TRIPLE THERAPY WITH AZITHROMYCIN, OMEPRAZOLE, AND AMOXICILLIN IS HIGHLY EFFECTIVE IN THE ERADICATION OF HELICOBACTER-PYLORI - A CONTROLLED TRIAL VERSUS OMEPRAZOLE PLUS AMOXICILLIN

Background: Azithromycin is a new-generation, acid-stable macrolide an tibiotic that achieves remarkably high concentrations in gastric tissu e, persisting above the MIG(90) for Helicobacter pylori over a 5-day p eriod after a single 500-mg oral dose. Methods: We evaluated a new met ronidazole-free triple therapy with omeprazole 20 mg b.i.d. plus amoxi cillin 1 g b.i.d. (both for 14 days) and azithromycin 500 mg mane (for the first 3 days only) (group I) versus double therapy with omeprazol e 20 mg b.i.d. plus amoxicillin 1 g t.i.d., both for 14 days (group II ). H. pylori status was determined by urease test and histology before and 6 wk after completion of therapy, Results: Ninety-two patients wi th peptic ulcer disease or nonulcer dyspepsia completed the study. H. pylori infection was eradicated in 44 (91.6%) of 48 patients randomize d to receive triple therapy versus 26 (59.1%) of 44 who received doubl e therapy (p < 0.001), Smoking, but not omeprazole pretreatment, prove d to be a risk factor for treatment failure only in the double-therapy group (p = 0.05). All ulcers healed by the time of the 8-wk endoscopi c control, Side effects, usually minor, were recorded in 12.5% and 9.1 % of patients, respectively (NS), but therapy had to be discontinued i n one patient in group I and in three in group II (NS), Conclusions: T wo-week triple therapy with omeprazole, amoxicillin, and (for the firs t 3 days) low-dose azithromycin is highly effective in eradicating H. pylori. This regimen is safe and well-tolerated, and we recommend that it be used as first-line treatment, as an alternative to less-effecti ve omeprazole-amoxicillin double therapy, Moreover, azithromycin appea rs to be a new, promising antibiotic for future innovative anti-H. pyl ori combinations.