title: Prucalopride decreases esophageal acid exposure and accelerates gastric emptying in healthy subjects.
abstract: BACKGROUND
  The 5-HT4 receptor agonist prucalopride is a prokinetic drug which improves colonic motility. Animal data and in vitro studies suggest that prucalopride also affects gastric and esophageal motor function. We aimed to assess the effect of prucalopride on gastric emptying, esophageal motility, and gastro-esophageal reflux in man.
  
  
  METHODS
  In this double-blind, placebo-controlled, randomized, crossover study, we included 21 healthy volunteers who received 4 mg prucalopride or placebo per day for 6 days. We performed high-resolution manometry (HRM) followed by 120-min HRM-pH-impedance monitoring after a standardized meal, ambulatory 24-h pH-impedance monitoring, and gastric emptying for solids.
  
  
  RESULTS
  Prucalopride decreased (median [IQR]) total acid exposure time (3.4 [2.5-5.6] vs 1.7 [0.8-3.5] %, p < 0.05). The total number of reflux events was unaffected by prucalopride, however, the number of reflux events extending to the proximal esophagus was reduced by prucalopride (15.5 [9.8-25.5] vs 10.5 [5.3-17.5], p < 0.05). Furthermore, prucalopride improved acid clearance time (77.5 [47.8-108.8] vs 44.0 [30.0-67.8] s, p < 0.05). Prucalopride did not affect the number of transient lower esophageal sphincter (LES) relaxations or their association with reflux events. Esophageal motility and basal pressure of the LES were not affected by prucalopride. Prucalopride increased gastric emptying (T1/2 ; 32.7 [27.9-44.6] vs 49.8 [37.7-55.0] min, p < 0.05) and decreased residue after 120 min (8.8 [4.4-14.8] vs 2.7 [1.3-5.4] %, p < 0.05).
  
  
  CONCLUSIONS
  Prucalopride reduces esophageal acid exposure and accelerates gastric emptying in healthy male volunteers. These findings suggest that the drug could be effective for treatment of patients with reflux disease and functional dyspepsia.
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: B F
authors.initials: BF
authors.lastname: Kessing
authors.forename: A J P M
authors.initials: AJ
authors.lastname: Smout
authors.forename: R J
authors.initials: RJ
authors.lastname: Bennink
authors.forename: N
authors.initials: N
authors.lastname: Kraaijpoel
authors.forename: J M
authors.initials: JM
authors.lastname: Oors
authors.forename: A J
authors.initials: AJ
authors.lastname: Bredenoord
mesh_terms: D001572:Benzofurans / Q000009:adverse effects / Q000494:pharmacology*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005745:Gastric Acidity Determination; D005746:Gastric Emptying / Q000187:drug effects*; D005764:Gastroesophageal Reflux / Q000378:metabolism*; D064368:Healthy Volunteers; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008365:Manometry; D058828:Serotonin 5-HT4 Receptor Agonists / Q000494:pharmacology*
chemical_list: D001572:Benzofurans; D058828:Serotonin 5-HT4 Receptor Agonists; C406662:prucalopride
keywords: 5-HT4 receptor agonist; esophagus; gastric emptying; gastro-esophageal reflux disease; manometry; pH Monitoring; prucalopride; stomach