title: Randomized controlled trial of standard versus high-dose intravenous omeprazole after endoscopic therapy in high-risk patients with acute peptic ulcer bleeding.
abstract: BACKGROUND
  Rebleeding from peptic ulcers is a major contributor to death. This study compared standard (40-mg intravenous infusion of omeprazole once daily for 3 days) and high-dose (80-mg bolus of omeprazole followed by 8-mg/h infusion for 72 h) in reducing the rebleeding rate (primary endpoint), need for surgery, duration of hospital stay and mortality in patients with peptic ulcer bleeding after successful endoscopic therapy.
  
  
  METHODS
  This was a single-institution prospective randomized controlled study based on a postulated therapeutic equivalence of the two treatments. All patients who had successful endoscopic haemostasis of a bleeding peptic ulcer (Forrest classification Ia, Ib, IIa or IIb) were recruited. Informed consent was obtained and patients were randomized to receive standard- or high-dose infusions of intravenous omeprazole.
  
  
  RESULTS
  Two (3 per cent) of 61 patients in the high-dose group and ten (16 per cent) of 61 in the standard-dose group exhibited rebleeding, a difference of - 13 (95 per cent confidence interval - 25 to - 2) per cent. The upper limit of the one-sided confidence interval exceeded a predefined equivalence absolute difference of 16 per cent. Equivalence of standard- and high-dose omeprazole in preventing rebleeding was not demonstrated.
  
  
  CONCLUSIONS
  Intravenous standard-dose omeprazole was inferior to high-dose omeprazole in preventing rebleeding after endoscopic haemostasis for peptic ulcer bleeding.
  
  
  BACKGROUND
  NCT00519519 (http://www.clinicaltrials.gov).
authors.affiliation: Department of Surgery, Singapore General Hospital, National Heart Centre Singapore, Singapore, Republic of Singapore. gsucwh@sgh.com.sg
authors.forename: W H
authors.initials: WH
authors.lastname: Chan
authors.forename: L W
authors.initials: LW
authors.lastname: Khin
authors.forename: Y F A
authors.initials: YF
authors.lastname: Chung
authors.forename: Y C
authors.initials: YC
authors.lastname: Goh
authors.forename: H S
authors.initials: HS
authors.lastname: Ong
authors.forename: W K
authors.initials: WK
authors.lastname: Wong
mesh_terms: D000208:Acute Disease; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D005260:Female; D005773:Gastroscopy; D006488:Hemostasis, Surgical; D006801:Humans; D007262:Infusions, Intravenous; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage*; D010438:Peptic Ulcer Hemorrhage / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D011446:Prospective Studies; D012307:Risk Factors; D055502:Secondary Prevention; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D016896:Treatment Outcome
chemical_list: D000897:Anti-Ulcer Agents; D009853:Omeprazole