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

  • HRT (in ER)
  • MPEC (in-patient)
 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
Esoph
0 (0%)
1 (2%)
Stom
21 (42%)
27 (54%)
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%)

 

 

 

 

 

 

 

 
Day# Omeprazole Cimetidine
3*
0 (0%)
8 (16%)
14*
2 (4%)
12 (24%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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 Treatment

  • Epinephrine + 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
Stom
53 (44.1%)
48 (40%)
Duod
65 (54.2%)
65 (54.2%)
Stoma
2 (1.7%)
7 (5.8%)

 

 

 

 

 

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%)

 

 

 

 

 

 

 
Day# Omeprazole Cimetidine
3*
5 (4.2%)
24 (20%)
7*
7 (5.8%)
26 (21.7%)
30*
8 (6.7%)
27 (22.5%)

 

 

 

 

 

 

 

 

 

 

 

 
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

 

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