Helicobacter pylori first-line treatment and rescue option containing levofloxacin in patients allergic to penicillin.
OBJECTIVE
To assess the efficacy and tolerability of Helicobacter pylori first-line treatment (omeprazole-clarithromycin-metronidazole) and second-line rescue option (omeprazole-clarithromycin-levofloxacin) in patients allergic to penicillin.


METHODS



METHODS
Prospective multicenter study including consecutive patients allergic to penicillin. Therapy regimens: First-line treatment (50 patients): Omeprazole (20mg b.i.d.), clarithromycin (500 mg b.i.d.) and metronidazole (500 mg b.i.d.) for 7 days. Second-line treatment (15 therapy failures out of the aforementioned 50 patients): Omeprazole (20mg b.i.d.), clarithromycin (500 mg b.i.d.) and levofloxacin (500 mg b.i.d.) for 10 days.


METHODS
Negative (13)C-urea breath test 8 weeks after completion of treatment.


RESULTS
(1) First-line treatment (omeprazole-clarithromycin-metronidazole): Per-protocol and intention-to-treat eradication rates were 55% (27/49; 95%CI=40-70%) and 54% (27/50; 95%CI=39-69%). Compliance with treatment and follow-up was complete in 98% of cases (one patient was not compliant due to nausea). Adverse events were reported in 5 patients (10%): 4 nausea, 1 diarrhoea. (2) Second-line treatment (omeprazole-clarithromycin-levofloxacin): Per-protocol and intention-to-treat eradication rates were both 73% (11/15; 95%CI=45-92%). Compliance with treatment and follow-up was complete in all the cases. Adverse events were reported in 4 patients (20%), which did not prevent the completion of treatment: Mild nausea (2 patients), and vomiting and myalgias/arthralgias (1 patient).


CONCLUSIONS
In H. pylori infected patients allergic to penicillin, the generally recommended first-line treatment with omeprazole, clarithromycin and metronidazole has low efficacy for curing the infection. On the other hand, a levofloxacin-containing regimen (together with omeprazole and clarithromycin) represents an encouraging second-line alternative in the presence of penicillin allergy.
Gisbert
J P
JP
Gastroenterology Unit, Hospital Universitario de la Princesa and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain. gisbert@meditex.es
Pérez-Aisa
A
A
Castro-Fernández
M
M
Barrio
J
J
Rodrigo
L
L
Cosme
A
A
Gisbert
J-L
JL
Marcos
S
S
Moreno-Otero
R
R
D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage; D017291:Clarithromycin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004342:Drug Hypersensitivity / Q000150:complications*; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage*; D009853:Omeprazole / Q000008:administration & dosage; D010406:Penicillins / Q000009:adverse effects*; D011446:Prospective Studies; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D000897:Anti-Ulcer Agents; D010406:Penicillins; D008795:Metronidazole; D064704:Levofloxacin; D015242:Ofloxacin; D017291:Clarithromycin; D009853:Omeprazole