title: Helicobacter pylori first-line and rescue treatments in the presence of penicillin allergy.
abstract: BACKGROUND
  Helicobacter pylori eradication is a challenge in penicillin allergy.
  
  
  OBJECTIVE
  To assess the efficacy and safety of first-line and rescue treatments in patients allergic to penicillin.
  
  
  METHODS
  Prospective multicenter study. Patients allergic to penicillin were given a first-line treatment comprising (a) 7-day omeprazole-clarithromycin-metronidazole and (b) 10-day omeprazole-bismuth-tetracycline-metronidazole. Rescue treatments were as follows: (a) bismuth quadruple therapy; (b) 10-day PPI-clarithromycin-levofloxacin; and (c) 10-day PPI-clarithromycin-rifabutin. Eradication was confirmed by (13)C-urea breath test. Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated by questionnaires.
  
  
  RESULTS
  In total, 267 consecutive treatments were included. (1) First-line treatment: Per-protocol and intention-to-treat eradication rates with omeprazole-clarithromycin-metronidazole were 59 % (62/105; 95 % CI 49-62 %) and 57 % (64/112; 95 % CI 47-67 %). Respective figures for PPI-bismuth-tetracycline-metronidazole were 75 % (37/49; 95 % CI 62-89 %) and 74 % (37/50; 95 % CI (61-87 %) (p < 0.05). Compliance with treatment was 94 and 98 %, respectively. Adverse events were reported in 14 % with both regimens (all mild). (2) Second-line treatment: Intention-to-treat eradication rate with omeprazole-clarithromycin-levofloxacin was 64 % both after triple and quadruple failure; compliance was 88-100 %, with 23-29 % adverse effects (all mild). (3) Third-/fourth-line treatment: Intention-to-treat eradication rate with PPI-clarithromycin-rifabutin was 22 %.
  
  
  CONCLUSIONS
  In allergic to penicillin patients, a first-line treatment with a bismuth-containing quadruple therapy (PPI-bismuth-tetracycline-metronidazole) seems to be a better option than the triple PPI-clarithromycin-metronidazole regimen. A levofloxacin-based regimen (together with a PPI and clarithromycin) represents a second-line rescue option in the presence of penicillin allergy.
authors.affiliation: Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Playa de Mojácar 29. Urb. Bonanza, 28669, Boadilla del Monte, Madrid, Spain, javier.p.gisbert@gmail.com.
authors.forename: Javier P
authors.initials: JP
authors.lastname: Gisbert
authors.forename: Jesús
authors.initials: J
authors.lastname: Barrio
authors.forename: Inés
authors.initials: I
authors.lastname: Modolell
authors.forename: Javier
authors.initials: J
authors.lastname: Molina-Infante
authors.forename: Angeles Perez
authors.initials: AP
authors.lastname: Aisa
authors.forename: Manuel
authors.initials: M
authors.lastname: Castro-Fernández
authors.forename: Luis
authors.initials: L
authors.lastname: Rodrigo
authors.forename: Angel
authors.initials: A
authors.lastname: Cosme
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Gisbert
authors.forename: Miguel
authors.initials: M
authors.lastname: Fernández-Bermejo
authors.forename: Santiago
authors.initials: S
authors.lastname: Marcos
authors.forename: Alicia C
authors.initials: AC
authors.lastname: Marín
authors.forename: Adrián G
authors.initials: AG
authors.lastname: McNicholl
mesh_terms: D000863:Antacids / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D001729:Bismuth / Q000008:administration & dosage; D001944:Breath Tests; D017291:Clarithromycin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004342:Drug Hypersensitivity / Q000209:etiology*; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D064704:Levofloxacin / Q000008:administration & dosage; D008297:Male; D055118:Medication Adherence; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage; D010406:Penicillins / Q000009:adverse effects*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D017828:Rifabutin / Q000008:administration & dosage; D016879:Salvage Therapy; D013030:Spain; D013752:Tetracycline / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000863:Antacids; D000900:Anti-Bacterial Agents; D010406:Penicillins; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D017828:Rifabutin; D064704:Levofloxacin; D013752:Tetracycline; D017291:Clarithromycin; D009853:Omeprazole; D001729:Bismuth