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 antibiotic that achieves remarkably high concentrations in gastric tissue, persisting above the MIC90 for Helicobacter pylori over a 5-day period after a single 500-mg oral dose.


METHODS
We evaluated a new metronidazole-free triple therapy with omeprazole 20 mg b.i.d. plus amoxicillin 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 omeprazole 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 with peptic ulcer disease or nonulcer dyspepsia completed the study. H. pylori infection was eradicated in 44 (91.6%) of 48 patients randomized to receive triple therapy versus 26 (59.1%) of 44 who received double therapy (p < 0.001). Smoking, but not omeprazole pretreatment, proved 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 endoscopic control. Side effects, usually minor, were recorded in 12.5% and 9.1% of patients, respectively (NS), but therapy had to be discontinued in one patient in group I and in three in group II (NS).


CONCLUSIONS
Two-week triple therapy with omeprazole, amoxicillin, and (for the first 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-effective omeprazole-amoxicillin double therapy. Moreover, azithromycin appears to be a new, promising antibiotic for future innovative anti-H. pylori combinations.
Bertoni
G
G
Department of Digestive Endoscopy, S. Maria Nuova Hospital, Reggio Emilia, Italy.
Sassatelli
R
R
Nigrisoli
E
E
Tansini
P
P
Bianchi
G
G
Della Casa
G
G
Bagni
A
A
Bedogni
G
G
D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D017963:Azithromycin / Q000008:administration & dosage*; D004381:Duodenal Ulcer / Q000188:drug therapy; D004415:Dyspepsia / Q000188:drug therapy; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage*; D010406:Penicillins / Q000008:administration & dosage*; D012907:Smoking; D013276:Stomach Ulcer / Q000188:drug therapy; D013997:Time Factors
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D010406:Penicillins; D000658:Amoxicillin; D017963:Azithromycin; D009853:Omeprazole