title: Intravenous Esomeprazole for Prevention of Peptic Ulcer Rebleeding: A Randomized Trial in Chinese Patients.
abstract: BACKGROUND
  High-dose intravenous esomeprazole is the only approved pharmacological treatment for the prevention of peptic ulcer rebleeding (currently approved in over 100 countries worldwide), but has not yet been approved in China. This study aimed to evaluate a high-dose esomeprazole intravenous regimen vs. an active control (cimetidine) for the prevention of rebleeding in Chinese patients with a high risk of peptic ulcer rebleeding who had undergone primary endoscopic hemostatic treatment.
  
  
  METHODS
  This was a parallel-group study conducted at 20 centers in China. The study comprised a randomized, double-blind, intravenous treatment phase of 72 h in which 215 patients received either high-dose esomeprazole (80 mg + 8 mg/h) or cimetidine (200 mg + 60 mg/h), followed by an open-label oral treatment phase in which all patients received esomeprazole 40 mg tablets once daily for 27 days. The primary outcome was the rate of clinically significant rebleeding within the first 72 h after initial endoscopic hemostatic therapy. Secondary outcomes included the rates of clinically significant rebleeding within 7 and 30 days; proportions of patients who had endoscopic retreatment and other surgery due to rebleeding; and number of blood units transfused.
  
  
  RESULTS
  The rate of clinically significant rebleeding within 72 h was low overall (3.3%) and numerically lower in patients treated with esomeprazole compared with cimetidine (0.9% vs. 5.6%). Overall, the results of the secondary outcomes also showed a numerical trend towards superiority of esomeprazole over cimetidine. All treatments were well tolerated.
  
  
  CONCLUSIONS
  In this phase 3, multicenter, randomized trial conducted in China, esomeprazole showed a numerical trend towards superior clinical benefit over cimetidine in the prevention of rebleeding in patients who had successfully undergone initial hemostatic therapy of a bleeding peptic ulcer, with a similar safety and tolerability profile. These findings suggest that esomeprazole may be an alternative treatment option to cimetidine for this indication in China.
  
  
  BACKGROUND
  AstraZeneca.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier, NCT01757275.
authors.affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Bai
authors.affiliation: Department of Gastroenterology, Daping Hospital, Third Military Medical University, Chongqing, China.
authors.forename: Dong-Feng
authors.initials: DF
authors.lastname: Chen
authors.affiliation: Department of Gastroenterology, Southwest Hospital, Third Military Medical University, Chongqing, China.
authors.forename: Rong-Quan
authors.initials: RQ
authors.lastname: Wang
authors.affiliation: Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China.
authors.forename: You-Xiang
authors.initials: YX
authors.lastname: Chen
authors.affiliation: Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing, China.
authors.forename: Rui-Hua
authors.initials: RH
authors.lastname: Shi
authors.affiliation: Department of Gastroenterology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: De-An
authors.initials: DA
authors.lastname: Tian
authors.affiliation: AstraZeneca R&D, Shanghai, China.
authors.forename: Huifang
authors.initials: H
authors.lastname: Chen
authors.affiliation: AstraZeneca Gothenburg, Mölndal, Sweden.
authors.forename: Stefan
authors.initials: S
authors.lastname: Eklund
authors.affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China. li.zhaoshen@hotmail.com.
authors.forename: Zhao-Shen
authors.initials: ZS
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D002681:China; D002927:Cimetidine / Q000627:therapeutic use; D004311:Double-Blind Method; D064098:Esomeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016558:Hemostasis, Endoscopic / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D010438:Peptic Ulcer Hemorrhage / Q000188:drug therapy* / Q000209:etiology / Q000628:therapy; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D002927:Cimetidine; D064098:Esomeprazole
keywords: Esomeprazole; Hemostasis, endoscopic; Peptic ulcer bleeding; Peptic ulcer hemorrhage; Proton pump inhibitors