First-line triple therapy with levofloxacin for Helicobacter pylori eradication.
BACKGROUND
At present, the efficacy of proton pump inhibitor-clarithromycin-amoxicillin regimen is relatively low.


OBJECTIVE
To evaluate the efficacy and tolerability of a first-line triple clarithromycin-free regimen including ranitidine bismuth citrate, levofloxacin and amoxicillin.


METHODS



METHODS
Prospective study.


METHODS
Helicobacter pylori-positive patients complaining of dyspeptic symptoms referred for gastroscopy.


METHODS
Levofloxacin (500 mg b.d.), amoxicillin (1 g b.d.) and ranitidine bismuth citrate (400 mg b.d.) was prescribed for 10 days.


RESULTS
Eradication was confirmed by a (13)C-urea breath test 8 weeks after therapy. Compliance with therapy was determined by questioning and the recovery of empty envelopes of medications. Incidence of adverse effects was evaluated by means of a specific questionnaire.


RESULTS
Sixty-four patients were included (30% peptic ulcer, 70% functional dyspepsia). Almost all (97%) patients took all the medications correctly. Per-protocol and intention-to-treat eradication rates were 88.5% (95% CI =78-95%) and 84.4 (74-91%). Adverse effects were reported in 9.5% of the patients, mainly including diarrhoea (7.9%); none of them were severe.


CONCLUSIONS
This new 10-day levofloxacin-based combination represents an alternative to clarithromycin-based therapy, as it meets the criteria set for regimens used as primary H. pylori treatment: effectiveness (>80%), simplicity (twice-daily dosing and excellent compliance) and safety (low incidence of adverse effects).
Gisbert
J P
JP
Gastroenterology Unit, Hospital Universitario de la Princesa, Madrid, Spain. gisbert@meditex.es
Fernández-Bermejo
M
M
Molina-Infante
J
J
Pérez-Gallardo
B
B
Prieto-Bermejo
A-B
AB
Mateos-Rodríguez
J-M
JM
Robledo-Andrés
P
P
González-García
G
G
D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001729:Bismuth / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D011899:Ranitidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D064704:Levofloxacin; C073340:ranitidine bismuth citrate; D000658:Amoxicillin; D011899:Ranitidine; D015242:Ofloxacin; D001729:Bismuth