title: Factors predictive of treatment-emergent adverse events of prucalopride: an integrated analysis of four randomized, double-blind, placebo-controlled trials.
abstract: OBJECTIVE
  This integrated analysis aimed to identify the factors associated with the most frequently re-ported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks.
  
  
  METHODS
  Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on pa-tients treated with prucalopride 2 mg or placebo were ana-lyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model.
  
  
  RESULTS
  Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly as-sociated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differ-ences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to expe-rience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. Con-clusions Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians. (Gut Liver, 2015;9208-213).
authors.affiliation: Division of Gastroenterology, Department of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Somchai
authors.initials: S
authors.lastname: Leelakusolvong
authors.affiliation: Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China.
authors.forename: MeiYun
authors.initials: M
authors.lastname: Ke
authors.affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Duowu
authors.initials: D
authors.lastname: Zou
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Wonkwang University College of Medicine, Digestive Disease Research Institute, Iksan, Korea.
authors.forename: Suck Chei
authors.initials: SC
authors.lastname: Choi
authors.affiliation: Department of Clinical and Experimental Medicine, Translational Research Center for GastroIntestinal Disorders (TARGID), University of Leuven, Leuven, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Tack
authors.affiliation: Division of Gastroenterology and Hepatology, Houston Methodist Hospital and Weill Cornell Medical College, Houston, TX, USA.
authors.forename: Eamonn M M
authors.initials: EM
authors.lastname: Quigley
authors.affiliation: Department of Statistical Programming, Janssen Research & Development, Shanghai, China.
authors.forename: Andy
authors.initials: A
authors.lastname: Liu
authors.affiliation: Regional Medical Affairs, Janssen Asia-Pacific, Singapore.
authors.forename: Jin Yong
authors.initials: JY
authors.lastname: Kim
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People / Q000706:statistics & numerical data; D001572:Benzofurans / Q000009:adverse effects*; D017326:Clinical Trials, Phase III as Topic; D003248:Constipation / Q000188:drug therapy* / Q000208:ethnology; D003967:Diarrhea / Q000139:chemically induced*; D004311:Double-Blind Method; D005260:Female; D006261:Headache / Q000139:chemically induced*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009325:Nausea / Q000139:chemically induced; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis
chemical_list: D001572:Benzofurans; C406662:prucalopride
keywords: Adverse events; Chronic constipation; Predictors; Prucalopride