Ebrotidine versus ranitidine in the treatment of acute duodenal ulcer. A multicentre, randomized, double-blind, controlled clinical trial.
A total of 478 patients with endoscopically confirmed duodenal ulcer entered this randomized, parallel, double-blind trial. Patients were randomly assigned to receive ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene)amino]- 4-thiazolyl]methyl]thio]ethyl]amino]methylene]-4-bromo-benzenesulfona mid e, CAS 100981-43-9, FI-3542) 400 mg or ranitidine 300 mg tablets (4:1) respectively, administered in single evening doses. Endoscopy, clinical examination and symptom assessment were performed at baseline and at weeks 4 and 8. Safety evaluations including laboratory tests, treatment compliance and antacid consumption checks were conducted at the beginning and/or at the 4 and 8 week visits. Patients whose ulcer showed endoscopic healing at the 4-week control left the study. Both groups were matched in all parameters studied. The healing rates at 4 weeks were 76.4% and 75.3% for ebrotidine and ranitidine respectively, while at 8 weeks the final rates were 95% and 91.8% respectively. Accompanying symptoms disappeared rapidly and the patients returned to normal. Smoking proved to be a highly significant negative risk factor, since healing rates were 83.4% and 71.2% at 4 weeks and 97.4% and 92.3% at 8 weeks in non-smokers and smokers respectively (p = 0.0046). Smokers treated with ranitidine showed significantly lower final healing rates than non-smokers (86% vs 100%; p = 0.0358), while the healing rates among patients treated with ebrotidine were similar regardless of whether they were smokers or not (93.9% and 96.7% N.S.). Ebrotidine (94%) proved to be more effective than ranitidine (86%) in smokers with higher healing rates (p < 0.05). Alcohol intake showed no significant relationship with the healing rates. Both drugs demonstrated an excellent safety. There were no changes in blood parameters, and no significant adverse events were reported.
Matov
V
V
Clinical Centre of Gastroenterology, University Hospital Queen Joanna, Sofia, Bulgaria.
Metchkov
G
G
Krastev
Z
Z
Tchernev
K
K
Mitova
R
R
Márquez
M
M
Torres
J
J
Herrero
E
E
Fillat
O
O
Ortiz
J A
JA
D015746:Abdominal Pain / Q000188:drug therapy; D000328:Adult; D001557:Benzenesulfonates / Q000627:therapeutic use*; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy*; D005260:Female; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011899:Ranitidine / Q000627:therapeutic use*; D012907:Smoking; D013844:Thiazoles / Q000627:therapeutic use*
D001557:Benzenesulfonates; D006635:Histamine H2 Antagonists; D013844:Thiazoles; D011899:Ranitidine; C075156:ebrotidine