[Comparison of 2 schedules based on pantoprazole for eradication of Helicobacter pylori in patients with active duodenal ulcer].

OBJECTIVE

To compare the efficacy and tolerability of a triple vs dual pantoprazole based therapy to eradicate Helicobacter pylori (H. pylori) in mexican patients with florid duodenal ulcer.

BACKGROUND

The treatment of peptic ulcer disease was revolutionized by the fact that H. pylori generally induces chronic gastritis and peptic ulcer disease and that the cure of the infection prevents ulcer relapses.

MATERIAL AND METHODS

74 H. pylori positive patients with florid duodenal ulcer were randomized to receive either pantoprazole 40 mg bid in combination with clarithromycin 500 mg tid and amoxicillin 1 g bid (triple regimen PAC) or pantoprazole in combination with clarithromycin and placebo (dual regimen PC) during 14 days. To ensure complete ulcer healing all patients received an additional 2 weeks treatment with pantoprazole 40 mg od. 14C Urea Breath test (UBT) was the main criteria used to determine eradication rate with < 150 disintegrations per minute (DPM) to consider a patient eradicated. In all patients culture, antibiotic susceptibility (E-test) and histology were performed.

RESULTS

In the per protocol analysis (n = 66) the eradication rate was: PAC 93.5% vs PC 54.3% (p < 0.001). 76% of H. pylori strains were resistant to metronidazole. Tolerance and compliance were excellent in both groups.

CONCLUSIONS

Triple therapy (PAC) was shown to be superior to dual therapy (PC) for H. pylori eradication in mexican patients with florid duodenal ulcer.