Bcy. Wong et al., Triple therapy with clarithromycin, omeprazole, and amoxicillin for eradication of Helicobacter pylori in duodenal ulcer patients in Asia and Africa, ALIM PHARM, 14(11), 2000, pp. 1529-1535
Background: Studies assessing the efficacy of triple therapy containing cla
rithromycin and amoxicillin for the eradication of Helicobacter pylori infe
ction and healing of duodenal ulcers in Asian and African countries are lim
ited.
Aim: To determine the efficacy and safety of 1-week triple therapy with ome
prazole, amoxicillin and clarithromycin for eradicating H. pylori infection
in patients with active duodenal ulcer living in Asian and African regions
.
Methods: This was an open-label, multicentre study in 11 centres in Asia an
d Africa. Patients with endoscopy-proven duodenal ulcer and who were H. pyl
ori-positive were treated with clarithromycin 500 mg, omeprazole 20 mg, and
amoxicillin 1000 mg, all given twice daily for 7 days. Upper endoscopy was
repeated at week 6 to check for ulcer healing and H. pylori status.
Results: A total of 117 patients were recruited. H. pylori eradication rate
s were 85% by per protocol analysis and 80% by intention-to-treat analysis.
Ulcer healing was found in 94% of subjects (per protocol analysis). Clinic
al success, measured by change of pre-treatment ulcer symptoms, was strongl
y supported by complete resolution or improvement in 100% of the evaluable
patients (per protocol analysis). Since treatment-related adverse events, w
hen present, were largely mild or moderate, the triple therapy regimen was
considered safe.
Conclusion: Seven-day triple therapy with omeprazole, amoxicillin, and clar
ithromycin was efficacious for treating Asian and African patients with duo
denal ulcer disease associated with H. pylori infection, and the treatment
regimen was well-tolerated.