolterodine: a safe and effective treatment for older patients with overactive bladder. Am. Ceriatr Soc. 49(6), 700–705 (2001).
  • •This placebo-controlled Phase III trial showed that tolterodine IR, particularly 2 mg b.i.d., was effective with no safety concerns in elderly (65 years) OAB patients.
  • Van Kerrebroeck PEVA, Sermant G. Clinical efficacy and safety of tolterodine compared to oxybutynin in patients with overactive bladder. Neurourol Urodyn. 16(5), 478–479 (1997).
  • Millard R, Tuttle J, Moore K etal Clinical efficacy and safety of tolterodine compared to placebo in detrusor overactivity. j Ural 161 (5), 1551–1555 (1999).
  • Van Kerrebroeck PE, 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 the overactive bladder. Urology57 (3), 414–421 (2001).
  • ••First published paper of the clinicalefficacy and tolerability of the once-daily, ER formulation of tolterodine in OAB.
  • Appell RA, Abrams P, Drutz HP etal Treatment of overactive bladder: long-term tolerability and efficacy of tolterodine. World J. Ural 19 (2), 141–147 (2001).
  • Abrams P, Malone-Lee J, Jacquetin B et al. Twelve-month treatment of overactive bladder: efficacy and tolerability of tolterodine. Drugs Aging- 18 (7), 551–560 (2001).
  • •This extension study of four 4-week trials, showed a high proportion of patients with OAB completing 12 months, open-label therapy with tolterodine IR 2 mg b.i.d.
  • Kreder K, Mayne C, Jonas U. Long-term safety, tolerability and efficacy of extended-release tolterodine in the treatment of overactive bladder. Eur Ural 41(6), 588–595 (2002).
  • •This large trial shows that the favourable safety, tolerability and efficacy of tolterodine ER is maintained over 12 months in OAB patients.
  • Coyne K, Matza L. Validation of the patient perception of bladder condition measure in overactive bladder. Proceedings of the International Continence Society 32nd Annual Meeting, Heidelberg, Germany, August 28–30 (2002).
  • Appell RA. Clinical efficacy and safety of tolterodine in the treatment of overactive bladder: a pooled analysis. Urology 50(Suppl. 6A), 90–96 (1997).
  • ••Pooled analysis of the safety efficacy andtolerability of tolterodine (1 or 2 mg b.i.d.) in four 12-week, Phase III trials in patients with OAB. Tolterodine was compared with oxybutynin in three rials.
  • Swift S. Overactive bladder in females: treatment with once-daily tolterodine. Int. Urogynecol J. Pelvic Roar Dysfunct. 12\(Suppl. 3), S71. (2001).
  • Malone-Lee JG. The efficacy, tolerability and safety profile of tolterodine in the treatment of overactive/unstable bladder. Rev Contemp. Pharmacother. 11(1), 29–42 (2000).
  • Guay DR. Tolterodine, a new antimuscarinic drug for treatment of bladder overactivity. Pharmacotherapy 19(3), 267–280 (1999).
  • Schwantes U, Topfmeier P Importance of pharmacological and physicochemical properties for tolerance of antimuscarinic drugs in the treatment of detrusor instability and detrusor hyperreflexia-chances for improvement of therapy. int. Clin. Pharmacol Ther. 37,209–218 (1999).
  • Goessl C, Sauter T, Michael T, Berge B, Staehler M, Miller K. Efficacy and tolerability of tolterodine in children with detrusor hyperreflexia. Urology 55 (3), 414–418 (2000).
  • •First published study of tolterodine in children with detrusor hyper-reflexia showed the drug to be well-tolerated and urodynamically effective.
  • Hjälmás. K, Hellström AL, Mogren K, Lackgren G, Stenberg A. The overactive bladder in children: a potential future indication for tolterodine. BJU/nt. 87(6), 569–574 (2001).
  • Malone-Lee J, Shaffu B, Anand C, Powell C. Tolterodine: superior tolerability than and comparable efficacy to oxybutynin in individuals 50 years old or older with overactive bladder: a randomized controlled trial.j Ural 165 (5), 1452–1456 (2001).
  • Munding M, Wessells H, Thornberry B, Riden D. Use of tolterodine in children with dysfunctional voiding: an initial report. 1 Ural 165(3), 926–928 (2001).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.