Second-line rescue therapy with levofloxacin after H. pylori treatment failure: a Spanish multicenter study of 300 patients.
OBJECTIVE
Quadruple therapy is generally recommended as second-line therapy after Helicobacter pylori (H. pylori) eradication failure. However, this regimen requires the administration of four drugs with a complex scheme, is associated with a relatively high incidence of adverse effects, and bismuth salts are not available worldwide anymore. Our aim was to evaluate the efficacy and tolerability of a triple second-line levofloxacin-based regimen in patients with H. pylori eradication failure.


METHODS



METHODS
Prospective multicenter study.


METHODS
in whom a first treatment with proton pump inhibitor-clarithromycin-amoxicillin had failed.


METHODS
A second eradication regimen with levofloxacin (500 mg b.i.d.), amoxicillin (1 g b.i.d.), and omeprazole (20 mg b.i.d.) was prescribed for 10 days.


RESULTS
Eradication was confirmed with (13)C-urea breath test 4-8 wk after therapy. Compliance with therapy was determined from the interview and the recovery of empty envelopes of medications. Incidence of adverse effects was evaluated by means of a specific questionnaire.


RESULTS
Three hundred consecutive patients were included. Mean age was 48 yr, 47% were male, 38% had peptic ulcer, and 62% functional dyspepsia. Almost all (97%) patients took all the medications correctly. Per-protocol and intention-to-treat eradication rates were 81% (95% CI 77-86%) and 77% (73-82%). Adverse effects were reported in 22% of the patients, mainly including nausea (8%), metallic taste (5%), abdominal pain (3%), and myalgias (3%); none of them were severe.


CONCLUSIONS
Ten-day levofloxacin-based rescue therapy constitutes an encouraging second-line strategy, representing an alternative to quadruple therapy in patients with previous proton pump inhibitor-clarithromycin-amoxicillin failure, being simple and safe.
Gisbert
Javier P
JP
Hospital de la Princesa, Madrid.
Bermejo
Fernando
F
Castro-Fernández
Manuel
M
Pérez-Aisa
Angeles
A
Fernández-Bermejo
Miguel
M
Tomas
Albert
A
Barrio
José
J
Bory
Felipe
F
Almela
Pedro
P
Sánchez-Pobre
Pilar
P
Cosme
Angel
A
Ortiz
Vicente
V
Niño
Pilar
P
Khorrami
Sam
S
Benito
Luis-Miguel
LM
Carneros
Jose-Antonio
JA
Lamas
Eloisa
E
Modolell
Inés
I
Franco
Alejandro
A
Ortuño
Juan
J
Rodrigo
Luis
L
García-Durán
Fernando
F
O'Callaghan
Elena
E
Ponce
Julio
J
Valer
María-Paz
MP
Calvet
Xavier
X
D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001944:Breath Tests; D017291:Clarithromycin / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005500:Follow-Up Studies; D005753:Gastric Mucosa / Q000382:microbiology / Q000473:pathology; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification*; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000627:therapeutic use*; D009853:Omeprazole / Q000627:therapeutic use*; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D017211:Treatment Failure; D014508:Urea / Q000032:analysis
D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D064704:Levofloxacin; D000658:Amoxicillin; D014508:Urea; D015242:Ofloxacin; D017291:Clarithromycin; D009853:Omeprazole