Three-day antibiotic therapy with azithromycin and tinidazole plus lansoprazole or pantoprazole to cure Helicobacter pylori infection: a pilot study.
OBJECTIVE
The aim of the present study was to investigate and compare the effects of two proton-pump inhibitors, lansoprazole (Limpidex 30 mg, Sigmatau) vs pantoprazole (Peptazol 40 mg, Boehringer Mannheim), included in a three-day antibiotic therapy regimen with azithromycin (Zitromax 500 mg, Pfizer) and tinidazole (Fasigin 500 mg, Pfizer).


METHODS
Seventy consecutive, H. pylori-positive patients were randomly pre-treated with lansoprazole 30 mg o.d. (once daily) or pantoprazole 40 mg o.d. for two days, and subsequently respectively assigned to one of the two following treatment regimens, given for only three days: regimen A (LAT) comprising lansoprazole 30 mg o.d. plus azithromycin 500 mg o.d. and tinidazole 500 mg b.i.d. (bis in die), or regimen B (PAT) comprising pantoprazole 40 mg o.d. plus azithromycin 500 mg o.d. and tinidazole 500 mg b.i.d. H. pylori status was evaluated by means of histology and rapid urease test at entry, and by 13C-urea breath test alone 8 weeks after treatment.


METHODS
Sixty-nine of the enrolled patients completed the study: 34 in the LAT group and 35 in the PAT group. One patient in the LAT group was lost to follow-up. In the LAT group, after the end of treatment, 28/34 patients were H. pylori-negative (per protocol: 82%; intention-to-treat: 80%). In the PAT group, after treatment, 29/35 patients were H. pylori-negative (per protocol and intention-to-treat: 83%). Mild or slight side-effects occurred in only one patient in the LAT group and in one in the PAT group.


CONCLUSIONS
From this study there is no evidence that either of the two proton-pump inhibitors used is preferable in a three-day antibiotic regimen with azithromycin and tinidazole. The excellent side-effect and tolerability profiles, associated with acceptable eradication rates, make the two treatment regimens we tested particularly useful when patient compliance is difficult to achieve.
Cammarota
G
G
Department of Internal Medicine, Catholic University SC, Rome, Italy.
Papa
A
A
Cianci
R
R
Cannizzaro
O
O
Armuzzi
A
A
Gasbarrini
A
A
Addolorato
G
G
Gasbarrini
G B
GB
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D017963:Azithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004381:Duodenal Ulcer / Q000188:drug therapy*; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077402:Pantoprazole; D010865:Pilot Projects; D011446:Prospective Studies; D054328:Proton Pump Inhibitors; D013276:Stomach Ulcer / Q000188:drug therapy*; D013454:Sulfoxides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D014011:Tinidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D004791:Enzyme Inhibitors; D054328:Proton Pump Inhibitors; D013454:Sulfoxides; D014011:Tinidazole; D064747:Lansoprazole; D017963:Azithromycin; D000077402:Pantoprazole; D009853:Omeprazole