Second-line levofloxacin-based triple schemes for Helicobacter pylori eradication.
BACKGROUND
The recommended second-line therapy for Helicobacter pylori (H. pylori) eradication is a quadruple regimen that fails in up to 30% of patients. Several recent studies suggest levofloxacin-based triple therapies as an alternative rescue treatment. However, dosage and length of levofloxacin-based regimens have not been established.


OBJECTIVE
To compare the efficacy and tolerability of four second-line levofloxacin-based schemes for H. pylori eradication.


METHODS
One hundred and sixty patients (aged 18-70 years, 72 male patients) who were H. pylori positive after standard triple therapies were randomised to receive esomeprazole 20mg b.d. and amoxicillin 1g b.d. plus levofloxacin 500 mg o.d., for 7 or 10 days (Groups A and B) or levofloxacin 500 mg b.d. for 7 days or 10 days (Groups C and D). H. pylori status was assessed by 13-C Urea Breath Test or rapid urease test, before and 6 weeks after therapy. Incidence of side effects was evaluated by a questionnaire.


RESULTS
No dropouts were observed. Eradication of H. pylori infection was successful in: 65% of patients in Group A; 90% in Group B; 70% in Group C; 85% in Group D. Based upon duration of treatment, eradication rates were: 67.5% in 7 days groups and 87.5% in 10 days groups (p=0.004). Dosage of levofloxacin did not affect the eradication rates (77.5% both in the once daily and twice daily groups). Mild adverse events were reported overall in 16% of patients (22.5% in 7 days groups; 27.5% in 10 days groups; p=0.58; 12% in the once daily group; 32.5% in the twice daily group; p=0.04).


CONCLUSIONS
10 days levofloxacin-based second-line regimens were effective in curing H. pylori infection in more than 85% of patients with a lower incidence of adverse effects in levofloxacin single-dosage scheme. The 10 days levofloxacin-based regimens were more effective than 7 days course of treatment showing that duration of therapy is the crucial factor affecting eradication rate.
Di Caro
S
S
Gastroenterology and Digestive Endoscopy Unit, San Raffaele-Giglio Hospital, Cefalù, Italy. simonadicaro@yahoo.it
Franceschi
F
F
Mariani
A
A
Thompson
F
F
Raimondo
D
D
Masci
E
E
Testoni
A
A
La Rocca
E
E
Gasbarrini
A
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D001944:Breath Tests; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage*; D016879:Salvage Therapy / Q000379:methods*; D055815:Young Adult
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D064704:Levofloxacin; D000658:Amoxicillin; D015242:Ofloxacin; D064098:Esomeprazole