Table 2: Continuous-Infusion Omeprazole for the Treatment of Peptic Ulcer-Related Acute GI Bleeds
| Investigator | Study Design/Subjects | Antisecretory Treatment | Ulcer Characteristics n (%) | Incidence of Rebleeding n (%) | |||||
|---|---|---|---|---|---|---|---|---|---|
| Lin et al (1998)16 | Single-blind, randomized,
placebo-controlled trial Study Duration: 8 months Subjects (n=100) Active bleed (Forrest Type Ia or Ib); n= 34 NBVV (Forrest Type IIa); n = 66 Endoscopic Treatment |
IV
Omeprazole (n=50) 40 mg IV bolus + CI of 6.7 mg/hr x 72 hrs, followed by 20 mg PO once daily x 2 months IV Cimetidine (n=50) 300 mg IV bolus + CI of 50 mg/hr X 72 hrs, followed by 400 mg PO twice daily x 2 months |
Location of Ulcer | ||||||
| Site | Omeprazole | Cimetidine | Day# | Omeprazole | Cimetidine | ||||
| Esoph | 0 (0%) | 1 (2%) | 3* | 0 (0%) | 8 (16%) | ||||
| Stom | 21 (42%) | 27 (54%) | 14* | 2 (4%) | 12 (24%) | ||||
| Duod | 28 (56%) | 19 (38%) | |||||||
| Stoma | 1 (2%) | 3 (6%) | |||||||
Ulcer Classification |
|||||||||
| Class | Omeprazole | Cimetidine | |||||||
| Ia | 9 (18%) | 12 (24%) | |||||||
| Ib | 4 (8%) | 9 (18%) | |||||||
| IIa | 37 (74%) | 29 (58%) | |||||||
| Lau et al (2000)20 | Double-blind, randomized,
placebo-controlled trial Study Duration: 14 months Subjects (n=240) Active bleed (Forrest Type Ia or Ib); n= 122 Recent bleed (Forrest Type IIa or IIb); n = 118 Endoscopic TreatmentEpinephrine + HPT |
IV Omeprazole (n=120) 80 mg IV bolus + CI of 8mg/hr x 72 hrs Placebo (n=120) Placebo x 72 hours All patients received Omeprazole 20 mg PO once daily for 8 weeks, starting on study day 4 |
Location of Ulcer | ||||||
| Site | Omeprazole | Cimetidine | Day# | Omeprazole | Cimetidine | ||||
| Stom | 53 (44.1%) | 48 (40%) | 3* | 5 (4.2%) | 24 (20%) | ||||
| Duod | 65 (54.2%) | 65 (54.2%) | 7* | 7 (5.8%) | 26 (21.7%) | ||||
| Stoma | 2 (1.7%) | 7 (5.8%) | 30* | 8 (6.7%) | 27 (22.5%) | ||||
Ulcer Classification |
|||||||||
| Class | Omeprazole | Cimetidine | |||||||
| Ia | 14 (11.7%) | 9 (7.5%) | |||||||
| Ib | 50 (41.7%) | 49 (40.8%) | |||||||
| IIa | 38 (31.7%) | 36 (30%) | |||||||
| IIb | 18 (15%) | 26 (21.7%) | |||||||
IV=Intravenous; CI=Continuous infusion; NBVV=Non-bleeding visible vessel;
HPT=Heater-probe
thermocoagulation; MPEC=Multi-probe electrocoagulation;
ER=Emergency room;
PO=By mouth; Stom=Stomach; Esoph=Esophagus;
Duod=Duodenum * = p < 0.05 between each treatment group on indicated day