Clinical trial: clarithromycin vs. levofloxacin in first-line triple and sequential regimens for Helicobacter pylori eradication.
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.
Molina-Infante
J
J
Department of Gastroenterology, Hospital San Pedro de Alcantara, Caceres, Spain. xavi_molina@hotmail.com <xavi_molina@hotmail.com>
Perez-Gallardo
B
B
Fernandez-Bermejo
M
M
Hernandez-Alonso
M
M
Vinagre
G
G
Dueñas
C
C
Mateos-Rodriguez
J M
JM
Gonzalez-Garcia
G
G
Abadia
E G
EG
Gisbert
J P
JP
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
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D008795:Metronidazole; D064704:Levofloxacin; D000658:Amoxicillin; D015242:Ofloxacin; D017291:Clarithromycin; D009853:Omeprazole