Roxatidine versus ranitidine in the treatment of duodenal ulcers: a randomized double-blind controlled multicentre study in Singapore.
Roxatidine acetate, a new H2 receptor antagonist, was compared with ranitidine in the treatment of duodenal ulcers in a double-blind multicentre study. Eighty-four patients with endoscopically proven duodenal ulcer were randomized to receive 150 mg roxatidine acetate or 300 mg ranitidine at bedtime. Repeat endoscopy was performed after 4 weeks (25-33 days) and if the ulcer had not healed, another endoscopy was performed after a further 4 weeks of treatment. Using per protocol analysis 73.6% of ulcers treated with roxatidine healed at 4 weeks compared to 72.2% of ulcers treated with ranitidine (P = NS). The healing rates at 8 weeks were 92% with roxatidine and 83.3% with ranitidine (P = NS). Using equivalence tests, the healing rate of roxatidine was found to be equivalent to that of ranitidine within a 20% region. Roxatidine users took significantly less antacids than ranitidine users (P < 0.05). There were no significant adverse effects due to roxatidine or ranitidine. Roxatidine is a safe effective drug in the treatment of duodenal ulcers with a healing rate comparable to that of ranitidine.
Fock
K M
KM
Department of Medicine, Toa Payoh Hospital, Singapore.
Kang
J Y
JY
Ng
H S
HS
Ng
T M
TM
Gwee
K A
KA
Lim
C C
CC
D000328:Adult; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy*; D004384:Duodenoscopy; D005260:Female; D005500:Follow-Up Studies; D006635:Histamine H2 Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use*; D011899:Ranitidine / Q000009:adverse effects / Q000627:therapeutic use*; D012846:Singapore; D012907:Smoking
D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists; D010880:Piperidines; D011899:Ranitidine; C053742:roxatidine acetate