Levofloxacin-based and clarithromycin-based triple therapies as first-line and second-line treatments for Helicobacter pylori infection: a randomised comparative trial with crossover design
- Jyh-Ming Liou1,2,
- Jaw-Town Lin1,3,
- Chi-Yang Chang3,
- Mei-Jyh Chen1,
- Tsu-Yao Cheng1,4,
- Yi-Chia Lee1,2,
- Chien-Chuan Chen1,
- Wang-Huei Sheng1,
- Hsiu-Po Wang1,
- Ming-Shiang Wu1,5
- 1Departments of Internal Medicine, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan
- 2Graduate Institute of Epidemiology, College of Public Health, National Taiwan University, Taipei, Taiwan
- 3Department of Internal Medicine, E-DA Hospital and I-Shou University, Kaohsiung County, Taiwan
- 4Laboratory Medicine, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan
- 5Primary Care Medicine, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan
- Correspondence to Professor Ming-Shiang Wu, Department of Internal Medicine and Primary Care Medicine, National Taiwan University Hospital, National Taiwan University, College of Medicine, No. 7, Chung-Shan S. Road, Taipei, Taiwan;
- Revised 17 November 2009
- Accepted 8 December 2009
Background The efficacy of a levofloxacin-based regimen as the first-line treatment and a clarithromycin-based regimen as the second-line treatment for Helicobacter pylori infection remains unknown. The aim of this study was to assess the eradication rates of these two regimens using different administration sequences.
Methods Eligible patients were randomised to receive LAL: levofloxacin (750 mg once a day), amoxicillin (1000 mg twice a day) and lansoprazole (30 mg twice a day) for 7 days, or CAL: clarithromycin (500 mg twice a day), amoxicillin (1000 mg twice a day) and lansoprazole (30 mg twice a day) for 7 days. Patients with positive [13C]urea breath test after treatment were retreated with the rescue regimen in a crossover manner for 10 days.
Result When used as first-line treatment (n=432), the eradication rates of LAL (n=217) and CAL (n=215) were 74.2 and 83.7% (p=0.015) in the intent-to-treat (ITT) analysis, and 80.1 and 87.4% (p=0.046) in the per-protocol (PP) analysis, respectively. When used as second-line treatment, the eradication rates of LAL (n=26) and CAL (n=40) were 76.9 and 60% (p=0.154) in the ITT analysis, and 80 and 61.5% (p=0.120) in the PP analysis, respectively. The overall eradication rates of CAL followed by LAL were better than the reverse sequence in both the ITT analysis (93% vs 85.3%, p=0.01) and the PP analysis (97.6% vs 92.5%, p=0.019). The eradication rate was significantly lower in the presence of levofloxacin resistance in the LAL group (50% vs 84.4%, p=0.018) and clarithromycin resistance in the CAL group (44.4% vs 90.7%, p=0.002).
Conclusion CAL achieved a higher eradication rate than LAL as the first-line treatment, but not as the second-line treatment. The strategy of using CAL as the initial treatment and LAL as the rescue regimen achieved higher eradication rates than the reverse sequence.
Clinical trial number NCT00816140.
- Antibiotics–clinical trials
- Helicobacter pylori
- susceptibility test
J-M Liou and J-TL contributed equally to this work.
Guarantors of the article, J-ML, M-SW; concept and design, J-ML, J-TL, M-SW; analysis and interpretation of the data, J-ML, J-TL, M-SW; collection and assembly of the data, -ML, M-SW, J-TL, C-YC, M-JC, C-CC, T-YC, Y-CL, W-HS, H-PW; drafting of the article, J-ML, M-SW; critical revision, J-ML, J-TL, M-SW; final approval, J-ML, M-SW, J-TLin.
Funding The study was funded by the National Clinical Trial Center of National Taiwan University Hospital (grant no. NCTRC200707). J-ML received research grants from the National Science Council, Executive Yuan, ROC, Taiwan (grant no. 97-2314-B-002-116-MY3). The study drugs and urea breath test used in the present study were sponsored by the Daiichi Sankyo Taiwan.
Competing interests None.
Ethics approval This study was conducted with the approval of the National Taiwan University Hospital.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.