Lg. Puig et al., HEALING OF GASTRIC OR PRE-PYLORIC ULCERS WITH ONCE-DAILY OMEPRAZOLE 20MG OR RANITIDINE 300MG, Journal of drug development and clinical practice, 7(3), 1995, pp. 173-180
Omeprazole is significantly more effective than H-2-receptor antagonis
ts for healing duodenal ulcer and erosive oesophagitis, but studies in
gastric ulcer have yielded conflicting results. The aim of this doubl
e-blind multicentre study was to compare heeling rates and symptom rel
ief in patients with benign gastric (GU) or pre-pyloric ulcers (PPU) a
fter four or eight weeks' randomised treatment with either omeprazole
20 mg once daily or ranitidine 300 mg at night Healing was assessed by
endoscopy at two weeks (PPU only), four weeks and eight weeks and pat
ients recorded day-time and night-time ulcer symptoms daily on diary c
ards. Cumulative healing rates (per Protocol) for omeprazole (n = 94),
and ranitidine (n = 94), respectively, at four weeks, were 72% and 70
% overall (NS); 85% and 75% for PPU (NS); 67% and 69% for GU (NS); and
at eight weeks were 94% and 88% overall (NS); 100% and 82% for PPU (p
< 0.05); 91% and 90% for GU (NS). After only two weeks, 75% of patien
ts on omeprazole and 65% of patients on ranitidine were symp tom-free,
compared with 7% and 3%, respectively, pre-entry. The incidence of ad
verse events was similar for omeprazole (6%) and ranitidine (5%). In c
onclusion, similar heeling rates were observed for GU during treatment
with either omeprazole 20 mg once daily or ranitidine 300 mg at night
, with the exception of a small sub-group of patients with PPU, who sh
owed significantly higher heeling rates on omeprazole.