Nizatidine, 300 mg once nightly, was compared with cimetidine, 800 mg
once nightly, for treatment of 212 adult out-patients with acute duode
nal ulcers in an eight-week randomized, double-blind, multicentre tria
l. Patients were endoscoped at weeks 2, 4 and 8, regardless of ulcer h
ealing status. No significant differences in ulcer healing rates betwe
en treatment groups were seen at weeks 2 and 4, but at week 8, nizatid
ine had a significantly higher ulcer healing rate (P=0.36) than cimeti
dine (86% versus 74%, respectively). Patients with healed ulcers at ei
ther week 2 or week 4 had a final endoscopy performed at week 8. The r
ate of ulcer recurrence was significantly greater (P=0.021) in the cim
etidine group at week 8 compared with the nizatidine group: 21% versus
7.3%. respectively. Increasing tolerance to H-2 receptor antagonist t
herapy with prolonged use may explain the higher recurrence rate of ci
metidine. Both drugs provided equally rapid and effective symptomatic
relief from epigastric pain after two weeks of therapy. Both were equa
lly safe and free from treatment-related adverse effects.