Can Helicobacter pylori eradication regimens be shortened in clinical practice? An open-label, randomized, pilot study of 4 and 7-day triple therapy with rabeprazole, high-dose levofloxacin, and tinidazole.
BACKGROUND
Rabeprazole is a proton pump inhibitor which is particularly suitable for use in short-term Helicobacter pylori eradication treatment. Levofloxacin-based H. pylori eradication regimens have shown good efficacy and very few side effects. Shorter treatment and absence of significant side effects should improve compliance to therapy and increase the Hp H. pylori eradication rate.


OBJECTIVE
To evaluate the effectiveness of 2 rabeprazole-based H. pylori eradication regimens in an open-label, randomized study carried out in a clinical practice setting.


METHODS
One hundred sixty-nine consecutive, treatment-naive patients with H. pylori infection were randomized to receive rabeprazole (20 mg, bid), levofloxacin (500 mg, bid), and tinidazole (500 mg, bid) for either 4 [4-d rabeprazole, levofloxacin, tinidazole (RLT), n=85] or 7 days (7-d RLT, n=84). Before treatment, all patients underwent upper digestive endoscopy. Cure rates were assessed by means of C-urea breath test. and were compared with the eradication rate obtained with standard triple therapy in our Unit (ie, 78%) and average eradication rate reported in the literature (ie, 79%).


RESULTS
The intention-to-treat eradication rates were 94% [87% to 98%, 95% confidence interval (CI)] and 95% (88% to 99%, 95% CI) in the 4-day RLT and 7-day RLT regimens, respectively, whereas per-protocol eradication rates were 95% (88% to 99%, 95% CI) in the 4-day RLT and 96% (90% to 99%, 95% CI) in the 7-day RLT. Both treatment regimens obtained significantly higher eradication rates as compared with standard triple therapy. The 4-day RLT showed significantly fewer side effects.


CONCLUSIONS
In a clinical practice setting, both 4-day and 7-day rabeprazole, high-dose levofloxacin, tinidazole-based regimens achieved relevant H. pylori eradication rates in treatment-naive patients. The lower number of side effects makes the shorter treatment regimen preferable over the conventional 7-day treatment.
Giannini
Edoardo G
EG
Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy. egiannini@unige.it
Bilardi
Claudio
C
Dulbecco
Pietro
P
Mamone
Mario
M
Santi
Maria L
ML
Testa
Roberto
R
Mansi
Carlo
C
Savarino
Vincenzo
V
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D000994:Antitrichomonal Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use*; D001944:Breath Tests; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D064704:Levofloxacin; D015242:Ofloxacin / Q000627:therapeutic use*; D009853:Omeprazole / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010865:Pilot Projects; D064750:Rabeprazole; D014011:Tinidazole / Q000627:therapeutic use*; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D000994:Antitrichomonal Agents; D001562:Benzimidazoles; D014011:Tinidazole; D064750:Rabeprazole; D064704:Levofloxacin; D015242:Ofloxacin; D009853:Omeprazole