Sv. Van Zanten et al., One-week triple therapy with esomeprazole provides effective eradication of Helicobacter pylori in duodenal ulcer disease, ALIM PHARM, 14(12), 2000, pp. 1605-1611
Background: Esomeprazole is the first proton pump inhibitor to be developed
as an optical isomer for the treatment of acid-related diseases.
Methods: Four hundred and forty eight duodenal ulcer patients with Helicoba
cter pylori infection, confirmed by C-13-urea breath test (UBT), and no cur
rent ulcer, were randomised to double-blind treatment with esomeprazole 20
mg twice daily (b.d.) (n=224) or omeprazole 20 mg b.d. (n=224), in combinat
ion with amoxicillin 1 g b.d. and clarithromycin 500 mg b.d. for 1 week (EA
C and OAC, respectively). A negative UBT at both 4 and 8 weeks after comple
ting therapy indicated successful H. pylori eradication.
Results: Intention-to-treat (ITT) analysis comprised 400 patients (EAC, n=2
04; OAC, n=196) and per protocol (PP) analysis 377 patients (EAC, n=192; OA
C, n=185). Eradication rates (95% confidence intervals) for ITT and PP popu
lations were: EAC, 90% (85-94%) and 91% (86-94%); OAC, 88% (82-92%) and 91%
(86-95%). Between-group differences in eradication rates were not statisti
cally significant. Both regimens were well tolerated, with an adverse event
profile and frequency typical of proton pump inhibitor plus antibiotic com
bination therapy.
Conclusions: Esomeprazole-based triple therapy for 1 week is highly effecti
ve in eradicating H. pylori infection in duodenal ulcer disease, offers com
parable efficacy to omeprazole-based therapy, and is well tolerated.