Second-line therapy with levofloxacin after failure of treatment to eradicate helicobacter pylori infection: time trends in a Spanish Multicenter Study of 1000 patients.
BACKGROUND
Second-line bismuth-containing quadruple therapy is complex and frequently induces adverse effects. A triple rescue regimen containing levofloxacin is a potential alternative; however, resistance to quinolones is rapidly increasing.


OBJECTIVE
To evaluate the efficacy and tolerability of a second-line triple-regimen-containing levofloxacin in patients whose Helicobacter pylori eradication treatment failed and to assess whether the efficacy of the regimen decreases with time.


METHODS



METHODS
Prospective multicenter study.


METHODS
In whom treatment with a regimen comprising a proton-pump inhibitor, clarithromycin, and amoxicillin had failed.


METHODS
Levofloxacin (500 mg bid), amoxicillin (1 g bid), and omeprazole (20 mg bid) for 10 days.


RESULTS
Eradication was confirmed using the C-urea breath test 4 to 8 weeks after therapy. Compliance/tolerance: Compliance was determined through questioning and recovery of empty medication envelopes. Incidence of adverse effects was evaluated by means of a questionnaire.


RESULTS
The study sample comprised 1000 consecutive patients (mean age, 49 ± 15 y, 42% men, 33% peptic ulcer) of whom 97% took all medications correctly. Per-protocol and intention-to-treat eradication rates were 75.1% (95% confidence interval, 72%-78%) and 73.8% (95% confidence interval, 71%-77%). Efficacy (intention-to-treat) was 76% in the year 2006, 68% in 2007, 70% in 2008, 76% in 2009, 74% in 2010, and 81% in 2011. In the multivariate analysis, none of the studied variables (including diagnosis and year of treatment) were associated with success of eradication. Adverse effects were reported in 20% of patients, most commonly nausea (7.9%), metallic taste (3.9%), myalgia (3.1%), and abdominal pain (2.9%).


CONCLUSIONS
Ten-day levofloxacin-containing therapy is an encouraging second-line strategy, providing a safe and simple alternative to quadruple therapy in patients whose previous standard triple therapy has failed. The efficacy of this regimen remains stable with time.
Gastroenterology Unit, La Princesa, Instituto de Investigación Sanitaria Princesa (IP) y, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. gisbert@meditex.es
Javier P
JP
Gisbert
Angeles
A
Pérez-Aisa
Fernando
F
Bermejo
Manuel
M
Castro-Fernández
Pedro
P
Almela
Jesús
J
Barrio
Angel
A
Cosme
Inés
I
Modolell
Felipe
F
Bory
Miguel
M
Fernández-Bermejo
Luis
L
Rodrigo
Jesús
J
Ortuño
Pilar
P
Sánchez-Pobre
Sam
S
Khorrami
Alejandro
A
Franco
Albert
A
Tomas
Iván
I
Guerra
Eloisa
E
Lamas
Julio
J
Ponce
Xavier
X
Calvet
D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001944:Breath Tests; D017291:Clarithromycin / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000254:growth & development; D006801:Humans; D064704:Levofloxacin; D016015:Logistic Models; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D015999:Multivariate Analysis; D015242:Ofloxacin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009853:Omeprazole / Q000627:therapeutic use; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D012074:Remission Induction; D013030:Spain / Q000453:epidemiology; D011795:Surveys and Questionnaires; D013997:Time Factors; D017211:Treatment Failure
D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D064704:Levofloxacin; D000658:Amoxicillin; D015242:Ofloxacin; D017291:Clarithromycin; D009853:Omeprazole