PMID- 17892634
OWN - NLM
STAT- MEDLINE
DCOM- 20080116
LR  - 20190911
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 23
IP  - 11
DP  - 2007 Nov
TI  - Long-term darifenacin treatment for overactive bladder in patients aged 65 years 
      and older: analysis of results from a 2-year, open-label extension study.
PG  - 2697-704
AB  - OBJECTIVES: This analysis evaluated the long-term safety, tolerability and 
      efficacy of darifenacin, a muscarinic M3 selective receptor antagonist, in the 
      treatment of overactive bladder (OAB) in patients > or = 65 years of age. 
      METHODS: Patients who completed one of two 12-week, placebo-controlled, 
      double-blind, feeder studies received once-daily (o.d.) treatment with 
      darifenacin 7.5 mg for the first 2 weeks of the 2-year, open-label extension 
      study. The dose could be subsequently adjusted (7.5 or 15 mg o.d.) according to 
      need. Safety and tolerability were assessed, and efficacy variables/endpoints 
      were evaluated from patient diary data. RESULTS: 214 patients (65-89 years) 
      entered and 137 (64.0%) completed the 2-year extension study, amounting to 308 
      patient-years' drug exposure. Darifenacin was well tolerated with no new safety 
      concerns. The most common adverse events (AEs) were dry mouth and constipation, 
      which infrequently resulted in discontinuation (2.3% and 4.2%, respectively). 
      Darifenacin produced significant improvements in OAB symptoms that were 
      maintained over the 2-year period (median reduction from feeder-study baseline to 
      2 years: -11.0 [-83.7%] for incontinence episodes/week and -1.2 [-12.4%] for 
      micturitions/day, both p < 0.05), with 44.4% patients achieving > or = 90% 
      reduction in incontinence episodes at 2 years. CONCLUSIONS: Darifenacin 
      demonstrated good tolerability and safety in older patients with OAB. The 
      improvement in OAB symptoms was sustained throughout the 2-year extension, 
      resulting in high treatment persistence rates. Results were comparable with those 
      in the overall OAB population from this study, indicating that darifenacin 
      treatment is effective and well tolerated irrespective of age.
FAU - Hill, Simon
AU  - Hill S
AD  - Royal Blackburn Hospital, Blackburn, UK. simon.hill@elht.nhs.uk
FAU - Elhilali, Mostafa
AU  - Elhilali M
FAU - Millard, Richard J
AU  - Millard RJ
FAU - Dwyer, Peter L
AU  - Dwyer PL
FAU - Lheritier, Karine
AU  - Lheritier K
FAU - Kawakami, Fernando T
AU  - Kawakami FT
FAU - Steel, Michael
AU  - Steel M
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Benzofurans)
RN  - 0 (Muscarinic Antagonists)
RN  - 0 (Placebos)
RN  - 0 (Pyrrolidines)
RN  - APG9819VLM (darifenacin)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Benzofurans/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Muscarinic Antagonists/*therapeutic use
MH  - Placebos
MH  - Pyrrolidines/*therapeutic use
MH  - Urinary Bladder, Overactive/*drug therapy
EDAT- 2007/09/26 09:00
MHDA- 2008/01/17 09:00
CRDT- 2007/09/26 09:00
PHST- 2007/09/26 09:00 [pubmed]
PHST- 2008/01/17 09:00 [medline]
PHST- 2007/09/26 09:00 [entrez]
AID - 10.1185/030079907x233160 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2007 Nov;23(11):2697-704. doi: 10.1185/030079907x233160.