Efficacy and safety of Levofloxacin, Clarithromycin and Esomeprazol as first line triple therapy for Helicobacter pylori eradication in Middle East. Prospective, randomized, blind, comparative, multicenter study.
OBJECTIVE
Antibiotic resistance and poor compliance are the main causes of Helicobacter pylori (H. pylori ) eradication failure. This study evaluated the eradication rate, tolerability, and compliance of Levofloxacin, Clarithromycin and Esomeprazol combined triple therapy for H. pylori eradication.


METHODS
Four hundred-fifty patients from 3 centres who were diagnosed to have Helicobacter pylori infection by (13)C-urea breath test were randomized into 3 equal groups; group 1 (CAE) received Clarithromycin 500mg twice daily, Amoxicillin 1000mg twice daily, plus Esomeprazol 20mg twice daily for 7 days, group 2 (LAE) received Levofloxacin 500mg once daily, Amoxicillin 1000mg twice daily, plus Esomeprazol 20mg twice daily for 7 days, group 3 (CLE) received Levofloxacin 500mg once daily, Clarithromycin 500mg twice daily, plus Esomeprazol 20mg twice daily for 7 days. 436 patients were re-evaluated by (13)C-urea breath test after 6weeks from completion of treatment.


RESULTS
H. pylori eradication (intention to treat) was successful in 136/150 (90.6%) with CLE, 127/150 (84.7%) with LAE and 118/150 (78.6%) with CAE. There was a significant difference (p<0.001) regarding treatment success between CLE and LAE when compared with CAE. There was no difference among the treatment groups with regard to the incidence and severity of adverse events reported.


CONCLUSIONS
The combined Levofloxacin, and Clarithromycin and Esomeprazol based regimen as first line triple therapy for H. pylori eradication can give more significant eradication rate with same safety when compared with classic triple therapy.
Assem
M
M
Hepatology Department, National Liver Institute, Sheben Al koom, Egypt. medassem68@yahoo.com
El Azab
G
G
Rasheed
M Abdel
MA
Abdelfatah
M
M
Shastery
M
M
D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D064704:Levofloxacin; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage / Q000627:therapeutic use*; D009853:Omeprazole / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D016037:Single-Blind Method; D055815:Young Adult
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D064704:Levofloxacin; D000658:Amoxicillin; D015242:Ofloxacin; D017291:Clarithromycin; D009853:Omeprazole