title: Clinical trial: clarithromycin vs. levofloxacin in first-line triple and sequential regimens for Helicobacter pylori eradication.
abstract: BACKGROUND
  Helicobacter pylori eradication rates with standard triple therapy have declined to unacceptable levels.
  
  
  OBJECTIVE
  To compare clarithromycin and levofloxacin in triple and sequential first-line regimens.
  
  
  METHODS
  A total of 460 patients were randomized into four 10-day therapeutic schemes (115 patients per group): (i) standard OCA, omeprazole, clarithromycin and amoxicillin; (ii) triple OLA, omeprazole, levofloxacin and amoxicillin; (iii) sequential OACM, omeprazole plus amoxicillin for 5 days, followed by omeprazole plus clarithromycin plus metronidazole for 5 days; and (iv) modified sequential OALM, using levofloxacin instead of clarithromycin. Eradication was confirmed by 13C-urea breath test. Adverse effects and compliance were assessed by a questionnaire.
  
  
  RESULTS
  Per protocol cure rates were: OCA (66%; 95% CI: 57-74%), OLA (82.6%; 75-89%), OACM (80.8%; 73-88%) and OALM (85.2%; 78-91%). Intention-to-treat cure rates were: OCA (64%; 55-73%), OLA (80.8%; 73-88%), OACM (76.5%; 69-85%) and OALM (82.5%; 75-89%). Eradication rates were lower with OCA than with all the other regimens (P < 0.05). No differences in compliance or adverse effects were demonstrated among treatments.
  
  
  CONCLUSIONS
  Levofloxacin-based and sequential therapy are superior to standard triple scheme as first-line regimens in a setting with high clarithromycin resistance. However, all of these therapies still have a 20% failure rate.
authors.affiliation: Department of Gastroenterology, Hospital San Pedro de Alcantara, Caceres, Spain. xavi_molina@hotmail.com <xavi_molina@hotmail.com>
authors.forename: J
authors.initials: J
authors.lastname: Molina-Infante
authors.forename: B
authors.initials: B
authors.lastname: Perez-Gallardo
authors.forename: M
authors.initials: M
authors.lastname: Fernandez-Bermejo
authors.forename: M
authors.initials: M
authors.lastname: Hernandez-Alonso
authors.forename: G
authors.initials: G
authors.lastname: Vinagre
authors.forename: C
authors.initials: C
authors.lastname: Dueñas
authors.forename: J M
authors.initials: JM
authors.lastname: Mateos-Rodriguez
authors.forename: G
authors.initials: G
authors.lastname: Gonzalez-Garcia
authors.forename: E G
authors.initials: EG
authors.lastname: Abadia
authors.forename: J P
authors.initials: JP
authors.lastname: Gisbert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D015242:Ofloxacin / Q000627:therapeutic use*; D009853:Omeprazole / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D008795:Metronidazole; D064704:Levofloxacin; D000658:Amoxicillin; D015242:Ofloxacin; D017291:Clarithromycin; D009853:Omeprazole