ABSTRACT
In a multicentre single-blind study, ranitidine was compared to cimetidine as prophylactic treatment against stress-induced upper gastrointestinal bleeding in seriously ill patients in the intensive care unit (ICU). 380 patients entered the study. 192 patients were treated with ranitidine 50 mg q.i.d. as i.v. bolus followed by 150 mg orally twice daily. 188 patients received cimetidine 400 mg q.i.d. intravenously and 1,000 mg daily orally in divided doses. Five patients in the ranitidine group (2.6%) and 12 in the cimetidine group (6.4%) developed gastrointestinal bleeding definitely or possibly due to stress lesions. This difference was not significant. The incidence of stress erosions or ulcerations developing during the study was 11.8% for the ranitidine group and 18.3% for the cimetidine group (non-significant difference). Adverse events in the ranitidine group were nausea, tachycardia or vomiting in 4 patients. 5 cimetidine-treated patients developed cholestasis, and 5 additional central nervous system problems. The high degree of efficacy of both drugs compared very favourably with the high incidence of stress ulceration and hemorrhage in similar untreated populations.
