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

• Published in: International journal of clinical practice (Esher) Vol. 64; no. 11; pp. 1530 - 1534
• Main Authors: Chen, L.-W., Chien, R.-N., Chang, J.-J., Fang, K.-M., Chang, L.-C.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.10.2010; Wiley-Blackwell; Hindawi Limited
• Subjects: Adult; Aged; Amoxicillin; Amoxicillin - administration & dosage; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Anti-Ulcer Agents - administration & dosage; Antibiotics; Bacterial diseases; Bacterial diseases of the digestive system and abdomen; Bacterial infections; Biological and medical sciences; Clarithromycin; Clarithromycin - administration & dosage; Clinical trials; Comparative studies; Drug Administration Schedule; Drug dosages; Drug Therapy, Combination - methods; Drugs; Esomeprazole - administration & dosage; Female; General aspects; Helicobacter Infections - prevention & control; Helicobacter pylori; Human bacterial diseases; Humans; Infection; Infectious diseases; Levofloxacin; Male; Medical sciences; Middle Aged; Miscellaneous; Ofloxacin - administration & dosage; Ofloxacin - adverse effects; Omeprazole; peptic ulcers; Prospective Studies; Public health. Hygiene; Public health. Hygiene-occupational medicine; Side effects; Stomach; Treatment Outcome; Ulcers; Levofloxacin; Spirillales; Spirillaceae; Standard; Eradication; Standards; First line treatment; Infection; Medicine; Prospective; Fluoroquinolone derivatives; Daily; Randomization; Helicobacter pylori; Bacteriosis; Bacteria; Antibacterial agent; Daily dose; Quinolone derivatives; Comparative study
• ISSN: 1368-5031; 1742-1241
• DOI: 10.1111/j.1742-1241.2010.02482.x

Summary Background/Aims:  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. Patients and 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 40mg 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. Conclusion:  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.