Comparison of the once-daily levofloxacin-containing triple therapy with the twice-daily standard triple therapy for first-line Helicobacter pylori eradication: a prospective randomised study.
OBJECTIVE
Simple compound of Helicobacter pylori eradication therapy may improve drug compliance of patients. The aims of this study were to compare the efficacy and tolerability of a simple combination containing levofloxacin 7-day once-daily with standard twice-daily triple therapy.


METHODS
This was a prospective, randomised, open-label trial. A total of 189 consecutive patients diagnosed with peptic ulcer and H. pylori infection were enrolled. Patients were randomly divided into two groups: LEC group--levofloxacin 500 mg, esomeprazole 40 mg and clarithromycin 500 mg once daily for 7 days; AEC group--amoxicillin 1 g, esomeprazole 40 mg and clarithromycin 500 mg twice daily for 7 days.


RESULTS
There were 90 patients in the LEC group and 99 patients in the AEC group. By intention-to-treat and per-protocol analysis, the H. pylori eradication rate was 78.9% [71/90; 95% confidence interval (CI), 70.3-87.5%] and 83.5% (71/85; 95% CI, 75.5-91.6%) respectively, in the LEC group; and 74.8% (74/99; 95% CI, 66.0-83.5%) and 86.0% (74/86; 95% CI, 78.6-93.5%) respectively, in the AEC group. The incidence and tolerability of side effects were similar between these two groups.


CONCLUSIONS
The efficacy and tolerability of once-daily levofloxacin-containing triple therapy are equal to those of the standard twice-daily triple therapy in this study. However, none of the treatment regimens evaluated achieved enough eradication efficacies to be considered as a recommendable first-line treatment.
Chen
L-W
LW
Department of Gastroenterology, Chang Gung Memorial Hospital and University, Keelung, TaiwanDepartment of Pathology, Chang Gung Memorial Hospital and University, Keelung, Taiwan.
Chien
R-N
RN
Department of Gastroenterology, Chang Gung Memorial Hospital and University, Keelung, TaiwanDepartment of Pathology, Chang Gung Memorial Hospital and University, Keelung, Taiwan.
Chang
J-J
JJ
Department of Gastroenterology, Chang Gung Memorial Hospital and University, Keelung, TaiwanDepartment of Pathology, Chang Gung Memorial Hospital and University, Keelung, Taiwan.
Fang
K-M
KM
Department of Gastroenterology, Chang Gung Memorial Hospital and University, Keelung, TaiwanDepartment of Pathology, Chang Gung Memorial Hospital and University, Keelung, Taiwan.
Chang
L-C
LC
Department of Gastroenterology, Chang Gung Memorial Hospital and University, Keelung, TaiwanDepartment of Pathology, Chang Gung Memorial Hospital and University, Keelung, Taiwan.
D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000897:Anti-Ulcer Agents / Q000008:administration & dosage; D017291:Clarithromycin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000379:methods; D064098:Esomeprazole / Q000008:administration & dosage; D005260:Female; D016481:Helicobacter Infections / Q000517:prevention & control*; D016480:Helicobacter pylori; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D064704:Levofloxacin; D000658:Amoxicillin; D015242:Ofloxacin; D017291:Clarithromycin; D064098:Esomeprazole