PMID- 25693609
OWN - NLM
STAT- MEDLINE
DCOM- 20150813
LR  - 20181202
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Print)
IS  - 0269-2813 (Linking)
VI  - 41
IP  - 7
DP  - 2015 Apr
TI  - Randomised clinical trial: the 5-HT4 agonist revexepride in patients with 
      gastro-oesophageal reflux disease who have persistent symptoms despite PPI 
      therapy.
PG  - 649-61
LID - 10.1111/apt.13115 [doi]
AB  - BACKGROUND: A substantial proportion of patients with gastro-oesophageal reflux 
      disease (GERD) have only a partial response to proton pump inhibitor (PPI) 
      therapy. Prokinetic drugs may improve reflux symptoms by enhancing oesophageal 
      motility and gastric emptying. AIM: To evaluate the effect of revexepride, a 
      novel prokinetic 5-hydroxytryptamine type 4 (5-HT4 ) receptor agonist, compared 
      with placebo, in patients with GERD who have a partial response to PPIs. METHODS: 
      A phase 2b, double-blind, parallel-group study was conducted, in which patients 
      were randomised to one of three revexepride treatment groups (0.1, 0.5 and 2.0 mg 
      three times daily) or placebo (1:1:1:1 ratio). Daily e-diary data captured 
      patients' symptoms over an 8-week treatment period. The primary efficacy outcome 
      was the weekly percentage of regurgitation-free days in the second half of the 
      study (weeks 5-8). RESULTS: In total, 480 patients were randomised and 477 
      received treatment (mean age 47.9 years; 61% women). The mean percentage of 
      regurgitation-free days increased from baseline (range, 15.0-18.8%) to week 8 
      (62.3-70.5%) in all four study arms; however, there were no statistically 
      significant differences in this change between placebo and the three treatment 
      arms. No dose-dependent relationship in treatment effect was observed for any of 
      the study endpoints. The incidence of treatment-emergent adverse events (TEAEs) 
      was revexepride dose-dependent. Only one serious TEAE occurred and none resulted 
      in death. CONCLUSIONS: Revexepride was no more effective than placebo in 
      controlling regurgitation in patients with GERD symptoms partially responsive to 
      PPIs. Revexepride was well tolerated. ClinicalTrials.gov Identifier: NCT01472939.
CI  - (c) 2015 Shire Development LLC. Alimentary Pharmacology & Therapeutics published by 
      John Wiley & Sons Ltd.
FAU - Shaheen, N J
AU  - Shaheen NJ
AD  - Center for Esophageal Diseases and Swallowing, University of North Carolina 
      School of Medicine, Chapel Hill, NC, USA.
FAU - Adler, J
AU  - Adler J
FAU - Dedrie, S
AU  - Dedrie S
FAU - Johnson, D
AU  - Johnson D
FAU - Malfertheiner, P
AU  - Malfertheiner P
FAU - Miner, P
AU  - Miner P
FAU - Meulemans, A
AU  - Meulemans A
FAU - Poole, L
AU  - Poole L
FAU - Tack, J
AU  - Tack J
FAU - Thielemans, L
AU  - Thielemans L
FAU - Troy, S
AU  - Troy S
FAU - Vakil, N
AU  - Vakil N
FAU - Zerbib, F
AU  - Zerbib F
FAU - Ruth, M
AU  - Ruth M
LA  - eng
SI  - ClinicalTrials.gov/NCT01472939
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150219
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Benzofurans)
RN  - 0 (Proton Pump Inhibitors)
RN  - 0 (Serotonin 5-HT4 Receptor Agonists)
RN  - 8C63R2Y02M (revexepride)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Area Under Curve
MH  - Benzofurans/administration & dosage/adverse effects/pharmacokinetics/*therapeutic 
      use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Gastric Emptying
MH  - Gastroesophageal Reflux/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Proton Pump Inhibitors/therapeutic use
MH  - Quality of Life
MH  - Serotonin 5-HT4 Receptor Agonists/administration & dosage/adverse 
      effects/pharmacokinetics/*therapeutic use
PMC - PMC5024018
EDAT- 2015/02/20 06:00
MHDA- 2015/08/14 06:00
PMCR- 2016/09/15
CRDT- 2015/02/20 06:00
PHST- 2014/10/06 00:00 [received]
PHST- 2014/10/16 00:00 [revised]
PHST- 2014/12/19 00:00 [revised]
PHST- 2015/01/23 00:00 [revised]
PHST- 2015/01/23 00:00 [accepted]
PHST- 2015/02/20 06:00 [entrez]
PHST- 2015/02/20 06:00 [pubmed]
PHST- 2015/08/14 06:00 [medline]
PHST- 2016/09/15 00:00 [pmc-release]
AID - APT13115 [pii]
AID - 10.1111/apt.13115 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2015 Apr;41(7):649-61. doi: 10.1111/apt.13115. Epub 2015 
      Feb 19.