PMID- 16879437
OWN - NLM
STAT- MEDLINE
DCOM- 20070116
LR  - 20121115
IS  - 1464-4096 (Print)
IS  - 1464-4096 (Linking)
VI  - 98
IP  - 5
DP  - 2006 Nov
TI  - Long-term treatment with darifenacin for overactive bladder: results of a 2-year, 
      open-label extension study.
PG  - 1025-32
AB  - OBJECTIVE: To examine, in a 2-year, non-comparative, open-label extension study, 
      the safety, tolerability and efficacy of darifenacin controlled-release (CR) 
      7.5/15 mg once daily in patients with overactive bladder (OAB) who completed two 
      12-week randomized, double-blind, placebo-controlled 'feeder' studies. PATIENTS 
      AND METHODS: Patients entering the extension received darifenacin 7.5 mg once 
      daily for 2 weeks, after which a voluntary increase in dose to 15 mg was 
      permitted. Thereafter, patients could adjust the dose (either 7.5 or 15 mg). 
      Safety and tolerability were assessed from adverse events (AEs) and 
      discontinuations. Efficacy was determined using various endpoints. RESULTS: In 
      all, 716 patients entered the extension (mean age 57.3 years; 85.1% women) and 
      475 (66.3%) completed it (1089.9 patient-years of exposure). Darifenacin was well 
      tolerated with no significant safety concerns. The most commonly reported AEs 
      were dry mouth and constipation (all-causality rates 23.3% and 20.9%, 
      respectively), leading to discontinuation in 1.3% and 2.4% of patients, 
      respectively. Constipation infrequently required intervention, and analysis of 
      bowel-habit questionnaires revealed that the reporting of constipation was 
      related to minor changes in bowel habit rather than true constipation. The 
      efficacy of darifenacin was maintained, including significant improvements in the 
      number of incontinence episodes/week (median change -84.4% at 2 years, P < 0.001 
      vs feeder-study baseline). After 2 years, > 40% of patients achieved a > or = 90% 
      reduction in incontinence episodes/week. CONCLUSION: In the first published 
      2-year, open-label study of a CR antimuscarinic agent, darifenacin 7.5/15 mg once 
      daily had a favourable safety, tolerability and efficacy profile during the 
      long-term treatment of OAB. As such, darifenacin represents a valuable 
      therapeutic option for OAB.
FAU - Haab, Francois
AU  - Haab F
AD  - Department d'Urologie, Hopital Tenon, Paris, France. 
      francois.haab@tnn.ap-hop-paris.fr
FAU - Corcos, Jacques
AU  - Corcos J
FAU - Siami, Paul
AU  - Siami P
FAU - Glavind, Karin
AU  - Glavind K
FAU - Dwyer, Peter
AU  - Dwyer P
FAU - Steel, Michael
AU  - Steel M
FAU - Kawakami, Fernando
AU  - Kawakami F
FAU - Lheritier, Karine
AU  - Lheritier K
FAU - Steers, William D
AU  - Steers WD
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20060728
PL  - England
TA  - BJU Int
JT  - BJU international
JID - 100886721
RN  - 0 (Benzofurans)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Muscarinic Antagonists)
RN  - 0 (Pyrrolidines)
RN  - APG9819VLM (darifenacin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Benzofurans/*administration & dosage/adverse effects
MH  - Constipation/chemically induced
MH  - Delayed-Action Preparations/administration & dosage
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Muscarinic Antagonists/*administration & dosage/adverse effects
MH  - Pyrrolidines/*administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Urinary Incontinence/*drug therapy
MH  - Xerostomia/chemically induced
EDAT- 2006/08/02 09:00
MHDA- 2007/01/17 09:00
CRDT- 2006/08/02 09:00
PHST- 2006/08/02 09:00 [pubmed]
PHST- 2007/01/17 09:00 [medline]
PHST- 2006/08/02 09:00 [entrez]
AID - BJU6439 [pii]
AID - 10.1111/j.1464-410X.2006.06439.x [doi]
PST - ppublish
SO  - BJU Int. 2006 Nov;98(5):1025-32. doi: 10.1111/j.1464-410X.2006.06439.x. Epub 2006 
      Jul 28.