PMID- 23765630
OWN - NLM
STAT- MEDLINE
DCOM- 20141112
LR  - 20220408
IS  - 1520-6777 (Electronic)
IS  - 0733-2467 (Linking)
VI  - 33
IP  - 3
DP  - 2014 Mar
TI  - Efficacy and safety of repeated dosing of netupitant, a neurokinin-1 receptor 
      antagonist, in treating overactive bladder.
PG  - 335-40
LID - 10.1002/nau.22406 [doi]
AB  - AIM: NK-1 receptors in sensory nerves, the spinal cord and bladder smooth muscle 
      participate in complex sensory mechanisms that regulate bladder activity. This 
      study was designed to assess the efficacy and safety of a new NK-1 receptor 
      antagonist, netupitant, in patients with OAB. METHODS: This was a phase II, 
      multicenter, double-blind study in which adults with OAB symptoms >6 months were 
      randomized to receive 1 of 3 doses of netupitant (50, 100, 200 mg) or placebo 
      once daily for 8 weeks. The primary efficacy endpoint was percentage change from 
      baseline in average number of daily micturitions at week 8. Urinary incontinence, 
      urge urinary incontinence (UUI), and urgency episodes were also assessed. 
      RESULTS: The primary efficacy endpoint was similar in the treatment groups 
      (-13.85 for placebo to -16.17 in the netupitant 200 mg group) with no 
      statistically significant differences between netupitant and placebo. The same 
      was true for most secondary endpoints although a significant difference for 
      improvement in UUI episodes and a trend for the greatest decrease in urgency 
      episodes were seen in the netupitant 100 mg group. Netupitant was well tolerated 
      with most treatment emergent adverse events (AEs) being mild. While the overall 
      incidence of AEs increased with netupitant dose, there was no evidence for this 
      dose dependency based on relationship to treatment, intensity, or time to onset. 
      CONCLUSIONS: The study failed to demonstrate superiority of netupitant versus 
      placebo in decreasing OAB symptoms, despite a trend favoring netupitant 100 mg. 
      There were no safety concerns with daily administration of netupitant over 8 
      weeks.
CI  - (c) 2013 Wiley Periodicals, Inc.
FAU - Haab, F
AU  - Haab F
AD  - Department of Urology, Hopital Tenon, Paris, France.
FAU - Braticevici, B
AU  - Braticevici B
FAU - Krivoborodov, G
AU  - Krivoborodov G
FAU - Palmas, M
AU  - Palmas M
FAU - Zufferli Russo, M
AU  - Zufferli Russo M
FAU - Pietra, C
AU  - Pietra C
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20130614
PL  - United States
TA  - Neurourol Urodyn
JT  - Neurourology and urodynamics
JID - 8303326
RN  - 0 (Neurokinin-1 Receptor Antagonists)
RN  - 0 (Pyridines)
RN  - 0 (Receptors, Neurokinin-1)
RN  - 0 (Urological Agents)
RN  - 7732P08TIR (netupitant)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Europe
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neurokinin-1 Receptor Antagonists/*administration & dosage/adverse 
      effects/pharmacokinetics
MH  - Pyridines/*administration & dosage/adverse effects/pharmacokinetics
MH  - Receptors, Neurokinin-1/*drug effects/metabolism
MH  - Time Factors
MH  - Treatment Outcome
MH  - Urinary Bladder/*drug effects/metabolism/physiopathology
MH  - Urinary Bladder, Overactive/diagnosis/*drug therapy/metabolism/physiopathology
MH  - Urinary Incontinence, Urge/diagnosis/*drug therapy/metabolism/physiopathology
MH  - Urodynamics/drug effects
MH  - Urological Agents/*administration & dosage/adverse effects
MH  - Young Adult
OTO - NOTNLM
OT  - netupitant
OT  - neurokinin-1 receptors
OT  - overactive bladder
EDAT- 2013/06/15 06:00
MHDA- 2014/11/13 06:00
CRDT- 2013/06/15 06:00
PHST- 2013/12/10 00:00 [received]
PHST- 2013/03/04 00:00 [accepted]
PHST- 2013/06/15 06:00 [entrez]
PHST- 2013/06/15 06:00 [pubmed]
PHST- 2014/11/13 06:00 [medline]
AID - 10.1002/nau.22406 [doi]
PST - ppublish
SO  - Neurourol Urodyn. 2014 Mar;33(3):335-40. doi: 10.1002/nau.22406. Epub 2013 Jun 
      14.