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Efficacy, safety, and tolerability of extended-release once-daily tolterodine treatment for overactive bladder in older versus younger patients

Zinner, NR; Mattiasson, Anders LU and Stanton, SL (2002) In Journal of the American Geriatrics Society 50(5). p.799-807
Abstract
OBJECTIVES: To evaluate the efficacy, safety, and tolerability of a new, once-daily extended-release (ER) formulation of tolterodine in treating overactive bladder in older (greater than or equal to65) and younger (<65) patients. DESIGN: A 12-week double-blind, placebo-controlled clinical trial. SETTING: An international study conducted at 167 medical centers. PARTICIPANTS: One thousand fifteen patients (43.1% aged 65) with urge incontinence and urinary frequency. INTERVENTION: Patients were randomized to treatment with tolterodine ER 4 mg once daily (qd) (n = 507) or placebo (n = 508) for 12 weeks. MEASUREMENTS: Efficacy, measured with micturition charts (incontinence episodes, micturitions, volume voided per micturition) and... (More)
OBJECTIVES: To evaluate the efficacy, safety, and tolerability of a new, once-daily extended-release (ER) formulation of tolterodine in treating overactive bladder in older (greater than or equal to65) and younger (<65) patients. DESIGN: A 12-week double-blind, placebo-controlled clinical trial. SETTING: An international study conducted at 167 medical centers. PARTICIPANTS: One thousand fifteen patients (43.1% aged 65) with urge incontinence and urinary frequency. INTERVENTION: Patients were randomized to treatment with tolterodine ER 4 mg once daily (qd) (n = 507) or placebo (n = 508) for 12 weeks. MEASUREMENTS: Efficacy, measured with micturition charts (incontinence episodes, micturitions, volume voided per micturition) and subjective patient assessments, safety, and tolerability endpoints were evaluated, relative to placebo, according to two age cohorts: younger than 65 and 65 and older. RESULTS: Mean age in the older and younger patient cohorts was 74 (range 65-93) and 51 (range 20-64), respectively. Compared with placebo, significant improvements in micturition chart variables with tolterodine ER showed no age-related differences. Irrespective of age, significantly more tolterodine ER recipients than placebo recipients reported an improvement in urgency symptoms. After 12 weeks of treatment with tolterodine ER, a fivefold increase in the percentage of patients able to finish tasks before voiding in response to urgency was noted in both age groups (<65: from 6.5-32.8%, greater than or equal to65: from 5.1-26.2%). Tolterodine ER recipients, irrespective of age, also had significant improvements in their bladder condition than did placebo recipients. Overall, a greater percentage of patients, irrespective of age, perceived any benefit with tolterodine ER than with placebo (P<.001). Dry mouth (of an), severity was the most common adverse event in both the tolterodine ER and placebo treatment arms, irrespective of age (<65: ER 22.7%, placebo 8.1%; greater than or equal to65: ER 24.3%, placebo 7.2%). Few patients (<2%) experienced severe dry mouth. No central nervous system, visual, cardiac (per electrocardiogram), or laboratory safety concerns were noted. Withdrawal rates due to adverse events on tolterodine ER 4 mg qd were comparable in the two age cohorts (<65: 5.5%; greater than or equal to65: 5.1%; P = .8 7). CONCLUSIONS: The new, once-daily ER formulation of tolterodine is efficacious, safe, and well tolerated in the treatment of patients with symptoms of overactive bladder, irrespective of age. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
urinary incontinence, older adults, tolterodine, overactive bladder
in
Journal of the American Geriatrics Society
volume
50
issue
5
pages
799 - 807
publisher
Wiley-Blackwell
external identifiers
  • pmid:12028164
  • wos:000175435500003
  • scopus:0036252468
ISSN
0002-8614
DOI
10.1046/j.1532-5415.2002.50203.x
language
English
LU publication?
yes
id
ad5076b7-7f97-41ec-991f-fc4f1caf8029 (old id 338546)
date added to LUP
2007-11-09 16:31:35
date last changed
2017-08-20 03:29:58
@article{ad5076b7-7f97-41ec-991f-fc4f1caf8029,
  abstract     = {OBJECTIVES: To evaluate the efficacy, safety, and tolerability of a new, once-daily extended-release (ER) formulation of tolterodine in treating overactive bladder in older (greater than or equal to65) and younger (&lt;65) patients. DESIGN: A 12-week double-blind, placebo-controlled clinical trial. SETTING: An international study conducted at 167 medical centers. PARTICIPANTS: One thousand fifteen patients (43.1% aged 65) with urge incontinence and urinary frequency. INTERVENTION: Patients were randomized to treatment with tolterodine ER 4 mg once daily (qd) (n = 507) or placebo (n = 508) for 12 weeks. MEASUREMENTS: Efficacy, measured with micturition charts (incontinence episodes, micturitions, volume voided per micturition) and subjective patient assessments, safety, and tolerability endpoints were evaluated, relative to placebo, according to two age cohorts: younger than 65 and 65 and older. RESULTS: Mean age in the older and younger patient cohorts was 74 (range 65-93) and 51 (range 20-64), respectively. Compared with placebo, significant improvements in micturition chart variables with tolterodine ER showed no age-related differences. Irrespective of age, significantly more tolterodine ER recipients than placebo recipients reported an improvement in urgency symptoms. After 12 weeks of treatment with tolterodine ER, a fivefold increase in the percentage of patients able to finish tasks before voiding in response to urgency was noted in both age groups (&lt;65: from 6.5-32.8%, greater than or equal to65: from 5.1-26.2%). Tolterodine ER recipients, irrespective of age, also had significant improvements in their bladder condition than did placebo recipients. Overall, a greater percentage of patients, irrespective of age, perceived any benefit with tolterodine ER than with placebo (P&lt;.001). Dry mouth (of an), severity was the most common adverse event in both the tolterodine ER and placebo treatment arms, irrespective of age (&lt;65: ER 22.7%, placebo 8.1%; greater than or equal to65: ER 24.3%, placebo 7.2%). Few patients (&lt;2%) experienced severe dry mouth. No central nervous system, visual, cardiac (per electrocardiogram), or laboratory safety concerns were noted. Withdrawal rates due to adverse events on tolterodine ER 4 mg qd were comparable in the two age cohorts (&lt;65: 5.5%; greater than or equal to65: 5.1%; P = .8 7). CONCLUSIONS: The new, once-daily ER formulation of tolterodine is efficacious, safe, and well tolerated in the treatment of patients with symptoms of overactive bladder, irrespective of age.},
  author       = {Zinner, NR and Mattiasson, Anders and Stanton, SL},
  issn         = {0002-8614},
  keyword      = {urinary incontinence,older adults,tolterodine,overactive bladder},
  language     = {eng},
  number       = {5},
  pages        = {799--807},
  publisher    = {Wiley-Blackwell},
  series       = {Journal of the American Geriatrics Society},
  title        = {Efficacy, safety, and tolerability of extended-release once-daily tolterodine treatment for overactive bladder in older versus younger patients},
  url          = {http://dx.doi.org/10.1046/j.1532-5415.2002.50203.x},
  volume       = {50},
  year         = {2002},
}