Esomeprazole-based therapy in Helicobacter pylori eradication: any effect by increasing the dose of esomeprazole or prolonging the treatment?
OBJECTIVE
To study the efficacy of esomeprazole-based triple therapy in Helicobacter pylori eradication and to evaluate, by a randomized trial, the effect of increasing the dose of esomeprazole or prolonging the treatment.


METHODS
Four-hundred and fifty duodenal ulcer patients were randomized to receive: (1) esomeprazole (20 mg b.i.d.), clarithromycin (500 mg b.i.d.), and amoxicillin (1 g b.i.d.), for 7 days (E20-7d); (2) esomeprazole (40 mg b.i.d.) with the same antibiotics, also for 7 days (E40-7d); and (3) esomeprazole (40 mg b.i.d.) with the same antibiotics, for 10 days (E40-10d). Cure rates were evaluated by (13)C-urea breath test.


RESULTS
One-hundred and fifty patients received each treatment. Groups were comparable in terms of demographic variables. Eight percent of the patients did not return for follow-up. Compliance (98%) and side effects (only mild to moderate) in the two groups were comparable. Per-protocol cure rates were 83.5% (E20-7d), 84.8% (E40-7d), and 88.2% (E40-10d). Intention-to-treat cure rates were, respectively, 74%, 78%, and 80% (nonstatistically significant differences).


CONCLUSIONS
Esomeprazole-based triple therapies offer comparable efficacy to omeprazole-based therapies used in previous studies. Increasing the dose of esomeprazole or prolonging the treatment does not improve the results. Therefore, if esomeprazole-based triple therapy is used in duodenal ulcer patients, a regimen with only 20 mg twice daily of esomeprazole and for only 7 days may be sufficient.
Gisbert
Javier P
JP
Servicio de Aparato Digestivo, Hospital Universitario de la Princesa, Madrid, Spain.
Domínguez-Muñoz
Antonio
A
Domínguez-Martín
Antonio
A
Gisbert
Jose Luis
JL
Marcos
Santiago
S
D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D017291:Clarithromycin / Q000008:administration & dosage; D004381:Duodenal Ulcer / Q000188:drug therapy; D064098:Esomeprazole; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage*
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole; D064098:Esomeprazole