Benefit-risk assessment of tolterodine in the treatment of overactive bladder in adults

Drug Safety

Volumn 27, Issue 13, 2004, Pages 1043-1057

  Garely, Alan D ^a,c   Burrows, Lara ^b  

^a WINTHROP UNIVERSITY HOSPITAL   (United States)

^b UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^c NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA ADRENERGIC RECEPTOR STIMULATING AGENT; ANTICOAGULANT AGENT; ANTIFUNGAL AGENT; BETA ADRENERGIC RECEPTOR STIMULATING AGENT; BOTULINUM TOXIN; CAPSAICIN; CHOLINESTERASE INHIBITOR; CYCLOSPORIN; DARIFENACIN; EMEPRONIUM BROMIDE; ESTROGEN; FLAVOXATE; FLUOXETINE; GESTAGEN; KETOCONAZOLE; MACROLIDE; MUSCARINIC RECEPTOR BLOCKING AGENT; ORAL CONTRACEPTIVE AGENT; OXYBUTYNIN; POTASSIUM CHANNEL STIMULATING AGENT; PROPIVERINE; RESINIFERATOXIN; RIVASTIGMINE; SOLIFENACIN; TACHYKININ RECEPTOR ANTAGONIST; TOLTERODINE; TROSPIUM CHLORIDE; UNINDEXED DRUG; VINBLASTINE; WARFARIN;

ABDOMINAL PAIN; ALZHEIMER DISEASE; AMNESIA; BLADDER FUNCTION; BRADYCARDIA; BREAST CANCER; CONFUSION; CONSTIPATION; CONTROLLED STUDY; CONVULSION; DIZZINESS; DRUG EFFICACY; DRUG FORMULATION; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DYSPEPSIA; DYSURIA; ENDOMETRIUM CANCER; ESTROGEN THERAPY; FATIGUE; FLATULENCE; GASTROESOPHAGEAL REFLUX; GASTROINTESTINAL HEMORRHAGE; GERIATRIC PATIENT; HALLUCINATION; HEADACHE; HEART ATRIUM FIBRILLATION; HEART FAILURE; HEART VENTRICLE ARRHYTHMIA; HUMAN; HYPERTENSION; ILEUS; KIDNEY DISEASE; LACTATION; LIVER DISEASE; MAJOR CLINICAL STUDY; MEMORY DISORDER; OVERACTIVE BLADDER; PERIPHERAL EDEMA; POSTMARKETING SURVEILLANCE; PREGNANCY; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SOMNOLENCE; SPINAL CORD INJURY; SYNCOPE; TRANSIENT ISCHEMIC ATTACK; URINE INCONTINENCE; VAGINA ATROPHY; VERTIGO; VISUAL HALLUCINATION; XEROSTOMIA;

ADULT; AGED; BENZHYDRYL COMPOUNDS; CONSTIPATION; CRESOLS; FEMALE; HUMANS; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; PHENYLPROPANOLAMINE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS; RISK ASSESSMENT; URINARY INCONTINENCE;

EID: 8444236332     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200427130-00005     Document Type: Review

References (65)

1. Nilvebrant L, Andersson KE, Gillberg PG, et al. Tolterodine: a new bladder-selective antimuscarinic agent. Eur J Pharmacol 1997: 327: 195-207
2. 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 (5): 990-8
3. Olsson B, Szamosi J. Multiple dose pharmacokinetics of a new once daily extended release tolterodine formulation versus immediate release tolterodine. Clin Pharmacokinet 2001; 40 (3): 227-35
4. Van Kerrebroeck P, Kreder K, Jonas U, et al. Tolterodine once-daily: superior efficacy and tolerability in the treatment of the overactive bladder. Urology 2001; 57 (3): 414-21
5. Periodic Safety Update Report (PSUR) for Detrusitol/Detrol tablets and Detrusitol/Detrol prolonged-release capsules (tolterodine). Period covered: 2002 Sep 06 through 2003 Mar 5. North Peapack (NJ): Pharmacia Corporation, 2003
6. Garnett S, Abrams P. The natural history of the overactive bladder and detrusor overactivity: a review of the evidence regarding the long-term outcome of the overactive bladder. J Urol 2003; 169 (3): 843-8
7. Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003; 20 (6): 327-36
8. Milsom I, Abrams P, Cardozo L, et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 2001; 87 (9): 760-6
9. Scientific Committee of the First International Consultation on Incontinence. Assessment and treatment of urinary incontinence. Lancet 2000: 355 (9221): 2153-8
10. Jonas U, Hofner K, Madersbacher H, et al. 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. World J Urol 1997; 15 (2): 144-51
11. Van Kerrebroeck PE, Amarenco G, Thuroff JW, et al. Dose-ranging study of tolterodine in patients with detrusor hyperreflexia. Neurourol Urodyn 1998: 17 (5): 499-512
12. Rentzhog L, Stanton SL, Cardozo L, et al. Efficacy and safety of tolterodine in patients with detrusor instability: a dose-ranging study. Br J Urol 1998; 81 (1): 42-8
13. 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 (6): 700-5
14. 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 (5): 799-807
15. Chancellor MB, Freedman S, Mitcheson HD, et al. Tolterodine, an effective and well tolerated treatment for urge incontinence and other overactive bladder symptoms. Clin Drug Invest 2000; 19 (2): 83-91
16. Freeman R, Hill S, Millard R, et al. Reduced perception of urgency in treatment of overactive bladder with extended-release tolterodine. Obstet Gynecol 2003; 102 (3): 605-11
17. Millard R, Tuttle J, Moore K, et al. Clinical efficacy and safety of tolterodine compared to placebo in detrusor overactivity. J Urol 1999; 161 (5): 1551-5
18. Drutz HP, Appell RA, Gleason D, et al. Clinical efficacy and safety of tolterodine compared to oxybutynin and placebo in patients with overactive bladder. Int Urogynecol J Pelvic Floor Dysfunct 1999; 10 (5): 283-9
19. Abrams P, Freeman R, Anderstrom C, et al. Tolterodine, a new antimuscarinic agent: as effective but better tolerated than oxybutynin in patients with an overactive bladder. Br J Urol 1998; 81 (6): 801-10
20. Jacquetin B, Wyndaele J. Tolterodine reduces the number of urge incontinence episodes in patients with an overactive bladder. Eur J Obstet Gynecol Reprod Biol 2001; 98 (1): 97-102
21. Abrams P, Malone-Lee J, Jacquetin B, et al. Twelve-month treatment of overactive bladder: efficacy and tolerability of tolterodine. Drugs Aging 2001; 18 (7): 551-60
22. Appell RA, Abrams P, Drutz HP, et al. Treatment of overactive bladder: long-term tolerability and efficacy of tolterodine. World J Urol 2001; 19 (2): 141-7
23. Kreder K, Mayne C, Jonas U. Long-term safety, tolerability and efficacy of extended-release tolterodine in the treatment of overactive bladder. Eur Urol 2002; 41 (6): 588-95
24. Kelleher CJ, Reese PR, Pleil AM, et al. Health-related quality of life of patients receiving extended-release tolterodine for overactive bladder. Am J Manag Care 2002; 8 (19 Suppl.): S608-15
25. Kelleher CJ, Kreder KJ, Pleil AM, et al. Long-term health-related quality of life of patients receiving extended-release tolterodine for overactive bladder. Am J Manag Care 2002; 8 (19 Suppl.): S616-30
26. Mattiasson A, Blaakaer J, Hoye K, et al. Simplified bladder training augments the effectiveness of tolterodine in patients with an overactive bladder. BJU Int 2003; 91 (1): 54-60
27. Appell RA. Clinical efficacy and safety of tolterodine in the treatment of overactive bladder: a pooled analysis. Urology 1997; 50 (6A Suppl.): 90-6
28. Malone-Lee J, Shaffu B, Anand C, et al. Tolterodine: superior tolerability than and comparable efficacy to oxybutynin in individuals 50 years old or older with overactive bladder: a randomized controlled trial. J Urol 2001; 165 (5): 1452-6
29. Lee JG, Hong JY, Choo MS, et al. Tolterodine: as effective but better tolerated than oxybutynin in Asian patients with symptoms of overactive bladder. Int J Urol 2002; 9 (5): 247-52
30. Leung HY, Yip SK, Cheon C, et al. A randomized controlled trial of tolterodine and oxybutynin on tolerability and clinical efficacy for treating Chinese women with an overactive bladder. BJU Int 2002; 90 (4): 375-80
31. Appell RA, Sand P, Dmochowski R, et al. 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 (4): 358-63
32. Diokno AC, Appell RA, Sand PK, et al. 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 (6): 687-95
33. Sussman D, Garely A. Treatment of overactive bladder with once-daily extended-release tolterodine or oxybutynin: the antimuscarinic clinical effectiveness trial (ACET). Curr Med Res Opin 2002; 18 (4): 177-84
34. Junemann KP, Halaska M, Rittstein T, et al. Propiverine vs tolterodine: efficacy and tolerability in patients with detrusor overactivity [abstract]. International Continence Society; 2003 Oct 5-9; Florence
35. Junemann KP, Al-Shukr S. Efficacy and tolerability of trospium chloride and tolterodine in 234 patients with urge syndrome: a double-blind, placebo-controlled, multicentre clinical trial [abstract]. International Continence Society; 2000 Aug 27-Sep 3; Tampere
36. Chapple CR, Parkhouse H, Gardener C, et al. Double-blind, placebo-controlled, cross-over study of flavoxate in the treatment of idiopathic detrusor instability. Br J Urol 1990; 66 (5): 491-4
37. Briggs RS, Castleden CM, Asher MJ. The effect of flavoxate on uninhibited detrusor contractions and urinary incontinence in the elderly. J Urol 1980; 123 (5): 665-6
38. Alhasso A, Glazener CM, Pickard R, et al. Adrenergic drugs for urinary incontinence in adults. Cochrane Database Syst Rev 2003; (2): CD001842
39. Moehrer B, Hextall A, Jackson S. Oestrogens for urinary incontinence in women. Cochrane Database Syst Rev 2003; (2): CD001405
40. Crandall C. Vaginal estrogen preparations: a review of safety and efficacy for vaginal atrophy. J Womens Health (Larchmt) 2002; 11 (10): 857-77
41. Yoshimura N, Chancellor MB. Current and future pharmacological treatment for overactive bladder. J Urol 2002; 168 (5): 1897-913
42. Schurch B, Stohrer M, Kramer G, et al. Botulinum-A toxin for treating detrusor hyperreflexia in spinal cord injured patients: a new alternative to anticholinergic drugs? Preliminary results. J Urol 2000; 164 (3 Pt 1): 692-7
43. Giannantoni A, Di Stasi SM, Stephen RL, et al. Intravesical capsaicin versus resiniferatoxin in patients with detrusor hyperreflexia: a prospective randomized study. J Urol 2002; 167 (4): 1710-4
44. PSUR Bridging Summary Report for Detrusitol/Detrol. Peapack (NJ): Pharmacia Corporation, 2002
45. Periodic Safety Update Report (PSUR) for Detrusitol/Detrol tablets and Detrusitol/Detrol prolonged-release capsules (tolterodine). Period covered: 2002 Mar 6 through 2002 Sep 2. North Peapack (NJ): Pharmacia Corporation, 2002
46. Detrol® (tolterodine tartrate tablets): full prescribing information. Kalamazoo (MI): Pharmacia and Upjohn Company, 2003
47. Detrol® LA (tolterodine tartrate extended release capsules): full prescribing information. Kalamazoo (MI): Pharmacia and Upjohn Company, 2003
48. Chancellor MB, Appell RA, Sathyan G, et al. A comparison of the effects on saliva output of oxybutynin chloride and tolterodine tartrate. Clin Ther 2001; 23 (5): 753-60
49. Chapple CR, Nilvebrant L. Tolterodine: selectivity for the urinary bladder over the eye (as measured by visual accommodation) in healthy volunteers. Drugs R D 2002; 3 (2): 75-81
50. Charach G, Greenstein A, Rabinovich P, et al. Alleviating constipation in the elderly improves lower urinary tract symptoms. Gerontology 2001; 47 (2): 72-6
51. Layton D, Pearce GL, Shakir SA. Safety profile of tolterodine as used in general practice in England: results of prescription-event monitoring. Drug Saf 2001; 24 (9): 703-13
52. Todorova A, Vonderheid-Guth B, Dimpfel W. Effects of tolterodine, trospium chloride, and oxybutynin on the central nervous system. J Clin Pharmacol 2001; 41 (6): 636-44
53. Clemett D, Jarvis B. Tolterodine: a review of its use in the treatment of overactive bladder. Drugs Aging 2001; 18 (4): 277-304
54. Abrams P. Evidence for the efficacy and safety of tolterodine in the treatment of overactive bladder. Expert Opin Pharmacother 2001; 2 (10): 1685-701
55. Brynne N, Stahl MM, Hallen B, et al. Pharmacokinetics and pharmacodynamics of tolterodine in man: a new drug for the treatment of urinary bladder overactivity. Int J Clin Pharmacol Ther 1997; 35 (7): 287-95
56. Brynne N, Bottiger Y, Hallen B, et al. Tolterodine does not affect the human in vivo metabolism of the probe drugs caffeine, debrisoquine and omeprazole. Br J Clin Pharmacol 1999; 47 (2): 145-50
57. Brynne N, Forslund C, Hallen B, et al. Ketoconazole inhibits the metabolism of tolterodine in subjects with deficient CYP2D6 activity. Br J Clin Pharmacol 1999; 48 (4): 564-72
58. Brynne N, Dalen P, Alvan G, et al. Influence of CYP2D6 polymorphism on the pharmacokinetics and pharmacodynamic of tolterodine. Clin Pharmacol Ther 1998; 63 (5): 529-39
59. Rahimy M, Hallen B, Narang P. Effect of tolterodine on the anticoagulant actions and pharmacokinetics of single-dose warfarin in healthy volunteers. Arzneimittel Forschung 2002; 52 (12): 890-5
60. Olsson B, Landgren BM. The effect of tolterodine on the pharmacokinetics and pharmacodynamics of a combination oral contraceptive containing ethinyl estradiol and levonorgestrel. Clin Ther 2001; 23 (11): 1876-88
61. Spina E, Pisani F, Perucca E. Clinically significant pharmacokinetic drug interactions with carbamazepine: an update. Clin Pharmacokinet 1996; 31 (3): 198-214
62. Brynne N, Svanstrom C, Aberg-Wistedt A, et al. Fluoxetine inhibits the metabolism of tolterodine-pharmacokinetic implications and proposed clinical relevance. Br J Clin Pharmacol 1999; 48 (4): 553-63
63. Edwards KR, O'Connor JT. Risk of delirium with concomitant use of tolterodine and acetylcholinesterase inhibitors. J Am Geriatr Soc 2002; 50 (6): 1165-6
64. Ciancio SG. Medications as a risk factor for caries and periodontal disease. N Y State Dent J 1997; 63 (8): 32-6
65. Lenander-Lumikari M, Loimaranta V. Saliva and dental caries. Adv Dent Res 2000; 14: 40-7