title: Randomized, double-blind comparison of immediate-release omeprazole oral suspension versus intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill patients.
abstract: OBJECTIVE
  To demonstrate that a new immediate-release omeprazole oral suspension is effective in preventing upper gastrointestinal bleeding in critically ill patients.
  
  
  METHODS
  A noninferiority analysis was used to compare rates of clinically significant upper gastrointestinal bleeding in a prospective, phase 3, double-blind trial with parallel omeprazole suspension and cimetidine treatment groups.
  
  
  METHODS
  A total of 47 intensive care units in the United States.
  
  
  METHODS
  A total of 359 critically ill patients who required mechanical ventilation for > or =48 hrs, had an Acute Physiology and Chronic Health Evaluation score of > or =11 at baseline, had an intact stomach with a nasogastric or orogastric tube in place, and had at least one additional risk factor for upper gastrointestinal bleeding.
  
  
  METHODS
  Patients were randomized to treatment with omeprazole suspension (two 40-mg doses on day 1, via orogastric or nasogastric tube, and 40 mg each day thereafter) or intravenous cimetidine (300-mg bolus and 50 mg/hr thereafter) for up to 14 days. Gastric aspirates were sampled for bleeding and pH. Medication doses were doubled for failure of pH control (two successive aspirates with pH < or = 4).
  
  
  RESULTS
  Clinically significant upper gastrointestinal bleeding (bright red blood not clearing after 5-10 mins of lavage or persistent Gastroccult-positive "coffee-grounds" material for 8 hrs on days 1-2 or for 2-4 hrs on days 3-14 and not clearing with > or =100 mL of lavage) was the primary end point of the trial. The rate of clinically significant bleeding in the per-protocol population was 4.5% with omeprazole suspension and 6.8% with cimetidine, meeting the criteria for the noninferiority of omeprazole suspension. Median gastric pH was > or =6 on all trial days with omeprazole suspension treatment and on 50% of days with cimetidine treatment (p < .001, all trial days). In the omeprazole suspension group, median gastric pH was >4 on each trial day in 95% of patients.
  
  
  CONCLUSIONS
  Immediate-release omeprazole suspension is effective in preventing upper gastrointestinal bleeding and more effective than intravenous cimetidine in maintaining gastric pH of >4 in critically ill patients.
authors.affiliation: Louisiana State University, Shreveport, LA, USA.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Conrad
authors.forename: Andrea
authors.initials: A
authors.lastname: Gabrielli
authors.forename: Benjamin
authors.initials: B
authors.lastname: Margolis
authors.forename: Andrew
authors.initials: A
authors.lastname: Quartin
authors.forename: J Steven
authors.initials: JS
authors.lastname: Hata
authors.forename: William O
authors.initials: WO
authors.lastname: Frank
authors.forename: Robert G
authors.initials: RG
authors.lastname: Bagin
authors.forename: James A
authors.initials: JA
authors.lastname: Rock
authors.forename: Bonnie
authors.initials: B
authors.lastname: Hepburn
authors.forename: Loren
authors.initials: L
authors.lastname: Laine
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D002927:Cimetidine / Q000008:administration & dosage*; D003422:Critical Care / Q000379:methods*; D004304:Dosage Forms; D004311:Double-Blind Method; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage*; D013270:Stomach / Q000503:physiopathology; D016019:Survival Analysis; D013535:Suspensions; D016896:Treatment Outcome
chemical_list: D000897:Anti-Ulcer Agents; D004304:Dosage Forms; D013535:Suspensions; D002927:Cimetidine; D009853:Omeprazole