Efficacy of ecabet sodium for Helicobacter pylori eradication triple therapy in comparison with a lansoprazole-based regimen.
BACKGROUND
The cytoprotective agent, ecabet sodium, inhibits urease activity and growth of Helicobacter pylori.


OBJECTIVE
To evaluate the efficacy and safety of ecabet sodium-based eradication of H. pylori infection, compared with a lansoprazole-based regimen, in a randomized multicentre study.


METHODS
A total of 120 H. pylori-positive patients were assigned to one of two treatment regimens for 2 weeks: ecabet sodium 1 g b.d., amoxicillin 500 mg t.d.s. and clarithromycin 400 mg b.d. (EAC: 60 patients); or lansoprazole 30 mg (o.m.) with the same antimicrobial agents (LAC: 60 patients). Cure of infection was assessed by a 13C-urea breath test 1 month after completion of treatment.


RESULTS
One patient in the EAC group and two in the LAC group did not complete therapy because of an adverse event, and three did not undergo the 13C-urea breath test. Cure rates for the intention-to-treat, all-patients-treated and per protocol analysis in the EAC group were 85%, 86% and 88%, respectively, whereas those in the LAC group were 85%, 88% and 91%. There were no significant differences in cure rate or adverse events between the two regimens.


CONCLUSIONS
Ecabet sodium in combination with amoxicillin and clarithromycin is as effective as lansoprazole-based eradication therapy for H. pylori.
Adachi
K
K
Department of Internal Medicine II, Shimane Medical University, Izumo, Japan. kadachi@shimane-med.ac.jp
Ishihara
S
S
Hashimoto
T
T
Hirakawa
K
K
Ishimura
N
N
Niigaki
M
M
Kaji
T
T
Kawamura
A
A
Sato
H
H
Fujishiro
H
H
Hattori
S
S
Watanabe
M
M
Kinoshita
Y
Y
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D045784:Abietanes; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001944:Breath Tests; D002247:Carbon Isotopes; D017291:Clarithromycin / Q000627:therapeutic use; D004224:Diterpenes / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D010406:Penicillins / Q000627:therapeutic use; D010434:Pepsin A / Q000037:antagonists & inhibitors; D011446:Prospective Studies; D016896:Treatment Outcome; D014508:Urea / Q000032:analysis / Q000097:blood; D014510:Urease / Q000037:antagonists & inhibitors
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D045784:Abietanes; D000900:Anti-Bacterial Agents; D002247:Carbon Isotopes; D004224:Diterpenes; D010406:Penicillins; D064747:Lansoprazole; C061681:ecabet; D000658:Amoxicillin; D014508:Urea; D010434:Pepsin A; D014510:Urease; D017291:Clarithromycin; D009853:Omeprazole