title: Comparison of the efficacy and safety between generic intravenous omeprazole (Zefxon) and original omeprazole (Losec) in the adjunct treatment of non-variceal upper gastrointestinal bleeding in Siriraj Hospital.
abstract: BACKGROUND
  Clinical efficacy and safety of generic omeprazole have not been well studied in Thailand.
  
  
  OBJECTIVE
  Determine whether generic omeprazole (Zefxon) is inferior to original omeprazole (Losec) in the treatment of non-variceal upper gastrointestinal bleeding (UGIB) in Siriraj Hospital.
  
  
  METHODS
  Medical records of adult patients with the diagnosis of non-variceal UGIB receiving intravenous omeprazole (either Zefxon or Losec) in Siriraj Hospital between January 2006 and September 2010 were reviewed Noninferiority study was used to investigate whether the generic omeprazole was no more than 10% less effective than the original omeprazole. The primary endpoints were recurrent bleeding and mortality within seven and 30 days. Surgery, endoscopic retreatment, blood transfusions, length of hospital stay and safety were also analyzed
  
  
  RESULTS
  Of 200 randomly selected patients in each group, there was no difference in age, gender co-morbidities, severity of UGIB, endoscopic findings and endoscopic intervention between patients receiving generic omeprazole and original omeprazole. Overall rate of recurrent bleeding, mortality, and surgical intervention within 30 days were 12.3%, 5.5% and 2.0%, respectively. The rates of recurrent bleeding, overall mortality, and non-variceal UGIB related mortality within seven and 30 days were not significantly different between the two groups. Neither were the rates of endoscopic retreatment and surgery. The incidence of adverse side effects was 3.5% in each group. Cox regression analysis showed no significant association between type of omeprazole and recurrent bleeding or mortality. Compared to the original omeprazole, the hazard ratio of recurrent bleeding, overall mortality, and non-variceal UGIB related mortality in patients receiving generic omeprazole was 1.44 (95% CI 0.82-2.53; p = 0.21), 2.12 (95% CI 0.90-5.43; p = 0.08) and 1.82 (95% CI 0.53-6.21; p = 0.34), respectively.
  
  
  CONCLUSIONS
  Although the original omeprazole Losec tended to have more favorable outcomes in the treatment of non-variceal UGIB in the present study, non-inferiority test showed that the efficacy and safety of the generic omeprazole Zefxon was not inferior to those of the original omeprazole.
authors.affiliation: Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Darin
authors.initials: D
authors.lastname: Lohsiriwat
authors.forename: Ratikorn
authors.initials: R
authors.lastname: Saejong
authors.forename: Varut
authors.initials: V
authors.lastname: Lohsiriwat
authors.forename: Sasima
authors.initials: S
authors.lastname: Tongsai
authors.forename: Visanu
authors.initials: V
authors.lastname: Thamlikitkul
mesh_terms: D000368:Aged; D016145:Endoscopy, Digestive System; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D012189:Retrospective Studies; D018570:Risk Assessment; D013785:Thailand; D013810:Therapeutic Equivalency
chemical_list: D054328:Proton Pump Inhibitors; D009853:Omeprazole