PMID- 17333521
OWN - NLM
STAT- MEDLINE
DCOM- 20080325
LR  - 20181113
IS  - 0301-1623 (Print)
IS  - 0301-1623 (Linking)
VI  - 39
IP  - 4
DP  - 2007
TI  - Safety and tolerability of extended-release oxybutynin once daily in urinary 
      incontinence: combined results from two phase 4 controlled clinical trials.
PG  - 1069-77
AB  - Early studies of extended-release oxybutynin in patients with overactive bladder 
      used adjusted-dose regimens ranging from 5 to 30 mg/day to achieve an optimal 
      balance of efficacy and tolerability. The safety and tolerability of 
      extended-release oxybutynin at a fixed dose of 10 mg once daily (commonly 
      prescribed in clinical practice) is reported using pooled data from 2 
      multicenter, randomized, double-blind, parallel-group trials with a similar study 
      design. One study compared extended-release oxybutynin with immediate-release 
      tolterodine 2 mg bid. The other study compared extended-release oxybutynin with 
      extended-release tolterodine 4 mg qd. In total, 576 patients received 
      extended-release oxybutynin, 399 received extended-release tolterodine, and 193 
      received immediate-release tolterodine. The incidence of adverse events (AEs) was 
      similar in the three treatment groups (extended-release oxybutynin, 70%; 
      extended-release tolterodine, 64%; and immediate-release tolterodine, 79%). The 
      most common adverse event was dry mouth (extended-release oxybutynin, 29%; 
      extended-release tolterodine, 22%; and immediate-release tolterodine, 33%). Other 
      AEs occurring in more than 5% of patients in any treatment group included 
      constipation, diarrhea, headache, urinary tract infection, pain, dyspepsia, and 
      peripheral edema, with no apparent difference across treatment groups. Most AEs 
      (>90%) were mild or moderate in intensity in all treatment groups. The proportion 
      of patients who discontinued study medication due to AEs was 6.1, 4.8, and 7.8% 
      in the extended-release oxybutynin, extended-release tolterodine, and 
      immediate-release tolterodine groups, respectively. In total, 1.2, 1.0, and 1.6% 
      of patients in the extended-release oxybutynin, extended-release tolterodine, and 
      immediate-release tolterodine groups, respectively, discontinued study medication 
      due to dry mouth.
FAU - Armstrong, Robert B
AU  - Armstrong RB
AD  - Ortho-McNeil Neurologics, Inc., 1125 Trenton-Harbourton Road, Titusville, NJ 
      08560-0200, USA. rarmstro@ompus.jnj.com
FAU - Dmochowski, Roger R
AU  - Dmochowski RR
FAU - Sand, Peter K
AU  - Sand PK
FAU - Macdiarmid, Scott
AU  - Macdiarmid S
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20070302
PL  - Netherlands
TA  - Int Urol Nephrol
JT  - International urology and nephrology
JID - 0262521
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Cresols)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Mandelic Acids)
RN  - 0 (Muscarinic Antagonists)
RN  - 33RU150WUN (Phenylpropanolamine)
RN  - 5T619TQR3R (Tolterodine Tartrate)
RN  - K9P6MC7092 (oxybutynin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Benzhydryl Compounds/*administration & dosage/*adverse effects
MH  - Cresols/*administration & dosage/*adverse effects
MH  - Delayed-Action Preparations
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Mandelic Acids/*administration & dosage/*adverse effects
MH  - Middle Aged
MH  - Muscarinic Antagonists/*administration & dosage/*adverse effects
MH  - Phenylpropanolamine/*administration & dosage/*adverse effects
MH  - Prospective Studies
MH  - Tolterodine Tartrate
MH  - Treatment Outcome
MH  - Urinary Incontinence/*drug therapy
EDAT- 2007/03/03 09:00
MHDA- 2008/03/26 09:00
CRDT- 2007/03/03 09:00
PHST- 2006/07/25 00:00 [received]
PHST- 2006/11/13 00:00 [accepted]
PHST- 2007/03/03 09:00 [pubmed]
PHST- 2008/03/26 09:00 [medline]
PHST- 2007/03/03 09:00 [entrez]
AID - 10.1007/s11255-006-9157-7 [doi]
PST - ppublish
SO  - Int Urol Nephrol. 2007;39(4):1069-77. doi: 10.1007/s11255-006-9157-7. Epub 2007 
      Mar 2.