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. Issue 5 (28th April 2010)

• Record Type: Journal Article
• Authors: Liou, Jyh-Ming; Lin, Jaw-Town; Chang, Chi-Yang; Chen, Mei-Jyh; Cheng, Tsu-Yao; Lee, Yi-Chia; Chen, Chien-Chuan; Sheng, Wang-Huei; Wang, Hsiu-Po; Wu, Ming-Shiang
• Is Part Of: Gut. Volume 59:Issue 5(2010)
• Page Start: 572
• Page End: 578
• Publication Date: 2010-04-28
• Subjects: Antibiotics–clinical trials -- clarithromycin -- eradication -- Helicobacter pylori -- levofloxacin -- randomised -- sequence -- susceptibility test; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gut.2009.198309
• Languages: English
• ISSNs: 0017-5749

Abstract

Abstract : 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 [ 13 C]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.