High-dose versus low-dose clarithromycin in 1-week triple therapy, including rabeprazole and levofloxacin, for Helicobacter pylori eradication.

Author(s): Cammarota G, Cianci R, Cannizzaro O, Martino A, Fedeli P, Lecca PG, di Caro S, Cesaro P, Branca G, Gasbarrini G

Affiliation(s): Department of Internal Medicine, Institute of Microbiology, Catholic University of Rome, Italy. gcammarota@rm.unicatt.it

Publication date & source: 2004-02, J Clin Gastroenterol., 38(2):110-4.

Publication type: Clinical Trial; Randomized Controlled Trial

GOALS: To compare high-dose versus low-dose clarithromycin in 1-week triple therapy including rabeprazole and levofloxacin. BACKGROUND: Regimens containing rabeprazole and levofloxacin have proved to be effective against H. pylori infection. STUDY: One-hundred H. pylori-positive patients were randomly assigned to one of the following 1-week regimens: rabeprazole 20 mg o.d. plus levofloxacin 500 mg o.d. and clarithromycin 250 mg b.d. (RLC-1 group); rabeprazole 20 mg o.d. plus levofloxacin 500 mg o.d. and clarithromycin 500 mg b.d. (RLC-2 group). H. pylori status was assessed at entry and after the treatment. Patients who experienced treatment failure underwent antibiotic susceptibility testing. RESULTS: Forty-two patients in RLC-1 group (both PP and ITT analysis: 84%; 95%CI: 71-93%) and 47 in RLC2 group (both PP and ITT analysis: 94%; 95% CI: 83-98%) became H. pylori negative. Clarithromycin resistance was detected in all of 8 (100%) RLC-1 failures and in 1 out of 3 (33%) RLC-2 failures. Side effects occurred in 8% of patients in RLC-1 group and in 12% in RLC-2. CONCLUSIONS: Regimens tested are competitive with other PPI-based treatments. One-week triple therapy containing rabeprazole plus, levofloxacin, and high-dose clarithromycin yielded a higher eradicating rate than the one containing low-dose clarithromycin and may be considered as a first-line therapy option.