title: Effect of proton pump inhibitors on the outcomes of peptic ulcer bleeding: comparison of event rates in routine clinical practice and a clinical trial.
abstract: OBJECTIVE
  To assess clinical outcomes in patients treated with proton pump inhibitors (PPIs) after endoscopic hemostasis in routine clinical care, and to compare these outcomes to those seen in a randomized controlled trial (RCT) of i.v. esomeprazole.
  
  
  METHODS
  Patients with peptic ulcer bleeding and endoscopic stigmata of recent hemorrhage, who were treated with i.v. esomeprazole or pantoprazole ≥120 mg/day following therapeutic endoscopy, were identified from 12 hospitals in Spain (n = 539). Outcomes assessed included further bleeding, all-cause mortality and surgery. The results were compared to those of the RCT.
  
  
  RESULTS
  Overall, 9.1% (95% confidence interval [CI]: 6.7-11.5) of patients experienced further bleeding within 72 h following initial endoscopy, 14.3% (95% CI: 11.3-17.2) of patients had further bleeding within 30 days and 3.3% (95% CI: 1.8-4.9) of patients died within 30 days. In the RCT, the rate of rebleeding within 72 h was significantly lower in the esomeprazole arm (5.9%) than in the placebo arm (10.3%; p = 0.026). The further bleeding rate in patients treated with esomeprazole in routine clinical practice (7.8%; 95% CI: 4.6-11.1) was between these two values. Similar results were seen with the other outcomes studied.
  
  
  CONCLUSIONS
  The proportion of patients treated with i.v. esomeprazole in routine clinical practice who experienced further bleeding following endoscopic treatment for peptic ulcer bleeding was between the rates observed in the esomeprazole group and the placebo group in the RCT.
authors.affiliation: Servicio de Aparato Digestivo, Hospital Clínico, Universidad de Zaragoza, IIS Aragón, Zaragoza, Spain. alanas@unizar.es
authors.forename: Angel
authors.initials: A
authors.lastname: Lanas
authors.forename: Mónica
authors.initials: M
authors.lastname: Polo-Tomas
authors.forename: Luis A
authors.initials: LA
authors.lastname: García-Rodríguez
authors.forename: Santiago
authors.initials: S
authors.lastname: García
authors.forename: María Teresa
authors.initials: MT
authors.lastname: Arroyo-Villarino
authors.forename: Julio
authors.initials: J
authors.lastname: Ponce
authors.forename: Luis
authors.initials: L
authors.lastname: Bujanda
authors.forename: José L
authors.initials: JL
authors.lastname: Calleja
authors.forename: Xavier
authors.initials: X
authors.lastname: Calvet
authors.forename: Faust
authors.initials: F
authors.lastname: Feu
authors.forename: Angeles
authors.initials: A
authors.lastname: Perez-Aisa
authors.forename: Joseph J Y
authors.initials: JJ
authors.lastname: Sung
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use*; D000368:Aged; D016001:Confidence Intervals; D064098:Esomeprazole / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006396:Hematemesis / Q000209:etiology; D016558:Hemostasis, Endoscopic; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D000077402:Pantoprazole; D010438:Peptic Ulcer Hemorrhage / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012189:Retrospective Studies; D012769:Shock / Q000209:etiology; D013030:Spain / Q000453:epidemiology
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; D000077402:Pantoprazole; D064098:Esomeprazole