PMID- 27046653
OWN - NLM
STAT- MEDLINE
DCOM- 20170928
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 32
IP  - 8
DP  - 2016 Aug
TI  - Safety and efficacy of fesoterodine fumarate in patients with overactive bladder: 
      results of a post-marketing surveillance study in Korea.
PG  - 1361-6
LID - 10.1080/03007995.2016.1174680 [doi]
AB  - OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of 
      fesoterodine fumarate (fesoterodine; Toviaz ) in Korean patients with overactive 
      bladder (OAB) in routine clinical practice. METHODS: This was an open-label, 
      non-interventional, prospective, post-marketing surveillance study submitted to 
      the Korean Ministry of Food and Drug Safety. A total of 3109 patients aged >/=18 
      years with OAB symptoms were prescribed flexible doses of fesoterodine at the 
      investigator's discretion. Safety was assessed based upon the reporting of 
      adverse events (AEs). Efficacy was evaluated on the basis of patient 
      self-assessment using a bladder diary as well as on the basis of investigator 
      assessment in terms of overall clinical efficacy. RESULTS: A final analysis was 
      performed on 3107 (99.9%) and 2978 (95.8%) patients for safety and efficacy 
      analysis, respectively. The mean treatment duration of fesoterodine was 83.2 
      days. The incidence of AEs was 8.5% (265/3107). Common AEs that accounted for 
      more than 1.0% of the total AE incidence included dry mouth (5.4%, 168/3107), 
      constipation (1.5%, 48/3107) and micturition disorder (1.1%, 35/3107). Mean 
      episodes of urinary frequency, urgency, and urgency urinary incontinence (UUI) 
      per 24 hours decreased by 4.0, 2.4, and 0.8, respectively (all p < 0.001). At the 
      final follow-up visit, the investigators found improvement in clinical efficacy 
      for the majority of patients (90.1%, 2684/2978). Limitations of this study 
      include the observational study design and the relatively short treatment 
      duration. CONCLUSION: These results suggest that fesoterodine is a well tolerated 
      and effective treatment for Korean patients with OAB in routine clinical 
      practice.
FAU - Kim, Tae Heon
AU  - Kim TH
AD  - a Department of Urology , Samsung Changwon Hospital, Sungkyunkwan University 
      School of Medicine , Changwon , Korea ;
FAU - Lee, Sang Eun
AU  - Lee SE
AD  - b Department of Urology , Samsung Medical Center, Sungkyunkwan University School 
      of Medicine , Seoul , Korea ;
FAU - Lee, Hahn-Ey
AU  - Lee HE
AD  - c Pfizer Pharmaceuticals Korea Ltd. , Seoul , Korea ;
FAU - Lee, Kyu-Sung
AU  - Lee KS
AD  - b Department of Urology , Samsung Medical Center, Sungkyunkwan University School 
      of Medicine , Seoul , Korea ;
AD  - d Department of Medical Device Management & Research , S.A.I.H.S.T., Sungkyunkwan 
      University , Seoul , Korea.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20160505
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Muscarinic Antagonists)
RN  - 621G617227 (fesoterodine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Benzhydryl Compounds/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Muscarinic Antagonists/adverse effects/*therapeutic use
MH  - *Product Surveillance, Postmarketing
MH  - Prospective Studies
MH  - Urinary Bladder, Overactive/*drug therapy
OTO - NOTNLM
OT  - Antimuscarinic agents
OT  - Fesoterodine
OT  - Overactive bladder
OT  - Post-marketing surveillance
EDAT- 2016/04/06 06:00
MHDA- 2017/09/29 06:00
CRDT- 2016/04/06 06:00
PHST- 2016/04/06 06:00 [entrez]
PHST- 2016/04/06 06:00 [pubmed]
PHST- 2017/09/29 06:00 [medline]
AID - 10.1080/03007995.2016.1174680 [pii]
AID - 10.1080/03007995.2016.1174680 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2016 Aug;32(8):1361-6. doi: 10.1080/03007995.2016.1174680. 
      Epub 2016 May 5.