Stress ulcer prophylaxis protects against clinically important gastroi
ntestinal bleeding and has gained widespread use. This study compares
the efficacy of omeprazole to ranitidine for this indication. This was
a prospective, randomized clinical trial. Sixty-seven high-risk patie
nts were randomized to receive either ranitidine 150 mg (N = 35) intra
venously daily or omeprazole 40 mg (N = 32) daily orally or by nasogas
tric route. Patients were monitored for clinically important bleeding.
There was no statistically significant difference between treatment g
roups in the number of patients enrolled, gender, race, or age. The st
udy groups were comparable in regard to the severity of illness based
on their similar APACHE II score, duration of ICU stay, duration of ve
ntilator dependence, and mortality rate. A significant difference was
found only in regard to the number of risk factors per patient, The ra
nitidine-treated group had 2.7 risk factors per patient while the omep
razole-treated group had 1.9 (P < 0.05). Eleven patients (31%) given r
anitidine and two patients (6%) given omeprazole developed clinically
important bleeding (P < 0.05). Nosocomial pneumonia developed in five
patients (14%) receiving ranitidine and one patient (3%) receiving ome
prazole (P > 0.05). We conclude that oral omeprazole is safe, effectiv
e, and clinically feasible for stress ulcer prophylaxis.