Levofloxacin-based triple therapy vs. quadruple therapy in second-line Helicobacter pylori treatment: a randomized trial.
BACKGROUND
Levofloxacin has been shown to be effective in Helicobacter pylori eradication. Two 10-day levofloxacin-based triple therapies were compared with standard 7- and 14-day quadruple regimens in second-line treatment.


METHODS
Two hundred and eighty consecutive patients who failed to respond to standard triple therapy (clarithromycin, amoxicillin, rabeprazole) were randomly assigned to four groups: (1) levofloxacin 500 mg o.d., amoxicillin 1 g b.d., rabeprazole 20 mg b.d. for 10 days (LAR, n = 70); (2) levofloxacin 500 mg o.d., tinidazole 500 mg b.d., rabeprazole 20 mg b.d. for 10 days (LTR, n = 70); (3) tetracycline 500 mg q.d.s., metronidazole 500 mg t.d.s., bismuth salt 120 mg q.d.s., rabeprazole 20 mg b.d. for 7 days (7TMBR, n = 70); and (4) for 14 days (14TMBR, n = 70). Helicobacter pylori status and side-effects were assessed 6 weeks after treatment.


RESULTS
The eradication rate was 94% in the LAR group and 90% in the LTR group in both intention-to-treat and per protocol analyses. Helicobacter pylori eradication was achieved in 63 and 69% of the 7TMBR group and in 69 and 80% of the 14TMBR group in intention-to-treat and per protocol analysis, respectively. Side-effects were significantly lower in the LAR and LTR groups than in the 14TMBR group.


CONCLUSIONS
Ten-day levofloxacin-based therapies are better than standard quadruple regimens as second-line option for H. pylori eradication.
Nista
E C
EC
Internal Medicine Department, Catholic University, Rome, Italy.
Candelli
M
M
Cremonini
F
F
Cazzato
I A
IA
Di Caro
S
S
Gabrielli
M
M
Santarelli
L
L
Zocco
M A
MA
Ojetti
V
V
Carloni
E
E
Cammarota
G
G
Gasbarrini
G
G
Gasbarrini
A
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000863:Antacids / Q000008:administration & dosage / Q000009:adverse effects; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001729:Bismuth / Q000008:administration & dosage / Q000009:adverse effects; D004359:Drug Therapy, Combination / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D010349:Patient Compliance; D011446:Prospective Studies; D016896:Treatment Outcome
D000863:Antacids; D000890:Anti-Infective Agents; D064704:Levofloxacin; D015242:Ofloxacin; D001729:Bismuth