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Clinical trial: clarithromycin vs. levofloxacin in first‐line triple and sequential regimens for Helicobacter pylori eradication
Author(s) -
MOLINAINFANTE J.,
PEREZGALLARDO B.,
FERNANDEZBERMEJO M.,
HERNANDEZALONSO M.,
VINAGRE G.,
DUEÑAS C.,
MATEOSRODRIGUEZ J. M.,
GONZALEZGARCIA G.,
ABADIA E. G.,
GISBERT J. P.
Publication year - 2010
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2010.04274.x
Subject(s) - clarithromycin , levofloxacin , medicine , omeprazole , amoxicillin , helicobacter pylori , metronidazole , gastroenterology , adverse effect , intention to treat analysis , antibacterial agent , breath test , randomized controlled trial , antibiotics , microbiology and biotechnology , biology
Aliment Pharmacol Ther 31 , 1077–1084 Summary Background Helicobacter pylori eradication rates with standard triple therapy have declined to unacceptable levels. Aim 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.